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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. The completion date has passed and the status has not been verified in more than two years.
Verified July 2002 by NIH AIDS Clinical Trials Information Service.
Recruitment status was:  Active, not recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT00005000
First Posted: August 31, 2001
Last Update Posted: June 24, 2005
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
NIH 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 Intervention Phase
HIV Infections Drug: Nelfinavir mesylate Drug: Efavirenz Drug: Lamivudine Drug: Keyhole-Limpet Hemocyanin Drug: Stavudine Drug: Zidovudine Drug: Didanosine Phase 4

Study Type: Interventional
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

Resource links provided by NLM:


Further study details as provided by NIH AIDS Clinical Trials Information Service:

Estimated Enrollment: 200
Study Start Date: December 1999
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.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00005000


Locations
United States, California
Agouron Pharmaceuticals Inc
San Diego, California, United States, 92121
Sponsors and Collaborators
Agouron Pharmaceuticals
  More Information

ClinicalTrials.gov Identifier: NCT00005000     History of Changes
Other Study ID Numbers: 259H
AG1343-1127
First Submitted: March 21, 2000
First Posted: August 31, 2001
Last Update Posted: June 24, 2005
Last Verified: July 2002

Keywords provided by NIH AIDS Clinical Trials Information Service:
HIV-1
Drug Therapy, Combination
Lymphoid Tissue
HIV Protease Inhibitors
Genotype
Phenotype
Nelfinavir
Reverse Transcriptase Inhibitors
Anti-HIV Agents
Viral Load
Adipose Tissue
Glucose
Lipids
Immunophenotyping
efavirenz

Additional relevant MeSH terms:
HIV Infections
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Lamivudine
Zidovudine
Efavirenz
Stavudine
Didanosine
Nelfinavir
Keyhole-limpet hemocyanin
Reverse Transcriptase Inhibitors
Nucleic Acid Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anti-Retroviral Agents
Antiviral Agents
Anti-Infective Agents
Anti-HIV Agents
Antimetabolites
Cytochrome P-450 CYP2C9 Inhibitors
Cytochrome P-450 Enzyme Inhibitors
Cytochrome P-450 CYP2C19 Inhibitors
Cytochrome P-450 CYP2B6 Inducers
Cytochrome P-450 Enzyme Inducers