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

本子项目是利用由NIH/NCRR资助的中心赠款提供的资源的众多研究子项目之一。子项目和研究者（PI）可能已经从另一个NIH来源获得了主要资金，因此可以在其他CRISP条目中表示。列出的机构是中心的，不一定是研究者的机构。评估潜在成功的主要分析将包括以下置信区间：1)间歇性治疗的患者显示hiv特异性CD8和/或CD4活性增加的比例，以及2)这些患者显示耐受药物休假28天的能力的比例，没有病毒突破。在持续治疗的情况下，这些终点的成功率分别低于40%和10%。因此，研究结果表明，90%置信区间的下限高于标准的持续HAART治疗方案的预期值，将作为间歇性治疗有益效果的支持。初步分析评估间歇性治疗患者的比例：1)产生耐药性，2)在药物休假后（有或没有改变治疗）必须改变治疗以获得病毒控制。所有这些受试者的比例将与90%的置信区间一起呈现。将持续治疗组的数据与间歇治疗组的数据进行hiv特异性CD4和CD8活性组的比较，这种比较必须非常谨慎地解释。持续治疗组的主要作用是描述可能归因于间歇性治疗的影响在持续治疗患者中可能发生的程度。

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.