NCT01728961

Pharmacology of Antimalarial Therapy With or Without Antiretroviral Therapy

Pharmacology of Artemisinin-Based Antimalarial Therapy Within the Context of Antiretroviral Therapy

• Status: Terminated
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 19 (estimated)
• Sponsor: International Maternal Pediatric Adolescent AIDS Clinical Trials Group · Network
• Sex: All
• Age: 3 Years – 12 Years
• Healthy volunteers: Not accepted

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.

Conditions

• HIV Infection
• Malaria

Interventions

Type	Name	Description
DRUG	Artemether/Lumefantrine (AL)

Timeline

• Start date: 2012-02-01
• Primary completion: 2014-03-01
• Completion: 2014-03-01
• First posted: 2012-11-20
• Last updated: 2014-05-19

Locations

3 sites across 2 countries: Malawi, Uganda