DELAVIRDINE MESYLATE PLUS NELFINAVIR, DIDANOSINE, STAVUDINE FOR HIV 1

该方案采用多中心、多剂量、随机开放标签设计，将评估安全性、耐受性、抗病毒疗效和药代动力学（在一部分患者中）。HIV-1阳性的男性和女性，如果CD计数为>或= 50个细胞/mm，血浆HIV-1 RNA水平为>或= 20,000拷贝/mL，将接受delavirdine（400或600 mg TID）、didanosine（200或125 mg BID）、奈非那韦（750 mg TID）和司他夫定（30 mg或40 mg BID）治疗。患者之前必须没有司他夫定、蛋白酶抑制剂（包括奈非那韦）或NNRTI经历；二腺苷经验必须少于6个月。该研究包括四种给药方案：DLV + NFV + d4T， DLV + NFV + ddI, NFV + d4T + ddI, DLV + NFV + d4T + ddI（每组40例患者），治疗24周，并可根据研究者的决定继续参与额外的24周研究。在试验中接受delavirdine和奈非那韦治疗的前20名患者将在第1,2,3和4周通过化学和血液学面板以及delavirdine和奈非那韦的槽水平评估来评估安全性。大约在第4周，这20名患者将需要一天的时间进行完整的药代动力学评估。根据这些患者的结果，另外160名患者可能会接受调整剂量的研究药物。对于所有患者，安全性将在每次患者就诊时进行评估。病毒负荷将通过FDA批准的质aRNA JPCR实时测定和结果提供给研究人员。最初，患者将根据HIV-1 RNA PCR水平（20,000至200,000和bbb20万）进行分层，并随机分为四个治疗组之一。

This protocol features a multicenter, multiple-dose, randomized open-label design which will evaluate safety, tolerance, antiviral efficacy, and pharmacokinetics ( in a subset of patients). HIV-1 + males and females with a CD count of > or = 50 cells/mm and plasma HIV-1 RNA levels > or = 20,000 copies/mL will be treated with delavirdine (400 or 600 mg TID), didanosine (200 mg or 125 mg BID), nelfinavir (750 mg TID), and stavudine (30 mg or 40 mg BID). Patients must have no prior stavudine, protease inhibitor, (including nelfinavir), or NNRTI experience; didanosine experience must be less than six months. The study consists of four dosage regimens: DLV + NFV + d4T, DLV + NFV + ddI, NFV + d4T + ddI, DLV + NFV + d4T + ddI (40 patient per group) to be treated for 24 weeks with the option of continuing study participation for an additional 24 weeks at the discretion of the investigator. The first 20 patients receiving delavirdine and nelfinavir on the trial will be evaluated on weeks 1,2,3, and 4 for safety via chemistry and hematology panels and trough level evaluations for delavirdine and nelfinavir. On approximately week 4, the 20 patients will need to have one day for full pharmacokinetic evaluation. Based on the results from these patients, and additional 160 patients may receive an adjusted dose of study medication. For all patients, safety will be assessed at each patient visit. Viral burden will be measured by an FDA approved plasm aRNA JPCR real-time assay and results provided to investigators. Initially, patients will be stratified by HIV-1 RNA PCR levels (20,000 to 200,000 and > 200,000) and randomized into one of the four treatment groups.