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

• ClinicalTrials.gov Identifier: NCT00002195
• Recruitment Status: Completed
• First Posted: August 31, 2001
• Last Update Posted: June 24, 2005
• Sponsor: Glaxo Wellcome
• Information provided by: NIH AIDS Clinical Trials Information Service

Study Description

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

• 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

Outcome Measures

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• 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

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

• ClinicalTrials.gov Identifier: NCT00002195
• 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:

Infections; HIV Infections; Acquired Immunodeficiency Syndrome; Blood-Borne Infections; Communicable Diseases; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus 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; Antiviral Agents; Anti-Infective Agents; Anti-HIV Agents; Anti-Retroviral Agents; Antimetabolites; Antibiotics, Antitubercular; Antitubercular Agents; Anti-Bacterial Agents; HIV Protease Inhibitors