INTENSIFICATION OF HIV-SPECIFIC CD4 AND CD8 ACTIVITY BY CYCLING HIGHLY ACTIVE

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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. PACTG P1015 is a multi-center, treatment trial of the Pediatric AIDS Clinical Trials Group (PACTG) supported by the National Institute of Allergy and Infectious Diseases (NIAID) and the National Institute of Child Health and Human Development (NICHD), NIH. This is a proof of concept study comparing cycling on and off of HAART with continuous HAART in subjects aged between 2 and 21 years to determine (1) if initially brief intervals of HAART suspension followed by increasingly prolonged intervals of HAART suspension result in increased HIV-specific CD8 and/or CD4 activity; (2) whether such an increase will result in prolonged suppression of viremia with subsequent suspension of HAART; (3) whether the stimulation of HIV-specific immunity reduces HIV proviral load and (4) whether cycles of HAART holidays of increasing duration result in the emergence of drug resistant virus or if drug sensitive virus persists. Version 3.0 dated 12/05/2003 added a fourth consecutive detectable cycle if the RNA is ? 50 copies/mL to address the Roche RNA assay variability concern.