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)
Phoenix Body Positive
🇺🇸Phoenix, Arizona, United States
Health for Life Clinic
🇺🇸Little Rock, Arkansas, United States
Orange County Ctr for Special Immunology
🇺🇸Fountain Valley, California, United States
Pacific Horizons Med Group
🇺🇸San Francisco, California, United States
Beacon Clinic / Boulder Community Hosp
🇺🇸Boulder, Colorado, United States
Georgetown Univ Med Ctr
🇺🇸Washington, District of Columbia, United States
Dupont Circle Physicians Group
🇺🇸Washington, District of Columbia, United States
Infectious Disease Consultants
🇺🇸Fairfax, Virginia, United States
North Broward Hosp District / HIV Clinical Research
🇺🇸Fort Lauderdale, Florida, United States
SBMA Research
🇺🇸Miami Beach, Florida, United States
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