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

This study has been completed.
Sponsor:
Collaborator:
Trimeris
Information provided by:
NIH AIDS Clinical Trials Information Service
ClinicalTrials.gov Identifier:
NCT00008528
First received: January 12, 2001
Last updated: June 23, 2005
Last verified: June 2001
  Purpose

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.


Condition Intervention Phase
HIV Infections
Drug: Enfuvirtide
Phase 3

Study Type: Interventional
Study Design: Intervention Model: Parallel Assignment
Primary Purpose: Treatment
Official Title: 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)

Resource links provided by NLM:


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

Estimated Enrollment: 525
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.

  Eligibility

Ages Eligible for Study:   16 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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).
  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: NCT00008528

  Hide Study Locations
Locations
United States, Alabama
Univ of Alabama at Birmingham
Birmingham, Alabama, United States, 352942050
United States, Arizona
Phoenix Body Positive
Phoenix, Arizona, United States, 85006
United States, California
Pacific Oaks Med Group
Beverly Hills, California, United States, 90211
AIDS Healthcare Foundation
Los Angeles, California, United States, 900276069
Univ of California, San Diego
San Diego, California, United States, 92103
San Francisco Gen Hosp
San Francisco, California, United States, 94110
San Francisco VA Med Ctr
San Francisco, California, United States, 94121
United States, Colorado
Univ of Colorado Health Sciences Ctr
Denver, Colorado, United States, 80262
United States, District of Columbia
Whitman Walker Clinic/Elizabeth Taylor Med Ctr
Washington, District of Columbia, United States, 20009
United States, Florida
IDC Research Initiative
Altamonte Springs, Florida, United States, 32701
Steinhart Medical Associates
Miami, Florida, United States, 33133
United States, Georgia
AIDS Research Consortium of Atlanta
Atlanta, Georgia, United States, 30308
United States, Illinois
Trevor Slom
Chicago, Illinois, United States, 60611
United States, Indiana
Indiana Univ Hosp
Indianapolis, Indiana, United States, 462025250
United States, Massachusetts
New England Med Ctr
Boston, Massachusetts, United States, 02111
Massachusetts Gen Hosp
Boston, Massachusetts, United States, 02114
Community Research Initiative of New England
Brookline, Massachusetts, United States, 02445
United States, Minnesota
Regions Hosp
St. Paul, Minnesota, United States, 55101
United States, New York
Albany Med College
Albany, New York, United States, 12208
Columbia Presbyterian Med Ctr
New York, New York, United States, 100323784
Peter Tsang
New York, New York, United States, 10011
United States, North Carolina
Univ of North Carolina / SOCA
Chapel Hill, North Carolina, United States, 275997030
United States, Ohio
Univ of Cincinnati
Cincinnati, Ohio, United States, 452670405
Case Western Reserve Univ / AIDS Clinical Trials Unit
Cleveland, Ohio, United States, 44106
United States, Oregon
Oregon Health Sciences Univ
Portland, Oregon, United States, 97201
United States, Pennsylvania
Pennsylvania Oncology and Hematology Associates
Philadelphia, Pennsylvania, United States, 19106
MCP Hahnemann Univ
Philadelphia, Pennsylvania, United States, 19102
Univ of Pittsburgh
Pittsburgh, Pennsylvania, United States, 15213
United States, Tennessee
Vanderbilt Univ Med Ctr
Nashville, Tennessee, United States, 37212
United States, Texas
Nicholas Bellos
Dallas, Texas, United States, 75246
Univ of Texas Med Branch
Galveston, Texas, United States, 77555
Univ of Texas / Thomas Street Clinic
Houston, Texas, United States, 77030
United States, Washington
Univ of Washington / AIDS Clinical Trial Unit
Seattle, Washington, United States, 98104
Vancouver Clinic
Vancouver, Washington, United States, 98664
Canada, Ontario
Toronto Gen Hosp
Toronto, Ontario, Canada
Canada, Quebec
Clinique Medicale L'Actuele
Montreal, Quebec, Canada
Centre Hospitalier de la Universite de Montreal (CHUM)
Montreal, Quebec, Canada
Sponsors and Collaborators
Hoffmann-La Roche
Trimeris
  More Information

Publications:
ClinicalTrials.gov Identifier: NCT00008528     History of Changes
Other Study ID Numbers: 295C, T20-301
Study First Received: January 12, 2001
Last Updated: June 23, 2005
Health Authority: United States: Food and Drug Administration

Keywords provided by NIH AIDS Clinical Trials Information Service:
HIV-1
Drug Therapy, Combination
Drug Resistance, Microbial
RNA, Viral
Membrane Fusion
Anti-HIV Agents
Viral Load

Additional relevant MeSH terms:
HIV Infections
Acquired Immunodeficiency Syndrome
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Slow Virus Diseases
Enfuvirtide
Anti-HIV Agents
HIV Fusion Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Anti-Retroviral Agents
Antiviral Agents
Anti-Infective Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on August 28, 2014