Blood Levels of Abacavir After One Dose in HIV-Infected Children and Adolescents
- Conditions
- HIV Infections
- Registration Number
- NCT00011479
- Brief Summary
The purpose of this study is to measure blood levels of abacavir in children and adolescents over a period of time following a single dose so that a dosage for adolescents can be determined.
Little is known about how abacavir is cleared by the body in adolescents. It has been shown that young children require a higher abacavir dose based on weight than adults. Older children, or adolescents, may not require as high a dose. This study may provide information as to whether the children's dose or the adult dose is better for HIV-infected adolescents.
- Detailed Description
Pharmacokinetic differences between children and adults have resulted in recommended doses of abacavir based on weight that are higher for children than for adults. There are insufficient data to determine whether the pediatric or adult dose is more appropriate for HIV-infected adolescent patients. This study measures pharmacokinetic data for abacavir in the adolescent population so that an appropriate dosage can be determined.
Patients are evenly enrolled into 2 groups based on Tanner Stage. Group I patients are Tanner Stage 1 or 2 (pre-pubertal). Group II patients are Tanner Stage 3, 4, or 5 (pubertal). Each patient receives a single oral dose of abacavir given as the commercially available oral solution. Pharmacokinetic blood samples are collected before dosing and at 0.5, 1.0, 1.5, 2.0, 2.5, 3.0, 4, 6, and 8 hours post dose for abacavir concentrations.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 24
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 (24)
Med College of Georgia
🇺🇸Augusta, Georgia, United States
Children's Med Ctr of Dallas
🇺🇸Dallas, Texas, United States
Los Angeles County - USC Med Ctr
🇺🇸Los Angeles, California, United States
Univ of Alabama at Birmingham - Pediatric
🇺🇸Birmingham, Alabama, United States
Children's Hospital of L.A. (Pediatric)
🇺🇸Los Angeles, California, United States
Children's Hosp of Washington DC
🇺🇸Washington, District of Columbia, United States
The Med Ctr Inc
🇺🇸Columbus, Georgia, United States
Cook County Hosp
🇺🇸Chicago, Illinois, United States
Chicago Children's Memorial Hosp
🇺🇸Chicago, Illinois, United States
Univ of Chicago Children's Hosp
🇺🇸Chicago, Illinois, United States
Children's Hosp of Boston
🇺🇸Boston, Massachusetts, United States
Montefiore Med Ctr Adolescent AIDS Program
🇺🇸Bronx, New York, United States
Metropolitan Hosp Ctr
🇺🇸New York, New York, United States
Univ of Rochester Med Ctr
🇺🇸Rochester, New York, United States
State Univ of New York at Stony Brook
🇺🇸Stony Brook, New York, United States
Columbus Children's Hosp
🇺🇸Columbus, Ohio, United States
Univ of California, San Diego
🇺🇸San Diego, California, United States
Duke Univ Med Ctr
🇺🇸Durham, North Carolina, United States
Univ of Miami (Pediatric)
🇺🇸Miami, Florida, United States
Texas Children's Hosp / Baylor Univ
🇺🇸Houston, Texas, United States
Med Univ of South Carolina
🇺🇸Charleston, South Carolina, United States
Univ of Florida Health Science Ctr / Pediatrics
🇺🇸Jacksonville, Florida, United States
Saint Jude Children's Research Hosp of Memphis
🇺🇸Memphis, Tennessee, United States
Univ of Medicine & Dentistry of New Jersey / Univ Hosp
🇺🇸Newark, New Jersey, United States