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

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.

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.

Study Overview

• Status: Completed
• Conditions: HIV Infections
• Intervention / Treatment: Drug: Lamivudine; Drug: Zidovudine; Drug: Amprenavir

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 Type: Interventional
• Enrollment: 290
• Phase: Phase 3

Contacts and Locations

Study Locations

• United States
  • California
    • Beverly Hills, California, United States, 90211
      • Pacific Oaks Research
  • District of Columbia
    • Washington, District of Columbia, United States, 20037
      • Dr Bruce Rashbaum
  • Florida
    • Coral Gables, Florida, United States, 33146
      • Community Research Initiative of South Florida
    • Maitland, Florida, United States, 32751
      • Community Research Initiative of Central Florida
    • Miami, Florida, United States, 33136
      • Univ of Miami School of Medicine
  • Illinois
    • Chicago, Illinois, United States, 60610
      • Chicago Ctr for Clinical Research
  • Massachusetts
    • Brookline, Massachusetts, United States, 02445
      • Community Research Initiative of New England
  • New York
    • New York, New York, United States, 10011
      • Saint Vincent's AIDS Ctr
  • Tennessee
    • Memphis, Tennessee, United States, 38104
      • Methodist Hosp

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Interventional Model: Parallel Assignment

Collaborators and Investigators

• Sponsor: Glaxo Wellcome

Study record dates

Study Registration Dates

• First Submitted: November 2, 1999
• First Submitted That Met QC Criteria: August 30, 2001
• First Posted (Estimate): August 31, 2001

Study Record Updates

• Last Update Posted (Estimate): June 24, 2005
• Last Update Submitted That Met QC Criteria: June 23, 2005
• Last Verified: November 1, 1998

More Information

Terms related to this study

• Keywords: Drug Therapy, Combination; Reverse Transcriptase Inhibitors; Anti-HIV Agents; Lamivudine; Viral Load; Zidovudine; HIV Protease Inhibitors; VX 478
• Additional Relevant MeSH Terms: RNA Virus Infections; Virus Diseases; Blood-Borne Infections; Communicable Diseases; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; Immunologic Deficiency Syndromes; Immune System Diseases; Slow Virus Diseases; HIV Infections; Infections; Acquired Immunodeficiency Syndrome; Molecular Mechanisms of Pharmacological Action; Anti-Infective Agents; Antiviral Agents; Reverse Transcriptase Inhibitors; Nucleic Acid Synthesis Inhibitors; Enzyme Inhibitors; Anti-HIV Agents; Anti-Retroviral Agents; Antimetabolites; Protease Inhibitors; Anti-Bacterial Agents; HIV Protease Inhibitors; Viral Protease Inhibitors; Antitubercular Agents; Antibiotics, Antitubercular; Lamivudine; Zidovudine; Amprenavir
• Other Study ID Numbers: 264D; PROA3001