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)
Usc La Nichd Crs
🇺🇸Los Angeles, California, United States
The Children's Hosp. of Philadelphia IMPAACT CRS
🇺🇸Philadelphia, Pennsylvania, United States
St. Christopher's Hosp. for Children
🇺🇸Philadelphia, Pennsylvania, United States
Univ. of Illinois College of Medicine at Chicago, Dept. of Peds.
🇺🇸Chicago, Illinois, United States
BMC, Div. of Ped Infectious Diseases
🇺🇸Boston, Massachusetts, United States
Univ. of Connecticut Health Ctr., Dept. of Ped.
🇺🇸Farmington, Connecticut, United States
Children's National Med. Ctr., ACTU
🇺🇸Washington, District of Columbia, United States
Yale Univ. School of Medicine - Dept. of Peds., Div. of Infectious Disease
🇺🇸New Haven, Connecticut, United States
St. Joseph's Hosp. & Med. Ctr. of New Jersey
🇺🇸Paterson, New Jersey, United States
Tulane/LSU Maternal/Child CRS
🇺🇸New Orleans, Louisiana, United States
St. Jude/UTHSC CRS
🇺🇸Memphis, Tennessee, United States
DUMC Ped. CRS
🇺🇸Durham, North Carolina, United States
Univ. of Puerto Rico Ped. HIV/AIDS Research Program CRS
🇵🇷San Juan, Puerto Rico
Univ. of Colorado Denver NICHD CRS
🇺🇸Aurora, Colorado, United States
Children's Hospital of Michigan NICHD CRS
🇺🇸Detroit, Michigan, United States
Long Beach Memorial Med. Ctr., Miller Children's Hosp.
🇺🇸Long Beach, 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
Howard Univ. Washington DC NICHD CRS
🇺🇸Washington, District of Columbia, United States
Emory Univ. School of Medicine, Dept. of Peds., Div. of Infectious Diseases
🇺🇸Atlanta, Georgia, United States
Univ. of Miami Ped. Perinatal HIV/AIDS CRS
🇺🇸Miami, Florida, United States
Cook County Hosp.
🇺🇸Chicago, Illinois, United States
Chicago Children's CRS
🇺🇸Chicago, Illinois, United States
Univ. of Chicago - Dept. of Peds., Div. of Infectious Disease
🇺🇸Chicago, Illinois, United States
HMS - Children's Hosp. Boston, Div. of Infectious Diseases
🇺🇸Boston, Massachusetts, United States
Univ. of Maryland Med. Ctr., Div. of Ped. Immunology & Rheumatology
🇺🇸Baltimore, Maryland, United States
Baystate Health, Baystate Med. Ctr.
🇺🇸Springfield, Massachusetts, United States
WNE Maternal Pediatric Adolescent AIDS CRS
🇺🇸Worcester, Massachusetts, United States
UMDNJ - Robert Wood Johnson
🇺🇸New Brunswick, New Jersey, United States
Cooper Univ. Hosp.
🇺🇸Camden, New Jersey, United States
Children's Hospital at Albany Medical Center, Dept. of Peds.
🇺🇸Albany, New York, United States
SUNY Downstate Med. Ctr., Children's Hosp. at Downstate NICHD CRS
🇺🇸Brooklyn, New York, United States
Bronx-Lebanon Hosp. IMPAACT CRS
🇺🇸Bronx, New York, United States
North Shore-Long Island Jewish Health System, Dept. of Peds.
🇺🇸Great Neck, New York, United States
Schneider Children's Hosp., Div. of Infectious Diseases
🇺🇸New Hyde Park, New York, United States
NYU Med. Ctr., Dept. of Medicine
🇺🇸New York, New York, United States
Metropolitan Hosp. NICHD CRS
🇺🇸New York, New York, United States
Columbia IMPAACT CRS
🇺🇸New York, New York, United States
Incarnation Children's Ctr.
🇺🇸New York, New York, United States
SUNY Upstate Med. Univ., Dept. of Peds.
🇺🇸Syracuse, New York, United States
Harlem Hosp. Ctr. NY NICHD CRS
🇺🇸New York, New York, United States
SUNY Stony Brook NICHD CRS
🇺🇸Stony Brook, New York, United States
UNC at Chapel Hill School of Medicine - Dept. of Peds., Div. of Immunology & Infectious Diseases
🇺🇸Chapel Hill, North Carolina, United States
Univ. of Rochester ACTG CRS
🇺🇸Rochester, New York, United States
Children's Med. Ctr. Dallas
🇺🇸Dallas, Texas, United States
Med. Univ. of South Carolina, Div. of Ped. Infectious Diseases
🇺🇸Charleston, South Carolina, United States
Texas Children's Hosp. CRS
🇺🇸Houston, Texas, United States
UW School of Medicine - CHRMC
🇺🇸Seattle, Washington, United States
Univ. Hosp. Ramón Ruiz Arnau, Dept. of Peds.
🇵🇷Bayamon, Puerto Rico
San Juan City Hosp. PR NICHD CRS
🇵🇷San Juan, Puerto Rico
Univ. of Florida Jacksonville NICHD CRS
🇺🇸Jacksonville, Florida, United States