A Randomized, Comparative Trial of Zidovudine (AZT) Versus 2',3'-Didehydro-3'-Deoxythymidine (Stavudine; d4T) in Children With HIV Infection
- Conditions
- HIV Infections
- Registration Number
- NCT00000789
- Brief Summary
PRIMARY: To compare the relative safety and tolerance of oral zidovudine (AZT) versus oral stavudine (d4T) in symptomatic HIV-infected children.
SECONDARY: To compare the clinical, virologic, and immunologic responses between the two treatment groups, and to obtain pharmacokinetic data for both drugs.
At present, AZT is considered the drug of choice for initial treatment of most children with HIV infection, although disease progression or drug intolerance is associated with its long-term use. In preliminary studies in children, d4T, another HIV inhibitor, has been well tolerated, although an optimum dose has not been determined.
- Detailed Description
At present, AZT is considered the drug of choice for initial treatment of most children with HIV infection, although disease progression or drug intolerance is associated with its long-term use. In preliminary studies in children, d4T, another HIV inhibitor, has been well tolerated, although an optimum dose has not been determined.
Patients are randomized to receive either oral AZT or oral d4T. Treatment continues until the last patient enrolled has received 52 weeks of therapy, or until the study is terminated.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 230
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 (54)
Long Beach Memorial Med. Ctr., Miller Children's Hosp.
🇺🇸Long Beach, California, United States
Usc La Nichd Crs
🇺🇸Los Angeles, California, United States
UCLA-Los Angeles/Brazil AIDS Consortium (LABAC) CRS
🇺🇸Los Angeles, California, United States
Children's Hosp. & Research Ctr. Oakland, Ped. Clinical Research Ctr. & Research Lab.
🇺🇸Oakland, California, United States
UCSD Maternal, Child, and Adolescent HIV CRS
🇺🇸San Diego, California, United States
UCSF Pediatric AIDS CRS
🇺🇸San Francisco, California, United States
Harbor - UCLA Med. Ctr. - Dept. of Peds., Div. of Infectious Diseases
🇺🇸Torrance, California, United States
Univ. of Colorado Denver NICHD CRS
🇺🇸Aurora, Colorado, United States
Univ. of Connecticut Health Ctr., Dept. of Ped.
🇺🇸Farmington, Connecticut, United States
Yale Univ. School of Medicine - Dept. of Peds., Div. of Infectious Disease
🇺🇸New Haven, Connecticut, United States
Scroll for more (44 remaining)Long Beach Memorial Med. Ctr., Miller Children's Hosp.🇺🇸Long Beach, California, United States