Ignite Creation Date:
2025-12-24 @ 7:12 PM
Ignite Modification Date:
2025-12-24 @ 7:12 PM
Study NCT ID:
NCT01379703
Status:
COMPLETED
Last Update Posted:
2011-10-17
First Post:
2011-06-22
Is Possible Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Multicountry, Multicenter Post-Marketing Observational Study of Clinical, Biological and Virological Outcomes, Compliance and Tolerability of Kaletra® in Routine Clinical Use
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'phone': '1-800-633-9110', 'title': 'Global Medical Services', 'organization': 'Abbott'}, 'certainAgreement': {'otherDetails': 'Abbott requests that any investigator or institution that plans on presenting/publishing results disclosure, provide written notification of their request 60 days prior to their presentation/publication. Abbott requests that no presentation/publication will be instituted until 12 months after a study is completed, or after the first presentation/publication whichever occurs first. A delay may be proposed of a presentation/publication if Abbott needs to secure patent or proprietary protection.', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'Study start through 9 months for all participants, and study start through 18 months for participants receiving lopinavir/ritonavir capsules.', 'description': "Adverse events (AEs) and Serious AEs occurring during the study were recorded. Serious AEs were reported from the time the physician obtained the patient's authorization to use and disclose information (or the patient's informed consent) until 30 days following intake of the last dose of the physician-prescribed lopinavir/ritonavir treatment.", 'eventGroups': [{'id': 'EG000', 'title': 'Total Study Population', 'description': 'HIV-1 infected participants who received any formulation of lopinavir/ritonavir during Parts I or II of the study (including 66 participants who received both tablet and capsule formulations, or oral solution).', 'otherNumAtRisk': 2288, 'otherNumAffected': 109, 'seriousNumAtRisk': 2288, 'seriousNumAffected': 46}, {'id': 'EG001', 'title': 'Capsule Formulation', 'description': 'Participants who received the capsule formulation (only) of lopinavir/ritonavir during Part I or Part II of the study.', 'otherNumAtRisk': 1206, 'otherNumAffected': 77, 'seriousNumAtRisk': 1206, 'seriousNumAffected': 22}, {'id': 'EG002', 'title': 'Tablet Formulation', 'description': 'Participants who received the tablet formulation (only) of lopinavir/ritonavir during Parts I or II of the study.', 'otherNumAtRisk': 1016, 'otherNumAffected': 34, 'seriousNumAtRisk': 1016, 'seriousNumAffected': 22}], 'otherEvents': [{'term': 'Anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2288, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 1206, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 1016, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'Abdominal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2288, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 1206, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 1016, 'numAffected': 3}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'Abdominal pain upper', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2288, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 1206, 'numAffected': 6}, {'groupId': 'EG002', 'numAtRisk': 1016, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'Diarrhoea', 'notes': 'One or more adverse events occurred in the 66 participants receiving both capsules and tablets, or oral solution.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2288, 'numAffected': 67}, {'groupId': 'EG001', 'numAtRisk': 1206, 'numAffected': 43}, {'groupId': 'EG002', 'numAtRisk': 1016, 'numAffected': 21}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'Flatulence', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2288, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 1206, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 1016, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'Gastrointestinal disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2288, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 1206, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 1016, 'numAffected': 3}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'Nausea', 'notes': 'One or more adverse events occurred in the 66 participants receiving both capsules and tablets, or oral solution.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2288, 'numAffected': 38}, {'groupId': 'EG001', 'numAtRisk': 1206, 'numAffected': 30}, {'groupId': 'EG002', 'numAtRisk': 1016, 'numAffected': 7}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'Vomiting', 'notes': 'One or more adverse events occurred in the 66 participants receiving both capsules and tablets, or oral solution.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2288, 'numAffected': 24}, {'groupId': 'EG001', 'numAtRisk': 1206, 'numAffected': 17}, {'groupId': 'EG002', 'numAtRisk': 1016, 'numAffected': 6}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'Asthenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2288, 'numAffected': 10}, {'groupId': 'EG001', 'numAtRisk': 1206, 'numAffected': 6}, {'groupId': 'EG002', 'numAtRisk': 1016, 'numAffected': 4}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'Fatigue', 'notes': 'One or more adverse events occurred in the 66 participants receiving both capsules and tablets, or oral solution.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2288, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 1206, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 1016, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'Drug hypersensitivity', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2288, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 1206, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 1016, 'numAffected': 0}], 'organSystem': 'Immune system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'Weight decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2288, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 1206, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 1016, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'Decreased appetite', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2288, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 1206, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 1016, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'Hypertriglyceridaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2288, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 1206, 'numAffected': 5}, {'groupId': 'EG002', 'numAtRisk': 1016, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2288, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 1206, 'numAffected': 5}, {'groupId': 'EG002', 'numAtRisk': 1016, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'Depression', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2288, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 1206, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 1016, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'Pruritus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2288, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 1206, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 1016, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'Rash', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2288, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 1206, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 1016, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}], 'seriousEvents': [{'term': 'Anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2288, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 1206, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 1016, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'Haemolytic anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2288, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1206, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 1016, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'Lymphadenopathy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2288, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1206, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 1016, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'Thrombocytopenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2288, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 1206, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 1016, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'Exophthalmos', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2288, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1206, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 1016, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'Iridocyclitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2288, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 1206, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 1016, 'numAffected': 2}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'Mydriasis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2288, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1206, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 1016, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'Abdominal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2288, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1206, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 1016, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2288, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 1206, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 1016, 'numAffected': 3}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2288, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1206, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 1016, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'Asthenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2288, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1206, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 1016, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'Chest pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2288, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1206, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 1016, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'Death', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2288, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 1206, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 1016, 'numAffected': 5}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'Fatigue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2288, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1206, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 1016, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'Pyrexia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2288, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 1206, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 1016, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'Acquired immunodeficiency syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2288, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 1206, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 1016, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'Acute sinusitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2288, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1206, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 1016, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'Bronchitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2288, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1206, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 1016, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'Cellulitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2288, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 1206, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 1016, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'Cerebral toxoplasmosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2288, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 1206, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 1016, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'Encephalitis cytomegalovirus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2288, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1206, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 1016, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'Hepatitis C', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2288, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1206, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 1016, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'Meningitis cryptococcal', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2288, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1206, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 1016, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'Mycobacterium avium complex infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2288, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 1206, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 1016, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'Pharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2288, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1206, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 1016, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'Pneumocystis jiroveci pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2288, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 1206, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 1016, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'Pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2288, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1206, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 1016, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'Septic shock', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2288, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1206, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 1016, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'Tuberculosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2288, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1206, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 1016, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'Mycobacteria test', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2288, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1206, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 1016, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'Cachexiae', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2288, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1206, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 1016, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'Diabetes mellitus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2288, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1206, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 1016, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'Musculoskeletal stiffness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2288, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1206, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 1016, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'Synovitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2288, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1206, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 1016, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'Cerebral haemorrhage', 'notes': 'Adverse event occurred in one of the 66 participants receiving both capsules and tablets, or oral solution.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2288, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1206, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 1016, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2288, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 1206, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 1016, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'Hypoaesthesia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2288, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1206, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 1016, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'Neuralgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2288, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1206, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 1016, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'Completed suicide', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2288, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1206, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 1016, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'Depression', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2288, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1206, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 1016, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'Disorientation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2288, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1206, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 1016, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'Renal failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2288, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1206, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 1016, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'Renal failure acute', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2288, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1206, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 1016, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'Pulmonary oedema', 'notes': 'One of the two adverse events occurred in one of the 66 participants receiving both capsules and tablets, or oral solution.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2288, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 1206, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 1016, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'Toxic skin eruption', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2288, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1206, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 1016, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'Hospitalisation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2288, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1206, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 1016, 'numAffected': 1}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'Thrombectomy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2288, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1206, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 1016, 'numAffected': 1}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'Deep vein thrombosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2288, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1206, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 1016, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'Venous thrombosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2288, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1206, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 1016, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}], 'frequencyThreshold': '0.2'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'CD4 Count', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2220', 'groupId': 'OG000'}, {'value': '1165', 'groupId': 'OG001'}, {'value': '993', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Total Study Population', 'description': 'HIV-1 infected participants who received any formulation of lopinavir/ritonavir during Parts I or II of the study (including 66 participants who received both tablet and capsule formulations, or oral solution).'}, {'id': 'OG001', 'title': 'Capsule Formulation', 'description': 'Participants who received the capsule formulation (only) of lopinavir/ritonavir during Part I or Part II of the study.'}, {'id': 'OG002', 'title': 'Tablet Formulation', 'description': 'Participants who received the tablet formulation (only) of lopinavir/ritonavir during Parts I or II of the study.'}], 'classes': [{'title': 'Mean CD4 count', 'categories': [{'measurements': [{'value': '229.9', 'spread': '194.2', 'groupId': 'OG000'}, {'value': '208.8', 'spread': '187.2', 'groupId': 'OG001'}, {'value': '246.8', 'spread': '194.8', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline', 'description': "CD4 lymphocyte count is a measure of a participant's immunologic health. Participants' CD4-positive (CD4+) T-lymphocyte counts were assessed by measuring the number of CD4+ cells at baseline.", 'unitOfMeasure': 'cells per mm³', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Mean CD4 count is based on number of participants in each group who had CD4 count results at Baseline.'}, {'type': 'PRIMARY', 'title': 'Changes in CD4 Count', 'denoms': [{'units': 'Participants', 'counts': [{'value': '670', 'groupId': 'OG000'}, {'value': '348', 'groupId': 'OG001'}, {'value': '293', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Total Study Population', 'description': 'HIV-1 infected participants who received any formulation of lopinavir/ritonavir during Parts I or II of the study (including 66 participants who received both tablet and capsule formulations, or oral solution).'}, {'id': 'OG001', 'title': 'Capsule Formulation', 'description': 'Participants who received the capsule formulation (only) of lopinavir/ritonavir during Part I or Part II of the study.'}, {'id': 'OG002', 'title': 'Tablet Formulation', 'description': 'Participants who received the tablet formulation (only) of lopinavir/ritonavir during Parts I or II of the study.'}], 'classes': [{'title': 'Mean CD4 count at 1 month', 'categories': [{'measurements': [{'value': '288.7', 'spread': '185.1', 'groupId': 'OG000'}, {'value': '277.1', 'spread': '195.7', 'groupId': 'OG001'}, {'value': '296.1', 'spread': '172.1', 'groupId': 'OG002'}]}]}, {'title': 'Change in CD4 count', 'categories': [{'measurements': [{'value': '60.3', 'spread': '137.4', 'groupId': 'OG000'}, {'value': '54.9', 'spread': '158.3', 'groupId': 'OG001'}, {'value': '70.6', 'spread': '113.8', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline to 1 month', 'description': "Increases in CD4 count are a biomarker for antiretroviral treatment effectiveness in restoring immunologic function. Changes in participants' CD4-positive (CD4+) T-lymphocyte counts were assessed by measuring the change from Baseline in the number of CD4+ cells at scheduled study visits.", 'unitOfMeasure': 'cells per mm³', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Change from baseline analysis is based on participants with CD4 count results available at 1 month.'}, {'type': 'PRIMARY', 'title': 'Changes in CD4 Count', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1633', 'groupId': 'OG000'}, {'value': '838', 'groupId': 'OG001'}, {'value': '738', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Total Study Population', 'description': 'HIV-1 infected participants who received any formulation of lopinavir/ritonavir during Parts I or II of the study (including 66 participants who received both tablet and capsule formulations, or oral solution).'}, {'id': 'OG001', 'title': 'Capsule Formulation', 'description': 'Participants who received the capsule formulation (only) of lopinavir/ritonavir during Part I or Part II of the study.'}, {'id': 'OG002', 'title': 'Tablet Formulation', 'description': 'Participants who received the tablet formulation (only) of lopinavir/ritonavir during Parts I or II of the study.'}], 'classes': [{'title': 'Mean CD4 count at 3 months', 'categories': [{'measurements': [{'value': '323.9', 'spread': '219.3', 'groupId': 'OG000'}, {'value': '310.1', 'spread': '227.9', 'groupId': 'OG001'}, {'value': '332.4', 'spread': '206.7', 'groupId': 'OG002'}]}]}, {'title': 'Change in CD4 count', 'categories': [{'measurements': [{'value': '94.5', 'spread': '162.9', 'groupId': 'OG000'}, {'value': '97.7', 'spread': '188.7', 'groupId': 'OG001'}, {'value': '93.2', 'spread': '123.9', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline to 3 months', 'description': "Increases in CD4 count are a biomarker for antiretroviral treatment effectiveness in restoring immunologic function. 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Changes in participants' CD4-positive (CD4+) T-lymphocyte counts were assessed by measuring the change from Baseline in the number of CD4+ cells at scheduled study visits.", 'unitOfMeasure': 'cells per mm³', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Change from baseline analysis is based on participants with CD4 count results available at 6 months.'}, {'type': 'PRIMARY', 'title': 'Changes in CD4 Count', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1410', 'groupId': 'OG000'}, {'value': '713', 'groupId': 'OG001'}, {'value': '645', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Total Study Population', 'description': 'HIV-1 infected participants who received any formulation of lopinavir/ritonavir during Parts I or II of the study (including 66 participants who received both tablet and capsule formulations, or oral solution).'}, {'id': 'OG001', 'title': 'Capsule Formulation', 'description': 'Participants who received the capsule formulation (only) of lopinavir/ritonavir during Part I or Part II of the study.'}, {'id': 'OG002', 'title': 'Tablet Formulation', 'description': 'Participants who received the tablet formulation (only) of lopinavir/ritonavir during Parts I or II of the study.'}], 'classes': [{'title': 'Mean CD4 count at 9 months', 'categories': [{'measurements': [{'value': '384.1', 'spread': '221.4', 'groupId': 'OG000'}, {'value': '363.5', 'spread': '222.2', 'groupId': 'OG001'}, {'value': '395.0', 'spread': '209.0', 'groupId': 'OG002'}]}]}, {'title': 'Change in CD4 count', 'categories': [{'measurements': [{'value': '151.5', 'spread': '174.4', 'groupId': 'OG000'}, {'value': '144.8', 'spread': '191.7', 'groupId': 'OG001'}, {'value': '156.0', 'spread': '151.5', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline to 9 months', 'description': "Increases in CD4 count are a biomarker for antiretroviral treatment effectiveness in restoring immunologic function. Changes in participants' CD4-positive (CD4+) T-lymphocyte counts were assessed by measuring the change from Baseline in the number of CD4+ cells at scheduled study visits.", 'unitOfMeasure': 'cells per mm³', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Change from baseline analysis is based on participants with CD4 count results available at 9 months.'}, {'type': 'PRIMARY', 'title': 'Changes in CD4 Count', 'denoms': [{'units': 'Participants', 'counts': [{'value': '729', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Capsule Formulation', 'description': 'Participants who received the capsule formulation of lopinavir/ritonavir during Part 1 or Part II of the study.'}], 'classes': [{'title': 'Mean CD4 count at 12 months', 'categories': [{'measurements': [{'value': '392.0', 'spread': '216.5', 'groupId': 'OG000'}]}]}, {'title': 'Change in CD4 count', 'categories': [{'measurements': [{'value': '170.4', 'spread': '201.7', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline to 12 months', 'description': "Increases in CD4 count are a biomarker for antiretroviral treatment effectiveness in restoring immunologic function. Changes in participants' CD4-positive (CD4+) T-lymphocyte counts were assessed by measuring the change from Baseline in the number of CD4+ cells at scheduled study visits.", 'unitOfMeasure': 'cells per mm³', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Only participants receiving lopinavir/ritonavir capsules were planned to be followed past 9 months. Change from baseline analysis is based on participants receiving capsule formulation with CD4 count results available at 12 months.'}, {'type': 'PRIMARY', 'title': 'Changes in CD4 Count', 'denoms': [{'units': 'Participants', 'counts': [{'value': '701', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Capsule Formulation', 'description': 'Participants who received the capsule formulation of lopinavir/ritonavir during Part 1 or Part II of the study.'}], 'classes': [{'title': 'Mean CD4 count at 15 months', 'categories': [{'measurements': [{'value': '412.6', 'spread': '240.5', 'groupId': 'OG000'}]}]}, {'title': 'Change in CD4 count', 'categories': [{'measurements': [{'value': '194.8', 'spread': '228.5', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline to 15 months', 'description': "Increases in CD4 count are a biomarker for antiretroviral treatment effectiveness in restoring immunologic function. Changes in participants' CD4-positive (CD4+) T-lymphocyte counts were assessed by measuring the change from Baseline in the number of CD4+ cells at scheduled study visits.", 'unitOfMeasure': 'cells per mm³', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Only participants receiving lopinavir/ritonavir capsules were planned to be followed past 9 months. Change from baseline analysis is based on participants receiving capsule formulation with CD4 count results available at 15 months.'}, {'type': 'PRIMARY', 'title': 'Changes in CD4 Count', 'denoms': [{'units': 'Participants', 'counts': [{'value': '599', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Capsule Formulation', 'description': 'Participants who received the capsule formulation of lopinavir/ritonavir during Part 1 or Part II of the study.'}], 'classes': [{'title': 'Mean CD4 count at 18 months', 'categories': [{'measurements': [{'value': '429.7', 'spread': '249.4', 'groupId': 'OG000'}]}]}, {'title': 'Change in CD4 count', 'categories': [{'measurements': [{'value': '222.2', 'spread': '228.7', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline to 18 months', 'description': "Increases in CD4 count are a biomarker for antiretroviral treatment effectiveness in restoring immunologic function. Changes in participants' CD4-positive (CD4+) T-lymphocyte counts were assessed by measuring the change from Baseline in the number of CD4+ cells at scheduled study visits.", 'unitOfMeasure': 'cells per mm³', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Only participants receiving lopinavir/ritonavir capsules were planned to be followed past 9 months. Change from baseline analysis is based on participants receiving capsule formulation with CD4 count results available at 18 months.'}, {'type': 'PRIMARY', 'title': 'Viral Load', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1572', 'groupId': 'OG000'}, {'value': '739', 'groupId': 'OG001'}, {'value': '781', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Total Study Population', 'description': 'HIV-1 infected participants who received any formulation of lopinavir/ritonavir during Parts I or II of the study (including 66 participants who received both tablet and capsule formulations, or oral solution).'}, {'id': 'OG001', 'title': 'Capsule Formulation', 'description': 'Participants who received the capsule formulation (only) of lopinavir/ritonavir during Part I or Part II of the study.'}, {'id': 'OG002', 'title': 'Tablet Formulation', 'description': 'Participants who received the tablet formulation (only) of lopinavir/ritonavir during Parts I or II of the study.'}], 'classes': [{'title': 'Mean viral load', 'categories': [{'measurements': [{'value': '4.44', 'spread': '1.26', 'groupId': 'OG000'}, {'value': '4.49', 'spread': '1.17', 'groupId': 'OG001'}, {'value': '4.43', 'spread': '1.31', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline', 'description': 'Viral load is a direct measure of the viral burden by providing a count of the number of HIV-RNA copies in blood (plasma). The number of HIV-RNA copies in the blood was measured at baseline.', 'unitOfMeasure': 'Log10 copies per ml', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Mean viral load is based on number of participants in each group who had laboratory results for viral load at baseline.'}, {'type': 'PRIMARY', 'title': 'Viral Load', 'denoms': [{'units': 'Participants', 'counts': [{'value': '420', 'groupId': 'OG000'}, {'value': '218', 'groupId': 'OG001'}, {'value': '175', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Total Study Population', 'description': 'HIV-1 infected participants who received any formulation of lopinavir/ritonavir during Parts I or II of the study (including 66 participants who received both tablet and capsule formulations, or oral solution).'}, {'id': 'OG001', 'title': 'Capsule Formulation', 'description': 'Participants who received the capsule formulation (only) of lopinavir/ritonavir during Part I or Part II of the study.'}, {'id': 'OG002', 'title': 'Tablet Formulation', 'description': 'Participants who received the tablet formulation (only) of lopinavir/ritonavir during Parts I or II of the study.'}], 'classes': [{'categories': [{'measurements': [{'value': '3.28', 'spread': '1.08', 'groupId': 'OG000'}, {'value': '3.42', 'spread': '1.07', 'groupId': 'OG001'}, {'value': '3.19', 'spread': '1.04', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': '1 month', 'description': 'Viral load (number of HIV-RNA copies in the blood) was measured at baseline and scheduled study visits. A decrease in viral load is a measure used to assess the effectiveness of antiviral treatments.', 'unitOfMeasure': 'Log10 copies per ml', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Viral Load', 'denoms': [{'units': 'Participants', 'counts': [{'value': '995', 'groupId': 'OG000'}, {'value': '469', 'groupId': 'OG001'}, {'value': '478', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Total Study Population', 'description': 'HIV-1 infected participants who received any formulation of lopinavir/ritonavir during Parts I or II of the study (including 66 participants who received both tablet and capsule formulations, or oral solution).'}, {'id': 'OG001', 'title': 'Capsule Formulation', 'description': 'Participants who received the capsule formulation (only) of lopinavir/ritonavir during Part I or Part II of the study.'}, {'id': 'OG002', 'title': 'Tablet Formulation', 'description': 'Participants who received the tablet formulation (only) of lopinavir/ritonavir during Parts I or II of the study.'}], 'classes': [{'categories': [{'measurements': [{'value': '2.69', 'spread': '1.00', 'groupId': 'OG000'}, {'value': '2.86', 'spread': '0.97', 'groupId': 'OG001'}, {'value': '2.54', 'spread': '1.00', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': '3 months', 'description': 'Viral load (number of HIV-RNA copies in the blood) was measured at baseline and scheduled study visits. A decrease in viral load is a measure used to assess the effectiveness of antiviral treatments.', 'unitOfMeasure': 'Log10 copies per ml', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Viral Load', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1093', 'groupId': 'OG000'}, {'value': '506', 'groupId': 'OG001'}, {'value': '544', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Total Study Population', 'description': 'HIV-1 infected participants who received any formulation of lopinavir/ritonavir during Parts I or II of the study (including 66 participants who received both tablet and capsule formulations, or oral solution).'}, {'id': 'OG001', 'title': 'Capsule Formulation', 'description': 'Participants who received the capsule formulation (only) of lopinavir/ritonavir during Part I or Part II of the study.'}, {'id': 'OG002', 'title': 'Tablet Formulation', 'description': 'Participants who received the tablet formulation (only) of lopinavir/ritonavir during Parts I or II of the study.'}], 'classes': [{'categories': [{'measurements': [{'value': '2.40', 'spread': '0.89', 'groupId': 'OG000'}, {'value': '2.62', 'spread': '0.88', 'groupId': 'OG001'}, {'value': '2.21', 'spread': '0.84', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': '6 months', 'description': 'Viral load (number of HIV-RNA copies in the blood) was measured at baseline and scheduled study visits. A decrease in viral load is a measure used to assess the effectiveness of antiviral treatments.', 'unitOfMeasure': 'Log10 copies per ml', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Viral Load', 'denoms': [{'units': 'Participants', 'counts': [{'value': '918', 'groupId': 'OG000'}, {'value': '406', 'groupId': 'OG001'}, {'value': '471', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Total Study Population', 'description': 'HIV-1 infected participants who received any formulation of lopinavir/ritonavir during Parts I or II of the study (including 66 participants who received both tablet and capsule formulations, or oral solution).'}, {'id': 'OG001', 'title': 'Capsule Formulation', 'description': 'Participants who received the capsule formulation (only) of lopinavir/ritonavir during Part I or Part II of the study.'}, {'id': 'OG002', 'title': 'Tablet Formulation', 'description': 'Participants who received the tablet formulation (only) of lopinavir/ritonavir during Parts I or II of the study.'}], 'classes': [{'title': 'Mean viral load at 9 months', 'categories': [{'measurements': [{'value': '2.41', 'spread': '0.96', 'groupId': 'OG000'}, {'value': '2.65', 'spread': '1.02', 'groupId': 'OG001'}, {'value': '2.24', 'spread': '0.88', 'groupId': 'OG002'}]}]}, {'title': 'Change in viral load', 'categories': [{'measurements': [{'value': '-2.05', 'spread': '1.42', 'groupId': 'OG000'}, {'value': 'NA', 'spread': 'NA', 'comment': 'Change from baseline LOCF analysis for participants receiving capsule formulation was performed at 18 months.', 'groupId': 'OG001'}, {'value': '-2.21', 'spread': '1.44', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': '9 months', 'description': 'Viral load (number of HIV-RNA copies in the blood) was measured at baseline and scheduled study visits. A decrease in viral load is a measure used to assess the effectiveness of antiviral treatments.', 'unitOfMeasure': 'Log10 copies per ml', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Change from baseline analysis is based on last observation carried forward for total study population (N=1341) and tablet formulation group (N=677).'}, {'type': 'PRIMARY', 'title': 'Viral Load', 'denoms': [{'units': 'Participants', 'counts': [{'value': '444', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Capsule Formulation', 'description': 'Participants who received the capsule formulation of lopinavir/ritonavir during Part 1 or Part II of the study.'}], 'classes': [{'categories': [{'measurements': [{'value': '2.54', 'spread': '0.92', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': '12 months', 'description': 'Viral load (number of HIV-RNA copies in the blood) was measured at baseline and scheduled study visits. A decrease in viral load is a measure used to assess the effectiveness of antiviral treatments.', 'unitOfMeasure': 'Log10 copies per ml', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Only participants receiving lopinavir/ritonavir capsules were planned to be followed past 9 months.'}, {'type': 'PRIMARY', 'title': 'Viral Load', 'denoms': [{'units': 'Participants', 'counts': [{'value': '432', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Capsule Formulation', 'description': 'Participants who received the capsule formulation of lopinavir/ritonavir during Part 1 or Part II of the study.'}], 'classes': [{'categories': [{'measurements': [{'value': '2.49', 'spread': '0.92', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': '15 months', 'description': 'Viral load (number of HIV-RNA copies in the blood) was measured at baseline and scheduled study visits. A decrease in viral load is a measure used to assess the effectiveness of antiviral treatments.', 'unitOfMeasure': 'Log10 copies per ml', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Only participants receiving lopinavir/ritonavir capsules were planned to be followed past 9 months.'}, {'type': 'PRIMARY', 'title': 'Viral Load', 'denoms': [{'units': 'Participants', 'counts': [{'value': '413', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Capsule Formulation', 'description': 'Participants who received the capsule formulation of lopinavir/ritonavir during Part 1 or Part II of the study.'}], 'classes': [{'title': 'Mean viral load at 18 months', 'categories': [{'measurements': [{'value': '2.35', 'spread': '0.84', 'groupId': 'OG000'}]}]}, {'title': 'Change in viral load', 'categories': [{'measurements': [{'value': '-1.95', 'spread': '1.42', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': '18 months', 'description': 'Viral load (number of HIV-RNA copies in the blood) was measured at baseline and scheduled study visits. A decrease in viral load is a measure used to assess the effectiveness of antiviral treatments.', 'unitOfMeasure': 'Log10 copies per ml', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Only participants receiving lopinavir/ritonavir capsules were planned to be followed past 9 months. Change from baseline analysis is based on last observation carried forward (N=660).'}, {'type': 'PRIMARY', 'title': 'Laboratory Parameter Blood Glucose', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1831', 'groupId': 'OG000'}, {'value': '875', 'groupId': 'OG001'}, {'value': '899', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Total Study Population', 'description': 'HIV-1 infected participants who received any formulation of lopinavir/ritonavir during Parts I or II of the study (including 66 participants who received both tablet and capsule formulations, or oral solution).'}, {'id': 'OG001', 'title': 'Capsule Formulation', 'description': 'Participants who received the capsule formulation (only) of lopinavir/ritonavir during Part I or Part II of the study.'}, {'id': 'OG002', 'title': 'Tablet Formulation', 'description': 'Participants who received the tablet formulation (only) of lopinavir/ritonavir during Parts I or II of the study.'}], 'classes': [{'title': 'Baseline', 'categories': [{'measurements': [{'value': '4.87', 'spread': '2.05', 'groupId': 'OG000'}, {'value': '4.89', 'spread': '2.83', 'groupId': 'OG001'}, {'value': '4.85', 'spread': '0.86', 'groupId': 'OG002'}]}]}, {'title': '9 months', 'categories': [{'measurements': [{'value': '4.92', 'spread': '1.42', 'groupId': 'OG000'}, {'value': '4.87', 'spread': '1.38', 'groupId': 'OG001'}, {'value': '4.99', 'spread': '1.49', 'groupId': 'OG002'}]}]}, {'title': '18 months', 'categories': [{'measurements': [{'value': 'NA', 'spread': 'NA', 'comment': 'Only participants who received lopinavir/ritonavir capsules were planned to be followed past 9 months.', 'groupId': 'OG000'}, {'value': '5.07', 'spread': '2.64', 'groupId': 'OG001'}, {'value': 'NA', 'spread': 'NA', 'comment': 'Only participants who received lopinavir/ritonavir capsules were planned to be followed past 9 months.', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, 9 months, 18 months', 'description': 'Blood glucose laboratory values were assessed at baseline and scheduled study visits. Normal ranges are based on the standards for individual facilities in each country.', 'unitOfMeasure': 'millimoles per liter', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis was based on participants with laboratory values at each time point. Only participants receiving lopinavir/ritonavir capsules were planned to be followed after 9 months.'}, {'type': 'PRIMARY', 'title': 'Laboratory Parameter Transaminases', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2288', 'groupId': 'OG000'}, {'value': '1206', 'groupId': 'OG001'}, {'value': '1016', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Total Study Population', 'description': 'HIV-1 infected participants who received any formulation of lopinavir/ritonavir during Parts I or II of the study (including 66 participants who received both tablet and capsule formulations, or oral solution).'}, {'id': 'OG001', 'title': 'Capsule Formulation', 'description': 'Participants who received the capsule formulation (only) of lopinavir/ritonavir during Part I or Part II of the study.'}, {'id': 'OG002', 'title': 'Tablet Formulation', 'description': 'Participants who received the tablet formulation (only) of lopinavir/ritonavir during Parts I or II of the study.'}], 'classes': [{'title': 'AST - Baseline', 'categories': [{'measurements': [{'value': '38.9', 'spread': '37.1', 'groupId': 'OG000'}, {'value': '36.8', 'spread': '32.1', 'groupId': 'OG001'}, {'value': '41.4', 'spread': '42.4', 'groupId': 'OG002'}]}]}, {'title': 'AST - 9 months', 'categories': [{'measurements': [{'value': '35.2', 'spread': '33.0', 'groupId': 'OG000'}, {'value': '34.8', 'spread': '29.6', 'groupId': 'OG001'}, {'value': '36.0', 'spread': '36.9', 'groupId': 'OG002'}]}]}, {'title': 'AST - 18 months', 'categories': [{'measurements': [{'value': 'NA', 'spread': 'NA', 'comment': 'Only participants receiving lopinavir/ritonavir capsules were planned to be followed past 9 months.', 'groupId': 'OG000'}, {'value': '36.4', 'spread': '30.8', 'groupId': 'OG001'}, {'value': 'NA', 'spread': 'NA', 'comment': 'Only participants receiving lopinavir/ritonavir capsules were planned to be followed past 9 months.', 'groupId': 'OG002'}]}]}, {'title': 'ALT - Baseline', 'categories': [{'measurements': [{'value': '41.0', 'spread': '40.3', 'groupId': 'OG000'}, {'value': '39.6', 'spread': '38.7', 'groupId': 'OG001'}, {'value': '42.6', 'spread': '42.6', 'groupId': 'OG002'}]}]}, {'title': 'ALT - 9 months', 'categories': [{'measurements': [{'value': '39.8', 'spread': '52.5', 'groupId': 'OG000'}, {'value': '40.8', 'spread': '44.8', 'groupId': 'OG001'}, {'value': '39.0', 'spread': '60.3', 'groupId': 'OG002'}]}]}, {'title': 'ALT - 18 months', 'categories': [{'measurements': [{'value': 'NA', 'spread': 'NA', 'comment': 'Only participants receiving lopinavir/ritonavir capsules were planned to be followed past 9 months.', 'groupId': 'OG000'}, {'value': '42.0', 'spread': '44.8', 'groupId': 'OG001'}, {'value': 'NA', 'spread': 'NA', 'comment': 'Only participants receiving lopinavir/ritonavir capsules were planned to be followed past 9 months.', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, 9 months, 18 months', 'description': 'Serum aspartate aminotransferase (AST) and alanine aminotransferase (ALT) laboratory values were assessed at baseline and scheduled study visits. Normal ranges are based on the standards for individual facilities in each country.', 'unitOfMeasure': 'international units per liter', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis was based on participants with laboratory values at each time point. Only participants receiving lopinavir/ritonavir capsules were planned to be followed past 9 months.'}, {'type': 'PRIMARY', 'title': 'Laboratory Parameter Lipids', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2288', 'groupId': 'OG000'}, {'value': '1206', 'groupId': 'OG001'}, {'value': '1016', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Total Study Population', 'description': 'HIV-1 infected participants who received any formulation of lopinavir/ritonavir during Parts I or II of the study (including 66 participants who received both tablet and capsule formulations, or oral solution).'}, {'id': 'OG001', 'title': 'Capsule Formulation', 'description': 'Participants who received the capsule formulation (only) of lopinavir/ritonavir during Part I or Part II of the study.'}, {'id': 'OG002', 'title': 'Tablet Formulation', 'description': 'Participants who received the tablet formulation (only) of lopinavir/ritonavir during Parts I or II of the study.'}], 'classes': [{'title': 'Total Cholesterol - Baseline', 'categories': [{'measurements': [{'value': '4.37', 'spread': '1.50', 'groupId': 'OG000'}, {'value': '4.48', 'spread': '1.68', 'groupId': 'OG001'}, {'value': '4.28', 'spread': '1.35', 'groupId': 'OG002'}]}]}, {'title': 'Total Cholesterol - 9 months', 'categories': [{'measurements': [{'value': '4.96', 'spread': '1.81', 'groupId': 'OG000'}, {'value': '5.07', 'spread': '2.36', 'groupId': 'OG001'}, {'value': '4.89', 'spread': '1.25', 'groupId': 'OG002'}]}]}, {'title': 'Total Cholesterol - 18 Months', 'categories': [{'measurements': [{'value': 'NA', 'spread': 'NA', 'comment': 'Only participants receiving lopinavir/ritonavir capsules were planned to be followed past 9 months.', 'groupId': 'OG000'}, {'value': '5.01', 'spread': '1.29', 'groupId': 'OG001'}, {'value': 'NA', 'spread': 'NA', 'comment': 'Only participants receiving lopinavir/ritonavir capsules were planned to be followed past 9 months.', 'groupId': 'OG002'}]}]}, {'title': 'HDL Cholesterol - Baseline', 'categories': [{'measurements': [{'value': '1.39', 'spread': '0.84', 'groupId': 'OG000'}, {'value': '2.17', 'spread': '1.45', 'groupId': 'OG001'}, {'value': '1.19', 'spread': '0.44', 'groupId': 'OG002'}]}]}, {'title': 'HDL Cholesterol - 9 months', 'categories': [{'measurements': [{'value': '1.53', 'spread': '0.98', 'groupId': 'OG000'}, {'value': '2.08', 'spread': '1.64', 'groupId': 'OG001'}, {'value': '1.32', 'spread': '0.53', 'groupId': 'OG002'}]}]}, {'title': 'HDL Cholesterol - 18 months', 'categories': [{'measurements': [{'value': 'NA', 'spread': 'NA', 'comment': 'Only participants receiving lopinavir/ritonavir capsules were planned to be followed past 9 months.', 'groupId': 'OG000'}, {'value': '2.04', 'spread': '1.94', 'groupId': 'OG001'}, {'value': 'NA', 'spread': 'NA', 'comment': 'Only participants receiving lopinavir/ritonavir capsules were planned to be followed past 9 months.', 'groupId': 'OG002'}]}]}, {'title': 'LDL Cholesterol - Baseline', 'categories': [{'measurements': [{'value': '2.50', 'spread': '1.07', 'groupId': 'OG000'}, {'value': '2.87', 'spread': '1.10', 'groupId': 'OG001'}, {'value': '2.29', 'spread': '1.02', 'groupId': 'OG002'}]}]}, {'title': 'LDL Cholesterol - 9 months', 'categories': [{'measurements': [{'value': '2.73', 'spread': '1.07', 'groupId': 'OG000'}, {'value': '3.11', 'spread': '1.18', 'groupId': 'OG001'}, {'value': '2.51', 'spread': '0.95', 'groupId': 'OG002'}]}]}, {'title': 'LDL Cholesterol - 18 months', 'categories': [{'measurements': [{'value': 'NA', 'spread': 'NA', 'comment': 'Only participants receiving lopinavir/ritonavir capsules were planned to be followed past 9 months.', 'groupId': 'OG000'}, {'value': '3.09', 'spread': '1.14', 'groupId': 'OG001'}, {'value': 'NA', 'spread': 'NA', 'comment': 'Only participants receiving lopinavir/ritonavir capsules were planned to be followed past 9 months.', 'groupId': 'OG002'}]}]}, {'title': 'Triglycerides - Baseline', 'categories': [{'measurements': [{'value': '1.65', 'spread': '1.06', 'groupId': 'OG000'}, {'value': '1.66', 'spread': '1.11', 'groupId': 'OG001'}, {'value': '1.64', 'spread': '1.04', 'groupId': 'OG002'}]}]}, {'title': 'Triglycerides - 9 months', 'categories': [{'measurements': [{'value': '2.20', 'spread': '1.46', 'groupId': 'OG000'}, {'value': '2.21', 'spread': '1.49', 'groupId': 'OG001'}, {'value': '2.17', 'spread': '1.44', 'groupId': 'OG002'}]}]}, {'title': 'Triglycerides - 18 months', 'categories': [{'measurements': [{'value': 'NA', 'spread': 'NA', 'comment': 'Only participants receiving lopinavir/ritonavir capsules were planned to be followed past 9 months.', 'groupId': 'OG000'}, {'value': '2.13', 'spread': '1.35', 'groupId': 'OG001'}, {'value': 'NA', 'spread': 'NA', 'comment': 'Only participants receiving lopinavir/ritonavir capsules were planned to be followed past 9 months.', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, 9 months, 18 months', 'description': 'A blood lipid panel consisting of total cholesterol, triglyceride, high-density lipoprotein (HDL), and low-density lipoprotein (LDL) levels was performed at baseline and scheduled study visits. Normal ranges are based on the standards for individual facilities in each country.', 'unitOfMeasure': 'millimoles per liter', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis was based on participants with laboratory values at each time point. Only participants receiving lopinavir/ritonavir capsules were planned to be followed past 9 months.'}, {'type': 'SECONDARY', 'title': 'Reasons for Discontinuation of Lopinavir/Ritonavir', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2288', 'groupId': 'OG000'}, {'value': '1206', 'groupId': 'OG001'}, {'value': '1016', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Total Study Population', 'description': 'HIV-1 infected participants who received any formulation of lopinavir/ritonavir during Parts I or II of the study (including 66 participants who received both tablet and capsule formulations, or oral solution).'}, {'id': 'OG001', 'title': 'Capsule Formulation', 'description': 'Participants who received the capsule formulation (only) of lopinavir/ritonavir during Part I or Part II of the study.'}, {'id': 'OG002', 'title': 'Tablet Formulation', 'description': 'Participants who received the tablet formulation (only) of lopinavir/ritonavir during Parts I or II of the study.'}], 'classes': [{'title': 'Number of participants discontinued', 'categories': [{'measurements': [{'value': '269', 'groupId': 'OG000'}, {'value': '122', 'groupId': 'OG001'}, {'value': '143', 'groupId': 'OG002'}]}]}, {'title': 'Lost to Follow-up', 'categories': [{'measurements': [{'value': '167', 'groupId': 'OG000'}, {'value': '61', 'groupId': 'OG001'}, {'value': '104', 'groupId': 'OG002'}]}]}, {'title': 'Adverse Event', 'categories': [{'measurements': [{'value': '24', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}, {'value': '10', 'groupId': 'OG002'}]}]}, {'title': 'Withdrawal by Subject', 'categories': [{'measurements': [{'value': '7', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}]}]}, {'title': 'Treatment failure', 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}]}]}, {'title': 'Other - Tuberculosis/TB treatment', 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'Other - Medication not available', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}]}]}, {'title': 'Other - Poor general condition', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'Other - Increased triglycerides', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'Patient Noncompliance', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}]}]}, {'title': 'Reason unknown', 'categories': [{'measurements': [{'value': '57', 'groupId': 'OG000'}, {'value': '31', 'groupId': 'OG001'}, {'value': '24', 'groupId': 'OG002'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '9 months', 'description': 'For participants who discontinued lopinavir/ritonavir treatment, the reasons for discontinuation are provided.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Reasons for Discontinuation of Lopinavir/Ritonavir', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1206', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Capsule Formulation', 'description': 'Participants who received the capsule formulation of lopinavir/ritonavir during Part 1 or Part II of the study.'}], 'classes': [{'title': 'Number of participants discontinued', 'categories': [{'measurements': [{'value': '352', 'groupId': 'OG000'}]}]}, {'title': 'Lost to Follow-up', 'categories': [{'measurements': [{'value': '239', 'groupId': 'OG000'}]}]}, {'title': 'Adverse Event', 'categories': [{'measurements': [{'value': '20', 'groupId': 'OG000'}]}]}, {'title': 'Withdrawal by Subject', 'categories': [{'measurements': [{'value': '17', 'groupId': 'OG000'}]}]}, {'title': 'Treatment failure', 'categories': [{'measurements': [{'value': '7', 'groupId': 'OG000'}]}]}, {'title': 'Other - Tuberculosis/TB treatment', 'categories': [{'measurements': [{'value': '6', 'groupId': 'OG000'}]}]}, {'title': 'Patient Noncompliance', 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}]}]}, {'title': 'Other - Medication not available', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}]}]}, {'title': 'Other - Fatigue', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'Other - Increased triglycerides', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'Reason unknown', 'categories': [{'measurements': [{'value': '54', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '18 months', 'description': 'For participants who discontinued lopinavir/ritonavir treatment, the reasons for discontinuation are provided.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Only participants receiving lopinavir/ritonavir capsules were planned to be followed past 9 months.'}, {'type': 'SECONDARY', 'title': 'Compliance With Lopinavir/Ritonavir', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2288', 'groupId': 'OG000'}, {'value': '1206', 'groupId': 'OG001'}, {'value': '1016', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Total Study Population', 'description': 'HIV-1 infected participants who received any formulation of lopinavir/ritonavir during Parts I or II of the study (including 66 participants who received both tablet and capsule formulations, or oral solution).'}, {'id': 'OG001', 'title': 'Capsule Formulation', 'description': 'Participants who received the capsule formulation (only) of lopinavir/ritonavir during Part I or Part II of the study.'}, {'id': 'OG002', 'title': 'Tablet Formulation', 'description': 'Participants who received the tablet formulation (only) of lopinavir/ritonavir during Parts I or II of the study.'}], 'classes': [{'title': 'Reported never missing a dose', 'categories': [{'measurements': [{'value': '1377', 'groupId': 'OG000'}, {'value': '729', 'groupId': 'OG001'}, {'value': '616', 'groupId': 'OG002'}]}]}, {'title': 'Reported missing one or more doses', 'categories': [{'measurements': [{'value': '853', 'groupId': 'OG000'}, {'value': '459', 'groupId': 'OG001'}, {'value': '361', 'groupId': 'OG002'}]}]}, {'title': 'Information not reported', 'categories': [{'measurements': [{'value': '58', 'groupId': 'OG000'}, {'value': '18', 'groupId': 'OG001'}, {'value': '39', 'groupId': 'OG002'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '9 months', 'description': 'Participants reported whether they had missed doses of their antiretroviral treatment.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Compliance With Lopinavir/Ritonavir', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1206', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Capsule Formulation', 'description': 'Participants who received the capsule formulation of lopinavir/ritonavir during Part 1 or Part II of the study.'}], 'classes': [{'title': 'Reported never missing a dose', 'categories': [{'measurements': [{'value': '616', 'groupId': 'OG000'}]}]}, {'title': 'Reported missing one or more doses', 'categories': [{'measurements': [{'value': '578', 'groupId': 'OG000'}]}]}, {'title': 'Information not reported', 'categories': [{'measurements': [{'value': '12', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '18 months', 'description': 'Participants reported whether they had missed any doses of their antiretroviral treatment.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Only participants receiving lopinavir/ritonavir capsules for followed for up to 18 months.'}, {'type': 'SECONDARY', 'title': 'Adverse Events Observed on Treatment With Lopinavir/Ritonavir.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2288', 'groupId': 'OG000'}, {'value': '1206', 'groupId': 'OG001'}, {'value': '1016', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Total Study Population', 'description': 'HIV-1 infected participants who received any formulation of lopinavir/ritonavir during Parts I or II of the study (including 66 participants who received both tablet and capsule formulations, or oral solution).'}, {'id': 'OG001', 'title': 'Capsule Formulation', 'description': 'Participants who received the capsule formulation (only) of lopinavir/ritonavir during Part I or Part II of the study.'}, {'id': 'OG002', 'title': 'Tablet Formulation', 'description': 'Participants who received the tablet formulation (only) of lopinavir/ritonavir during Parts I or II of the study.'}], 'classes': [{'title': 'Total number of AEs with causal relationship', 'categories': [{'measurements': [{'value': '260', 'groupId': 'OG000'}, {'value': '175', 'groupId': 'OG001'}, {'value': '78', 'groupId': 'OG002'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '18 months', 'description': 'Total number of adverse events with causal relationship (rated by Investigator as probably or possibly related) to lopinavir/ritonavir treatment.\n\nAll serious adverse events and non serious adverse events (0.2% or greater frequency) are summarized in the "Reported Adverse Events" section of this record.', 'unitOfMeasure': 'Events', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Tablets and Capsules or Oral Solution', 'description': 'HIV-1 infected participants who received both tablet and capsule formulations or oral solution.'}, {'id': 'FG001', 'title': 'Capsule Formulation', 'description': 'Participants who received the capsule formulation (only) of lopinavir/ritonavir during Part I or Part II of the study.'}, {'id': 'FG002', 'title': 'Tablet Formulation', 'description': 'Participants who received the tablet formulation (only) of lopinavir/ritonavir during Parts I or II of the study.'}], 'periods': [{'title': 'Study Start Through 9 Months', 'milestones': [{'type': 'STARTED', 'achievements': [{'comment': 'Participants taking lopinavir/ritonavir tablets/capsules or oral solution during the study (66/2288)', 'groupId': 'FG000', 'numSubjects': '66'}, {'comment': 'Participants taking the lopinavir/ritonavir capsule formulation (only) during study (1206/2288)', 'groupId': 'FG001', 'numSubjects': '1206'}, {'comment': 'Participants taking the lopinavir/ritonavir tablet formulation (only) during study (1016/2288)', 'groupId': 'FG002', 'numSubjects': '1016'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '62'}, {'comment': 'Participants taking the capsule formulation were followed for an additional 9 months (up to 18 mos).', 'groupId': 'FG001', 'numSubjects': '1084'}, {'groupId': 'FG002', 'numSubjects': '873'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '122'}, {'groupId': 'FG002', 'numSubjects': '143'}]}], 'dropWithdraws': [{'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '61'}, {'groupId': 'FG002', 'numSubjects': '104'}]}, {'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '14'}, {'groupId': 'FG002', 'numSubjects': '10'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '6'}, {'groupId': 'FG002', 'numSubjects': '1'}]}, {'type': 'Treatment Failure', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '2'}, {'groupId': 'FG002', 'numSubjects': '2'}]}, {'type': 'Patient Noncompliance', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '1'}]}, {'type': 'Tuberculosis/TB treatment', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '4'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'Medication not available', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '2'}, {'groupId': 'FG002', 'numSubjects': '1'}]}, {'type': 'Poor general condition', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'Increased triglycerides', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'Reason unknown', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '31'}, {'groupId': 'FG002', 'numSubjects': '24'}]}]}, {'title': '9 Months Through 18 Months', 'milestones': [{'type': 'STARTED', 'achievements': [{'comment': 'Participants in this subgroup were followed for 9 months.', 'groupId': 'FG000', 'numSubjects': '0'}, {'comment': 'Participants taking the capsule formulation were followed for an additional 9 months (up to 18 mos).', 'groupId': 'FG001', 'numSubjects': '1084'}, {'comment': 'Participants in this subgroup were followed for 9 months.', 'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '854'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '230'}, {'groupId': 'FG002', 'numSubjects': '0'}]}], 'dropWithdraws': [{'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '178'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '11'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '6'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'Treatment failure', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '5'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'Patient Noncompliance', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '4'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'Tuberculosis/TB treatment', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '2'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'Fatigue', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'Reason Unknown', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '23'}, {'groupId': 'FG002', 'numSubjects': '0'}]}]}], 'recruitmentDetails': 'The study was carried out in two parts. The first part was initiated in 2004 with the lopinavir/ritonavir capsule formulation (Part I) and the second part (Part II) started in 2006 after the tablet formulation became available in participating countries.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '2288', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Total Study Population', 'description': 'HIV-1 infected participants who received lopinavir/ritonavir (any formulation) during any part of the study.'}], 'measures': [{'title': 'Age Continuous', 'classes': [{'categories': [{'measurements': [{'value': '32.6', 'spread': '11.0', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex/Gender, Customized', 'classes': [{'title': 'Female', 'categories': [{'measurements': [{'value': '867', 'groupId': 'BG000'}]}]}, {'title': 'Male', 'categories': [{'measurements': [{'value': '1419', 'groupId': 'BG000'}]}]}, {'title': 'Data not reported', 'categories': [{'measurements': [{'value': '2', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'Serbia', 'categories': [{'measurements': [{'value': '149', 'groupId': 'BG000'}]}]}, {'title': 'Czech Republic', 'categories': [{'measurements': [{'value': '107', 'groupId': 'BG000'}]}]}, {'title': 'Slovenia', 'categories': [{'measurements': [{'value': '123', 'groupId': 'BG000'}]}]}, {'title': 'Slovakia', 'categories': [{'measurements': [{'value': '26', 'groupId': 'BG000'}]}]}, {'title': 'Poland', 'categories': [{'measurements': [{'value': '381', 'groupId': 'BG000'}]}]}, {'title': 'Ukraine', 'categories': [{'measurements': [{'value': '266', 'groupId': 'BG000'}]}]}, {'title': 'Romania', 'categories': [{'measurements': [{'value': '422', 'groupId': 'BG000'}]}]}, {'title': 'Lithuania', 'categories': [{'measurements': [{'value': '3', 'groupId': 'BG000'}]}]}, {'title': 'Russian Federation', 'categories': [{'measurements': [{'value': '644', 'groupId': 'BG000'}]}]}, {'title': 'Israel', 'categories': [{'measurements': [{'value': '139', 'groupId': 'BG000'}]}]}, {'title': 'Georgia', 'categories': [{'measurements': [{'value': '10', 'groupId': 'BG000'}]}]}, {'title': 'Latvia', 'categories': [{'measurements': [{'value': '18', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 2288}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2004-02'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2011-10', 'completionDateStruct': {'date': '2010-02', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2011-10-10', 'studyFirstSubmitDate': '2011-06-22', 'resultsFirstSubmitDate': '2011-08-09', 'studyFirstSubmitQcDate': '2011-06-22', 'lastUpdatePostDateStruct': {'date': '2011-10-17', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2011-08-09', 'studyFirstPostDateStruct': {'date': '2011-06-23', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2011-09-12', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-02', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'CD4 Count', 'timeFrame': 'Baseline', 'description': "CD4 lymphocyte count is a measure of a participant's immunologic health. Participants' CD4-positive (CD4+) T-lymphocyte counts were assessed by measuring the number of CD4+ cells at baseline."}, {'measure': 'Changes in CD4 Count', 'timeFrame': 'Baseline to 1 month', 'description': "Increases in CD4 count are a biomarker for antiretroviral treatment effectiveness in restoring immunologic function. Changes in participants' CD4-positive (CD4+) T-lymphocyte counts were assessed by measuring the change from Baseline in the number of CD4+ cells at scheduled study visits."}, {'measure': 'Changes in CD4 Count', 'timeFrame': 'Baseline to 3 months', 'description': "Increases in CD4 count are a biomarker for antiretroviral treatment effectiveness in restoring immunologic function. Changes in participants' CD4-positive (CD4+) T-lymphocyte counts were assessed by measuring the change from Baseline in the number of CD4+ cells at scheduled study visits."}, {'measure': 'Changes in CD4 Count', 'timeFrame': 'Baseline to 6 months', 'description': "Increases in CD4 count are a biomarker for antiretroviral treatment effectiveness in restoring immunologic function. Changes in participants' CD4-positive (CD4+) T-lymphocyte counts were assessed by measuring the change from Baseline in the number of CD4+ cells at scheduled study visits."}, {'measure': 'Changes in CD4 Count', 'timeFrame': 'Baseline to 9 months', 'description': "Increases in CD4 count are a biomarker for antiretroviral treatment effectiveness in restoring immunologic function. Changes in participants' CD4-positive (CD4+) T-lymphocyte counts were assessed by measuring the change from Baseline in the number of CD4+ cells at scheduled study visits."}, {'measure': 'Changes in CD4 Count', 'timeFrame': 'Baseline to 12 months', 'description': "Increases in CD4 count are a biomarker for antiretroviral treatment effectiveness in restoring immunologic function. Changes in participants' CD4-positive (CD4+) T-lymphocyte counts were assessed by measuring the change from Baseline in the number of CD4+ cells at scheduled study visits."}, {'measure': 'Changes in CD4 Count', 'timeFrame': 'Baseline to 15 months', 'description': "Increases in CD4 count are a biomarker for antiretroviral treatment effectiveness in restoring immunologic function. Changes in participants' CD4-positive (CD4+) T-lymphocyte counts were assessed by measuring the change from Baseline in the number of CD4+ cells at scheduled study visits."}, {'measure': 'Changes in CD4 Count', 'timeFrame': 'Baseline to 18 months', 'description': "Increases in CD4 count are a biomarker for antiretroviral treatment effectiveness in restoring immunologic function. Changes in participants' CD4-positive (CD4+) T-lymphocyte counts were assessed by measuring the change from Baseline in the number of CD4+ cells at scheduled study visits."}, {'measure': 'Viral Load', 'timeFrame': 'Baseline', 'description': 'Viral load is a direct measure of the viral burden by providing a count of the number of HIV-RNA copies in blood (plasma). The number of HIV-RNA copies in the blood was measured at baseline.'}, {'measure': 'Viral Load', 'timeFrame': '1 month', 'description': 'Viral load (number of HIV-RNA copies in the blood) was measured at baseline and scheduled study visits. A decrease in viral load is a measure used to assess the effectiveness of antiviral treatments.'}, {'measure': 'Viral Load', 'timeFrame': '3 months', 'description': 'Viral load (number of HIV-RNA copies in the blood) was measured at baseline and scheduled study visits. A decrease in viral load is a measure used to assess the effectiveness of antiviral treatments.'}, {'measure': 'Viral Load', 'timeFrame': '6 months', 'description': 'Viral load (number of HIV-RNA copies in the blood) was measured at baseline and scheduled study visits. A decrease in viral load is a measure used to assess the effectiveness of antiviral treatments.'}, {'measure': 'Viral Load', 'timeFrame': '9 months', 'description': 'Viral load (number of HIV-RNA copies in the blood) was measured at baseline and scheduled study visits. A decrease in viral load is a measure used to assess the effectiveness of antiviral treatments.'}, {'measure': 'Viral Load', 'timeFrame': '12 months', 'description': 'Viral load (number of HIV-RNA copies in the blood) was measured at baseline and scheduled study visits. A decrease in viral load is a measure used to assess the effectiveness of antiviral treatments.'}, {'measure': 'Viral Load', 'timeFrame': '15 months', 'description': 'Viral load (number of HIV-RNA copies in the blood) was measured at baseline and scheduled study visits. A decrease in viral load is a measure used to assess the effectiveness of antiviral treatments.'}, {'measure': 'Viral Load', 'timeFrame': '18 months', 'description': 'Viral load (number of HIV-RNA copies in the blood) was measured at baseline and scheduled study visits. A decrease in viral load is a measure used to assess the effectiveness of antiviral treatments.'}, {'measure': 'Laboratory Parameter Blood Glucose', 'timeFrame': 'Baseline, 9 months, 18 months', 'description': 'Blood glucose laboratory values were assessed at baseline and scheduled study visits. Normal ranges are based on the standards for individual facilities in each country.'}, {'measure': 'Laboratory Parameter Transaminases', 'timeFrame': 'Baseline, 9 months, 18 months', 'description': 'Serum aspartate aminotransferase (AST) and alanine aminotransferase (ALT) laboratory values were assessed at baseline and scheduled study visits. Normal ranges are based on the standards for individual facilities in each country.'}, {'measure': 'Laboratory Parameter Lipids', 'timeFrame': 'Baseline, 9 months, 18 months', 'description': 'A blood lipid panel consisting of total cholesterol, triglyceride, high-density lipoprotein (HDL), and low-density lipoprotein (LDL) levels was performed at baseline and scheduled study visits. Normal ranges are based on the standards for individual facilities in each country.'}], 'secondaryOutcomes': [{'measure': 'Reasons for Discontinuation of Lopinavir/Ritonavir', 'timeFrame': '9 months', 'description': 'For participants who discontinued lopinavir/ritonavir treatment, the reasons for discontinuation are provided.'}, {'measure': 'Reasons for Discontinuation of Lopinavir/Ritonavir', 'timeFrame': '18 months', 'description': 'For participants who discontinued lopinavir/ritonavir treatment, the reasons for discontinuation are provided.'}, {'measure': 'Compliance With Lopinavir/Ritonavir', 'timeFrame': '9 months', 'description': 'Participants reported whether they had missed doses of their antiretroviral treatment.'}, {'measure': 'Compliance With Lopinavir/Ritonavir', 'timeFrame': '18 months', 'description': 'Participants reported whether they had missed any doses of their antiretroviral treatment.'}, {'measure': 'Adverse Events Observed on Treatment With Lopinavir/Ritonavir.', 'timeFrame': '18 months', 'description': 'Total number of adverse events with causal relationship (rated by Investigator as probably or possibly related) to lopinavir/ritonavir treatment.\n\nAll serious adverse events and non serious adverse events (0.2% or greater frequency) are summarized in the "Reported Adverse Events" section of this record.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['HIV-1 infected patients', 'Protease inhibitor', 'Kaletra®'], 'conditions': ['HIV-1 Patients']}, 'descriptionModule': {'briefSummary': 'KaleEAST is a non-interventional, post-marketing observational study (PMOS) in which lopinavir/ritonavir is prescribed in the usual manner in accordance with the terms of the local marketing authorization with regards to dose, population and indication. No additional procedures (other than the standard of care) are to be applied to the patients.\n\nThe KaleEAST PMOS was conducted in a prospective, single-arm, multicountry, multicenter format. The study was carried out in two (2) parts: the first part was initiated in 2004 with the lopinavir/ritonavir capsule formulation, the second part started in 2006 after the lopinavir/ritonavir tablets had become available in the participating countries.\n\nThe aim of this post-marketing observational study was to obtain further data on clinical, biological, and virological outcomes, compliance and tolerability of Kaletra®-containing regimen during routine clinical use in the participating countries.', 'detailedDescription': 'As this study is observational in nature, subject follow-up was not specified by the protocol but was left to the judgment of each physician within the 18 months period, which defines the survey for each participant. For indicative purposes, follow-up of each participant should enable approximately 7 visits during this period. These visits will take place at average intervals of 3 months, apart from the first visit following inclusion (usually at the end of the first treatment month) and apart from visits required because of intercurrent events. Participant visits were assigned as follows: Baseline/Day 0 (start of lopinavir/ritonavir treatment), Month 1 (day 1 to day 45), Month 3 (day 46 to day 136), Month 6 (day 137 to day 228), Month 9 (day 229 to day 319), Month 12 (day 320 to day 410), Month 15 (day 411 to day 501), Month 18 (day 502 to day 593). Each participant is planned to be observed during his/her lopinavir/ritonavir capsule containing treatment regimen for a maximum period of 18 months, and each participant is planned to be observed during his/her lopinavir/ritonavir tablet containing treatment regimen for a maximum period of 9 months.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'minimumAge': '2 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'KaleEAST is non-interventional, observational study in which Kaletra® is prescribed in the usual manner in accordance with the terms of the local marketing authorization with regard to dose, population and indication.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\nPatients infected by HIV-1 infection who are either:\n\n* Antiretroviral treatment (ART) naive or\n* Had failed or had been intolerant to one previous combined antiretroviral treatment (cART), not including a Protease inhibitor (PI) (first-line pretreated without a Protease inhibitor) or\n* Had failed or had been intolerant to one previous antiretroviral treatment ART, including one Protease inhibitor (first-line pretreated with a Protease Inhibitor).\n\nA ritonavir-boosted Protease inhibitor PI is considered as treatment with one Protease inhibitor PI.\n\nExclusion Criteria:\n\n* Treatment with drugs at risk for interactions with lopinavir/ritonavir\n* Uncontrolled AIDS defining disease\n* Two or more previous Protease inhibitors (PIs)\n* Participation in another study or clinical trial'}, 'identificationModule': {'nctId': 'NCT01379703', 'acronym': 'KaleEAST', 'briefTitle': 'Multicountry, Multicenter Post-Marketing Observational Study of Clinical, Biological and Virological Outcomes, Compliance and Tolerability of Kaletra® in Routine Clinical Use', 'organization': {'class': 'INDUSTRY', 'fullName': 'Abbott'}, 'officialTitle': 'Multicountry, Multicenter Post-Marketing Observational Study of Clinical, Biological and Virological Outcomes, Compliance and Tolerability of Kaletra® in Routine Clinical Use', 'orgStudyIdInfo': {'id': 'PMOS-EAST-04-1'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Single patients group', 'description': 'Single HIV-1 infected patients group'}]}, 'contactsLocationsModule': {'locations': [{'zip': '639 00', 'city': 'Brno', 'country': 'Czechia', 'facility': 'Site Ref # / Investigator 57102', 'geoPoint': {'lat': 49.19522, 'lon': 16.60796}}, {'zip': '370 87', 'city': 'České Budějovice', 'country': 'Czechia', 'facility': 'Site Ref # / Investigator 57054', 'geoPoint': {'lat': 48.97447, 'lon': 14.47434}}, {'zip': '50005', 'city': 'Hradec Králové', 'country': 'Czechia', 'facility': 'Site Ref # / Investigator 57055', 'geoPoint': {'lat': 50.20923, 'lon': 15.83277}}, {'zip': '708 52', 'city': 'Ostrava', 'country': 'Czechia', 'facility': 'Site Ref # / Investigator 57056', 'geoPoint': {'lat': 49.83465, 'lon': 18.28204}}, {'zip': '305 99', 'city': 'Pilsen', 'country': 'Czechia', 'facility': 'Site Ref # / Investigator 57052', 'geoPoint': {'lat': 49.74747, 'lon': 13.37759}}, {'zip': '180 01', 'city': 'Prague', 'country': 'Czechia', 'facility': 'Site Ref # / Investigator 5344', 'geoPoint': {'lat': 50.08804, 'lon': 14.42076}}, {'zip': '40011', 'city': 'Ústí nad Labem', 'country': 'Czechia', 'facility': 'Site Ref # / Investigator 57053', 'geoPoint': {'lat': 50.6607, 'lon': 14.03227}}, {'city': 'Tbilisi', 'country': 'Georgia', 'facility': 'Site Ref # / Investigator 7576', 'geoPoint': {'lat': 41.69143, 'lon': 44.83412}}, {'zip': '84101', 'city': 'Beersheba', 'country': 'Israel', 'facility': 'Site Ref # / Investigator 57050', 'geoPoint': {'lat': 31.25181, 'lon': 34.7913}}, {'zip': '31096', 'city': 'Haifa', 'country': 'Israel', 'facility': 'Site Ref # / Investigator 57048', 'geoPoint': {'lat': 32.81303, 'lon': 34.99928}}, {'zip': '91120', 'city': 'Jerusalem', 'country': 'Israel', 'facility': 'Site Ref # / Investigator 57049', 'geoPoint': {'lat': 31.76904, 'lon': 35.21633}}, {'zip': '44281', 'city': 'Kfar Saba', 'country': 'Israel', 'facility': 'Site Ref # / Investigator 6124', 'geoPoint': {'lat': 32.175, 'lon': 34.90694}}, {'zip': '76100', 'city': 'Rehovot', 'country': 'Israel', 'facility': 'Site Ref # / Investigator 57047', 'geoPoint': {'lat': 31.89421, 'lon': 34.81199}}, {'city': 'Tel Litwinsky', 'country': 'Israel', 'facility': 'Site Ref # / Investigator 57051', 'geoPoint': {'lat': 32.05096, 'lon': 34.84588}}, {'city': 'Riga', 'country': 'Latvia', 'facility': 'Site Ref # / Investigator 7578', 'geoPoint': {'lat': 56.946, 'lon': 24.10589}}, {'zip': 'LT-10105', 'city': 'Vilnius', 'country': 'Lithuania', 'facility': 'Site Ref # / Investigator 6127', 'geoPoint': {'lat': 54.68916, 'lon': 25.2798}}, {'zip': '15540', 'city': 'Bialystok', 'country': 'Poland', 'facility': 'Site Ref # / Investigator 6190', 'geoPoint': {'lat': 53.13333, 'lon': 23.16433}}, {'zip': '85-030', 'city': 'Bydgoszcz', 'country': 'Poland', 'facility': 'Site Ref # / Investigator 56885', 'geoPoint': {'lat': 53.1235, 'lon': 18.00762}}, {'zip': '41-500', 'city': 'Chorzów', 'country': 'Poland', 'facility': 'Site Ref # / Investigator 56887', 'geoPoint': {'lat': 50.30582, 'lon': 18.9742}}, {'zip': '80-214', 'city': 'Gdansk', 'country': 'Poland', 'facility': 'Site Ref # / Investigator 56883', 'geoPoint': {'lat': 54.35227, 'lon': 18.64912}}, {'zip': '31-531', 'city': 'Krakow', 'country': 'Poland', 'facility': 'Site Ref # / Investigator 56888', 'geoPoint': {'lat': 50.06143, 'lon': 19.93658}}, {'zip': '91-347', 'city': 'Lodz', 'country': 'Poland', 'facility': 'Site Ref # / Investigator 56889', 'geoPoint': {'lat': 51.77058, 'lon': 19.47395}}, {'zip': '61-285', 'city': 'Poznan', 'country': 'Poland', 'facility': 'Site Ref # / Investigator 56884', 'geoPoint': {'lat': 52.40692, 'lon': 16.92993}}, {'zip': '71-455', 'city': 'Szczecin', 'country': 'Poland', 'facility': 'Site Ref # / Investigator 56886', 'geoPoint': {'lat': 53.42894, 'lon': 14.55302}}, {'zip': '01-201', 'city': 'Warsaw', 'country': 'Poland', 'facility': 'Site Ref # / Investigator 56882', 'geoPoint': {'lat': 52.22977, 'lon': 21.01178}}, {'zip': '51-149', 'city': 'Wroclaw', 'country': 'Poland', 'facility': 'Site Ref # / Investigator 56890', 'geoPoint': {'lat': 51.10286, 'lon': 17.03006}}, {'zip': '500174', 'city': 'Brasov', 'country': 'Romania', 'facility': 'Site Ref # / Investigator 57064', 'geoPoint': {'lat': 45.64861, 'lon': 25.60613}}, {'zip': '021105', 'city': 'Bucharest', 'country': 'Romania', 'facility': 'Site Ref # / Investigator 6194', 'geoPoint': {'lat': 44.43225, 'lon': 26.10626}}, {'zip': '030303', 'city': 'Bucharest', 'country': 'Romania', 'facility': 'Site Ref # / Investigator 57062', 'geoPoint': {'lat': 44.43225, 'lon': 26.10626}}, {'zip': '900708', 'city': 'Constanța', 'country': 'Romania', 'facility': 'Site Ref # / Investigator 57063', 'geoPoint': {'lat': 44.18073, 'lon': 28.63432}}, {'zip': '200515', 'city': 'Craiova', 'country': 'Romania', 'facility': 'Site Ref # / Investigator 57067', 'geoPoint': {'lat': 44.31667, 'lon': 23.8}}, {'zip': '700116', 'city': 'Iași', 'country': 'Romania', 'facility': 'Site Ref # / Investigator 57068', 'geoPoint': {'lat': 47.16667, 'lon': 27.6}}, {'zip': '540394', 'city': 'Târgu Mureş', 'country': 'Romania', 'facility': 'Site Ref # / Investigator 57065', 'geoPoint': {'lat': 46.54245, 'lon': 24.55747}}, {'zip': '300310', 'city': 'Timișoara', 'country': 'Romania', 'facility': 'Site Ref # / Investigator 57066', 'geoPoint': {'lat': 45.75372, 'lon': 21.22571}}, {'zip': '658610', 'city': 'Barnaul', 'country': 'Russia', 'facility': 'Site Ref # / Investigator 57022', 'geoPoint': {'lat': 53.36199, 'lon': 83.72786}}, {'zip': '454052', 'city': 'Chelyabinsk', 'country': 'Russia', 'facility': 'Site Ref # 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