Ignite Creation Date:
2025-12-24 @ 1:20 PM
Ignite Modification Date:
2026-01-07 @ 6:16 AM
Study NCT ID:
NCT01830595
Status:
COMPLETED
Last Update Posted:
2024-12-31
First Post:
2013-04-10
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Lactoferrin Treatment in HIV Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D015658', 'term': 'HIV Infections'}], 'ancestors': [{'id': 'D000086982', 'term': 'Blood-Borne Infections'}, {'id': 'D003141', 'term': 'Communicable Diseases'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D015229', 'term': 'Sexually Transmitted Diseases, Viral'}, {'id': 'D012749', 'term': 'Sexually Transmitted Diseases'}, {'id': 'D016180', 'term': 'Lentivirus Infections'}, {'id': 'D012192', 'term': 'Retroviridae Infections'}, {'id': 'D012327', 'term': 'RNA Virus Infections'}, {'id': 'D014777', 'term': 'Virus Diseases'}, {'id': 'D000091662', 'term': 'Genital Diseases'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D007153', 'term': 'Immunologic Deficiency Syndromes'}, {'id': 'D007154', 'term': 'Immune System Diseases'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'baker@umn.edu', 'phone': '612-873-2705', 'title': 'Jason Baker', 'organization': 'Minneapolis Medical Research Foundation'}, 'certainAgreement': {'piSponsorEmployee': True}}, 'adverseEventsModule': {'timeFrame': '8 months', 'eventGroups': [{'id': 'EG000', 'title': 'Placebo', 'description': 'Matched placebo will be administered by mouth twice daily\n\nPlacebo', 'otherNumAtRisk': 54, 'deathsNumAtRisk': 54, 'otherNumAffected': 10, 'seriousNumAtRisk': 54, 'deathsNumAffected': 0, 'seriousNumAffected': 5}, {'id': 'EG001', 'title': 'Recombinant Lactoferrin', 'description': 'Recombinant lactoferrin will be administered by mouth twice daily\n\nRecombinant Lactoferrin', 'otherNumAtRisk': 54, 'deathsNumAtRisk': 54, 'otherNumAffected': 10, 'seriousNumAtRisk': 54, 'deathsNumAffected': 0, 'seriousNumAffected': 1}], 'otherEvents': [{'term': 'Bronchitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 54, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 54, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Chills', 'stats': [{'groupId': 'EG000', 'numAtRisk': 54, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 54, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Diarrhea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 54, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 54, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Decreased appetite', 'stats': [{'groupId': 'EG000', 'numAtRisk': 54, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 54, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Fatigue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 54, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 54, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Depression', 'stats': [{'groupId': 'EG000', 'numAtRisk': 54, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 54, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Insomnia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 54, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 54, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Elevated CK', 'stats': [{'groupId': 'EG000', 'numAtRisk': 54, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 54, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Elevated AST', 'stats': [{'groupId': 'EG000', 'numAtRisk': 54, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 54, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Skin infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 54, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 54, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Bone', 'notes': 'broke left arm', 'stats': [{'groupId': 'EG000', 'numAtRisk': 54, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 54, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Fatigue, cough and sore throat', 'stats': [{'groupId': 'EG000', 'numAtRisk': 54, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 54, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Bone spur on spine', 'stats': [{'groupId': 'EG000', 'numAtRisk': 54, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 54, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'surgery on rotator cuff', 'stats': [{'groupId': 'EG000', 'numAtRisk': 54, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 54, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'torn rotator cuff', 'stats': [{'groupId': 'EG000', 'numAtRisk': 54, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 54, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'tinnitus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 54, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 54, 'numAffected': 1}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'right leg pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 54, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 54, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 54, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 54, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'abdominal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 54, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 54, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Cough and respiratory congestion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 54, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 54, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Upper Respiratory infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 54, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 54, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Sinus Infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 54, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 54, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Sinus pain and congestion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 54, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 54, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Cough, congestion, sinus pressure, fatigue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 54, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 54, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}], 'seriousEvents': [{'term': 'Hospitalization due to altered mental status', 'stats': [{'groupId': 'EG000', 'numAtRisk': 54, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 54, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Hospitalization due to chest pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 54, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 54, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Hospitalization due to COPD', 'stats': [{'groupId': 'EG000', 'numAtRisk': 54, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 54, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'hospitalization for confusion, disorientation, shakiness, unsteady gait and vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 54, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 54, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Hospitalization for drug use', 'stats': [{'groupId': 'EG000', 'numAtRisk': 54, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 54, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Hospitalized for syncope episode', 'stats': [{'groupId': 'EG000', 'numAtRisk': 54, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 54, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Number of Participants With at Least One Side Effect, Adverse Event, and Serious Adverse Event', 'denoms': [{'units': 'Participants', 'counts': [{'value': '54', 'groupId': 'OG000'}, {'value': '54', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Matched placebo will be administered by mouth twice daily\n\nPlacebo'}, {'id': 'OG001', 'title': 'Recombinant Lactoferrin', 'description': 'Recombinant lactoferrin will be administered by mouth twice daily\n\nRecombinant Lactoferrin'}], 'classes': [{'title': 'At least one side effect', 'categories': [{'measurements': [{'value': '20', 'groupId': 'OG000'}, {'value': '17', 'groupId': 'OG001'}]}]}, {'title': 'At least one adverse event (includes SAE)', 'categories': [{'measurements': [{'value': '12', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}]}]}, {'title': 'At least one Serious Adverse Event', 'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'During 3 months on Lactoferrin or Placebo (and following washout period)', 'description': 'Self reported side effects and/or Division of AIDS (DAIDS) criteria will be used for grading adverse events (serious and non-serious)', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'IL-6 & D-dimer Score Changes From Baseline to 3 Months (or Month 5 to Month 8)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '45', 'groupId': 'OG000'}, {'value': '45', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Matched placebo will be administered by mouth twice daily\n\nPlacebo'}, {'id': 'OG001', 'title': 'Recombinant Lactoferrin', 'description': 'Recombinant lactoferrin will be administered by mouth twice daily\n\nRecombinant Lactoferrin'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.02', 'spread': '0.39', 'groupId': 'OG000'}, {'value': '0.06', 'spread': '.36', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.38', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': '3 months (Baseline to Month 3 or Month 5 to Month 8)', 'description': 'The IL-6 \\& D-dimer score is defined as: 0. 33\\*log2 IL-6 + 0.16\\*log2 D-dimer, where IL-6 is measured in pg/mL and D-dimer in ug/mL. Since the biomarkers are on the log2 scale, associations of risk with the IL-6 \\& D-dimer score are interpreted as "HR(event) per doubling of IL-6 and D-dimer", or "HR(event) per 20% increase in IL-6 and D-dimer"; the score itself is unitless.\n\nAmong the 3766 study participants for whom the score was developed, the min was -1.7, the max was 2.5.\n\nHigher scores are worse.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': '45 participants contributed data during phase two. Participants had to attend the first visit (baseline or month 5) and also one follow-up visit in order to contribute data to the analyses.'}, {'type': 'PRIMARY', 'title': 'Number of Participants Taking Medication as Assigned', 'denoms': [{'units': 'Participants', 'counts': [{'value': '44', 'groupId': 'OG000'}, {'value': '41', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Matched placebo will be administered by mouth twice daily\n\nPlacebo'}, {'id': 'OG001', 'title': 'Recombinant Lactoferrin', 'description': 'Recombinant lactoferrin will be administered by mouth twice daily\n\nRecombinant Lactoferrin'}], 'classes': [{'categories': [{'measurements': [{'value': '40', 'groupId': 'OG000'}, {'value': '38', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '3 months', 'description': 'Number of participants taking medication as assigned at 3 months', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Activated Monocyte Phenotype (CD16+)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '40', 'groupId': 'OG000'}, {'value': '39', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Matched placebo will be administered by mouth twice daily\n\nPlacebo'}, {'id': 'OG001', 'title': 'Recombinant Lactoferrin', 'description': 'Recombinant lactoferrin will be administered by mouth twice daily\n\nRecombinant Lactoferrin'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.45', 'spread': '5.44', 'groupId': 'OG000'}, {'value': '-1.42', 'spread': '9.26', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.55', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': '3 months', 'description': 'The change in CD16+ monocyte subsets will be compared between active and placebo treatment phases. During both the active and placebo treatment phase, all relevant time points are used in calculation of change (i.e., baseline, month 1 and month 3 for phase 1; and similarly months 5, 6 and 8 for phase 2).', 'unitOfMeasure': 'percent of total monocyte population', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': '45 participants contributed data during phase two. Participants had to attend the first visit (baseline or month 5) and also one follow-up visit in order to contribute data to the analyses. Fewer participants had pre-drug and post-drug cells collected so numbers are less than 45 for this measure.'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'sCD163', 'denoms': [{'units': 'Participants', 'counts': [{'value': '45', 'groupId': 'OG000'}, {'value': '45', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Matched placebo will be administered by mouth twice daily\n\nPlacebo'}, {'id': 'OG001', 'title': 'Recombinant Lactoferrin', 'description': 'Recombinant lactoferrin will be administered by mouth twice daily\n\nRecombinant Lactoferrin'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.01', 'spread': '0.06', 'groupId': 'OG000'}, {'value': '0.03', 'spread': '0.11', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.10', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': '3 months', 'description': 'The change in blood levels of sCD163 will be compared between active and placebo treatment phases. During both the active and placebo treatment phase, all relevant time points are used in calculation of change (i.e., baseline, month 1 and month 3 for phase 1; and similarly months 5, 6 and 8 for phase 2).', 'unitOfMeasure': 'mg/L', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': '45 participants contributed data during phase two. Participants had to attend the first visit (baseline or month 5) and also one follow-up visit in order to contribute data to the analyses.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Placebo First Then Lactoferrin', 'description': 'Participants receive placebo during first period, then Lactoferrin in second period after washout.'}, {'id': 'FG001', 'title': 'Lactoferrin First Then Placebo', 'description': 'Participants receive Lactoferrin during first period, then placebo in second period after washout.'}], 'periods': [{'title': 'First Period', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '26'}, {'groupId': 'FG001', 'numSubjects': '28'}]}, {'type': 'Received at Least One Dose', 'achievements': [{'groupId': 'FG000', 'numSubjects': '26'}, {'groupId': 'FG001', 'numSubjects': '28'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '25'}, {'groupId': 'FG001', 'numSubjects': '25'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '3'}]}], 'dropWithdraws': [{'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '3'}]}]}, {'title': 'Washout', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '25'}, {'groupId': 'FG001', 'numSubjects': '25'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '23'}, {'groupId': 'FG001', 'numSubjects': '23'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '2'}]}], 'dropWithdraws': [{'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '2'}]}]}, {'title': 'Second Period', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '23'}, {'groupId': 'FG001', 'numSubjects': '23'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '23'}, {'groupId': 'FG001', 'numSubjects': '23'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}], 'preAssignmentDetails': 'One participant was administratively withdrawn prior to receiving medication.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '54', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Entire Study Population', 'description': 'Includes groups randomized to receive placebo first and active drug first.'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '54', 'groupId': 'BG000'}]}], 'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '51', 'groupId': 'BG000'}]}, {'title': '>=65 years', 'measurements': [{'value': '3', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age, Continuous', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '54', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '51.6', 'spread': '7.0', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '54', 'groupId': 'BG000'}]}], 'categories': [{'title': 'Female', 'measurements': [{'value': '6', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '48', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'title': 'White', 'denoms': [{'units': 'Participants', 'counts': [{'value': '54', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '39', 'groupId': 'BG000'}]}]}, {'title': 'Hispanic', 'denoms': [{'units': 'Participants', 'counts': [{'value': '54', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '2', 'groupId': 'BG000'}]}]}, {'title': 'African American', 'denoms': [{'units': 'Participants', 'counts': [{'value': '54', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '11', 'groupId': 'BG000'}]}]}, {'title': 'Other', 'denoms': [{'units': 'Participants', 'counts': [{'value': '54', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '2', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Diastolic Blood Pressure', 'classes': [{'title': 'At Enrollment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '54', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '79.5', 'spread': '10.5', 'groupId': 'BG000'}]}]}, {'title': 'Beginning of Placebo Treatment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '49', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '78.6', 'spread': '9.9', 'groupId': 'BG000'}]}]}, {'title': 'Beginning of Lactoferrin', 'denoms': [{'units': 'Participants', 'counts': [{'value': '51', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '79.3', 'spread': '10.2', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'mm HG', 'dispersionType': 'STANDARD_DEVIATION', 'populationDescription': 'All 54 participants started the first period, not all participants started the second period. Across both periods of treatment a total of 51 participants started Lactoferrin treatment and 49 participants started placebo treatment.'}, {'title': 'Systolic Blood Pressure', 'classes': [{'title': 'At Enrollment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '54', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '129.7', 'spread': '15.4', 'groupId': 'BG000'}]}]}, {'title': 'Beginning of Placebo Treatment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '49', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '128.0', 'spread': '14.9', 'groupId': 'BG000'}]}]}, {'title': 'Beginning of Lactoferrin Treatment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '51', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '127.8', 'spread': '15.6', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'mm Hg', 'dispersionType': 'STANDARD_DEVIATION', 'populationDescription': 'All 54 participants started the first period, not all participants started the second period. Across both periods of treatment a total of 51 participants started Lactoferrin treatment and 49 participants started placebo treatment.'}, {'title': 'Weight', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '54', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '190.0', 'spread': '38.1', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'pounds', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Interleukin-6 and D-Dimer Score', 'classes': [{'title': 'At Enrollment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '54', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '-0.00', 'spread': '0.38', 'groupId': 'BG000'}]}]}, {'title': 'Beginning of Placebo Treatment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '49', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '0.02', 'spread': '0.39', 'groupId': 'BG000'}]}]}, {'title': 'Beginning of Lactoferrin Treatment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '51', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '-0.02', 'spread': '0.45', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'description': 'The IL-6 \\& D-dimer score is defined as: 0. 33\\*log2 IL-6 + 0.16\\*log2 D-dimer, where IL-6 is measured in pg/mL and D-dimer in ug/mL. Since the biomarkers are on the log2 scale, associations of risk with the IL-6 \\& D-dimer score are interpreted as "Hazard Ratio (HR)(event) per doubling of IL-6 and D-dimer", or "HR(event) per 20% increase in IL-6 and D-dimer"; the score itself is unitless.\n\nAmong the 3766 study participants for whom the score was developed, the min was -1.7, the max was 2.5.\n\nHigher scores are worse.', 'unitOfMeasure': 'scores on a scale', 'dispersionType': 'STANDARD_DEVIATION', 'populationDescription': 'All 54 participants started the first period, not all participants started the second period. Across both periods of treatment a total of 51 participants started Lactoferrin treatment and 49 participants started placebo treatment.'}, {'title': 'Small Artery Elasticity', 'classes': [{'title': 'At Enrollment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '54', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '6.49', 'spread': '2.91', 'groupId': 'BG000'}]}]}, {'title': 'Beginning of Placebo Treatment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '49', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '6.79', 'spread': '3.04', 'groupId': 'BG000'}]}]}, {'title': 'Beginning of Lactoferrin Treatment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '51', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '6.61', 'spread': '2.87', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'mL/mmHg x 100', 'dispersionType': 'STANDARD_DEVIATION', 'populationDescription': 'All 54 participants started the first period, not all participants started the second period. Across both periods of treatment a total of 51 participants started Lactoferrin treatment and 49 participants started placebo treatment.'}, {'title': 'Large Artery Elasticity', 'classes': [{'title': 'At Enrollment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '54', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '16.77', 'spread': '5.74', 'groupId': 'BG000'}]}]}, {'title': 'Beginning of Placebo Treatment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '49', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '17.02', 'spread': '5.56', 'groupId': 'BG000'}]}]}, {'title': 'Beginning of Lactoferrin Treatment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '51', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '16.89', 'spread': '5.48', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'mL/mmHg x 10', 'dispersionType': 'STANDARD_DEVIATION', 'populationDescription': 'All 54 participants started the first period, not all participants started the second period. Across both periods of treatment a total of 51 participants started Lactoferrin treatment and 49 participants started placebo treatment.'}, {'title': 'Monocyte CD16+', 'classes': [{'title': 'At Enrollment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '54', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '10.55', 'spread': '7.11', 'groupId': 'BG000'}]}]}, {'title': 'Beginning of Placebo Treatment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '49', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '10.41', 'spread': '7.56', 'groupId': 'BG000'}]}]}, {'title': 'Beginning of Lactoferrin Treatment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '51', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '11.96', 'spread': '9.56', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'percent of total monocyte population', 'dispersionType': 'STANDARD_DEVIATION', 'populationDescription': 'All 54 participants started the first period, not all participants started the second period. Across both periods of treatment a total of 51 participants started Lactoferrin treatment and 49 participants started placebo treatment.'}, {'title': 'sCD163', 'classes': [{'title': 'At Enrollment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '54', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '0.21', 'spread': '0.12', 'groupId': 'BG000'}]}]}, {'title': 'Beginning of Placebo Treatment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '49', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '0.23', 'spread': '0.15', 'groupId': 'BG000'}]}]}, {'title': 'Beginning of Lactoferrin Treatment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '51', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '0.19', 'spread': '0.10', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'mg/L', 'dispersionType': 'STANDARD_DEVIATION', 'populationDescription': 'All 54 participants started the first period, not all participants started the second period. Across both periods of treatment a total of 51 participants started Lactoferrin treatment and 49 participants started placebo treatment.'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2015-03-25', 'size': 367111, 'label': 'Study Protocol, Statistical Analysis Plan, and Informed Consent Form', 'hasIcf': True, 'hasSap': True, 'filename': 'Prot_SAP_ICF_000.pdf', 'typeAbbrev': 'Prot_SAP_ICF', 'uploadDate': '2018-05-29T15:43', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 55}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-09', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-12', 'completionDateStruct': {'date': '2018-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-12-13', 'studyFirstSubmitDate': '2013-04-10', 'resultsFirstSubmitDate': '2018-05-30', 'studyFirstSubmitQcDate': '2013-04-11', 'lastUpdatePostDateStruct': {'date': '2024-12-31', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2018-09-14', 'studyFirstPostDateStruct': {'date': '2013-04-12', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2018-09-18', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2017-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Activated Monocyte Phenotype (CD16+)', 'timeFrame': '3 months', 'description': 'The change in CD16+ monocyte subsets will be compared between active and placebo treatment phases. During both the active and placebo treatment phase, all relevant time points are used in calculation of change (i.e., baseline, month 1 and month 3 for phase 1; and similarly months 5, 6 and 8 for phase 2).'}, {'measure': 'sCD163', 'timeFrame': '3 months', 'description': 'The change in blood levels of sCD163 will be compared between active and placebo treatment phases. During both the active and placebo treatment phase, all relevant time points are used in calculation of change (i.e., baseline, month 1 and month 3 for phase 1; and similarly months 5, 6 and 8 for phase 2).'}], 'primaryOutcomes': [{'measure': 'Number of Participants With at Least One Side Effect, Adverse Event, and Serious Adverse Event', 'timeFrame': 'During 3 months on Lactoferrin or Placebo (and following washout period)', 'description': 'Self reported side effects and/or Division of AIDS (DAIDS) criteria will be used for grading adverse events (serious and non-serious)'}, {'measure': 'IL-6 & D-dimer Score Changes From Baseline to 3 Months (or Month 5 to Month 8)', 'timeFrame': '3 months (Baseline to Month 3 or Month 5 to Month 8)', 'description': 'The IL-6 \\& D-dimer score is defined as: 0. 33\\*log2 IL-6 + 0.16\\*log2 D-dimer, where IL-6 is measured in pg/mL and D-dimer in ug/mL. Since the biomarkers are on the log2 scale, associations of risk with the IL-6 \\& D-dimer score are interpreted as "HR(event) per doubling of IL-6 and D-dimer", or "HR(event) per 20% increase in IL-6 and D-dimer"; the score itself is unitless.\n\nAmong the 3766 study participants for whom the score was developed, the min was -1.7, the max was 2.5.\n\nHigher scores are worse.'}, {'measure': 'Number of Participants Taking Medication as Assigned', 'timeFrame': '3 months', 'description': 'Number of participants taking medication as assigned at 3 months'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['HIV Infection']}, 'referencesModule': {'references': [{'pmid': '30721997', 'type': 'DERIVED', 'citation': 'Sortino O, Hullsiek KH, Richards E, Rupert A, Schminke A, Tetekpor N, Quinones M, Prosser R, Schacker T, Sereti I, Baker JV. The Effects of Recombinant Human Lactoferrin on Immune Activation and the Intestinal Microbiome Among Persons Living with Human Immunodeficiency Virus and Receiving Antiretroviral Therapy. J Infect Dis. 2019 May 24;219(12):1963-1968. doi: 10.1093/infdis/jiz042.'}]}, 'descriptionModule': {'briefSummary': 'Our general goal is to evaluate the potential effectiveness of recombinant lactoferrin (1500mg bid) for reducing inflammation among HIV positive participants.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '40 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. HIV-positive participants receiving Antiretroviral Therapy (ART) for \\>1 year\n2. HIV RNA level \\<200 copies/mL for at least 6 months (≥2 separate values)\n3. Age \\>40 years\n\nExclusion Criteria:\n\n1. Prior cardiovascular disease or stroke\n2. Diabetes\n3. Rheumatologic Diseases\n4. Pregnancy\n5. Chronic kidney disease, stage IV or V (creatinine clearance \\<30 mL/min/1.73m2)\n6. Cirrhosis or end-stage liver disease'}, 'identificationModule': {'nctId': 'NCT01830595', 'briefTitle': 'Lactoferrin Treatment in HIV Patients', 'organization': {'class': 'OTHER', 'fullName': 'Hennepin Healthcare Research Institute'}, 'officialTitle': 'Recombinant Lactoferrin to Reduce Immune Activation and Coagulation Among HIV Positive Patients', 'orgStudyIdInfo': {'id': 'PCC-006'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Recombinant Lactoferrin', 'description': 'Recombinant lactoferrin will be administered by mouth twice daily', 'interventionNames': ['Drug: Recombinant Lactoferrin']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Matched placebo will be administered by mouth twice daily', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'Recombinant Lactoferrin', 'type': 'DRUG', 'armGroupLabels': ['Recombinant Lactoferrin']}, {'name': 'Placebo', 'type': 'DRUG', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '55415', 'city': 'Minneapolis', 'state': 'Minnesota', 'country': 'United States', 'facility': 'Hennepin County Medical Center', 'geoPoint': {'lat': 44.97997, 'lon': -93.26384}}], 'overallOfficials': [{'name': 'Jason V Baker, MD, MS', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Hennepin Healthcare Research Institute'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Jason Baker', 'class': 'OTHER'}, 'collaborators': [{'name': 'Ventria Bioscience', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Associate Professor of Medicine', 'investigatorFullName': 'Jason Baker', 'investigatorAffiliation': 'Hennepin Healthcare Research Institute'}}}}