A Study of Retrovir and Epivir Alone or in Combination With 141W94 in HIV-Infected Patients

Study Description

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Brief Summary:

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 or disease	Intervention/treatment	Phase
HIV Infections	Drug: Amprenavir; Drug: Lamivudine; Drug: Zidovudine	Phase 3

Detailed Description:

This is a double-blind, placebo-controlled, two-arm study comparing treatment with a triple regimen consisting of 141W94, retrovir, and epivir and a double regimen consisting of retrovir and epivir.

Study Design

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Study Type :	Interventional (Clinical Trial)
Enrollment :	290 participants
Intervention Model:	Parallel Assignment
Primary Purpose:	Treatment
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.

Arms and Interventions

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Outcome Measures

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Eligibility Criteria

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Ages Eligible for Study:	18 Years and older (Adult, Senior)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria

Patients must have:

• HIV-positive status.
• Screening viral load >= 10,000 copies/mm3 14 days prior to entry.
• CD4+ cell counts >= 200 cells/mm3 14 days prior to entry.

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:

• Greater than 4 weeks of any nucleoside antiretroviral therapy.
• Previous therapy with an HIV protease inhibitor.
• Cytotoxic chemotherapeutic agents within 4 weeks prior to entry.
• Immunomodulating agents within 3 months prior to entry.

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.

Contacts and Locations

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Locations

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 South Florida
Coral Gables, Florida, United States, 33146
Community Research Initiative of Central Florida
Maitland, Florida, United States, 32751
Univ of Miami School of Medicine
Miami, Florida, United States, 33136
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

Sponsors and Collaborators

Glaxo Wellcome

More Information

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

ClinicalTrials.gov Identifier:	NCT00002195 History of Changes
Other Study ID Numbers:	264D; PROA3001
First Posted:	August 31, 2001
Last Update Posted:	June 24, 2005
Last Verified:	November 1998

Keywords provided by NIH AIDS Clinical Trials Information Service:

Drug Therapy, Combination; Zidovudine; HIV Protease Inhibitors; Lamivudine	VX 478; Reverse Transcriptase Inhibitors; Anti-HIV Agents; Viral Load

Additional relevant MeSH terms:

Infection; HIV Infections; Acquired Immunodeficiency Syndrome; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Immunologic Deficiency Syndromes; Immune System Diseases; Slow Virus Diseases; Lamivudine; Zidovudine; Amprenavir	Reverse Transcriptase Inhibitors; Nucleic Acid Synthesis Inhibitors; Enzyme Inhibitors; Molecular Mechanisms of Pharmacological Action; Anti-Retroviral Agents; Antiviral Agents; Anti-Infective Agents; Anti-HIV Agents; Antimetabolites; Antibiotics, Antitubercular; Antitubercular Agents; Anti-Bacterial Agents; HIV Protease Inhibitors; Protease Inhibitors