AACTG A5216: CYCLOSPORINE A/TRIZIVIR/KALETRA VERSUS TRIZIVIR/KALETRA ALONE

这个子项目是许多利用 由NIH/NCRR资助的中心赠款提供的资源。子项目和 研究者（PI）可能从另一个NIH来源获得了主要资金， 因此可在其他CRISP条目中表示。所列机构为 研究中心，而研究中心不一定是研究者所在的机构。 这项研究假设在急性HIV感染期间防止高水平的T细胞活化将降低整合的HIV前病毒的水平。 主要目的是减少T细胞活化。 次要目的是确定减少T细胞活化是否会防止急性HIV感染期间的CD 4损失，并证明环孢素A（CsA）在原发性HIV感染期间的安全性。 这是一项多中心II期研究，50例接受原发性HIV感染治疗的受试者以2：1的比例随机接受Trizivir、Kaletra和CsA治疗，前4周接受治疗，随后44周不接受CsA治疗，对比接受相同抗逆转录病毒药物治疗但不接受CsA治疗的患者。CsA将每天两次经口给予0.3 mg/kg，持续4周，剂量因毒性而降低，并相对于谷浓度升高。 将在基线、第12、24和48周进行测量前病毒DNA的意向治疗分析。 还将测量T细胞和HIV血浆RNA水平。初步研究表明，对联合用药的耐受性和持续升高的CD 4和T细胞计数。 这项研究的信息可能会导致对原发性HIV感染者的护理标准化。

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. This study hypothesizes preventing high-level T-cell activation during acute HIV infection will reduce the level of integrated HIV provirus. The primary objective is to reduce T-cell activation. The secondary objectives are to determine if reduced T-cell activation will prevent CD4 loss during acute HIV infection and to demonstrate the safety of cyclosporine A (CsA) during primary HIV infection. This is a multicenter phase II study of 50 subjects undergoing primary HIV infection with treatment randomized in a 2:1 fashion to Trizivir, Kaletra and CsA for the first 4 weeks followed by 44 weeks without CsA versus patients treated with the same antiretrovirals without CsA. CsA will be given 0.3 mg/kg orally twice a day for 4 weeks, with the dose reduced for toxicity and raised in relation to trough levels. Intention-to-treat analysis measuring proviral DNA will be done at baseline, weeks 12, 24, and 48. T-cell and HIV plasma RNA levels will also be measured. Pilot studies have suggested tolerance to combinations and elevated CD4 and T-cell counts that persisted. Information from this study may result in standardization of care of the individual with primary HIV infection.