This is a phase III randomized, open-label, controlled trial of combination antiretroviral therapy. A total of 444 subjects nationwide will be enrolled. The study will be open to HIV-infected subjects with limited antiretroviral experience. Subjects will be randomized to one of three treatment arms and followed for at least 72 weeks beyond the enrollment of the last subjecgts. The three groups are (1) 3TC 150 mg/ZDV 300 mg BID + IDV 800 mg TID (control arm), (2) 3TC 150 mg/ZDV 300 mg BID + IDV 1000 mg TID + EFZ 600 mg QD, and (3) 3TC 150 mg/ZDV 300 mg BID + IDV 1000 mg TID + NFV 1250 BID. Other drugs will be available if patients experience virologic failure or relapse on these regimens. The CRC is essential for 3 of the 6 substudies. A Compartmental Substudy and Virologic Failure Substudy will evaluate the presence and type of HIV in lymph nodees and other tissues. An Intensive Pharmacokinetics/Pharmacodynamics Substudy will evaluate patients for systemic exposure of the drugs in Groups 1 and 3.
NIH ExPorter
NIH ExPorter