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| Sponsor: | Agouron Pharmaceuticals |
|---|---|
| Information provided by: | NIH AIDS Clinical Trials Information Service |
| ClinicalTrials.gov Identifier: | NCT00005000 |
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 IV |
| 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 |
| 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| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria
Patients may be eligible for this trial if they:
Exclusion Criteria
Patients may not be eligible for this study if they:
Contacts and Locations More Information
| Study ID Numbers: | 259H, AG1343-1127 |
| Study First Received: | March 21, 2000 |
| Last Updated: | June 23, 2005 |
| ClinicalTrials.gov Identifier: | NCT00005000 History of Changes |
| Health Authority: | United States: Food and Drug Administration |
|
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 |
|
Antimetabolites Anti-Infective Agents Sexually Transmitted Diseases, Viral Slow Virus Diseases Stavudine Immunologic Factors Molecular Mechanisms of Pharmacological Action Physiological Effects of Drugs Zidovudine Lamivudine Infection Keyhole-limpet hemocyanin Reverse Transcriptase Inhibitors Anti-Retroviral Agents Therapeutic Uses |
Nelfinavir Retroviridae Infections Nucleic Acid Synthesis Inhibitors Efavirenz HIV Protease Inhibitors RNA Virus Infections Anti-HIV Agents Immune System Diseases Acquired Immunodeficiency Syndrome Adjuvants, Immunologic Enzyme Inhibitors Antiviral Agents Immunologic Deficiency Syndromes Pharmacologic Actions Protease Inhibitors |
