Efficacy of VHM After Treatment Interruption in Subjects Initiating ART During Acute HIV Infection

Sponsor
SEARCH Research Foundation
Study ID
NCT02475915
Phase
PHASE1/PHASE2
Status
Completed

Conditions

  • Acute HIV Infection

Eligibility Criteria

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

Interventions

  • Vorinostat — DRUG
    Vorinostat (suberoylanilide hydroxamic acid) inhibits histone deacetylases class I and II. Vorinostat is supplied as 100mg capsules and will be administered at 400mg/ day in 2 week cycles beginning at week 0 for 10 weeks - 42 doses.
  • Hydroxychloroquine — DRUG
    Hydroxychloroquine is supplied as 200mg tablets and will be administered at week 0 for 10 weeks
  • Maraviroc — DRUG
    Maraviroc will be administered at 150 to 600mg/ml twice daily depending on the subject's ART regimen at week 0 for 10 weeks
  • Tenofovir — DRUG
    NRTI. Tenofovir will be administered at 300mg 1 X day at week 0 for 10 weeks
  • Emtricitabine — DRUG
    NRTI. Emtricitabine will be administered at 200mg 1 X day at week 0 for 10 weeks
  • Efavirenz — DRUG
    NNRTI. Efavirenz will be administered at 600 mg 1 X day at week 0 for 10 weeks
  • Darunavir — DRUG
    Protease Inhibitor. Darunavir will be administered at a dose of 900mg 1 X day for subjects on NNRTI based ART beginning at week 8 until week 10

Study Details

This study is a two-arm prospective 1:1 randomised controlled trial comparing the proportion of patients between: Group 1: vorinostat/hydroxychloroquine/maraviroc (VHM) co-administered with anti-retroviral therapy (ART) Group 2: ART only who are able to maintain HIV RNA \< 50 copies/ml following treatment interruption. Subjects will be recruited from RV254/SEARCH 010, an acute HIV infection cohort conducted by the Thai Red Cross AIDS Research Centre in Bangkok, Thailand. The study will run for a minimum of 34 weeks from screening.

Key Dates

Start date
Jan 31, 2015
Status verified
Jun 2023
Primary completion
Nov 30, 2015
Completion
Mar 31, 2016

Study Design

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

Arms

  • Experimental: ART + VHM
    Group 1: Combination Antiretroviral Therapy prescribed at week 0 for a period of 10 weeks. Likely consisting of two NRTI such as tenofovir and emtricitabine and an NNRTI, such as efavirenz. For subjects on NNRTI therapy, a protease inhibitor, such as darunavir will be substituted for the NNRTI 2 weeks prior to treatment interruption. Plus: 3 X 14-day cycles of vorinostat administered at weeks 0, 4 and 8; hydroxychloroquine and maraviroc prescribed at week 0 for a period of 10 weeks.
  • Active Comparator: ART alone
    Group 2: Combination Antiretroviral Therapy prescribed at week 0 for a period of 10 weeks. Likely consisting of two NRTI such as tenofovir and emtricitabine and either an NNRTI, such as efavirenz. For subjects on NNRTI therapy, a protease inhibitor, such as darunavir will be substituted for the NNRTI 2 weeks prior to treatment interruption.

Primary Outcome Measure

Proportion of patients with HIV RNA < 50 copies/ml following ART interruption [ Time Frame: 24 weeks ]

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