Phase 2
Completed N=31
Selective Estrogen Receptor Modulators to Enhance the Efficacy of Viral Reactivation With Histone Deacetylase Inhibitors
Source: ClinicalTrials.gov NCT03382834 ↗Enrolled (actual)
31
Serious AEs
0.0%
Results posted
Dec 2019
Primary outcomePrimary: Proportion of Participants With New Grade 3 or Greater Adverse Events — 0; 0 proportion of participants
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Proportion of Participants With New Grade 3 or Greater Adverse Events |
0; 0 | — |
| PRIMARY Change From Baseline in Cell-associated HIV-1 RNA in CD4+ T Cells |
0.06; 0.17 | 0.68 |
| SECONDARY Number of Participants With HIV-1 RNA Levels (Measured by Single Copy Assay) Greater or Equal to the Lower Limit of Quantification |
10; 6; 9; 3; 11; 4 | — |
| SECONDARY Change From Baseline in Total HIV-1 DNA Levels in CD4+ T Cells |
0; -0.04 | 0.73 |
Eligibility 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.
Data sourced from ClinicalTrials.gov (NCT03382834). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.