Selective Estrogen Receptor Modulators to Enhance the Efficacy of Viral Reactivation With Histone… (NCT03382834) | Clinical Trial Compass
CompletedPhase 2
Selective Estrogen Receptor Modulators to Enhance the Efficacy of Viral Reactivation With Histone Deacetylase Inhibitors
United States31 participantsStarted 2018-04-26
Plain-language 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.
Who can participate
Age range18 Years – 65 Years
SexFEMALE
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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 …
What they're measuring
1
Proportion of Participants With New Grade 3 or Greater Adverse Events
Timeframe: Measured from study entry through Day 65
2
Change From Baseline in Cell-associated HIV-1 RNA in CD4+ T Cells
Timeframe: Pre-entry, entry, and Day 38
Trial details
NCT IDNCT03382834
SponsorNational Institute of Allergy and Infectious Diseases (NIAID)