This is an open-label, randomized study, enrolling a total of 24 HIV-1 infected men and women without AIDS-defining illness. Subjects should be antiretroviral naive. Viral load measured at screening should be at least 20,000 copies/mL to permit a measurable period or viral decay. STEP 1: Assignment to Group A (Initial Antiretroviral Therapy) and Group B (4 Drug Regimen without intensive viral dynamics). GROUP A: A group of 16 subjects with viral loads 20,000 copies/mL will be randomized to one of the following four initial treatments arms and will be evaluated as inpatients for a 72 hour period. ARM A: Fixed dose combinaiton 3TC 150mg/ZDV 300 mg BID ARM B: Nevirapine 200 mg daily ARM C: Indinavir 800 mg q8hrs ARM D: FDC 3TC 150mg/ZDV 300 mg BID + NVP 200 mg BID + IDV 1000 mg q 8 hrs. This dosing will be maintained over the first 72 hours and blood for viral dynamic evaluations collected. At the end of this 72 hours period, subjects may be discharged from the GCRC. Seventy two hours after the first dose (Day 3), subjects in ARMS A, B, and C will initiate the follow four drug regimen: FDC 3TC 150mg/ZDV 300 mg BID + NVD 200 mg BID + IDV 1000 mg q8hrs. GROUP B: Subjects not participating in the intensive viral dynamics portion of the study will begin the following 4-drug regimen on Day 0: ARM E: FDC 3TC 150mg/ZDV 300 mg BID + NVP 200 mg BID + IDV 1000 mg q 8hrs. STEP 2: On Day 7, all 24 subjects will be randomized to receive one of the following therapies in addition to the 4-drug regimen. ARM F: GM-CSF 250 mcg sc/day ARM G: IL-12 300 ng/kg sc twice per week ARM H: No immune modulation
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