The Effect of Vorinostat on HIV RNA Expression in the Resting CD4+ T Cells of HIV+ Pts on Stable ART

Conditions

• HIV-1 Infection

Eligibility Criteria

Sex

ALL

Age

18 Years - 65 Years

Healthy Volunteers

Not accepted

Interventions

• Vorinostat — DRUG
  Vorinostat (VOR) 400mg will be given as single doses by mouth. Participants eligible to advance in study will have opportunity to receive more than one dose of VOR. Each participant will only take one dose of VOR in a 24 hour period. Repeat doses will be administered at least 24 hours apart, with option for dosing at intervals up to 96 hour

Study Details

The purpose of this study is to compare HIV RNA expression and infection within resting (CD4)+ cells in HIV-infected patients on stable ART before and after a single exposure to Vorinostat (VOR), after exposure to short intervals of VOR, and after repeated short interval exposure to VOR dosed over several weeks. Hypotheses: 1. The frequency of resting CD4+ T cell- associated HIV RNA (RCVL) will be increased following single and repeated exposure to VOR when given at appropriate intervals, and 2. That repeated exposure to VOR will reduce the frequency of HIV infection within resting CD4+ T cells (RCI)

Key Dates

Start date

Feb 28, 2011

Status verified

Apr 2017

Primary completion

Mar 31, 2016

Completion

Mar 31, 2016

Study Design

Enrollment

25 participants (actual)

Allocation

NA

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Arms

• Experimental: Open Label, Translational Research
  Vorinostat will be administered to all eligible participants in each step of each phase (period) of the study

Primary Outcome Measure

Number of Participants Exhibiting an in Vivo Resting CD4+ T Cell- Associated HIV RNA (RCVL) Increase After Receiving a Single Dose of VOR 400 mg PO [ Time Frame: Arm1: Baseline, Visit 5 and Arm 2: Baseline and Visit 3 ]

Locations (1)

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