A Study to Compare Three Doses of T-20 When Given in Combination With Abacavir, Amprenavir, Ritonavir, and Efavirenz to HIV-Infected Adults
- Conditions
- HIV Infections
- Registration Number
- NCT00002239
- Lead Sponsor
- Hoffmann-La Roche
- Brief Summary
The purpose of this study is to see if it is safe and effective to give T-20, a new type of anti-HIV drug, with a combination of other anti-HIV drugs. The other anti-HIV drugs used are abacavir (ABC), amprenavir (APV), ritonavir (RTV), and efavirenz (EFV). Three different doses of T-20 are tested.
- Detailed Description
Patients are assigned to one of four groups. Three dose groups receive a background antiretroviral regimen (ABC, APV, RTV, and EFV) and T-20, which is given at one of three doses on a twice-daily regimen. The fourth group (control) receives the background antiretroviral regimen alone. For each treatment group, 17 patients are enrolled. Treatment is administered for 16 weeks, followed by a 32-week treatment extension, and a 2-week follow-up period. The following are assessed throughout the trial: safety parameters (as measured by hematology, clinical chemistry, urinalysis, and treatment-emergent adverse events); virologic and immunologic activity; phenotypic and genotypic resistance; T-20 plasma levels; and pharmacokinetics of T-20 and oral antiretrovirals. The total study duration is 1 year.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 68
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (19)
UCLA Care Ctr
🇺🇸Los Angeles, California, United States
AIDS Research Consortium of Atlanta
🇺🇸Atlanta, Georgia, United States
Pennsylvania Oncology and Hematology Associates
🇺🇸Philadelphia, Pennsylvania, United States
Johns Hopkins Hosp
🇺🇸Baltimore, Maryland, United States
Washington Univ School of Medicine
🇺🇸St. Louis, Missouri, United States
IDC Research Initiative
🇺🇸Altamonte Springs, Florida, United States
Quest Clinical Research
🇺🇸San Francisco, California, United States
Associates of Med and Mental Health
🇺🇸Tulsa, Oklahoma, United States
Donald Northfelt
🇺🇸Palm Springs, California, United States
New York Univ Med Ctr
🇺🇸New York, New York, United States
Trimeris Inc
🇺🇸Durham, North Carolina, United States
ViRx Inc
🇺🇸San Francisco, California, United States
Philadelphia FIGHT
🇺🇸Philadelphia, Pennsylvania, United States
Central Texas Clinical Research
🇺🇸Austin, Texas, United States
Univ of Pittsburgh
🇺🇸Pittsburgh, Pennsylvania, United States
Pacific Oaks Research
🇺🇸Beverly Hills, California, United States
Dupont Circle Physicians Group
🇺🇸Washington, District of Columbia, United States
UCSD
🇺🇸San Diego, California, United States
Gary Richmond MD
🇺🇸Fort Lauderdale, Florida, United States