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. A5115 is a phase II, randomized, controlled, two-arm pilot study to evaluate plasma HIV-1 RNA switch thresholds among subjects with relapse on a current HAART regimen. Subjects with a sustained and current plasma HIV-1 RNA 200 copies/mL but < 10,000 copies/mL while on a stable HAART regimen will be randomized to a switch threshold of either > 200 copies/mL or 10,000 copies/mL. This study will provide an opportunity to determine, in a randomized prospective manner, whether functional immune reconstitution is maintained in the setting of partial virologic suppression and the impact of delayed therapy on viral resistance. It will also provide an opportunity to investigate the value of various assays as surrogate markers in the setting of persistent viremia and increasing or stable CD4+ cell counts.
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