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

该子项目是利用NIH/NCRR资助的中心赠款提供的资源的许多研究子项目之一。子项目和研究者（PI）可能从另一个NIH来源获得了主要资金，因此可以在其他CRISP条目中表示。所列机构为中心，不一定是研究者所在机构。评价潜在成功的主要分析将包括以下置信区间：1）显示HIV特异性CD 8和/或CD 4活性增加的间歇治疗患者比例，2）显示能够耐受28天休药期且无病毒突破的患者比例。在持续治疗的情况下，这些终点的成功率预计分别低于40%和10%。因此，表明90%置信区间下限高于标准连续HAART方案预期值的结果将被视为间歇治疗有益效果的支持。主要分析评价间歇性治疗患者中发生以下情况的比例：1）发生耐药性，2）停药期后必须改变治疗以获得病毒控制（改变或不改变治疗）。所有此类受试者的比例将沿着列出，并给出90%的置信区间。 在HIV特异性CD 4和CD 8活性组方面，将连续治疗组的数据与间歇治疗组的数据进行比较，必须非常谨慎地解释此类比较。连续治疗组的主要作用是描述可能归因于间歇治疗的效应在连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.