Comparison of Stavudine Used Alone or in Combination With Didanosine in HIV-Infected Children
- Conditions
- HIV Infections
- Registration Number
- NCT00000851
- Brief Summary
To evaluate the safety and determine the pharmacokinetic disposition of stavudine (d4T) alone and in combination with didanosine (ddI), and whether concurrent administration alters the disposition of either drug. To compare d4T versus d4T plus ddI with respect to short and long term changes from baseline in plasma HIV RNA concentrations. To determine the relationship, if any, between drug exposure and viral burden.
In a pilot study of d4T and ddI given to eight children with advanced HIV for 24 weeks, the three children with baseline counts greater than 50 cells/micro liter experienced a 20% increase in their CD4+ lymphocyte counts. Based on these results, controlled trials of the same regimen for children with less advanced HIV disease should be undertaken.
- Detailed Description
In a pilot study of d4T and ddI given to eight children with advanced HIV for 24 weeks, the three children with baseline counts greater than 50 cells/micro liter experienced a 20% increase in their CD4+ lymphocyte counts. Based on these results, controlled trials of the same regimen for children with less advanced HIV disease should be undertaken.
Eligible subjects receiving d4T will be assigned in an open manner to Arm 1, and subjects who have been receiving zidovudine (AZT) will be assigned in a randomized, double blind manner to Arms 2 and 3. Each subject will receive study drug for 48 weeks as follows: Arm 1 - d4T plus ddI, Arm 2 - d4T alone, Arm 3 - d4T plus ddI.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 198
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 (35)
Univ. of Maryland Med. Ctr., Div. of Ped. Immunology & Rheumatology
🇺🇸Baltimore, Maryland, United States
St. Christopher's Hosp. for Children
🇺🇸Philadelphia, Pennsylvania, United States
Cook County Hosp.
🇺🇸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 Miami Ped. Perinatal HIV/AIDS CRS
🇺🇸Miami, Florida, United States
Texas Children's Hosp. CRS
🇺🇸Houston, Texas, United States
DUMC Ped. CRS
🇺🇸Durham, North Carolina, United States
Univ. Hosp. Ramón Ruiz Arnau, Dept. of Peds.
🇵🇷Bayamon, Puerto Rico
San Juan City Hosp. PR NICHD CRS
🇵🇷San Juan, Puerto Rico
Metropolitan Hosp. NICHD CRS
🇺🇸New York, New York, United States
Children's National Med. Ctr., ACTU
🇺🇸Washington, District of Columbia, 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
Schneider Children's Hosp., Div. of Infectious Diseases
🇺🇸New Hyde Park, New York, United States
Incarnation Children's Ctr.
🇺🇸New York, New York, United States
SUNY Downstate Med. Ctr., Children's Hosp. at Downstate NICHD CRS
🇺🇸Brooklyn, New York, United States
Columbia IMPAACT CRS
🇺🇸New York, New York, United States
Strong Memorial Hospital Rochester NY NICHD CRS
🇺🇸Rochester, New York, United States
Children's Med. Ctr. Dallas
🇺🇸Dallas, Texas, United States
Univ. of Puerto Rico Ped. HIV/AIDS Research Program CRS
🇵🇷San Juan, Puerto Rico
Univ. of Florida Jacksonville NICHD CRS
🇺🇸Jacksonville, Florida, United States
Univ. of Connecticut Health Ctr., Dept. of Ped.
🇺🇸Farmington, Connecticut, United States
Harbor - UCLA Med. Ctr. - Dept. of Peds., Div. of Infectious Diseases
🇺🇸Torrance, California, United States
Connecticut Children's Med. Ctr.
🇺🇸Hartford, Connecticut, United States
Chicago Children's CRS
🇺🇸Chicago, Illinois, United States
Howard Univ. Washington DC NICHD CRS
🇺🇸Washington, District of Columbia, United States
UMDNJ - Robert Wood Johnson
🇺🇸New Brunswick, New Jersey, United States
NJ Med. School CRS
🇺🇸Newark, New Jersey, United States
North Shore-Long Island Jewish Health System, Dept. of Peds.
🇺🇸Great Neck, New York, United States
Univ. of Colorado Denver NICHD CRS
🇺🇸Aurora, Colorado, United States
Tulane/LSU Maternal/Child CRS
🇺🇸New Orleans, Louisiana, United States
Children's Hospital of Michigan NICHD CRS
🇺🇸Detroit, Michigan, United States
Bronx-Lebanon Hosp. IMPAACT CRS
🇺🇸Bronx, New York, United States
Med. Univ. of South Carolina, Div. of Ped. Infectious Diseases
🇺🇸Charleston, South Carolina, United States