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

• Status: Active, not recruiting
• Trial end date: 2023-06-30
• Target enrollment: 0
• Participant gender: Female

Summary

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: National Institute of Allergy and Infectious Diseases (NIAID)
• Treatments: Anti-Retroviral Agents; Tamoxifen; Vorinostat

Criteria

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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.