Selective Estrogen Receptor Modulators to Enhance the Efficacy of Viral Reactivation With Histone Deacetylase Inhibitors
NCT ID: NCT03382834
Last Updated: 2024-07-03
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
31 participants
INTERVENTIONAL
2018-04-26
2023-07-27
Brief Summary
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Detailed Description
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The 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.
Study 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.
During 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.
Step 1 and Step 2 have been completed and this results submission pertains to both.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Arm A: Tamoxifen + Vorinostat
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.
Tamoxifen
20 mg orally
Vorinostat
400 mg orally
Antiretroviral drugs
Participants will receive antiretroviral drugs provided by their own doctors. Antiretroviral drugs will not be provided by the study.
Arm B: Vorinostat alone
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.
Vorinostat
400 mg orally
Antiretroviral drugs
Participants will receive antiretroviral drugs provided by their own doctors. Antiretroviral drugs will not be provided by the study.
Interventions
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Tamoxifen
20 mg orally
Vorinostat
400 mg orally
Antiretroviral drugs
Participants will receive antiretroviral drugs provided by their own doctors. Antiretroviral drugs will not be provided by the study.
Eligibility Criteria
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Inclusion Criteria
* Postmenopausal at study entry with agreement not to participate in assisted reproductive technology in the future.
* CD4+ cell count greater than 300 cells/uL obtained within 90 days prior to study entry.
* 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.
* 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.
* Ability and willingness of potential participant to provide written informed consent.
Exclusion Criteria
* History of stroke.
* Known history of hypercoagulable state.
* Tobacco smoking or e-cigarette use within 90 days prior to study entry.
* History of any malignancy requiring systemic chemotherapy or systemic immunotherapy.
* History of endometrial or breast cancer or known genetic testing with BRCA positive results indicating an increased risk for breast and ovarian cancer.
* Use of immunomodulators (e.g., interleukins, interferons, cyclosporine), HIV vaccine, or investigational therapy within 60 days prior to study entry.
* 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.
* Known allergy/sensitivity or any hypersensitivity to components of study drugs or their formulations.
18 Years
65 Years
FEMALE
No
Sponsors
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National Institute of Allergy and Infectious Diseases (NIAID)
NIH
Responsible Party
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Principal Investigators
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Rajesh Gandhi, MD
Role: STUDY_CHAIR
Massachusetts General Hospital (MGH) CRS
Eileen Scully, MD, PhD
Role: STUDY_CHAIR
Johns Hopkins University
Locations
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Alabama CRS
Birmingham, Alabama, United States
UCLA CARE Center CRS
Los Angeles, California, United States
Ucsf Hiv/Aids Crs
San Francisco, California, United States
Harbor-UCLA CRS
Torrance, California, United States
University of Colorado Hospital CRS
Aurora, Colorado, United States
Whitman-Walker Health CRS
Washington D.C., District of Columbia, United States
The Ponce de Leon Center CRS
Atlanta, Georgia, United States
Northwestern University CRS
Chicago, Illinois, United States
Massachusetts General Hospital CRS (MGH CRS)
Boston, Massachusetts, United States
New Jersey Medical School Clinical Research Center CRS
Newark, New Jersey, United States
Chapel Hill CRS
Chapel Hill, North Carolina, United States
Greensboro CRS
Greensboro, North Carolina, United States
Cincinnati Clinical Research Site
Cincinnati, Ohio, United States
Penn Therapeutics, CRS
Philadelphia, Pennsylvania, United States
Puerto Rico AIDS Clinical Trials Unit CRS
San Juan, , Puerto Rico
Countries
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References
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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.
Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Related Links
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Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), corrected Version 2.1, July 2017
Other Identifiers
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38190
Identifier Type: REGISTRY
Identifier Source: secondary_id
ACTG A5366
Identifier Type: -
Identifier Source: org_study_id
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