The Safety and Effectiveness of Zidovudine Plus Lamivudine, Used With and Without 1592U89, in HIV-1 Infected Children Who Have Taken Anti-HIV-1 Drugs
- Conditions
- HIV Infections
- Registration Number
- NCT00002391
- Lead Sponsor
- Glaxo Wellcome
- Brief Summary
To compare the safety, tolerance, durability of the viral load response and the antiviral activity of the 1592U89/zidovudine(ZDV)/lamivudine (3TC) regimen vs. ZDV/3TC regimen. To determine the clinical efficacy of the two regimens as measured survival, disease progression, weight growth velocity, and neuropsychological or neurological changes. To assess the development of viral resistance and relative pharmacokinetics associated with each regimen.
- Detailed Description
Patients are randomized to receive blinded treatment with ZDV/3TC alone or in combination with 1592U89, orally for 16 weeks. If after the 16-week period certain criteria are met, patients may have the option to switch to open-label treatment for the remainder of the study period.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- Not specified
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 (30)
Univ Alabama - Birmingham / Dept of Pediatrics / UAB Station
🇺🇸Birmingham, Alabama, United States
Children's Hosp Los Angeles
🇺🇸Los Angeles, California, United States
Los Angeles County - USC Med Ctr
🇺🇸Los Angeles, California, United States
Children's Diagnostic Treatment Ctr
🇺🇸Fort Lauderdale, Florida, United States
Univ of Florida - Gainesville / Infectious Dis & Immun
🇺🇸Gainesville, Florida, United States
Univ of Miami / Fox Cancer Research Ctr
🇺🇸Miami, Florida, United States
Arnold Palmer Hosp for Women and Children
🇺🇸Orlando, Florida, United States
Pediatric Special Immunology Clinic / HRS / PBC PHU
🇺🇸Riviera Beach, Florida, United States
Univ of South Florida All Children's Hosp
🇺🇸Saint Petersburg, Florida, United States
Dr Patricia Emmanuel
🇺🇸Tampa, Florida, United States
Scroll for more (20 remaining)Univ Alabama - Birmingham / Dept of Pediatrics / UAB Station🇺🇸Birmingham, Alabama, United States