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


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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.

Sponsored by: Agouron Pharmaceuticals
Information provided by: AIDS Clinical Trials Information Service

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

Further Study Details: 

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

Study ID Numbers:  259H; AG1343-1127
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

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Page Updated: September 6, 2005
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