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
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)
2 other identifiers
interventional
525
2 countries
37
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3 hiv-infections
37 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 12, 2001
CompletedFirst Posted
Study publicly available on registry
August 31, 2001
CompletedJune 24, 2005
June 1, 2001
January 12, 2001
June 23, 2005
Conditions
Keywords
Interventions
Eligibility Criteria
You may qualify if:
- 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).
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Hoffmann-La Rochelead
- Trimeriscollaborator
Study Sites (37)
Univ of Alabama at Birmingham
Birmingham, Alabama, 352942050, United States
Phoenix Body Positive
Phoenix, Arizona, 85006, United States
Pacific Oaks Med Group
Beverly Hills, California, 90211, United States
AIDS Healthcare Foundation
Los Angeles, California, 900276069, United States
Univ of California, San Diego
San Diego, California, 92103, United States
San Francisco Gen Hosp
San Francisco, California, 94110, United States
San Francisco VA Med Ctr
San Francisco, California, 94121, United States
Univ of Colorado Health Sciences Ctr
Denver, Colorado, 80262, United States
Whitman Walker Clinic/Elizabeth Taylor Med Ctr
Washington D.C., District of Columbia, 20009, United States
IDC Research Initiative
Altamonte Springs, Florida, 32701, United States
Steinhart Medical Associates
Miami, Florida, 33133, United States
AIDS Research Consortium of Atlanta
Atlanta, Georgia, 30308, United States
Trevor Slom
Chicago, Illinois, 60611, United States
Indiana Univ Hosp
Indianapolis, Indiana, 462025250, United States
New England Med Ctr
Boston, Massachusetts, 02111, United States
Massachusetts Gen Hosp
Boston, Massachusetts, 02114, United States
Community Research Initiative of New England
Brookline, Massachusetts, 02445, United States
Regions Hosp
Saint Paul, Minnesota, 55101, United States
Albany Med College
Albany, New York, 12208, United States
Peter Tsang
New York, New York, 10011, United States
Columbia Presbyterian Med Ctr
New York, New York, 100323784, United States
Univ of North Carolina / SOCA
Chapel Hill, North Carolina, 275997030, United States
Univ of Cincinnati
Cincinnati, Ohio, 452670405, United States
Case Western Reserve Univ / AIDS Clinical Trials Unit
Cleveland, Ohio, 44106, United States
Oregon Health Sciences Univ
Portland, Oregon, 97201, United States
MCP Hahnemann Univ
Philadelphia, Pennsylvania, 19102, United States
Pennsylvania Oncology and Hematology Associates
Philadelphia, Pennsylvania, 19106, United States
Univ of Pittsburgh
Pittsburgh, Pennsylvania, 15213, United States
Vanderbilt Univ Med Ctr
Nashville, Tennessee, 37212, United States
Nicholas Bellos
Dallas, Texas, 75246, United States
Univ of Texas Med Branch
Galveston, Texas, 77555, United States
Univ of Texas / Thomas Street Clinic
Houston, Texas, 77030, United States
Univ of Washington / AIDS Clinical Trial Unit
Seattle, Washington, 98104, United States
Vancouver Clinic
Vancouver, Washington, 98664, United States
Toronto Gen Hosp
Toronto, Ontario, Canada
Centre Hospitalier de la Universite de Montreal (CHUM)
Montreal, Quebec, Canada
Clinique Medicale L'Actuele
Montreal, Quebec, Canada
Related Publications (1)
Lalezari JP, Henry K, O'Hearn M, Montaner JS, Piliero PJ, Trottier B, Walmsley S, Cohen C, Kuritzkes DR, Eron JJ Jr, Chung J, DeMasi R, Donatacci L, Drobnes C, Delehanty J, Salgo M; TORO 1 Study Group. Enfuvirtide, an HIV-1 fusion inhibitor, for drug-resistant HIV infection in North and South America. N Engl J Med. 2003 May 29;348(22):2175-85. doi: 10.1056/NEJMoa035026. Epub 2003 Mar 13.
PMID: 12637625BACKGROUND