The Safety and Effectiveness of Adefovir Dipivoxil in HIV-Infected Children
- Conditions
- HIV Infections
- Registration Number
- NCT00000843
- Brief Summary
To evaluate the single-dose pharmacokinetic profile and acute toxicity of bis-POM PMEA ( adefovir dipivoxil ) in HIV-1 infected children, and to determine whether age-related differences exist. To ascertain dosages that may be suitable for a multiple-dose evaluation in this patient population.
Although the oral bioavailability of PMEA ( adefovir ) is low, the prodrug bis-POM PMEA has resulted in increased bioavailability in adult patients in clinical trials. However, the safety and pharmacokinetic patterns of drugs in infants often differ from those of adults and the direction of the variation is not predictable. This study will assess these parameters of bis-POM PMEA in children.
- Detailed Description
Although the oral bioavailability of PMEA ( adefovir ) is low, the prodrug bis-POM PMEA has resulted in increased bioavailability in adult patients in clinical trials. However, the safety and pharmacokinetic patterns of drugs in infants often differ from those of adults and the direction of the variation is not predictable. This study will assess these parameters of bis-POM PMEA in children.
Patients are stratified by age, and separate cohorts from each age group receive 1 of 2 single doses of bis-POM PMEA. The lower dose is given to patients ages 3 months through 17 years; if toxicity is acceptable, the other cohort in this age range receives the higher dose. At this point, accrual of infants \< 3 months old may begin at the lower dose, followed by accrual of this age group at the higher dose if toxicity is acceptable. Serum drug concentrations are monitored up to 8 hours post dose.
AS PER AMENDMENT 5/2/97: Based on data from both the low- and high-dose cohorts of the older age group (\>= 3 months to \< 18 years), the younger age group (\<3 months) will be started at the high-dose.
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 (10)
UCSF / Moffitt Hosp - Pediatric
🇺🇸San Francisco, California, United States
Vanderbilt Univ Med Ctr
🇺🇸Nashville, Tennessee, United States
Chicago Children's Memorial Hosp
🇺🇸Chicago, Illinois, United States
Johns Hopkins Hosp - Pediatric
🇺🇸Baltimore, Maryland, United States
Children's Hosp of Boston
🇺🇸Boston, Massachusetts, United States
Children's Hosp of New Jersey / UMDNJ - New Jersey Med Schl
🇺🇸Newark, New Jersey, United States
Children's Hosp of Philadelphia
🇺🇸Philadelphia, Pennsylvania, United States
Univ of Florida Health Science Ctr / Pediatrics
🇺🇸Jacksonville, Florida, United States
Univ of Puerto Rico / Univ Children's Hosp AIDS
🇵🇷San Juan, Puerto Rico
Saint Jude Children's Research Hosp of Memphis
🇺🇸Memphis, Tennessee, United States