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
- Conditions
- HIV Infections
- Registration Number
- NCT00008528
- Lead Sponsor
- Hoffmann-La Roche
- 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.
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 525
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (37)
Massachusetts Gen Hosp
🇺🇸Boston, Massachusetts, United States
Nicholas Bellos
🇺🇸Dallas, Texas, United States
Univ of Texas Med Branch
🇺🇸Galveston, Texas, United States
Phoenix Body Positive
🇺🇸Phoenix, Arizona, United States
Whitman Walker Clinic/Elizabeth Taylor Med Ctr
🇺🇸Washington, District of Columbia, United States
IDC Research Initiative
🇺🇸Altamonte Springs, Florida, United States
New England Med Ctr
🇺🇸Boston, Massachusetts, United States
Steinhart Medical Associates
🇺🇸Miami, Florida, United States
Regions Hosp
🇺🇸St. Paul, Minnesota, United States
Univ of Colorado Health Sciences Ctr
🇺🇸Denver, Colorado, United States
MCP Hahnemann Univ
🇺🇸Philadelphia, Pennsylvania, United States
Pennsylvania Oncology and Hematology Associates
🇺🇸Philadelphia, Pennsylvania, United States
Community Research Initiative of New England
🇺🇸Brookline, Massachusetts, United States
Columbia Presbyterian Med Ctr
🇺🇸New York, New York, United States
AIDS Research Consortium of Atlanta
🇺🇸Atlanta, Georgia, United States
Trevor Slom
🇺🇸Chicago, Illinois, United States
Indiana Univ Hosp
🇺🇸Indianapolis, Indiana, United States
Albany Med College
🇺🇸Albany, New York, United States
Peter Tsang
🇺🇸New York, New York, United States
Univ of North Carolina / SOCA
🇺🇸Chapel Hill, North Carolina, United States
Univ of Cincinnati
🇺🇸Cincinnati, Ohio, United States
Oregon Health Sciences Univ
🇺🇸Portland, Oregon, United States
Vanderbilt Univ Med Ctr
🇺🇸Nashville, Tennessee, United States
Univ of Texas / Thomas Street Clinic
🇺🇸Houston, Texas, United States
Univ of Pittsburgh
🇺🇸Pittsburgh, Pennsylvania, United States
Univ of Alabama at Birmingham
🇺🇸Birmingham, Alabama, United States
Pacific Oaks Med Group
🇺🇸Beverly Hills, California, United States
Univ of California, San Diego
🇺🇸San Diego, California, United States
San Francisco Gen Hosp
🇺🇸San Francisco, California, United States
San Francisco VA Med Ctr
🇺🇸San Francisco, California, United States
Case Western Reserve Univ / AIDS Clinical Trials Unit
🇺🇸Cleveland, Ohio, United States
Vancouver Clinic
🇺🇸Vancouver, Washington, United States
Univ of Washington / AIDS Clinical Trial Unit
🇺🇸Seattle, Washington, 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
AIDS Healthcare Foundation
🇺🇸Los Angeles, California, United States