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)
Children's Hosp Los Angeles
🇺🇸Los Angeles, California, United States
Children's Diagnostic Treatment Ctr
🇺🇸Fort Lauderdale, Florida, United States
UMDNJ / Division of Allergy Immunology & Infectious Diseases
🇺🇸Newark, New Jersey, United States
North Shore Univ Hosp / Pediatric Immunology
🇺🇸Great Neck, New York, United States
SUNY Health Ctr at Stony Brook / Pediatric Infectious Dis
🇺🇸Stony Brook, New York, United States
SUNY Health Sciences Ctr at Syracuse / Dept of Pediatrics
🇺🇸Syracuse, New York, United States
Univ of Miami / Fox Cancer Research Ctr
🇺🇸Miami, Florida, United States
Univ of Minnesota Med School
🇺🇸Minneapolis, Minnesota, United States
Duke Univ Med Ctr / Pediatrics Dept / Infec Dis
🇺🇸Durham, North Carolina, United States
Univ of Texas Health Sciences Ctr
🇺🇸San Antonio, Texas, United States
Univ of Florida - Gainesville / Infectious Dis & Immun
🇺🇸Gainesville, Florida, United States
Univ of South Florida All Children's Hosp
🇺🇸Saint Petersburg, Florida, United States
Los Angeles County - USC Med Ctr
🇺🇸Los Angeles, California, United States
Mt Sinai Hosp Med Ctr / Dept of Pediatrics
🇺🇸Chicago, Illinois, United States
Bronx Lebanon Hosp Ctr / Dept of Pediatrics
🇺🇸Bronx, New York, United States
Schneider Children's Hosp
🇺🇸New Hyde Park, New York, United States
Cook's Ft Worth Children Med Ctr / Pediatric Inf Dis
🇺🇸Fort Worth, Texas, United States
Children's Med Ctr of Dallas / ARMS Clinic
🇺🇸Dallas, Texas, United States
Univ Alabama - Birmingham / Dept of Pediatrics / UAB Station
🇺🇸Birmingham, Alabama, United States
Dr Patricia Emmanuel
🇺🇸Tampa, Florida, United States
Pediatric Special Immunology Clinic / HRS / PBC PHU
🇺🇸Riviera Beach, Florida, United States
PACT Program
🇺🇸Buffalo, New York, United States
New York Hosp - Cornell / Program for Children with AIDS
🇺🇸New York, New York, United States
St Luke's - Roosevelt Hosp Ctr
🇺🇸New York, New York, United States
The Children's Med Ctr / Division of Infectious Dis
🇺🇸Dayton, Ohio, United States
Eastern VA Med Sch / Children's Hosp of the King's Daughters
🇺🇸Norfolk, Virginia, United States
Arnold Palmer Hosp for Women and Children
🇺🇸Orlando, Florida, United States
Tulane Univ Med School
🇺🇸New Orleans, Louisiana, United States
Univ of North Carolina / Pediatric Infectious Diseases
🇺🇸Chapel Hill, North Carolina, United States
Med Univ of South Carolina
🇺🇸Charleston, South Carolina, United States