PACTG 1015: HIV-SPECIFIC CD4 AND CD8 ACTIVITY BY RECYCLING HAART IN PEDS/ADOLES

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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. The primary analyses evaluating potential success will consist of confidence intervals around: 1) the proportion of intermittently treated patients showing increased HIV-specific CD8 and/or CD4 activity and 2) the proportion of these patients demonstrating the ability to tolerate a drug holiday 28 days, without viral breakthrough. With continuous treatment, success rates on these endpoints would be expected to be less than 40% and 10%, respectively. Thus, findings indicating that the lower limits of 90% confidence intervals lie above the values expected with a standard, continuous HAART regimen will be taken as support for beneficial effects of intermittent treatment. The primary analyses evaluating proportions of intermittently treated patients who: 1) develop resistance, 2) have to change therapy to gain viral control after a drug holiday (with or without a change in therapy). The proportions of all such subjects will be presented along with 90% confidence intervals. Data from the continously treated group will be compared with tat from the intermittently treated group with respect to HIV-specific CD4 and CD8 activity groups, such comparisons must be interpreted with extreme caution. The primary role of the continuously treated group will be to describe the extent to which effects potentially attributable to intermittent treatment might be occurring among continuously treated patients.