Treatment With Nelfinavir or Efavirenz of HIV-Infected Patients Who Have Never Received Anti-HIV Drugs
Recruitment status was: Active, not recruiting
|HIV Infections||Drug: Nelfinavir mesylate Drug: Efavirenz Drug: Lamivudine Drug: Keyhole-Limpet Hemocyanin Drug: Stavudine Drug: Zidovudine Drug: Didanosine||Phase 4|
|Study Design:||Intervention Model: Crossover Assignment
Primary Purpose: Treatment
|Official Title:||A Randomized, Open-Label, Study of Nelfinavir or Efavirenz in HIV-1 Infected, Antiretroviral Naive Patients|
|Study Start Date:||December 1999|
Patients are randomized to initiate therapy and receive either nelfinavir (NFV) or efavirenz (EFV) in the first regimen (R1). All patients also receive zidovudine (AZT) and lamivudine (3TC). Patients are further randomized in a factorial fashion and by stratification based on HIV RNA level (less than 10,000, 10,000-100,000, or greater than 100,000 copies/ml) to be administered a single injection of a neo-antigen (KLH) at Week 12, 24, or 48. Therapy continues until switch criteria are met either before or after Week 24. When switch criteria are met, patients advance to the next regimen (R2).
R2 patients previously taking NFV switch to EFV; those randomized to EFV switch to NFV; the additional NRTIs change to stavudine (d4T) and didanosine (ddI). Therapy is continued for an additional 24 weeks.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00005000
|United States, California|
|Agouron Pharmaceuticals Inc|
|San Diego, California, United States, 92121|