Ignite Creation Date:
2025-12-24 @ 12:34 PM
Ignite Modification Date:
2025-12-27 @ 10:12 PM
Study NCT ID:
NCT01728961
Status:
TERMINATED
Last Update Posted:
2014-05-19
First Post:
2012-09-12
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Pharmacology of Antimalarial Therapy With or Without Antiretroviral Therapy
Sponsor:
International Maternal Pediatric Adolescent AIDS Clinical Trials Group
Organization:
Study Overview
Official Title:
Pharmacology of Artemisinin-Based Antimalarial Therapy Within the Context of Antiretroviral Therapy
Status:
TERMINATED
Status Verified Date:
2014-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Slow accrual and funding limitations.
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 see if taking nevirapine (NVP) for HIV changes the way artemether/lumefantrine (AL) works in children who are co-infected with both HIV and malaria. The brand of AL used in this study is Coartem® Dispersible. This study will compare the blood levels of AL in co-infected children who already take NVP prescribed by their doctor with the co-infected children who do not take anti HIV medicines because they do not meet national guidelines to start them. The study will also assess the safety of using both medications (AL and NVP) in children.
Detailed Description:
Malaria and HIV are among the two most important global health problems of our time. Malaria accounts for up to 3 million deaths each year, of which 90% occur in Africa where malaria is the leading cause of mortality in young children. Artemisinin-based combination therapy (ACT) are the mainstay of antimalarial therapy throughout much of the world, yet pediatric pharmacokinetic data on the most widely adopted ACT regimen, artemether/lumefantrine (AL) are lacking. Of equal importance is the assessment of key drug-drug interactions in HIV co-infected children as ARVs are known to affect the metabolic enzyme activity responsible for ACT elimination. This study proposes to investigate the drug-drug interaction between the antimalarial artemether/lumefantrine and nevirapine based antiretroviral (ARV) treatment for HIV in children co-infected in resource limited settings.
Study Oversight
Has Oversight DMC:
False
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?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| U01AI068632 | NIH | None | https://reporter.nih.gov/quic… | View |