DELAVIRDINE MESYLATE PLUS NELFINAVIR, DIDANOSINE, STAVUDINE FOR HIV 1

Indiana Univ-Purdue Univ At Indianapolis, Indianapolis IN

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Abstract

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 phamacokinetic 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 plasma RNA PCR 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.