Pharmacokinetic Interactions Between Antiretroviral Agents, Lopinavir/Ritonavir and Efavirenz and Antimalarial Drug Combinations, Artesunate/Amodiaquine and Artemether/Lumefantrine.

NCT00697892 Phase 1 COMPLETED

The purpose of the study is to determine in healthy volunteers whether certain anti-HIV medications (lopinavir/ritonavir and efavirenz) affect the drug levels of certain anti-malarial medications (artesunate/ amodiaquine and artemether/ lumefantrine) and vice versa. Since these drugs are degraded using overlapping pathways in the liver, it is predicted that changes in both drug level and overall drug exposure will be observed.

Details

Lead sponsor	Fran Aweeka
Phase	Phase 1
Status	COMPLETED
Enrolment	38
Start date	2005-07
Completion	2010-12

Conditions

• HIV Infections
• Malaria

Interventions

• lopinavir/ritonavir
• efavirenz
• artemether/lumefantrine

Primary outcomes

• AUC (zero to infinity) of the antimalarial agent — Each 3-day antimalarial treatment course throughout study

Countries

United States