Possibia

843

Last Update Posted: 2005-06-24

Recruiting has ended

All Genders

accepted

1 Day-17 Years

24 Estimated Participants

No Expanded Access

Interventional Study

Does not accept healthy volunteers

The Safety and Effectiveness of Adefovir Dipivoxil in HIV-Infected Children

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.

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.

Eligibility

Relevant conditions:

HIV Infections

If you aren't sure if you meet the criteria above speak to your healthcare professional. Criteria may be updated but not reflected here, do not hesitate to contact the study if you think are close to fitting criteria.

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Contact Information

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Data sourced from ClinicalTrials.gov