NCT00790881

Artemether/Lumefantrine and Nevirapine Interaction Study in HIV-infected Adults

Pharmacokinetic Interaction Between the Antimalarial Combination Artemether/Lumefantrine and Combination Antiretroviral Therapy Including Nevirapine in HIV-infected Adults

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 36 (estimated)
• Sponsor: University of Cape Town · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Despite the clinical significance of potential interactions between antimalarials and antiretrovirals, no drug interaction studies have been published and there is an urgent need to address this gap in current knowledge. This study aims to assess the drug interaction between the antimalarial Artemether/Lumefantrine used for management of uncomplicated malaria and Nevirapine-based antiretroviral therapy.

Conditions

• Malaria
• HIV

Interventions

Type	Name	Description
DRUG	Artemether/Lumefantrine	Coartem (fixed dose Artemether20mg /Lumefantrine 120mg) Dose: 4 tablets(80mg/480mg) twice daily for 3 days at 0,8,24,36,48 and 60 hours
DRUG	Artemether/ lumefantrine	Coartem (fixed dose Artemether20mg /Lumefantrine 120mg) Dose: 4 tablets(80mg/480mg) twice daily for 3 days at 0,8,24,36,48 and 60 hours

Timeline

• Start date: 2008-10-01
• Primary completion: 2009-08-01
• Completion: 2009-12-01
• First posted: 2008-11-14
• Last updated: 2010-06-28

Locations

1 site across 1 country: South Africa