Ignite Creation Date:
2024-05-05 @ 12:10 PM
Last Modification Date:
2024-10-26 @ 9:21 AM
Study NCT ID:
NCT00260078
Status:
COMPLETED
Last Update Posted:
2021-11-09
First Post:
2005-11-29
Brief Title:
Blood Levels of Anti-HIV Drugs Used in Combination Regimens 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:
Intensive Pharmacokinetic Studies of Antiretroviral Drug Combinations in Children
Status:
COMPLETED
Status Verified Date:
2016-07
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:
Limited data exist about combination anti-HIV treatment regimens in children including how those drugs are cleared by the body in children The purpose of this study is to measure the blood levels of the following combinations of anti-HIV drugs in HIV infected chilren tenofovir disoproxil fumurate TDF and efavirenz EFV or nevirapine NVP TDF and darunavir DRV with or without EFV and TDF and ritonavir RTV with or without EFV
Detailed Description:
Because all of the available non-nucleoside reverse transcriptase inhibitors NNRTIs and protease inhibitors PIs are metabolized by and affect hepatic cytochrome enzymes combinations of two or more of these drugs produce complex pharmacokinetic PK interactions However little data exist regarding PK of anti-HIV drug combinations in the pediatric population The purpose of this study is to assess steady-state PK of the following anti-HIV regimens TDF and EFV or NVP TDF and DRV with or without EFV and TDF and RTV with or without EFV In addition this study will evaluate how age length of treatment adverse effects and genes affect childrens response to different anti-HIV combinations
This study will last between 1 and 7 weeks Participants in this study will be grouped based on the treatment regimen they are receiving or about to initiate There are three groups in this study Group D participants will receive TDF and EFV or NVP Group E participants will receive TDF and DRV with or without EFV and Group F participants will receive TDF and RTV with or without EFV The inclusion of EFV or NVP will be dependent on each participants prescribed regimen Participants within each group will be stratified by age and how long they have been receiving their anti-HIV regimens Antiretrovirals will not be provided by this study
Most participants will have two study visits The first visit will occur at study entry Medical history a physical exam and blood collection will occur The second visit will occur within 35 days of study entry and will take approximately 24 hours Blood collection for PK studies a physical exam and medical history will be done at this visit Urine collection will occur at all visits for female participants
Participants will undergo PK testing at least 14 days after initiating their study regimens Participants will be given a dose of their anti-HIV medications with food A blood sample will be taken before dosing Blood samples will also be taken at 1 2 4 6 8 12 and 24 hours after dosing Participants in Groups E and F may need to repeat PK testing within 6 weeks of initial PK testing at the discretion of the investigator
This study will last between 1 and 7 weeks Participants in this study will be grouped based on the treatment regimen they are receiving or about to initiate There are three groups in this study Group D participants will receive TDF and EFV or NVP Group E participants will receive TDF and DRV with or without EFV and Group F participants will receive TDF and RTV with or without EFV The inclusion of EFV or NVP will be dependent on each participants prescribed regimen Participants within each group will be stratified by age and how long they have been receiving their anti-HIV regimens Antiretrovirals will not be provided by this study
Most participants will have two study visits The first visit will occur at study entry Medical history a physical exam and blood collection will occur The second visit will occur within 35 days of study entry and will take approximately 24 hours Blood collection for PK studies a physical exam and medical history will be done at this visit Urine collection will occur at all visits for female participants
Participants will undergo PK testing at least 14 days after initiating their study regimens Participants will be given a dose of their anti-HIV medications with food A blood sample will be taken before dosing Blood samples will also be taken at 1 2 4 6 8 12 and 24 hours after dosing Participants in Groups E and F may need to repeat PK testing within 6 weeks of initial PK testing at the discretion of the investigator
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 |
|---|---|---|---|
| 10050 | REGISTRY | DAIDS-ES | None |
| PACTG 1058 | None | None | None |
| IMPAACT P1058 | None | None | None |