Antimalarial Pharmacology in HIV Infected and Uninfected Children and Pregnant Women in Uganda

NCT01717885 COMPLETED

The burden of malaria is greatest in children and pregnant women in sub-Saharan Africa. Malaria is one of the most important infectious diseases in the world. Uganda reports among the highest transmission intensities in the world. Children and pregnant women are the most vulnerable populations. HIV is also reported at high rates for these populations. If malaria and HIV require treatment at the same time, there is a high risk for drug-drug interactions. This study will: 1. Determine if the use of anti-HIV medications including lopinavir/ritonavir (LPV/r), nevirapine (NVP) and efavirenz (EFV) will affect the pharmacokinetic (PK) exposure of antimalarial medications (specifically artemether-lumefantrine, AL) during the treatment for uncomplicated malaria in HIV-infected children and pregnant women, and 2. Evaluate the impact of age and pregnancy on the PK exposure of AL.

Details

Lead sponsor	University of California, San Francisco
Status	COMPLETED
Enrolment	473
Start date	2012-08
Completion	2016-09

Conditions

• Malaria
• HIV

Primary outcomes

• Primary outcome measurement is the area under the plasma concentration versus time curve for all drug analytes. — At time of the last dose of a 6 dose regimen and up to 42 days of F/U
  Pharmacokinetic exposure for the antimalarial medication is estimated through sparse or intensive blood sampling around the last dose and for several days following the last dose.

Countries

Uganda