Ignite Creation Date:
2025-12-17 @ 3:01 PM
Ignite Modification Date:
2025-12-23 @ 10:50 PM
Study NCT ID:
NCT00762892
Status:
COMPLETED
Last Update Posted:
2015-01-05
First Post:
2008-09-26
Is Possible Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Raltegravir vs. Atazanavir in Combination With Truvada® for the Treatment of Antiretroviral naïve HIV Infected Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-22'}, 'conditionBrowseModule': {'meshes': [{'id': 'D015658', 'term': 'HIV Infections'}, {'id': 'D000163', 'term': 'Acquired Immunodeficiency Syndrome'}], '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'}, {'id': 'D012897', 'term': 'Slow Virus Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000068898', 'term': 'Raltegravir Potassium'}, {'id': 'D000069480', 'term': 'Emtricitabine, Tenofovir Disoproxil Fumarate Drug Combination'}, {'id': 'D000068679', 'term': 'Emtricitabine'}, {'id': 'D000069446', 'term': 'Atazanavir Sulfate'}, {'id': 'D019438', 'term': 'Ritonavir'}], 'ancestors': [{'id': 'D011760', 'term': 'Pyrrolidinones'}, {'id': 'D011759', 'term': 'Pyrrolidines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D000068698', 'term': 'Tenofovir'}, {'id': 'D063065', 'term': 'Organophosphonates'}, {'id': 'D009943', 'term': 'Organophosphorus Compounds'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D003841', 'term': 'Deoxycytidine'}, {'id': 'D003562', 'term': 'Cytidine'}, {'id': 'D011741', 'term': 'Pyrimidine Nucleosides'}, {'id': 'D011743', 'term': 'Pyrimidines'}, {'id': 'D000225', 'term': 'Adenine'}, {'id': 'D011687', 'term': 'Purines'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D003853', 'term': 'Deoxyribonucleosides'}, {'id': 'D009705', 'term': 'Nucleosides'}, {'id': 'D009706', 'term': 'Nucleic Acids, Nucleotides, and Nucleosides'}, {'id': 'D004338', 'term': 'Drug Combinations'}, {'id': 'D004364', 'term': 'Pharmaceutical Preparations'}, {'id': 'D011725', 'term': 'Pyridines'}, {'id': 'D009842', 'term': 'Oligopeptides'}, {'id': 'D010455', 'term': 'Peptides'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}, {'id': 'D013844', 'term': 'Thiazoles'}, {'id': 'D013457', 'term': 'Sulfur Compounds'}, {'id': 'D001393', 'term': 'Azoles'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'Tanvir.K.Bell@uth.tmc.edu', 'phone': '713-500-6759', 'title': 'Tanvir Bell, MD', 'organization': 'UT Health Science Center Houston'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}, 'limitationsAndCaveats': {'description': 'Limitations are the relatively small sample size and loss to follow-up. Medical records of patients that were lost to follow up was reviewed to ensure that no SAE occurred. We also attempted multiple times to contact patients.'}}, 'adverseEventsModule': {'eventGroups': [{'id': 'EG000', 'title': 'Raltegravir', 'description': 'Raltegravir in combination with truvada (tenofovir and emtricitabine)\n\nRaltegravir and truvada: Raltegravir 400 mg po bid, truvada 1 tab q daily', 'otherNumAtRisk': 0, 'otherNumAffected': 0, 'seriousNumAtRisk': 14, 'seriousNumAffected': 1}, {'id': 'EG001', 'title': 'Atazanavir', 'description': 'Atazanavir, low dose ritonavir, and truvada (tenofovir and emtricitabine)\n\nAtazanavir, Norvir and Truvada: Atazanavir 300 mg po q daily, Norvir 100 mg po q daily and Truvada 1 tablet po q daily', 'otherNumAtRisk': 0, 'otherNumAffected': 0, 'seriousNumAtRisk': 14, 'seriousNumAffected': 0}], 'seriousEvents': [{'term': 'MAI infection, multi-organ failure, death', 'stats': [{'groupId': 'EG000', 'numAtRisk': 14, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 14, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Change From Baseline in CD4 Count at 48 Weeks', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Raltegravir', 'description': 'Raltegravir in combination with truvada (tenofovir and emtricitabine)\n\nRaltegravir and truvada: Raltegravir 400 mg po bid, truvada 1 tab q daily'}, {'id': 'OG001', 'title': 'Atazanavir', 'description': 'Atazanavir, low dose ritonavir, and truvada (tenofovir and emtricitabine)\n\nAtazanavir, Norvir and Truvada: Atazanavir 300 mg po q daily, Norvir 100 mg po q daily and Truvada 1 tablet po q daily'}], 'classes': [{'categories': [{'measurements': [{'value': '192', 'spread': '26', 'groupId': 'OG000'}, {'value': '205', 'spread': '27', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and 48 weeks', 'unitOfMeasure': 'cells/uL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Lipids at 48 Weeks', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Raltegravir', 'description': 'Raltegravir in combination with truvada (tenofovir and emtricitabine)\n\nRaltegravir and truvada: Raltegravir 400 mg po bid, truvada 1 tab q daily'}, {'id': 'OG001', 'title': 'Atazanavir', 'description': 'Atazanavir, low dose ritonavir, and truvada (tenofovir and emtricitabine)\n\nAtazanavir, Norvir and Truvada: Atazanavir 300 mg po q daily, Norvir 100 mg po q daily and Truvada 1 tablet po q daily'}], 'classes': [{'title': 'Total cholesterol', 'categories': [{'measurements': [{'value': '-0.25', 'spread': '7.66', 'groupId': 'OG000'}, {'value': '8.13', 'spread': '11.96', 'groupId': 'OG001'}]}]}, {'title': 'Triglycerides', 'categories': [{'measurements': [{'value': '-15.50', 'spread': '18.47', 'groupId': 'OG000'}, {'value': '16.88', 'spread': '40.89', 'groupId': 'OG001'}]}]}, {'title': 'HDL cholesterol', 'categories': [{'measurements': [{'value': '-1.5', 'spread': '2.58', 'groupId': 'OG000'}, {'value': '-1.38', 'spread': '3.08', 'groupId': 'OG001'}]}]}, {'title': 'LDL cholesterol', 'categories': [{'measurements': [{'value': '4.13', 'spread': '7.54', 'groupId': 'OG000'}, {'value': '5.88', 'spread': '14.46', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and 48 weeks', 'unitOfMeasure': 'mg/dL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Change From Baseline in Log HIV Viral Load at 48 Weeks', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Raltegravir', 'description': 'Raltegravir in combination with truvada (tenofovir and emtricitabine)\n\nRaltegravir and truvada: Raltegravir 400 mg po bid, truvada 1 tab q daily'}, {'id': 'OG001', 'title': 'Atazanavir', 'description': 'Atazanavir, low dose ritonavir, and truvada (tenofovir and emtricitabine)\n\nAtazanavir, Norvir and Truvada: Atazanavir 300 mg po q daily, Norvir 100 mg po q daily and Truvada 1 tablet po q daily'}], 'classes': [{'categories': [{'measurements': [{'value': '-3.05', 'spread': '0.28', 'groupId': 'OG000'}, {'value': '-3.29', 'spread': '0.26', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and 48 weeks', 'unitOfMeasure': 'copies/mL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Interleukin-6 (IL-6) at 48 Weeks', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Raltegravir', 'description': 'Raltegravir in combination with truvada (tenofovir and emtricitabine)\n\nRaltegravir and truvada: Raltegravir 400 mg po bid, truvada 1 tab q daily'}, {'id': 'OG001', 'title': 'Atazanavir', 'description': 'Atazanavir, low dose ritonavir, and truvada (tenofovir and emtricitabine)\n\nAtazanavir, Norvir and Truvada: Atazanavir 300 mg po q daily, Norvir 100 mg po q daily and Truvada 1 tablet po q daily'}], 'classes': [{'categories': [{'measurements': [{'value': '-2.71', 'spread': '1.63', 'groupId': 'OG000'}, {'value': '-4.47', 'spread': '2.51', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and 48 weeks', 'unitOfMeasure': 'pg/mL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Homocysteine at 6 Months', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Raltegravir', 'description': 'Raltegravir in combination with truvada (tenofovir and emtricitabine)\n\nRaltegravir and truvada: Raltegravir 400 mg po bid, truvada 1 tab q daily'}, {'id': 'OG001', 'title': 'Atazanavir', 'description': 'Atazanavir, low dose ritonavir, and truvada (tenofovir and emtricitabine)\n\nAtazanavir, Norvir and Truvada: Atazanavir 300 mg po q daily, Norvir 100 mg po q daily and Truvada 1 tablet po q daily'}], 'classes': [{'categories': [{'measurements': [{'value': '0.53', 'spread': '0.83', 'groupId': 'OG000'}, {'value': '0.10', 'spread': '0.94', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and 48 weeks', 'unitOfMeasure': 'umol/L', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Raltegravir', 'description': 'Raltegravir in combination with truvada (tenofovir and emtricitabine)\n\nRaltegravir and truvada: Raltegravir 400 mg po bid, truvada 1 tab q daily'}, {'id': 'FG001', 'title': 'Atazanavir', 'description': 'Atazanavir, low dose ritonavir, and truvada (tenofovir and emtricitabine)\n\nAtazanavir, Norvir and Truvada: Atazanavir 300 mg po q daily, Norvir 100 mg po q daily and Truvada 1 tablet po q daily'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '14'}, {'groupId': 'FG001', 'numSubjects': '14'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '9'}, {'groupId': 'FG001', 'numSubjects': '8'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '5'}, {'groupId': 'FG001', 'numSubjects': '6'}]}], 'dropWithdraws': [{'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '5'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'Death', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'Pregnancy', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'Incarceration', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}], 'recruitmentDetails': 'approached patients HIV positive, naive to therapy, single site, English and Spanish speaking/writing.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'BG000'}, {'value': '14', 'groupId': 'BG001'}, {'value': '28', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Raltegravir', 'description': 'Raltegravir in combination with truvada (tenofovir and emtricitabine)\n\nRaltegravir and truvada: Raltegravir 400 mg po bid, truvada 1 tab q daily'}, {'id': 'BG001', 'title': 'Atazanavir', 'description': 'Atazanavir, low dose ritonavir, and truvada (tenofovir and emtricitabine)\n\nAtazanavir, Norvir and Truvada: Atazanavir 300 mg po q daily, Norvir 100 mg po q daily and Truvada 1 tablet po q daily'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '14', 'groupId': 'BG000'}, {'value': '14', 'groupId': 'BG001'}, {'value': '28', 'groupId': 'BG002'}]}, {'title': '>=65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '40.7', 'spread': '11', 'groupId': 'BG000'}, {'value': '38.8', 'spread': '10', 'groupId': 'BG001'}, {'value': '39.8', 'spread': '10.4', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'year', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '7', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '10', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '7', 'groupId': 'BG000'}, {'value': '11', 'groupId': 'BG001'}, {'value': '18', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '14', 'groupId': 'BG000'}, {'value': '14', 'groupId': 'BG001'}, {'value': '28', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 33}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-12', 'completionDateStruct': {'date': '2013-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2014-12-19', 'studyFirstSubmitDate': '2008-09-26', 'resultsFirstSubmitDate': '2014-12-19', 'studyFirstSubmitQcDate': '2008-09-29', 'lastUpdatePostDateStruct': {'date': '2015-01-05', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2014-12-19', 'studyFirstPostDateStruct': {'date': '2008-09-30', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2015-01-05', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change From Baseline in CD4 Count at 48 Weeks', 'timeFrame': 'Baseline and 48 weeks'}, {'measure': 'Change From Baseline in Log HIV Viral Load at 48 Weeks', 'timeFrame': 'Baseline and 48 weeks'}], 'secondaryOutcomes': [{'measure': 'Change From Baseline in Lipids at 48 Weeks', 'timeFrame': 'Baseline and 48 weeks'}, {'measure': 'Change From Baseline in Interleukin-6 (IL-6) at 48 Weeks', 'timeFrame': 'Baseline and 48 weeks'}, {'measure': 'Change From Baseline in Homocysteine at 6 Months', 'timeFrame': 'Baseline and 48 weeks'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Raltegravir', 'Integrase inhibitor', 'Protease inhibitor', 'Naive patients', 'HIV disease', 'Lipids', 'Treatment Naïve'], 'conditions': ['HIV Infections']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'http://omicsonline.org/lipid-and-biomarker-differences-between-raltegravir-and-atazanavir-ritonavir-at-48-weeks-in-the-raltegravir-atazanavir-2155-6113.1000192.php?aid=11665', 'label': 'open access journal'}]}, 'descriptionModule': {'briefSummary': "This is a pilot that will evaluate two regimens for treating HIV infected patients that haven't been on treatment before. HIV/AIDS patients may have an increased risk of myocardial infarction and antiretroviral therapy used may contribute to this. We will evaluate virological, immunological and cardiovascular effects of two HIV treatment regimens.", 'detailedDescription': 'We will check blood studies used to evaluate HIV patients response to therapy including CD4 count and HIV viral load test. We will check routine safety labs done on HIV patients and also check homocysteine levels and creatine kinase level. We will evaluate homocysteine and IL6 levels at baseline, week 48, and week 96.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients must be HIV-1 positive and naïve to HIV therapy.\n* Patients must plan to participate and be available for the trial for the 96-week study period.\n* Patients followed at Thomas Street Clinic.\n* Patients must be over 18 years old.\n\nExclusion Criteria:\n\n* Patients must not be pregnant or plan to become pregnant over the 96-week study period.\n* Patients cannot be on a proton pump inhibitor.\n* Patients cannot be undergoing treatment for active tuberculosis.\n* Renal Insufficiency with a creatinine clearance \\< 50 ml/min/1.73 m2 by the MDRD GFR calculation.'}, 'identificationModule': {'nctId': 'NCT00762892', 'acronym': 'RAN', 'briefTitle': 'Raltegravir vs. Atazanavir in Combination With Truvada® for the Treatment of Antiretroviral naïve HIV Infected Patients', 'organization': {'class': 'OTHER', 'fullName': 'The University of Texas Health Science Center, Houston'}, 'officialTitle': 'A Pilot Study--randomized, Prospective, Single Site Trial Evaluating Raltegravir vs. Atazanavir in Combination With Truvada® for the Treatment of Antiretroviral naïve HIV Infected Patients', 'orgStudyIdInfo': {'id': 'raltegravir atazanavir naive'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Raltegravir', 'description': 'Raltegravir in combination with truvada (tenofovir and emtricitabine)', 'interventionNames': ['Drug: Raltegravir and truvada']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Atazanavir', 'description': 'Atazanavir, low dose ritonavir, and truvada (tenofovir and emtricitabine)', 'interventionNames': ['Drug: Atazanavir, Norvir and Truvada']}], 'interventions': [{'name': 'Raltegravir and truvada', 'type': 'DRUG', 'otherNames': ['Truvada is tenofovir 300 mg and emtricitabine 200 mg'], 'description': 'Raltegravir 400 mg po bid, truvada 1 tab q daily', 'armGroupLabels': ['Raltegravir']}, {'name': 'Atazanavir, Norvir and Truvada', 'type': 'DRUG', 'otherNames': ['Truvada is tenofovir 300 mg and emtricitabine 200 mg'], 'description': 'Atazanavir 300 mg po q daily, Norvir 100 mg po q daily and Truvada 1 tablet po q daily', 'armGroupLabels': ['Atazanavir']}]}, 'contactsLocationsModule': {'locations': [{'zip': '77009', 'city': 'Houston', 'state': 'Texas', 'country': 'United States', 'facility': 'Thomas Street Clinic', 'geoPoint': {'lat': 29.76328, 'lon': -95.36327}}], 'overallOfficials': [{'name': 'Tanvir K Bell, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'UT-Houston'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'The University of Texas Health Science Center, Houston', 'class': 'OTHER'}, 'collaborators': [{'name': 'Merck Sharp & Dohme LLC', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate Professor', 'investigatorFullName': 'Tanvir K. Bell, MD', 'investigatorAffiliation': 'The University of Texas Health Science Center, Houston'}}}}