A Comparison of 141W94 and Indinavir in HIV-Infected Patients

June 23, 2005 updated by: Glaxo Wellcome

A Phase III Trial to Compare the Safety and Antiviral Efficacy of 141W94 With Indinavir in Combination With Nucleoside Reverse Transcriptase Inhibitor (NRTI) Therapy, in NRTI-Experienced, Protease Inhibitor (PI)-Naive, HIV-1-Infected Patients.

The purpose of this study is to see if 141W94 is as safe and effective as indinavir when used with nucleoside reverse transcriptase inhibitors (NRTIs) for 48 weeks. This study also examines what effect other drugs have on how the body handles 141W94.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment

460

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Berkeley, California, United States, 94705
        • East Bay AIDS Ctr
      • Los Angeles, California, United States, 90027
        • AIDS Healthcare Foundation
      • San Francisco, California, United States, 94109
        • ViRx Inc
      • San Francisco, California, United States, 94109
        • Saint Francis Mem Hosp
    • Colorado
      • Denver, Colorado, United States, 80262
        • Univ of Colorado Health Sciences Ctr
    • District of Columbia
      • Washington, District of Columbia, United States, 20009
        • Whitman Walker Clinic Inc
    • Florida
      • Coral Gables, Florida, United States, 33146
        • CRI of South Florida
      • Maitland, Florida, United States, 32751
        • Community Research Initiative of Central Florida
      • Miami, Florida, United States, 33136
        • Univ of Miami Dept of Medicine
    • Illinois
      • Chicago, Illinois, United States, 60611
        • Northwestern Univ Med School
    • Louisiana
      • New Orleans, Louisiana, United States, 70112
        • Tulane Univ Med School
    • Massachusetts
      • Boston, Massachusetts, United States, 02215
        • Beth Israel Deaconess Med Ctr
      • Boston, Massachusetts, United States, 021182393
        • Boston Med Ctr / Evans - 556
    • Nebraska
      • Omaha, Nebraska, United States, 681985400
        • Univ of Nebraska Med Ctr
    • New York
      • New York, New York, United States, 10001
        • Community Research Initiative on AIDS
      • New York, New York, United States, 10027
        • Harlem Hosp
    • North Carolina
      • Charlotte, North Carolina, United States, 28207
        • The Nalle Clinic / Clinical Research Dept
    • Ohio
      • Toledo, Ohio, United States, 43614
        • Med College of Ohio / Division of Infectious Diseases
    • Oregon
      • Portland, Oregon, United States, 97210
        • The Research and Education Group
    • Tennessee
      • Memphis, Tennessee, United States, 38104
        • Methodist Hosp
    • Texas
      • Dallas, Texas, United States, 75217
        • Community Oriented Primary Care
      • Galveston, Texas, United States, 775550835
        • Univ of Texas Med Branch
      • Houston, Texas, United States, 770303498
        • Baylor College of Medicine / Dept of Medicine
    • Virginia
      • Hampton, Virginia, United States, 23666
        • Hampton Roads Med Specialists

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

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:

  • Documented HIV infection.
  • HIV RNA >= 400 copies/ml within 14 days prior to randomized study drug administration.
  • No active AIDS-defining opportunistic infection or disease.
  • Signed, informed consent from parent or legal guardian of patients less than 18 years of age.

Exclusion Criteria

Co-existing Condition:

Patients with the following conditions or symptoms are excluded:

  • Unlikely to complete the randomized dosing period.
  • Malabsorption syndrome or other gastrointestinal dysfunction that might interfere with drug absorption or ability to take oral medications.
  • Serious medical conditions (e.g., diabetes, cardiac dysfunction, hepatitis) that would compromise patient safety.

Concurrent Medication:

Excluded:

  • Cytotoxic chemotherapeutic agents (except local treatment for Kaposi's sarcoma).
  • Investigational treatments (treatment through Treatment IND or expanded-access programs are evaluated individually).
  • Immunomodulating agents such as systemic, high-dose corticosteroids, interleukins, or interferons.
  • Terfenadine, astemizole, cisapride, triazolam, midazolam, and ergotamine/dihydroergotamine-containing regimens.

Concurrent Treatment:

Excluded:

Radiation therapy (except local treatment for Kaposi's sarcoma).

Patients with the following prior conditions are excluded:

Clinically relevant pancreatitis or hepatitis within the last 6 months.

Prior Medication:

Excluded:

  • Cytotoxic chemotherapeutic agents within 30 days of study drug administration (except local treatment for Kaposi's sarcoma).
  • Protease inhibitor therapy.
  • Dose of vaccine through an investigational HIV vaccine trial within the 3 months prior to study drug administration.
  • Immunomodulating agents such as systemic, high-dose corticosteroids, interleukins, or interferons within 30 days of study drug administration.

Prior Treatment:

Excluded:

Radiation therapy within 30 days prior to study drug administration (except local treatment for Kaposi's sarcoma).

Risk Behavior:

Excluded:

Current alcohol or illicit drug use that may interfere with drug absorption or ability to take oral medication.

Required:

NRTI therapy at day of entry and up to screening.

Required:

>= 12 weeks of NRTI therapy.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Glaxo Wellcome

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

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

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 264E
  • PROA/B3006

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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