drugset / Trial / NCT00421473

Drug Interaction Study Between Atovaquone and Antiretroviral Agents in HIV-1 Infected Patients

NCT00421473

Phase 4 Completed 79 enrolled Radboud University Medical Center
Non-randomizedParallel-groupOpen-labelPrevention

Summary

Malarone® (atovaquone/proguanil) is frequently used in malaria prophylaxis. Unfortunately, there are indications that certain anti-HIV agents may decrease atovaquone plasma levels by induction of atovaquone metabolism. For travelling HIV patients, the clinical consequences of these possible drug drug interactions are serious, since a diminished exposure to the anti-malarial drug will result in suboptimal prophylaxis of malaria and potential development of drug resistant strains of Plasmodium falciparum. The purpose of this study is to find out if HIV patients using HAART regimes with either lopinavir/ritonavir, atazanavir/ritonavir or efavirenz have lower atovaquone plasma levels than healthy volunteers after a single dose of atovaquone/proguanil.

Timeline

Start
2007-03
Primary completion
2008-12
Completion
2008-12

Drugs

EvaluationDrugModalityDoseRoute
Subject Atovaquone Small molecule
Subject Proguanil Small molecule