Safety and Effect on HIV Transcription of Vorinostat in Patients Receiving Suppressive Combination Anti-retroviral Therapy

Sponsor
Bayside Health
Study ID
NCT01365065
Phase
PHASE2
Status
Unknown

Conditions

  • HIV Positive

Eligibility Criteria

Sex
ALL
Age
18 Years - 60 Years
Healthy Volunteers
Not accepted

Interventions

  • Vorinostat — DRUG
    Vorinostat 400mg (4 x 100mg) orally daily for 14 days

Study Details

The objective of the study is to assess the safety and ability of vorinostat, a drug currently licensed for the treatment of a type of lymphoma, to 'turn on' dormant HIV infected CD4 T-cells.

Key Dates

Start date
May 31, 2011
Status verified
Apr 2017
Primary completion
Dec 31, 2011
Completion
Jan 31, 2018

Study Design

Enrollment
20 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Vorinostat
    Vorinostat 400mg ( 4 X 100mg ) orally daily for 14 days

Primary Outcome Measure

To evaluate the effect of vorinostat on HIV transcription in CD4 T-cells. [ Time Frame: Day 1 (before drug, 2 and 8 hours after first dose), Day 2, 7, 14, 21 and 28 ]

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