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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 |
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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 History of Changes |
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 |
Sexually Transmitted Diseases, Viral HIV Protease Inhibitors Anti-HIV Agents Indinavir Acquired Immunodeficiency Syndrome Antiviral Agents Immunologic Deficiency Syndromes Protease Inhibitors Reverse Transcriptase Inhibitors |
Virus Diseases Anti-Bacterial Agents Amprenavir Anti-Retroviral Agents HIV Infections Sexually Transmitted Diseases Antitubercular Agents Retroviridae Infections |
Anti-Infective Agents Sexually Transmitted Diseases, Viral Slow Virus Diseases Indinavir Molecular Mechanisms of Pharmacological Action Infection Reverse Transcriptase Inhibitors Anti-Bacterial Agents Amprenavir Anti-Retroviral Agents Therapeutic Uses Retroviridae Infections Nucleic Acid Synthesis Inhibitors RNA Virus Infections HIV Protease Inhibitors |
Anti-HIV Agents Immune System Diseases Acquired Immunodeficiency Syndrome Enzyme Inhibitors Antiviral Agents Immunologic Deficiency Syndromes Pharmacologic Actions Antibiotics, Antitubercular Protease Inhibitors Virus Diseases HIV Infections Sexually Transmitted Diseases Lentivirus Infections Antitubercular Agents |