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

Part of paid clinical trials in Birmingham, Alabama.

Sponsor
National Institute of Allergy and Infectious Diseases (NIAID)
Study ID
NCT03382834
Phase
PHASE2
Status
Completed

Conditions

Eligibility Criteria

Sex
FEMALE
Age
18 Years - 65 Years
Healthy Volunteers
Not accepted

Interventions

  • Tamoxifen — DRUG
    20 mg orally
  • Vorinostat — DRUG
    400 mg orally
  • Antiretroviral drugs — DRUG
    Participants will receive antiretroviral drugs provided by their own doctors. Antiretroviral drugs will not be provided by the study.

Study Details

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.

Key Dates

Start date
Apr 26, 2018
Status verified
Aug 2023
Primary completion
Dec 4, 2018
Completion
Jul 27, 2023

Study Design

Enrollment
31 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Arm A: Tamoxifen + Vorinostat
    From Day 0 to Day 38, participants will receive tamoxifen orally once a day. On Days 35 and 38, participants will receive a single dose of vorinostat orally.
  • Active Comparator: Arm B: Vorinostat alone
    Day 0 to Day 38 will be an observation period with no tamoxifen. On Days 35 and 38, participants will receive a single dose of vorinostat orally.

Primary Outcome Measure

Proportion of Participants With New Grade 3 or Greater Adverse Events [ Time Frame: Measured from study entry through Day 65 ]

Locations (14)

FacilityCityStateZIPSite coordinators
Alabama CRSBirminghamAlabama35294-
UCLA CARE Center CRSLos AngelesCalifornia90035-
Ucsf Hiv/Aids CrsSan FranciscoCalifornia94110-
Harbor-UCLA CRSTorranceCalifornia90502-
University of Colorado Hospital CRSAuroraColorado80045-
Whitman-Walker Health CRSWashington D.C.District of Columbia20005-
The Ponce de Leon Center CRSAtlantaGeorgia30308-2012-
Northwestern University CRSChicagoIllinois60611-
Massachusetts General Hospital CRS (MGH CRS)BostonMassachusetts02114-
New Jersey Medical School Clinical Research Center CRSNewarkNew Jersey07103-
Chapel Hill CRSChapel HillNorth Carolina27599-
Greensboro CRSGreensboroNorth Carolina27401-
Cincinnati Clinical Research SiteCincinnatiOhio45219-
Penn Therapeutics, CRSPhiladelphiaPennsylvania19104-

Find similar trials in Birmingham, AL

By condition
HIV
By specialty
Infectious disease
By research site
Alabama CRS· Birmingham, ALUCLA CARE Center CRS· Los Angeles, CAUcsf Hiv/Aids Crs· San Francisco, CAHarbor-UCLA CRS· Torrance, CAUniversity of Colorado Hospital CRS· Aurora, COWhitman-Walker Health CRS· Washington D.C., DC

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