A5366: Selective Estrogen Receptor Modulators to Enhance the Efficacy of Viral Reactivation with Histone Deacetylase Inhibitors

Q:

Randomized, open-label, exploratory study assessing the effects of tamoxifen exposure in combination with vorinostat compared to vorinostat alone on viral reactivation among HIV-1 infected post-menopausal women with virologic suppression on antiretroviral therapy (ART).

POP:

30 (20 participants in Arm A, 10 participants in Arm B) HIV-1-infected post-menopausal women (age 18-65) with virologic suppression on ART.

MED:

Arm A:

Days 0-38: Tamoxifen 20 mg orally (PO) once a day (QD)

Day 35: Vorinostat 400 mg PO x 1

Day 38: Vorinostat 400 mg PO x 1

Day 39-65: Observation

Arm B:

Days 0-38: Observation period (no tamoxifen)

Day 35: Vorinostat 400 mg PO x 1

Day 38: Vorinostat 400 mg PO x 1

Day 39-65: Observation

DUR:

65 days per participant.

CALL:

Erin Hoffman, 919-843-0720 or Susan Blevins, ANP-C, 919-843-8763