Safety and Effectiveness of a Combination Anti-HIV Drug Treatment
- Conditions
- HIV Infections
- Registration Number
- NCT00005018
- Lead Sponsor
- Glaxo Wellcome
- Brief Summary
The purpose of this study is to see if it is safe and effective to give HIV-positive patients a combination of anti-HIV drugs (abacavir \[ABC\] plus efavirenz \[EFV\] plus didanosine \[ddI\]) with and without hydroxyurea (HU).
- Detailed Description
Patients are randomized into one of two treatment arms: ABC/EFV/ddI or ABC/EFV/ddI/HU. In the second treatment arm, patients are further randomized to receive HU beginning at Baseline, when ABC/EFV/ddI is started, or at Week 8. Delaying HU may help offset the cytopenic effect of HU, as reflected in a blunted CD4 cell response. Patients are stratified according to their screening plasma HIV-1 RNA level (400 to 10,000 copies/ml and more than 10,000 to 100,000 copies/ml). Participants in the study receive study-related exams, lab tests, and study medications at no cost over the 48-week treatment period. The safety and effectiveness of the non-protease inhibitor rescue therapy is evaluated routinely by measuring viral load and the CD4 cell count, as well as the side effects caused by the medications. All of the medications are approved by the FDA and are not considered investigational.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 150
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 (23)
East Bay AIDS Ctr
🇺🇸Berkeley, California, United States
Altamed Medical Health Services
🇺🇸Los Angeles, California, United States
Gary Richmond MD
🇺🇸Fort Lauderdale, Florida, United States
Burnside Clinic
🇺🇸Columbia, South Carolina, United States
Univ of Texas / Thomas Street Clinic
🇺🇸Houston, Texas, United States
St Lukes Medical Group
🇺🇸San Diego, California, United States
Univ of Miami School of Medicine
🇺🇸Miami, Florida, United States
Univ of Nebraska Medical Ctr
🇺🇸Omaha, Nebraska, United States
Univ of NC Infectious Diseases
🇺🇸Wilmington, North Carolina, United States
Univ of Kentucky Med Ctr
🇺🇸Lexington, Kentucky, United States
Boston Med Ctr / Evans - 556
🇺🇸Boston, Massachusetts, United States
Pacific Oaks Research
🇺🇸Beverly Hills, California, United States
Beth Israel Med Ctr
🇺🇸New York, New York, United States
Univ of Texas Med Branch
🇺🇸Galveston, Texas, United States
Saint Josephs Comprehensive Research Institute
🇺🇸Tampa, Florida, United States
CRI of New England
🇺🇸Brookline, Massachusetts, United States
Pacific Horizons Med Group
🇺🇸San Francisco, California, United States
Northstar Med Clinic
🇺🇸Chicago, Illinois, United States
Univ of North Carolina / Infectious Disease Division
🇺🇸Chapel Hill, North Carolina, United States
Saint Luke's - Roosevelt Hosp Ctr
🇺🇸New York, New York, United States
Hampton Roads Med Specialists
🇺🇸Hampton, Virginia, United States
Anderson Clinical Research Inc
🇺🇸Reading, Pennsylvania, United States
Miriam Hosp
🇺🇸Providence, Rhode Island, United States