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Sponsored by: |
Glaxo Wellcome |
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Information provided by: | NIH AIDS Clinical Trials Information Service |
ClinicalTrials.gov Identifier: | NCT00002195 |
The purpose of this study is to see if it is safe and effective to add 141W94 to an anti-HIV regimen that includes retrovir plus epivir.
Condition | Intervention | Phase |
---|---|---|
HIV Infections |
Drug: Amprenavir Drug: Lamivudine Drug: Zidovudine |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Parallel Assignment, Safety Study |
Official Title: | A Phase III Trial to Evaluate the Safety and Antiviral Efficacy of 141W94 in Combination With Retrovir and Epivir Compared to Retrovir and Epivir Alone in Patients With HIV Infection. |
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 symptoms or conditions are excluded:
Clinical diagnosis of AIDS (CDC 1993 Classification C).
Concurrent Medication:
Excluded:
Terfenadine, astemizole, cisapride, triazolam, medazolam, and ergotamine/dihydroergotamine-containing regimens.
Patients with the following prior conditions are excluded:
Clinically relevant hepatitis in the previous 6 months.
Prior Medication:
Excluded:
Prior Treatment:
Excluded:
Radiotherapy within 4 weeks prior to entry.
Risk Behavior:
Excluded:
Current alcohol or illicit drug use that may interfere with the patient's ability to comply with the dosing schedule or protocol evaluations.
United States, California | |
Pacific Oaks Research | |
Beverly Hills, California, United States, 90211 | |
United States, District of Columbia | |
Dr Bruce Rashbaum | |
Washington, District of Columbia, United States, 20037 | |
United States, Florida | |
Community Research Initiative of Central Florida | |
Maitland, Florida, United States, 32751 | |
Univ of Miami School of Medicine | |
Miami, Florida, United States, 33136 | |
Community Research Initiative of South Florida | |
Coral Gables, Florida, United States, 33146 | |
United States, Illinois | |
Chicago Ctr for Clinical Research | |
Chicago, Illinois, United States, 60610 | |
United States, Massachusetts | |
Community Research Initiative of New England | |
Brookline, Massachusetts, United States, 02445 | |
United States, New York | |
Saint Vincent's AIDS Ctr | |
New York, New York, United States, 10011 | |
United States, Tennessee | |
Methodist Hosp | |
Memphis, Tennessee, United States, 38104 |
Study ID Numbers: | 264D, PROA3001 |
Study First Received: | November 2, 1999 |
Last Updated: | June 23, 2005 |
ClinicalTrials.gov Identifier: | NCT00002195 History of Changes |
Health Authority: | United States: Food and Drug Administration |
Drug Therapy, Combination Zidovudine HIV Protease Inhibitors Lamivudine |
VX 478 Reverse Transcriptase Inhibitors Anti-HIV Agents Viral Load |
Antimetabolites Sexually Transmitted Diseases, Viral HIV Protease Inhibitors Anti-HIV Agents Acquired Immunodeficiency Syndrome Zidovudine Lamivudine 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 |
Antimetabolites Communicable Diseases Anti-Infective Agents Sexually Transmitted Diseases, Viral Slow Virus Diseases Molecular Mechanisms of Pharmacological Action Zidovudine Lamivudine Infection Reverse Transcriptase Inhibitors Anti-Bacterial Agents Amprenavir Anti-Retroviral Agents Therapeutic Uses Retroviridae Infections |
Nucleic Acid Synthesis Inhibitors HIV Protease Inhibitors RNA Virus Infections Anti-HIV Agents Immune System Diseases Acquired Immunodeficiency Syndrome Enzyme Inhibitors Antiviral Agents Immunologic Deficiency Syndromes Pharmacologic Actions Protease Inhibitors Antibiotics, Antitubercular Virus Diseases HIV Infections Sexually Transmitted Diseases |