ABC may produce a significant antiviral effect when used as an intensification agent in patients on a stable antiretroviral regimen. The results of this study will offer insight into the potential benefits of early treatment intensification. Patients completing 12 weeks of treatment continue on study for an additional 24 weeks to Week 36.
Patients discontinue treatment if virologic failure occurs at any time.
Patients still return to the clinic for HIV-1 RNA measurements at Weeks 12 and 36, depending on when discontinuation occurred. Plasma samples for population sequencing of HIV-1 PR and RT genes are collected on all patients at study entry and at the time of virologic failure. Samples from the time of failure are analyzed for the accumulation of additional resistance mutations. Phase Phase II A phase two trial follows phase one. It consists of a larger, randomized sample of patients.