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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
Recruitment status was: Active, not recruiting
Sponsor:
Agouron Pharmaceuticals
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
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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 | 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 |
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| 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00005000
Please refer to this study by its ClinicalTrials.gov identifier: 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 |
| Study First Received: | March 21, 2000 |
| Last Updated: | June 23, 2005 |
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 |
ClinicalTrials.gov processed this record on August 22, 2017