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Sponsored by: |
Glaxo Wellcome |
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Information provided by: | NIH AIDS Clinical Trials Information Service |
ClinicalTrials.gov Identifier: | NCT00002202 |
The purpose of this study is to see if 141W94 is as safe and effective as indinavir when used with nucleoside reverse transcriptase inhibitors (NRTIs) for 48 weeks. This study also examines what effect other drugs have on how the body handles 141W94.
Condition | Intervention | Phase |
---|---|---|
HIV Infections |
Drug: Indinavir sulfate Drug: Amprenavir |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Pharmacokinetics Study |
Official Title: | A Phase III Trial to Compare the Safety and Antiviral Efficacy of 141W94 With Indinavir in Combination With Nucleoside Reverse Transcriptase Inhibitor (NRTI) Therapy, in NRTI-Experienced, Protease Inhibitor (PI)-Naive, HIV-1-Infected Patients. |
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria
Patients must have:
Exclusion Criteria
Co-existing Condition:
Patients with the following conditions or symptoms are excluded:
Concurrent Medication:
Excluded:
Concurrent Treatment:
Excluded:
Radiation therapy (except local treatment for Kaposi's sarcoma).
Patients with the following prior conditions are excluded:
Clinically relevant pancreatitis or hepatitis within the last 6 months.
Prior Medication:
Excluded:
Prior Treatment:
Excluded:
Radiation therapy within 30 days prior to study drug administration (except local treatment for Kaposi's sarcoma).
Risk Behavior:
Excluded:
Current alcohol or illicit drug use that may interfere with drug absorption or ability to take oral medication.
Required:
NRTI therapy at day of entry and up to screening.
Required:
>= 12 weeks of NRTI therapy.
Study ID Numbers: | 264E, PROA/B3006 |
Study First Received: | November 2, 1999 |
Last Updated: | June 23, 2005 |
ClinicalTrials.gov Identifier: | NCT00002202 |
Health Authority: | United States: Food and Drug Administration |
HIV-1 Drug Therapy, Combination HIV Protease Inhibitors Indinavir RNA, Viral |
VX 478 Reverse Transcriptase Inhibitors Anti-HIV Agents Viral Load |
Virus Diseases Amprenavir Sexually Transmitted Diseases, Viral Indinavir HIV Infections |
Sexually Transmitted Diseases Acquired Immunodeficiency Syndrome Retroviridae Infections Immunologic Deficiency Syndromes |
Anti-Infective Agents RNA Virus Infections HIV Protease Inhibitors Slow Virus Diseases Anti-HIV Agents Immune System Diseases Molecular Mechanisms of Pharmacological Action Enzyme Inhibitors Infection |
Antiviral Agents Pharmacologic Actions Antibiotics, Antitubercular Protease Inhibitors Anti-Bacterial Agents Anti-Retroviral Agents Therapeutic Uses Lentivirus Infections Antitubercular Agents |