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

Summary

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.

Conditions

• Acute HIV Infection

Interventions

DRUG

Vorinostat

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.

DRUG

Hydroxychloroquine

Hydroxychloroquine is supplied as 200mg tablets and will be administered at week 0 for 10 weeks

DRUG

Maraviroc

Maraviroc will be administered at 150 to 600mg/ml twice daily depending on the subject's ART regimen at week 0 for 10 weeks

DRUG

Tenofovir

NRTI. Tenofovir will be administered at 300mg 1 X day at week 0 for 10 weeks

DRUG

Emtricitabine

NRTI. Emtricitabine will be administered at 200mg 1 X day at week 0 for 10 weeks

DRUG

Efavirenz

NNRTI. Efavirenz will be administered at 600 mg 1 X day at week 0 for 10 weeks

DRUG

Darunavir

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

Sponsors & Collaborators

• The Thai Red Cross AIDS Research Centre

  collaborator UNKNOWN

• Cooper Human Systems

  collaborator INDUSTRY

• SEARCH Research Foundation

  lead OTHER

Principal Investigators

• Somchai Sriplienchan, MD, MPH · SEARCH Research Foundation

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

60 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2015-01-31

Primary Completion

2015-11-30

Completion

2016-03-31

Countries

• Thailand

Study Locations