NCT00005000

Treatment With Nelfinavir or Efavirenz of HIV-Infected Patients Who Have Never Received Anti-HIV Drugs

A Randomized, Open-Label, Study of Nelfinavir or Efavirenz in HIV-1 Infected, Antiretroviral Naive Patients

• Status: Unknown
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 200 (planned)
• Sponsor: Agouron Pharmaceuticals · Industry
• Sex: All
• Age: 0 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to compare two drugs (nelfinavir \[NFV\] and efavirenz \[EFV\]) used in start-up anti-HIV treatment. Doctors want to see if one is better than the other in extending the time that viral load (level of HIV in the blood) is kept low. The study will also look at the response of the immune system to each drug.

Detailed description

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.

Conditions

• HIV Infections

Interventions

Type	Name	Description
DRUG	Nelfinavir mesylate
DRUG	Efavirenz
DRUG	Lamivudine
DRUG	Keyhole-Limpet Hemocyanin
DRUG	Stavudine
DRUG	Zidovudine
DRUG	Didanosine

Timeline

• Start date: 1999-12-01
• First posted: 2001-08-31
• Last updated: 2005-06-24

Locations

1 site across 1 country: United States