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

This study has been completed.
Sponsor:
Information provided by:
NIH AIDS Clinical Trials Information Service
ClinicalTrials.gov Identifier:
NCT00002195
First received: November 2, 1999
Last updated: June 23, 2005
Last verified: November 1998
  Purpose

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 3

Study Type: Interventional
Study Design: Endpoint Classification: Safety Study
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.

Resource links provided by NLM:


Further study details as provided by NIH AIDS Clinical Trials Information Service:

Estimated Enrollment: 290
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00002195

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

No publications provided

ClinicalTrials.gov Identifier: NCT00002195     History of Changes
Other Study ID Numbers: 264D, PROA3001
Study First Received: November 2, 1999
Last Updated: June 23, 2005
Health Authority: United States: Food and Drug Administration

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:
Acquired Immunodeficiency Syndrome
Communicable Diseases
HIV Infections
Infection
Immune System Diseases
Immunologic Deficiency Syndromes
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Sexually Transmitted Diseases
Sexually Transmitted Diseases, Viral
Slow Virus Diseases
Virus Diseases
Lamivudine
Reverse Transcriptase Inhibitors
Zidovudine
Anti-HIV Agents
Anti-Infective Agents
Anti-Retroviral Agents
Antimetabolites
Antiviral Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Nucleic Acid Synthesis Inhibitors
Pharmacologic Actions
Therapeutic Uses

ClinicalTrials.gov processed this record on October 22, 2014