T-20 With Anti-HIV Combination Therapy for Patients With Prior Anti-HIV Drug Treatment and/or Drug Resistance to Each of the Three Classes of Approved Anti-HIV Drugs

June 23, 2005 updated by: Hoffmann-La Roche

A Phase III Open-Label, Randomized, Active-Controlled Study Assessing the Efficacy and Safety of T-20 (HIV-1 Fusion Inhibitor) in Combination With an Optimized Background Regimen, Versus Optimized Background Therapy Alone, in Patients With Prior Experience and/or Prior Documented Resistance to Each of the Three Classes of Approved Antiretrovirals (Nucleoside Reverse Transcriptase, Non-Nucleoside Reverse Transcriptase and Protease Inhibitors)

The purpose of this study is to compare the change in viral load (amount of HIV in the blood) of patients who receive T-20 with selected anti-HIV drugs to that of patients who receive only selected anti-HIV drugs.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Eligible patients remain on their pre-study regimen until baseline. An OB regimen is chosen by the physician and patient based on the patient's prior treatment history, prior and current laboratory abnormalities, the screening GT/PT antiretroviral resistance testing, and any prior GT/PT antiretroviral resistance (if available). The drugs in the OB regimen are chosen from among the currently approved antiretrovirals and permitted newly approved/investigational antiretrovirals available in the countries where the study is implemented, and must consist of 3 to 5 drugs, including no more than 1 newly approved/investigational agent. Patients are stratified with respect to viral load and use (versus non-use) of any of the allowed newly approved/investigational antiretrovirals. Patients are randomized to receive 1 of the following 2 treatments for 48 weeks: OB or OB plus T-20. Patients are followed to assess viral load, safety, antiretroviral resistance, T-20 pharmacokinetics, and quality of life. At the end of 48 weeks of treatment patients are allowed to (a) roll over and receive OB plus T-20 (for patients receiving OB regimen alone) or (b) continue taking OB plus T-20 (for patients already receiving OB plus T-20), for an additional 48 weeks (plus 4 weeks safety follow-up period), or until 12 weeks after commercial availability of T-20 in the country in which they are treated, whichever comes first. All patients are followed in this study for a maximum of 100 weeks from their initial baseline visit date.

Study Type

Interventional

Enrollment

525

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

  • Canada
    • Ontario
      • Toronto, Ontario, Canada
        • Toronto Gen Hosp
    • Quebec
      • Montreal, Quebec, Canada
        • Clinique Medicale L'Actuele
      • Montreal, Quebec, Canada
        • Centre Hospitalier de la Universite de Montreal (CHUM)
  • United States
    • Alabama
      • Birmingham, Alabama, United States, 352942050
        • Univ of Alabama at Birmingham
    • Arizona
      • Phoenix, Arizona, United States, 85006
        • Phoenix Body Positive
    • California
      • Beverly Hills, California, United States, 90211
        • Pacific Oaks Med Group
      • Los Angeles, California, United States, 900276069
        • AIDS Healthcare Foundation
      • San Diego, California, United States, 92103
        • Univ of California, San Diego
      • San Francisco, California, United States, 94110
        • San Francisco Gen Hosp
      • San Francisco, California, United States, 94121
        • San Francisco VA Med Ctr
    • 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/Elizabeth Taylor Med Ctr
    • Florida
      • Altamonte Springs, Florida, United States, 32701
        • IDC Research Initiative
      • Miami, Florida, United States, 33133
        • Steinhart Medical Associates
    • Georgia
      • Atlanta, Georgia, United States, 30308
        • AIDS Research Consortium of Atlanta
    • Illinois
      • Chicago, Illinois, United States, 60611
        • Trevor Slom
    • Indiana
      • Indianapolis, Indiana, United States, 462025250
        • Indiana Univ Hosp
    • Massachusetts
      • Boston, Massachusetts, United States, 02111
        • New England Med Ctr
      • Boston, Massachusetts, United States, 02114
        • Massachusetts Gen Hosp
      • Brookline, Massachusetts, United States, 02445
        • Community Research Initiative of New England
    • Minnesota
      • St. Paul, Minnesota, United States, 55101
        • Regions Hosp
    • New York
      • Albany, New York, United States, 12208
        • Albany Med College
      • New York, New York, United States, 100323784
        • Columbia Presbyterian Med Ctr
      • New York, New York, United States, 10011
        • Peter Tsang
    • North Carolina
      • Chapel Hill, North Carolina, United States, 275997030
        • Univ of North Carolina / SOCA
    • Ohio
      • Cincinnati, Ohio, United States, 452670405
        • Univ of Cincinnati
      • Cleveland, Ohio, United States, 44106
        • Case Western Reserve Univ / AIDS Clinical Trials Unit
    • Oregon
      • Portland, Oregon, United States, 97201
        • Oregon Health Sciences Univ
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19106
        • Pennsylvania Oncology and Hematology Associates
      • Philadelphia, Pennsylvania, United States, 19102
        • MCP Hahnemann Univ
      • Pittsburgh, Pennsylvania, United States, 15213
        • Univ of Pittsburgh
    • Tennessee
      • Nashville, Tennessee, United States, 37212
        • Vanderbilt Univ Med Ctr
    • Texas
      • Dallas, Texas, United States, 75246
        • Nicholas Bellos
      • Galveston, Texas, United States, 77555
        • Univ of Texas Med Branch
      • Houston, Texas, United States, 77030
        • Univ of Texas / Thomas Street Clinic
    • Washington
      • Seattle, Washington, United States, 98104
        • Univ of Washington / AIDS Clinical Trial Unit
      • Vancouver, Washington, United States, 98664
        • Vancouver Clinic

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

16 years and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria

Patients may be eligible for this study if they:

  • Are HIV-infected.
  • Are at least 16 years old (have consent of parent or guardian if under 18).
  • Have a viral load (level of HIV in the blood) of 5,000 copies/ml or more.
  • Have received anti-HIV drugs for at least 6 months and/or have shown resistance to each of the 3 types of anti-HIV drugs as follows: nucleoside reverse transcriptase inhibitors (resistant to 1 or more); nonnucleoside reverse transcriptase inhibitors (resistant to 1 or more); and protease inhibitors (resistant to 2 or more, taken either together or 1 after the other for at least 6 months total).

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
  • Interventional Model: Parallel Assignment

Collaborators and Investigators

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

Sponsor

Hoffmann-La Roche

Collaborators

Trimeris

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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

January 12, 2001

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

June 1, 2001

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 295C
  • T20-301

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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