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Treatment With Nelfinavir or Efavirenz of HIV-Infected Patients Who Have Never Received Anti-HIV Drugs
Recruitment status was: Active, not recruiting
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Purpose
| 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 |
| 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 |
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 LocationsPlease refer to this study by its ClinicalTrials.gov identifier: NCT00005000
| United States, California | |
| Agouron Pharmaceuticals Inc | |
| San Diego, California, United States, 92121 | |
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 Nelfinavir Lamivudine Zidovudine Stavudine Didanosine Efavirenz |
Keyhole-limpet hemocyanin HIV Protease Inhibitors Protease Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Anti-HIV Agents Anti-Retroviral Agents Antiviral Agents Anti-Infective Agents Reverse Transcriptase Inhibitors Nucleic Acid Synthesis Inhibitors Adjuvants, Immunologic Immunologic Factors Physiological Effects of Drugs Antimetabolites |
ClinicalTrials.gov processed this record on June 28, 2017