Ignite Creation Date:
2024-05-05 @ 11:23 AM
Last Modification Date:
2024-10-26 @ 9:06 AM
Study NCT ID:
NCT00011479
Status:
COMPLETED
Last Update Posted:
2021-11-01
First Post:
2001-02-22
Brief Title:
Blood Levels of Abacavir After One Dose in HIV-Infected Children and Adolescents
Sponsor:
National Institute of Allergy and Infectious Diseases NIAID
Organization:
National Institute of Allergy and Infectious Diseases NIAID
Study Overview
Official Title:
Single Dose Pharmacokinetic Study of Abacavir in HIV-Infected Children and Adolescents
Status:
COMPLETED
Status Verified Date:
2021-10
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:
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 childrens dose or the adult dose is better for HIV-infected adolescents
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 childrens 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 05 10 15 20 25 30 4 6 and 8 hours post dose for abacavir concentrations
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 05 10 15 20 25 30 4 6 and 8 hours post dose for abacavir concentrations
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?:
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| PACTG P1018 | Registry Identifier | DAIDS ES | None |
| 11653 | REGISTRY | None | None |
| ACTG P1018 | None | None | None |