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

• Status: Completed
• Trial end date: 2016-03-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: South East Asia Research Collaboration with Hawaii
• Collaborators: Cooper Human Systems; The Thai Red Cross AIDS Research Centre
• Treatments: Darunavir; Efavirenz; Emtricitabine; HIV Protease Inhibitors; Hydroxychloroquine; Maraviroc; Protease Inhibitors; Tenofovir; Vorinostat

Criteria

Inclusion Criteria:

• HIV-1 infected adults 18-60 years

• Initiated ART during acute HIV infection period, defined serologically as up to a positive but incomplete profile by Western blot and has been on ART for at least 42 weeks

• HIV RNA <50 copies/ml within the past 7 months (28 weeks)

• CD4 cell count ≥ 450 cells/μl on at least 2 occasions during the past 6 months

• Informed consent

Exclusion Criteria:

• Any significant medical illness in the past 12 weeks

• Any evidence of AIDS-defining opportunistic infection

• Current or gastrointestinal disease that may impact absorption of the study drug

• ALT or AST >3X upper limit of normal

• Hemoglobin, white blood cell counts or platelets ≥ grade 2 by US NIH DAIDS grading system

• History of diabetes or fasting glucose >126mg/dl

• Documented hepatitis B infection as indicated by the presence of HBsAG

• History of clinically significant cardiac disease or clinically significant EKG abnormalities

• History of retinal disease

• History of malignancy

• Females who are pregnant or with a positive urine pregnancy test during screening or women of child bearing potential who are unwilling to use an acceptable method of contraception to avoid pregnancy for 4 weeks before, during the study and 4 weeks after the study