PHARMACOKINETICS STUDIES

ANTIMALARIAL PHARMACOLOGY IN HIV INFECTED AND UNINFECTED CHILDREN AND PREGNANT WOMEN IN UGANDA

A PHARMACOKINETIC AND PHARMACODYNAMIC STUDY FOR ARTEMETHER-LUMEFANTRINE (AL) TREATMENT FOR UNCOMPLICATED MALARIA IN HIV-INFECTED AND HIV-UNINFECTED CHILDREN AND PREGNANT WOMEN IN UGANDA

ClinicalTrials.gov Identifier: NCT01717885

Principal Investigators: Dr. Francesca Aweeka, UCSF and Dr. Norah Mwebaza, Makerere University

Co-Investigators: Dr. Sunil Parikh, Yale U; Prof Moses Kamya, Makerere University; Dr. Myiang Nyunt, Johns Hopkins University; Dr. Jane Achan, Makerere University; Dr. Deb Cohan, UCSF; Dr. Diane Havlir, UCSF; Dr. Phil Rosenthal, UCSF; Dr. Nancy Sambol, UCSF

Coordinator: Kajubi Richard, IDRC

Funded by: The Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)/NIH

Location: Tororo, Uganda 

Ongoing research includes assessing the clinical pharmacology of artemether-lumefantrine (AL), for treatment of uncomplicated malaria in children and pregnant women (R01HD068174). The R01 is evaluating distinctions in the disposition of AL in children and pregnant women compared to non-pregnant adults and evaluating the drug-drug interactions between treatment for HIV and AL. This R01 is in the 3rd year of a 5 year grant period. Pharmacokinetic data acquired to date in HIV infected children treated with a PI versus NNRTI regimen has been accepted for presentation as an Oral Presentation at CROI, 2013. Additional pharmacology work being carried out in Tororo includes assessing the disposition of piperaquine in children receiving DP for prophylaxis and evaluating the impact of malnutrition on the PK disposition of antiretroviral drugs