Ignite Creation Date:
2024-05-05 @ 11:35 AM
Last Modification Date:
2024-10-26 @ 9:10 AM
Study NCT ID:
NCT00087945
Status:
COMPLETED
Last Update Posted:
2013-10-08
First Post:
2004-07-16
Brief Title:
Blood Levels of Abacavir in HIV Infected Adolescents
Sponsor:
National Institute of Allergy and Infectious Diseases NIAID
Organization:
National Institute of Allergy and Infectious Diseases NIAID
Study Overview
Official Title:
Abacavir Pharmacokinetics During Chronic Therapy in HIV-1 Infected Adolescents and Young Adults
Status:
COMPLETED
Status Verified Date:
2013-10
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 way abacavir ABC behaves in the body differs between children and adults but little is known about ABC in adolescents It is unclear if adult doses of ABC are appropriate for adolescents The purpose of this study is to determine the blood levels of ABC in HIV infected adolescents who are on ABC-containing regimens
Detailed Description:
ABC is approved for the treatment of HIV in adults and children but it is unclear if currently recommended ABC doses are appropriate for adolescents Previous data suggest ABC clearance in children is about twice that found in adults but limited data exist on the pharmacokinetics of ABC in adolescents This study will evaluate the 8-hour pharmacokinetics of ABC in HIV infected adolescents who are currently on ABC-containing treatment regimens
There will be two groups in this study Group 1 participants will be 13 to 17 years old Group 2 participants will be 18 to 25 years old All participants will receive a 300 mg dose of ABC as either a single-agent tablet or a combination tablet of ABC lamivudine and zidovudine whichever they are currently taking Participants will have a medical history assessment and a physical exam at screening and study entry Participants will also be asked about adherence to their ABC-containing regimen at study entry During the 8-hour drug level study blood collection for pharmacokinetic analysis will occur prior to taking ABC and at 05 1 2 3 4 6 and 8 hours after taking ABC
There will be two groups in this study Group 1 participants will be 13 to 17 years old Group 2 participants will be 18 to 25 years old All participants will receive a 300 mg dose of ABC as either a single-agent tablet or a combination tablet of ABC lamivudine and zidovudine whichever they are currently taking Participants will have a medical history assessment and a physical exam at screening and study entry Participants will also be asked about adherence to their ABC-containing regimen at study entry During the 8-hour drug level study blood collection for pharmacokinetic analysis will occur prior to taking ABC and at 05 1 2 3 4 6 and 8 hours after taking ABC
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 10194 | REGISTRY | DAIDS ES | None |