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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified July 2002 by NIH AIDS Clinical Trials Information Service.
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by:
NIH AIDS Clinical Trials Information Service
ClinicalTrials.gov Identifier:
NCT00005000
First received: March 21, 2000
Last updated: June 23, 2005
Last verified: July 2002

March 21, 2000
June 23, 2005
December 1999
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Complete list of historical versions of study NCT00005000 on ClinicalTrials.gov Archive Site
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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

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.

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.

Interventional
Phase 4
Intervention Model: Crossover Assignment
Primary Purpose: Treatment
HIV Infections
  • Drug: Nelfinavir mesylate
  • Drug: Efavirenz
  • Drug: Lamivudine
  • Drug: Keyhole-Limpet Hemocyanin
  • Drug: Stavudine
  • Drug: Zidovudine
  • Drug: Didanosine
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
200
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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.
Both
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No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00005000
259H, AG1343-1127
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Agouron Pharmaceuticals
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NIH AIDS Clinical Trials Information Service
July 2002

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP