Efficacy of VHM After Treatment Interruption in Subjects Initiating ART During Acute HIV Infection
Acute HIV Infection
About this trial
This is an interventional treatment trial for Acute HIV Infection focused on measuring Treatment interruption, Controlling HIV
Eligibility 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
Sites / Locations
- SEARCH, the Thai Red Cross AIDS Research Centre
Arms of the Study
Arm 1
Arm 2
Experimental
Active Comparator
ART + VHM
ART alone
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.
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.