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

This is an interventional treatment trial for HIV Infections Read More

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.