ACTG A5142: COMPARISON OF THREE ANTIVIRAL REGIMENS FOR INITIAL THERAPY OF HIV-1

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This subproject is one of many research subprojects utilizing the resources provided by a Center grant funded by NIH/NCRR. The subproject and investigator (PI) may have received primary funding from another NIH source, and thus could be represented in other CRISP entries. The institution listed is for the Center, which is not necessarily the institution for the investigator. This is a multicenter trial of the adult ACTG that is sponsored by NIAID and with pharmaceutical support. The proposal addresses the problem of optimization of treatment for patients with HIV-1 infection. The investigators will test various combinations of therapy and examine not only the effects on viral load but also a variety of metabolic parameters that are frequently perturbed in HIV-1-treated patients, often as a result of therapy. This is a phase III, open-label randomized trial that compares the time to virologic failure pairwise between three antiviral treatment groups. The treatment groups include varying combinations of protease inhibitors, nucleoside reverse transcriptase inhibitors and non-nucleoside reverse transcriptase inhibitors. Individuals will be followed between 2-3 years. If therapy becomes ineffective or leads to unwanted side effects, the patient may be switched to another regimen. Secondary objectives include an analysis of peripheral lipoatrophy, as well as various metabolic abnormalities, such as hyperlactatemia, truncal fat accumulation, hypercholesterolemia, etc. in the various treatment groups. Two substudies are also proposed. In the first, brachial artery reactivity prior to and 4 and 24 weeks after therapy will be assessed by response to vasoactive stimuli. The second substudy will examine viral dynamics as measured by viral decay rates. The study continues to enroll subjects. No preliminary findings have been reported yet.