Safety and Effectiveness of TRIZIVIR (Abacavir/Lamivudine/Zidovudine) With Efavirenz in HIV-Infected Patients Who Have Never Taken Anti-HIV Drugs
- Conditions
- HIV Infections
- Registration Number
- NCT00011895
- Lead Sponsor
- GlaxoSmithKline
- Brief Summary
The purpose of this study is to determine the effect of treatment with Trizivir (TZV) plus efavirenz (EFV) or TZV alone on viral load (level of HIV in the blood).
- Detailed Description
Patients receive TZV plus EFV in the 48-week Induction Phase. Eligible patients, defined as those with plasma HIV-1 RNA under 50 copies/ml, participate in the 48-week Maintenance Phase. Patients are randomized equally to receive either TZV plus EFV or TZV alone.
An immunology substudy will be conducted, including approximately the first 100 patients enrolled who agree to participate.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 400
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 (41)
Therapeutic Concepts
🇺🇸Houston, Texas, United States
Diversified Med Practices, PA
🇺🇸Houston, Texas, United States
Infectious Diseases Associates of Houston
🇺🇸Houston, Texas, United States
Health for Life Clinic
🇺🇸Little Rock, Arkansas, United States
Northstar Med Clinic
🇺🇸Chicago, Illinois, United States
Infectious Disease Specialists of Atlanta
🇺🇸Decatur, Georgia, United States
Orange County Ctr for Special Immunology
🇺🇸Fountain Valley, California, United States
Dupont Circle Physicians Group
🇺🇸Washington, District of Columbia, United States
Dr Paul Benson
🇺🇸Berkley, Michigan, United States
SUNY / Health Sciences Ctr at Brooklyn
🇺🇸Brooklyn, New York, United States
SBMA Research
🇺🇸Miami Beach, Florida, United States
Aaron Diamond AIDS Rsch Ctr / Rockefeller Univ
🇺🇸New York, New York, United States
Infectious Disease Physicians Inc
🇺🇸Annandale, Virginia, United States
Phoenix Body Positive
🇺🇸Phoenix, Arizona, United States
Infectious Disease Consultants
🇺🇸Fairfax, Virginia, United States
Univ of Tennessee Med Ctr at Knoxville
🇺🇸Knoxville, Tennessee, United States
Associates in Med and Mental Health
🇺🇸Tulsa, Oklahoma, United States
Metroplex Infectious Disease
🇺🇸Fort Worth, Texas, United States
Regions Hosp / HIV/AIDS Program
🇺🇸St. Paul, Minnesota, United States
NJCRI
🇺🇸Newark, New Jersey, United States
HIV Outpatient Clinics / LA State Univ Med Ctr
🇺🇸New Orleans, Louisiana, United States
Univ of Miami / Jackson Memorial Hosp
🇺🇸Miami, Florida, United States
Hennepin County Med Ctr
🇺🇸Minneapolis, Minnesota, United States
Wellness Ctr / Las Vegas
🇺🇸Las Vegas, Nevada, United States
Pacific Horizons Med Group
🇺🇸San Francisco, California, United States
Univ of Oklahoma Infectious Disease Institute
🇺🇸Oklahoma City, Oklahoma, United States
North Broward Hosp District / HIV Clinical Research
🇺🇸Fort Lauderdale, Florida, United States
AIDS Outreach Center
🇺🇸Fort Worth, Texas, United States
East Carolina Univ School of Medicine
🇺🇸Greenville, North Carolina, United States
Tarrant County Infectious Diseases Associates
🇺🇸Fort Worth, Texas, United States
Georgetown Univ Med Ctr
🇺🇸Washington, District of Columbia, United States
Beacon Clinic / Boulder Community Hosp
🇺🇸Boulder, Colorado, United States
Cook County Gen Hosp / Division of Infect Diseases
🇺🇸Chicago, Illinois, United States
Boston Med Ctr
🇺🇸Boston, Massachusetts, United States
ID Consultants
🇺🇸Charlotte, North Carolina, United States
Hackensack University Medical Center
🇺🇸Hackensack, New Jersey, United States
CRC of Mississippi
🇺🇸Jackson, Mississippi, United States
Summa Health System
🇺🇸Akron, Ohio, United States
Texas Tech Health Sciences Ctr
🇺🇸El Paso, Texas, United States
Swedish Med Ctr
🇺🇸Seattle, Washington, United States
University of Louisville / ID Division
🇺🇸Louisville, Kentucky, United States