Primary Outcome Measures:
- Assess proportion of participants with HIV RNA levels <50 and < 400 copies/mL. [ Time Frame: week 48 ]
Secondary Outcome Measures:
- Assess proportion of participants with HIV RNA < 50 and <400 copies/ml. [ Time Frame: week 24 ]
- Assess the proportion of participants at study termination with VL < 50 copies/ml. [ Time Frame: week 48 ]
- Determine the time to viral suppression (VL < 50 copies/ml). [ Time Frame: 48 weeks ]
- Determine the median change in VL from baseline to week 24, to week 48 and to study termination. [ Time Frame: week 24, week 48 ]
- Assess the changes in CD4+ T cell count. [ Time Frame: week 24, 48 ]
- Assess development of HIV resistance mutations and in HIV co-receptor tropism changes in participants who develop virologic rebound. [ Time Frame: week 48 ]
- Assess safety and tolerability including any lipid changes. [ Time Frame: week 48 ]
As patients with HIV are living longer it is important to explore antiretroviral treatments which may reduce the development of long term complications while preserving future HIV treatment options. This trial explores an antiretroviral treatment regimen which does not include the nucleoside reverse transcriptase inhibitor class which is thought to have long-term toxicity. This is a non-randomized, open label trial in participants meeting entry requirements.
Participants will be evaluated at screening, baseline,and weeks 4, 8, 12, 24, 36, and 48 to include clinical assessments as well as laboratory assessments.
An interim analysis will be performed when all patients have reached the week 24 visit.
