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

这个子项目是许多研究子项目中利用 资源由NIH/NCRR资助的中心拨款提供。子项目和 调查员(PI)可能从NIH的另一个来源获得了主要资金， 并因此可以在其他清晰的条目中表示。列出的机构是 该中心不一定是调查人员的机构。 这项研究假设，在急性艾滋病毒感染期间阻止高水平的T细胞激活将降低整合的艾滋病毒前病毒的水平。主要目标是减少T细胞的激活。第二个目标是确定减少T细胞激活是否可以防止在急性HIV感染期间CD4的丢失，并证明环孢素A(CsA)在初次HIV感染期间的安全性。这是一项多中心的II期研究，研究对象为50名初次感染艾滋病毒的患者，他们以2：1的方式随机接受Trizivir、Kaletra和CsA前4周的治疗，随后44周不使用CsA，与接受相同抗逆转录病毒药物治疗而不使用CsA的患者进行比较。CsA每天两次口服0.3 mg/kg，连续4周，剂量因毒性而减少，并随谷值升高而增加。测量前病毒DNA的意向治疗分析将在基线、12周、24周和48周进行。T细胞和HIV血浆RNA水平也将被测量。初步研究表明，对联合疗法有耐受性，并持续提高了CD4和T细胞计数。这项研究的信息可能导致对原发艾滋病毒感染者的标准化护理。

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.