Ignite Creation Date:
2025-12-25 @ 2:27 AM
Ignite Modification Date:
2026-02-26 @ 12:20 AM
Study NCT ID:
NCT03382834
Status:
COMPLETED
Last Update Posted:
2024-07-03
First Post:
2017-12-19
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Selective Estrogen Receptor Modulators to Enhance the Efficacy of Viral Reactivation With Histone Deacetylase Inhibitors
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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D013629', 'term': 'Tamoxifen'}, {'id': 'D000077337', 'term': 'Vorinostat'}], 'ancestors': [{'id': 'D013267', 'term': 'Stilbenes'}, {'id': 'D001597', 'term': 'Benzylidene Compounds'}, {'id': 'D001555', 'term': 'Benzene Derivatives'}, {'id': 'D006841', 'term': 'Hydrocarbons, Aromatic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D000813', 'term': 'Anilides'}, {'id': 'D000577', 'term': 'Amides'}, {'id': 'D000814', 'term': 'Aniline Compounds'}, {'id': 'D000588', 'term': 'Amines'}, {'id': 'D006877', 'term': 'Hydroxamic Acids'}, {'id': 'D006898', 'term': 'Hydroxylamines'}, {'id': 'D006880', 'term': 'Hydroxy Acids'}, {'id': 'D002264', 'term': 'Carboxylic Acids'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'ACTGCT.Gov@s-3.com', 'phone': '3016283313', 'title': 'ACTG Clinicaltrials.gov Coordinator', 'organization': 'ACTG Network Coordinating Center, Social and Scientific Systems, Inc.'}, 'certainAgreement': {'otherDetails': 'In accordance with the Clinical Trials Agreement between NIAID (DAIDS) and company collaborators, NIAID (DAIDS) provides companies with a copy of any abstract, press release, or manuscript prior to submission for publication with sufficient time for company review and comment. The publication/other disclosure can be delayed for up to 30 additional business days for manuscripts and five (5) business days for abstracts, to preserve U.S. or foreign patent or other intellectual property rights', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'From study entry to end of study', 'description': 'The protocol required reporting of all diagnoses, all signs/symptoms/laboratory values Grade ≥ 3, and all diagnoses/signs/symptoms/laboratory values that led to treatment change or met SAE or EAE reporting requirements through Day 65 (Step 1), and all new cancer diagnoses/deaths during the subsequent 240 week long-term safety follow-up (Step 2). For grading, sites referred to the Division of AIDS AE Grading Table, corrected Version 2.1, July 2017.', 'eventGroups': [{'id': 'EG000', 'title': 'Arm A: Tamoxifen + Vorinostat', 'description': 'From Day 0 to Day 38, participants will receive tamoxifen orally once a day. On Days 35 and 38, participants will receive a single dose of vorinostat orally.\n\nTamoxifen: 20 mg orally\n\nVorinostat: 400 mg orally\n\nAntiretroviral drugs: Participants will receive antiretroviral drugs provided by their own doctors. Antiretroviral drugs will not be provided by the study.', 'otherNumAtRisk': 21, 'deathsNumAtRisk': 21, 'otherNumAffected': 3, 'seriousNumAtRisk': 21, 'deathsNumAffected': 1, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Arm B: Vorinostat Alone', 'description': 'Day 0 to Day 38 will be an observation period with no tamoxifen. On Days 35 and 38, participants will receive a single dose of vorinostat orally.\n\nVorinostat: 400 mg orally\n\nAntiretroviral drugs: Participants will receive antiretroviral drugs provided by their own doctors. Antiretroviral drugs will not be provided by the study.', 'otherNumAtRisk': 10, 'deathsNumAtRisk': 10, 'otherNumAffected': 0, 'seriousNumAtRisk': 10, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Hyperglycaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 21, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 10, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'Dysgeusia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 21, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 10, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'Thirst', 'stats': [{'groupId': 'EG000', 'numAtRisk': 21, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 10, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'Metastatic squamous cell carcinoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 21, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 10, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Proportion of Participants With New Grade 3 or Greater Adverse Events', 'denoms': [{'units': 'Participants', 'counts': [{'value': '21', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Arm A: Tamoxifen + Vorinostat', 'description': 'From Day 0 to Day 38, participants will receive tamoxifen orally once a day. On Days 35 and 38, participants will receive a single dose of vorinostat orally.\n\nTamoxifen: 20 mg orally\n\nVorinostat: 400 mg orally\n\nAntiretroviral drugs: Participants will receive antiretroviral drugs provided by their own doctors. Antiretroviral drugs will not be provided by the study.'}, {'id': 'OG001', 'title': 'Arm B: Vorinostat Alone', 'description': 'Day 0 to Day 38 will be an observation period with no tamoxifen. On Days 35 and 38, participants will receive a single dose of vorinostat orally.\n\nVorinostat: 400 mg orally\n\nAntiretroviral drugs: Participants will receive antiretroviral drugs provided by their own doctors. Antiretroviral drugs will not be provided by the study.'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000', 'lowerLimit': '0', 'upperLimit': '0.13'}, {'value': '0', 'groupId': 'OG001', 'lowerLimit': '0', 'upperLimit': '0.28'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Measured from study entry through Day 65', 'description': 'Proportion of participants with new Grade 3 or greater adverse events that are considered definitely, probably, or possibly related to study treatment (as judged by the core protocol team). The DAIDS AE Grading Table (corrected Version 2.1, July 2017) was used.', 'unitOfMeasure': 'proportion of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Enrolled participants who were exposed to study treatment'}, {'type': 'PRIMARY', 'title': 'Change From Baseline in Cell-associated HIV-1 RNA in CD4+ T Cells', 'denoms': [{'units': 'Participants', 'counts': [{'value': '19', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Arm A: Tamoxifen + Vorinostat', 'description': 'From Day 0 to Day 38, participants will receive tamoxifen orally once a day. On Days 35 and 38, participants will receive a single dose of vorinostat orally.\n\nTamoxifen: 20 mg orally\n\nVorinostat: 400 mg orally\n\nAntiretroviral drugs: Participants will receive antiretroviral drugs provided by their own doctors. Antiretroviral drugs will not be provided by the study.'}, {'id': 'OG001', 'title': 'Arm B: Vorinostat Alone', 'description': 'Day 0 to Day 38 will be an observation period with no tamoxifen. On Days 35 and 38, participants will receive a single dose of vorinostat orally.\n\nVorinostat: 400 mg orally\n\nAntiretroviral drugs: Participants will receive antiretroviral drugs provided by their own doctors. Antiretroviral drugs will not be provided by the study.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.06', 'groupId': 'OG000', 'lowerLimit': '-0.24', 'upperLimit': '0.36'}, {'value': '0.17', 'groupId': 'OG001', 'lowerLimit': '-0.15', 'upperLimit': '0.50'}]}]}], 'analyses': [{'pValue': '0.68', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 't-test, 1 sided', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'The hypothesis was that tamoxifen would enhance the HIV transcription effect of vorinostat (i.e., log10 change would be greater in Arm A than Arm B)'}], 'paramType': 'MEAN', 'timeFrame': 'Pre-entry, entry, and Day 38', 'description': 'Baseline is defined as the average of the pre-entry and entry values. Change was calculated as the value of Cell-associated HIV-1 RNA on Day 38 (5 hours post vorinostat) minus the value at baseline.', 'unitOfMeasure': 'log10 copies/million CD4 cells', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Efficacy population'}, {'type': 'SECONDARY', 'title': 'Number of Participants With HIV-1 RNA Levels (Measured by Single Copy Assay) Greater or Equal to the Lower Limit of Quantification', 'denoms': [{'units': 'Participants', 'counts': [{'value': '19', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Arm A: Tamoxifen + Vorinostat', 'description': 'From Day 0 to Day 38, participants will receive tamoxifen orally once a day. On Days 35 and 38, participants will receive a single dose of vorinostat orally.\n\nTamoxifen: 20 mg orally\n\nVorinostat: 400 mg orally\n\nAntiretroviral drugs: Participants will receive antiretroviral drugs provided by their own doctors. Antiretroviral drugs will not be provided by the study.'}, {'id': 'OG001', 'title': 'Arm B: Vorinostat Alone', 'description': 'Day 0 to Day 38 will be an observation period with no tamoxifen. On Days 35 and 38, participants will receive a single dose of vorinostat orally.\n\nVorinostat: 400 mg orally\n\nAntiretroviral drugs: Participants will receive antiretroviral drugs provided by their own doctors. Antiretroviral drugs will not be provided by the study.'}], 'classes': [{'title': 'Pre-entry SCA >= LOQ', 'categories': [{'measurements': [{'value': '10', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}]}]}, {'title': 'Entry SCA >=LOQ', 'categories': [{'measurements': [{'value': '9', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}]}, {'title': 'Day 28 SCA >=LOQ', 'categories': [{'measurements': [{'value': '11', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}]}]}, {'title': 'Day 35 SCA >=LOQ', 'categories': [{'measurements': [{'value': '11', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}]}]}, {'title': 'Day 38 SCA >=LOQ', 'categories': [{'measurements': [{'value': '7', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}]}]}, {'title': 'Day 45 SCA >=LOQ', 'categories': [{'measurements': [{'value': '9', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}]}]}, {'title': 'Day 65 SCA >=LOQ', 'categories': [{'measurements': [{'value': '10', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Pre-entry, entry, Day 28, Day 35, Day 38 (5 hours post vorinostat), Day 45, Day 65', 'description': 'Number of participants with HIV-1 RNA levels measured by single copy assay (SCA) greater or equal to the lower limit of quantification (LOQ). The lower limit of quantification for this study was 0.47 copies/mL.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Efficacy population'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Total HIV-1 DNA Levels in CD4+ T Cells', 'denoms': [{'units': 'Participants', 'counts': [{'value': '19', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Arm A: Tamoxifen + Vorinostat', 'description': 'From Day 0 to Day 38, participants will receive tamoxifen orally once a day. On Days 35 and 38, participants will receive a single dose of vorinostat orally.\n\nTamoxifen: 20 mg orally\n\nVorinostat: 400 mg orally\n\nAntiretroviral drugs: Participants will receive antiretroviral drugs provided by their own doctors. Antiretroviral drugs will not be provided by the study.'}, {'id': 'OG001', 'title': 'Arm B: Vorinostat Alone', 'description': 'Day 0 to Day 38 will be an observation period with no tamoxifen. On Days 35 and 38, participants will receive a single dose of vorinostat orally.\n\nVorinostat: 400 mg orally\n\nAntiretroviral drugs: Participants will receive antiretroviral drugs provided by their own doctors. Antiretroviral drugs will not be provided by the study.'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000', 'lowerLimit': '-0.12', 'upperLimit': '0.13'}, {'value': '-0.04', 'groupId': 'OG001', 'lowerLimit': '-0.33', 'upperLimit': '0.25'}]}]}], 'analyses': [{'pValue': '0.73', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': 'Pre-entry, entry, and Day 38', 'description': 'Baseline is defined as the average of the pre-entry and entry values. Change was calculated as the value of Total HIV-1 DNA on Day 38 (5 hours post vorinostat) minus the value at baseline.', 'unitOfMeasure': 'log10 copies/million CD4 cells', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Efficacy Population'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Arm A: Tamoxifen + Vorinostat', 'description': 'From Day 0 to Day 38, participants will receive tamoxifen orally once a day. On Days 35 and 38, participants will receive a single dose of vorinostat orally.\n\nTamoxifen: 20 mg orally\n\nVorinostat: 400 mg orally\n\nAntiretroviral drugs: Participants will receive antiretroviral drugs provided by their own doctors. Antiretroviral drugs will not be provided by the study.'}, {'id': 'FG001', 'title': 'Arm B: Vorinostat Alone', 'description': 'Day 0 to Day 38 will be an observation period with no tamoxifen. On Days 35 and 38, participants will receive a single dose of vorinostat orally.\n\nVorinostat: 400 mg orally\n\nAntiretroviral drugs: Participants will receive antiretroviral drugs provided by their own doctors. Antiretroviral drugs will not be provided by the study.'}], 'periods': [{'title': 'Step 1', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '21'}, {'groupId': 'FG001', 'numSubjects': '10'}]}, {'type': 'COMPLETED', 'comment': 'Completed Step 1 of the study.', 'achievements': [{'groupId': 'FG000', 'numSubjects': '21'}, {'groupId': 'FG001', 'numSubjects': '9'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}]}], 'dropWithdraws': [{'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}]}]}, {'title': 'Step 2', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '21'}, {'groupId': 'FG001', 'numSubjects': '9'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '17'}, {'groupId': 'FG001', 'numSubjects': '7'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '2'}]}], 'dropWithdraws': [{'type': 'Death', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '2'}]}, {'type': 'Site Terminated by Sponsor', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '21', 'groupId': 'BG000'}, {'value': '10', 'groupId': 'BG001'}, {'value': '31', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Arm A: Tamoxifen + Vorinostat', 'description': 'From Day 0 to Day 38, participants will receive tamoxifen orally once a day. On Days 35 and 38, participants will receive a single dose of vorinostat orally.\n\nTamoxifen: 20 mg orally\n\nVorinostat: 400 mg orally\n\nAntiretroviral drugs: Participants will receive antiretroviral drugs provided by their own doctors. Antiretroviral drugs will not be provided by the study.'}, {'id': 'BG001', 'title': 'Arm B: Vorinostat Alone', 'description': 'Day 0 to Day 38 will be an observation period with no tamoxifen. On Days 35 and 38, participants will receive a single dose of vorinostat orally.\n\nVorinostat: 400 mg orally\n\nAntiretroviral drugs: Participants will receive antiretroviral drugs provided by their own doctors. Antiretroviral drugs will not be provided by the study.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '21', 'groupId': 'BG000'}, {'value': '10', 'groupId': 'BG001'}, {'value': '31', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '57', 'groupId': 'BG000', 'lowerLimit': '54', 'upperLimit': '61'}, {'value': '55', 'groupId': 'BG001', 'lowerLimit': '51', 'upperLimit': '59'}, {'value': '57', 'groupId': 'BG002', 'lowerLimit': '53', 'upperLimit': '60'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'years', 'dispersionType': 'INTER_QUARTILE_RANGE'}, {'title': 'Age, Customized', 'classes': [{'title': 'Age categorized', 'denoms': [{'units': 'Participants', 'counts': [{'value': '21', 'groupId': 'BG000'}, {'value': '10', 'groupId': 'BG001'}, {'value': '31', 'groupId': 'BG002'}]}], 'categories': [{'title': '< 50 years', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}]}, {'title': '50 - 59 years', 'measurements': [{'value': '11', 'groupId': 'BG000'}, {'value': '7', 'groupId': 'BG001'}, {'value': '18', 'groupId': 'BG002'}]}, {'title': '>= 60 years', 'measurements': [{'value': '8', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '10', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Sex: Female, Male', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '21', 'groupId': 'BG000'}, {'value': '10', 'groupId': 'BG001'}, {'value': '31', 'groupId': 'BG002'}]}], 'categories': [{'title': 'Female', 'measurements': [{'value': '21', 'groupId': 'BG000'}, {'value': '10', 'groupId': 'BG001'}, {'value': '31', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '21', 'groupId': 'BG000'}, {'value': '10', 'groupId': 'BG001'}, {'value': '31', 'groupId': 'BG002'}]}], 'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '6', 'groupId': 'BG002'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '17', 'groupId': 'BG000'}, {'value': '8', 'groupId': 'BG001'}, {'value': '25', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '21', 'groupId': 'BG000'}, {'value': '10', 'groupId': 'BG001'}, {'value': '31', 'groupId': 'BG002'}]}], 'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}, {'title': 'Asian', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Black or African American', 'measurements': [{'value': '11', 'groupId': 'BG000'}, {'value': '7', 'groupId': 'BG001'}, {'value': '18', 'groupId': 'BG002'}]}, {'title': 'White', 'measurements': [{'value': '9', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '12', 'groupId': 'BG002'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'Puerto Rico', 'denoms': [{'units': 'Participants', 'counts': [{'value': '21', 'groupId': 'BG000'}, {'value': '10', 'groupId': 'BG001'}, {'value': '31', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}]}, {'title': 'United States', 'denoms': [{'units': 'Participants', 'counts': [{'value': '21', 'groupId': 'BG000'}, {'value': '10', 'groupId': 'BG001'}, {'value': '31', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '20', 'groupId': 'BG000'}, {'value': '10', 'groupId': 'BG001'}, {'value': '30', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Baseline Cell-associated HIV-1 RNA', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '19', 'groupId': 'BG000'}, {'value': '8', 'groupId': 'BG001'}, {'value': '27', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '1.81', 'groupId': 'BG000', 'lowerLimit': '1.38', 'upperLimit': '2.49'}, {'value': '2.5', 'groupId': 'BG001', 'lowerLimit': '2.01', 'upperLimit': '3.15'}, {'value': '2.17', 'groupId': 'BG002', 'lowerLimit': '1.56', 'upperLimit': '2.69'}]}]}], 'paramType': 'MEDIAN', 'description': 'Baseline cell-associated HIV-1 RNA levels (CA-RNA) (log10 copies/mL) were measured in CD4 T-cells. Baseline CA-RNA was calculated as the average of the pre-entry and entry CA-RNA results.', 'unitOfMeasure': 'log10 copies/million CD4 cells', 'dispersionType': 'INTER_QUARTILE_RANGE', 'populationDescription': 'CA-RNA analyses were performed on the efficacy population, defined as the subset of enrolled participants who received full study treatment and did not have ART interruption or confirmed viral load (VL) \\>= 200 copies/mL. The definition was expanded by team to exclude 2 participants; one with high pre-entry VL and one with wrong timing of samples.'}], 'populationDescription': 'All enrolled participants'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2017-12-08', 'size': 1111896, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_001.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2019-12-02T12:46', 'hasProtocol': True}, {'date': '2019-09-10', 'size': 189524, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_000.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2019-11-19T14:58', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 31}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-04-26', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-08', 'completionDateStruct': {'date': '2023-07-27', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-06-06', 'studyFirstSubmitDate': '2017-12-19', 'resultsFirstSubmitDate': '2019-12-02', 'studyFirstSubmitQcDate': '2017-12-19', 'lastUpdatePostDateStruct': {'date': '2024-07-03', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2019-12-02', 'studyFirstPostDateStruct': {'date': '2017-12-26', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2019-12-18', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-12-04', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Proportion of Participants With New Grade 3 or Greater Adverse Events', 'timeFrame': 'Measured from study entry through Day 65', 'description': 'Proportion of participants with new Grade 3 or greater adverse events that are considered definitely, probably, or possibly related to study treatment (as judged by the core protocol team). The DAIDS AE Grading Table (corrected Version 2.1, July 2017) was used.'}, {'measure': 'Change From Baseline in Cell-associated HIV-1 RNA in CD4+ T Cells', 'timeFrame': 'Pre-entry, entry, and Day 38', 'description': 'Baseline is defined as the average of the pre-entry and entry values. Change was calculated as the value of Cell-associated HIV-1 RNA on Day 38 (5 hours post vorinostat) minus the value at baseline.'}], 'secondaryOutcomes': [{'measure': 'Number of Participants With HIV-1 RNA Levels (Measured by Single Copy Assay) Greater or Equal to the Lower Limit of Quantification', 'timeFrame': 'Pre-entry, entry, Day 28, Day 35, Day 38 (5 hours post vorinostat), Day 45, Day 65', 'description': 'Number of participants with HIV-1 RNA levels measured by single copy assay (SCA) greater or equal to the lower limit of quantification (LOQ). The lower limit of quantification for this study was 0.47 copies/mL.'}, {'measure': 'Change From Baseline in Total HIV-1 DNA Levels in CD4+ T Cells', 'timeFrame': 'Pre-entry, entry, and Day 38', 'description': 'Baseline is defined as the average of the pre-entry and entry values. Change was calculated as the value of Total HIV-1 DNA on Day 38 (5 hours post vorinostat) minus the value at baseline.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['HIV Infections']}, 'referencesModule': {'references': [{'pmid': '35176755', 'type': 'DERIVED', 'citation': 'Scully EP, Aga E, Tsibris A, Archin N, Starr K, Ma Q, Morse GD, Squires KE, Howell BJ, Wu G, Hosey L, Sieg SF, Ehui L, Giguel F, Coxen K, Dobrowolski C, Gandhi M, Deeks S, Chomont N, Connick E, Godfrey C, Karn J, Kuritzkes DR, Bosch RJ, Gandhi RT. Impact of Tamoxifen on Vorinostat-Induced Human Immunodeficiency Virus Expression in Women on Antiretroviral Therapy: AIDS Clinical Trials Group A5366, The MOXIE Trial. Clin Infect Dis. 2022 Oct 12;75(8):1389-1396. doi: 10.1093/cid/ciac136.'}], 'seeAlsoLinks': [{'url': 'https://rsc.niaid.nih.gov/clinical-research-sites/daids-adverse-event-grading-tables', 'label': 'Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), corrected Version 2.1, July 2017'}]}, 'descriptionModule': {'briefSummary': 'This study evaluated the effects of tamoxifen exposure in combination with vorinostat on viral reactivation among HIV-1 infected post-menopausal women with virologic suppression on antiretroviral therapy (ART), when compared to vorinostat alone.', 'detailedDescription': 'The selective estrogen receptor modulator (SERM) tamoxifen may enhance the ability of the histone deacetylase inhibitor (HDACi) vorinostat to reverse HIV-1 latency. This study evaluated the safety of tamoxifen therapy combined with vorinostat and the effectiveness of this combination on latent virus reactivation in HIV-1 infected post-menopausal women with virologic suppression on antiretroviral therapy, when compared to vorinostat alone.\n\nThe study was conducted in two steps. During Step 1, the study enrolled women with HIV into two groups. Arm A received tamoxifen daily for 38 days, plus a single dose of vorinostat on Days 35 and 38. Arm B had a 38-day observation period with no tamoxifen, plus a single dose of vorinostat on Days 35 and 38. All participants continued to take ART drugs prescribed by their doctors. ART drugs were not be provided by the study.\n\nStudy visits during Step 1 occurred at Days 0, 28, 35, 38, 45, and 65. Study visits could include physical examinations, blood collection, electrocardiograms, and adherence assessments.\n\nDuring Step 2, all participants were followed for 240 additional weeks for annual long-term safety follow-up. These visits were conducted by phone and collected information from participants on vital status and any new cancer diagnoses.\n\nStep 1 and Step 2 have been completed and this results submission pertains to both.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* HIV-1 infection\n* Postmenopausal at study entry with agreement not to participate in assisted reproductive technology in the future.\n* CD4+ cell count greater than 300 cells/uL obtained within 90 days prior to study entry.\n* Continuous antiretroviral therapy (ART) for at least 2 years prior to enrollment with no known interruption in therapy for greater than 7 days within 90 days prior to study entry.\n* Plasma HIV-1 RNA level of less than 20 copies/mL obtained by Roche HIV-1 viral load assay or less than 40 copies/mL obtained by the Abbott assay, within 90 days prior to study entry.\n* Ability and willingness of potential participant to provide written informed consent.\n\nExclusion Criteria:\n\n* History of venous thromboembolism.\n* History of stroke.\n* Known history of hypercoagulable state.\n* Tobacco smoking or e-cigarette use within 90 days prior to study entry.\n* History of any malignancy requiring systemic chemotherapy or systemic immunotherapy.\n* History of endometrial or breast cancer or known genetic testing with BRCA positive results indicating an increased risk for breast and ovarian cancer.\n* Use of immunomodulators (e.g., interleukins, interferons, cyclosporine), HIV vaccine, or investigational therapy within 60 days prior to study entry.\n* Any systemic hormonal therapy defined as oral or injectable contraceptives, estrogen and combined estrogen-progesterone replacement therapy in the prior 12 months, or a hormone containing intrauterine device (IUD) within 6 months prior to study entry.\n* Known allergy/sensitivity or any hypersensitivity to components of study drugs or their formulations.'}, 'identificationModule': {'nctId': 'NCT03382834', 'briefTitle': 'Selective Estrogen Receptor Modulators to Enhance the Efficacy of Viral Reactivation With Histone Deacetylase Inhibitors', 'organization': {'class': 'NIH', 'fullName': 'National Institute of Allergy and Infectious Diseases (NIAID)'}, 'officialTitle': 'Selective Estrogen Receptor Modulators to Enhance the Efficacy of Viral Reactivation With Histone Deacetylase Inhibitors', 'orgStudyIdInfo': {'id': 'ACTG A5366'}, 'secondaryIdInfos': [{'id': '38190', 'type': 'REGISTRY', 'domain': 'DAIDS-ES Registry Number'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Arm A: Tamoxifen + Vorinostat', 'description': 'From Day 0 to Day 38, participants will receive tamoxifen orally once a day. On Days 35 and 38, participants will receive a single dose of vorinostat orally.', 'interventionNames': ['Drug: Tamoxifen', 'Drug: Vorinostat', 'Drug: Antiretroviral drugs']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Arm B: Vorinostat alone', 'description': 'Day 0 to Day 38 will be an observation period with no tamoxifen. On Days 35 and 38, participants will receive a single dose of vorinostat orally.', 'interventionNames': ['Drug: Vorinostat', 'Drug: Antiretroviral drugs']}], 'interventions': [{'name': 'Tamoxifen', 'type': 'DRUG', 'description': '20 mg orally', 'armGroupLabels': ['Arm A: Tamoxifen + Vorinostat']}, {'name': 'Vorinostat', 'type': 'DRUG', 'description': '400 mg orally', 'armGroupLabels': ['Arm A: Tamoxifen + Vorinostat', 'Arm B: Vorinostat alone']}, {'name': 'Antiretroviral drugs', 'type': 'DRUG', 'description': 'Participants will receive antiretroviral drugs provided by their own doctors. Antiretroviral drugs will not be provided by the study.', 'armGroupLabels': ['Arm A: Tamoxifen + Vorinostat', 'Arm B: Vorinostat alone']}]}, 'contactsLocationsModule': {'locations': [{'zip': '35294', 'city': 'Birmingham', 'state': 'Alabama', 'country': 'United States', 'facility': 'Alabama CRS', 'geoPoint': {'lat': 33.52066, 'lon': -86.80249}}, {'zip': '90035', 'city': 'Los Angeles', 'state': 'California', 'country': 'United States', 'facility': 'UCLA CARE Center CRS', 'geoPoint': {'lat': 34.05223, 'lon': -118.24368}}, {'zip': '94110', 'city': 'San Francisco', 'state': 'California', 'country': 'United States', 'facility': 'Ucsf Hiv/Aids Crs', 'geoPoint': {'lat': 37.77493, 'lon': -122.41942}}, {'zip': '90502', 'city': 'Torrance', 'state': 'California', 'country': 'United States', 'facility': 'Harbor-UCLA CRS', 'geoPoint': {'lat': 33.83585, 'lon': -118.34063}}, {'zip': '80045', 'city': 'Aurora', 'state': 'Colorado', 'country': 'United States', 'facility': 'University of Colorado Hospital CRS', 'geoPoint': {'lat': 39.72943, 'lon': -104.83192}}, {'zip': '20005', 'city': 'Washington D.C.', 'state': 'District of Columbia', 'country': 'United States', 'facility': 'Whitman-Walker Health CRS', 'geoPoint': {'lat': 38.89511, 'lon': -77.03637}}, {'zip': '30308-2012', 'city': 'Atlanta', 'state': 'Georgia', 'country': 'United States', 'facility': 'The Ponce de Leon Center CRS', 'geoPoint': {'lat': 33.749, 'lon': -84.38798}}, {'zip': '60611', 'city': 'Chicago', 'state': 'Illinois', 'country': 'United States', 'facility': 'Northwestern University CRS', 'geoPoint': {'lat': 41.85003, 'lon': -87.65005}}, {'zip': '02114', 'city': 'Boston', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'Massachusetts General Hospital CRS (MGH CRS)', 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}, {'zip': '07103', 'city': 'Newark', 'state': 'New Jersey', 'country': 'United States', 'facility': 'New Jersey Medical School Clinical Research Center CRS', 'geoPoint': {'lat': 40.73566, 'lon': -74.17237}}, {'zip': '27599', 'city': 'Chapel Hill', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Chapel Hill CRS', 'geoPoint': {'lat': 35.9132, 'lon': -79.05584}}, {'zip': '27401', 'city': 'Greensboro', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Greensboro CRS', 'geoPoint': {'lat': 36.07264, 'lon': -79.79198}}, {'zip': '45219', 'city': 'Cincinnati', 'state': 'Ohio', 'country': 'United States', 'facility': 'Cincinnati Clinical Research Site', 'geoPoint': {'lat': 39.12711, 'lon': -84.51439}}, {'zip': '19104', 'city': 'Philadelphia', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'Penn Therapeutics, CRS', 'geoPoint': {'lat': 39.95238, 'lon': -75.16362}}, {'zip': '00935', 'city': 'San Juan', 'country': 'Puerto Rico', 'facility': 'Puerto Rico AIDS Clinical Trials Unit CRS', 'geoPoint': {'lat': 18.46633, 'lon': -66.10572}}], 'overallOfficials': [{'name': 'Rajesh Gandhi, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'Massachusetts General Hospital (MGH) CRS'}, {'name': 'Eileen Scully, MD, PhD', 'role': 'STUDY_CHAIR', 'affiliation': 'Johns Hopkins University'}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL', 'SAP'], 'timeFrame': 'Beginning 3 months following publication and available throughout period of funding of the AIDS Clinical Trials Group by the NIH.', 'ipdSharing': 'YES', 'description': 'Individual participant data that underlie results in the publication, after deidentification.', 'accessCriteria': 'With whom?\n\nResearchers who provide a methodologically sound proposal for use of the data that is approved by the AIDS Clinical Trials Group.\n\nFor what types of analyses?\n\nTo achieve aims in the proposal approved by the AIDS Clinical Trials Group. By what mechanism will data be made available?\n\nResearchers may submit a request for access to data using the AIDS Clinical Trials Group "Data Request" form at: https://submit.mis.s-3.net/. Researchers of approved proposals will need to sign an AIDS Clinical Trials Group Data Use Agreement before receiving the data."'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'National Institute of Allergy and Infectious Diseases (NIAID)', 'class': 'NIH'}, 'responsibleParty': {'type': 'SPONSOR'}}}}