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Clinical Trial: Treatment with Nelfinavir or Efavirenz of HIV-Infected Patients Who Have Never Received Anti-HIV Drugs
This study is no longer recruiting patients.
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Purpose
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.
| Condition | Treatment or Intervention | Phase |
|---|---|---|
| HIV Infections | Drug: Nelfinavir mesylate Drug: Efavirenz Drug: Lamivudine Drug: Keyhole-Limpet Hemocyanin Drug: Stavudine Drug: Zidovudine Drug: Didanosine | Phase IV |
MedlinePlus related topics: AIDS
Study Type: Interventional
Study Design: Treatment, Crossover Assignment
Official Title: A Randomized, Open-label, Study of Nelfinavir or Efavirenz in HIV-1 Infected, Antiretroviral Naive Patients
Expected Total Enrollment: 200
Study start: 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.
Eligibility
Genders Eligible for Study: Both
Criteria
Inclusion Criteria
Patients may be eligible for this trial if they:
- Are HIV-positive.
- Have a CD4 count of at least 100 cells/mm3.
- Have a viral load of at least 5,000 copies/ml.
Exclusion Criteria
Patients may not be eligible for this study if they:
- Have taken any antiretroviral (anti-HIV) agent.
Location Information
California
Agouron Pharmaceuticals Inc, San Diego, California, 92121, United States
More Information
Record last reviewed: July 2002
Last Updated: October 13, 2004
Record first received: March 21, 2000
ClinicalTrials.gov Identifier: NCT00005000
Health Authority: United States: Food and Drug Administration
ClinicalTrials.gov processed this record on 2005-04-08
Source: ClinicalTrials.gov
Cache Date: April 9, 2005
Resources
- ClubDrugs.org (National Institute on Drug Abuse, NIH, HHS)
- Date Rape Drugs (National Women's Health Information Center)

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