Ignite Creation Date:
2024-05-05 @ 11:19 AM
Last Modification Date:
2024-10-26 @ 9:02 AM
Study NCT ID:
NCT00000843
Status:
COMPLETED
Last Update Posted:
2005-06-24
First Post:
1999-11-02
Brief Title:
The Safety and Effectiveness of Adefovir Dipivoxil in HIV-Infected Children
Sponsor:
National Institute of Allergy and Infectious Diseases NIAID
Organization:
National Institute of Allergy and Infectious Diseases NIAID
Study Overview
Official Title:
A Phase IA Single Dose Pharmacokinetics and Safety Study of the Oral Antiviral Compound 9-2-BispivaloyloxymethylPhosphonylmethoxyethylAdenine Bis-POM PMEA Adefovir Dipivoxil in Children With HIV-1 Infection
Status:
COMPLETED
Status Verified Date:
1998-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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 5297 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
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 5297 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
Study Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?: