Selective Estrogen Receptor Modulators to Enhance the Efficacy of Viral Reactivation With Histone Deacetylase Inhibitors

Completed · Phase 2

Conditions studied: HIV Infections

In brief

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.

Key facts

Study ID

NCT03382834

Run by

National Institute of Allergy and Infectious Diseases (NIAID)

People needed

31

Starts

2018-04-26

Expected to finish

2023-07-27

Last updated by the study team

2024-07-03

Who can join

Age: 18 and older, up to 65. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• HIV-1 infection
• 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.

You may not qualify if…

• History of venous thromboembolism.
• 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.

Where it is running

• 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

Full record on ClinicalTrials.gov

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