P1079 (DAIDS ID 10765): Pharmacology of Artemisinin-Based Antimalarial Therapy Within the Context of Antiretroviral Therapy

Study Status Study Restriction

Closed to Follow Up

Non-US

What is P1079?

P1079 is a prospective, pharmacokinetic (PK) study to investigate the drug-drug interaction between the antimalarial treatment artemether/lumefantrine (AL) and nevirapine (NVP)-based antiretroviral (ARV) treatment for HIV, in co-infected children in resource limited settings.  The primary objectives of the study are to determine if NVP-based ARV therapy versus no ARV therapy alters the AL PK exposure in children (ages ≥3 to ≤12 years) who are co-infected with malaria and HIV and to evaluate the 28 and 42-day safety and toxicity following co-administration of 6 doses of AL with NVP.  (Arm A only).  The target enrollment is 48 evaluable participants (24 on a NVP-based ARV regimen; 24 on no ARV regimen); each subject would receive 6 doses of AL over a 4 day period and would be followed for 42 days from entry.

Study Documents:

Sites where the study is implemented:

CRS ID Site Name City Country

12001

University of North Carolina Lilongwe CRS

Lilongwe

Malawi

30301

College of Medicine JHU CRS

Blantyre

Malawi

30293

Makerere University - Johns Hopkins University (MU-JHU) Research Collaboration

Kampala

Uganda

Study contacts:

Clinical Trials Specialist: Katie McCarthy

 

Funded by the National Institute of Allergy and Infectious Diseases, the Eunice Kennedy Shriver National Institute of Child Health and Human Development, and the National Institute of Mental Health of the US National Institutes of Health, US Department of Health and Human Services.