Pharmacokinetic Interactions Between Antiretroviral Agents, Lopinavir/Ritonavir and Efavirenz and Antimalarial Drug Combination, Artemether/Lumefantrine

NCT00266058 Phase 1 COMPLETED

The purpose of this study is to find out whether taking certain anti-HIV medicines with certain antimalarial medicines affects the amount of the medicines in the blood. The study medicines that will be used are artemether/lumefantrine (antimalarial medication) and lopinavir/ritonavir or efavirenz (anti-HIV medications). Artemether/lumefantrine is not approved by the United States Food and Drug Administration (FDA) but is recommended as standard of care medical treatment for malaria in Africa and Asia. Lopinavir/ritonavir and efavirenz are approved by the FDA. Artemether/lumefantrine and lopinavir/ritonavir or efavirenz may need to be used together to treat children in Africa and Asia. We seek to learn about whether or not the use of these medicines together results in a change in blood levels of any of these medicines. The information obtained from this study will help doctors to provide a better treatment to children and adults with malaria and HIV.

Details

Lead sponsor	University of California, San Francisco
Phase	Phase 1
Status	COMPLETED
Enrolment	33
Start date	2005-12
Completion	2010-11

Conditions

• HIV Infections
• Malaria

Interventions

• Lopinavir/Ritonavir, Efavirenz, Artemether/lumefantrine

Primary outcomes

• Pharmacokinetic assessment of potential drug-drug interactions of antimalarials and antiretroviral agents. — Intensive serial PK sampling of antimalarials conducted on study day 4 (without antiretrovirals) and study day 31 (in the context of antiretrovirals

Countries

United States