Drug Interaction Study Between Atovaquone and Antiretroviral Agents in HIV-1 Infected Patients
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.
|Study Design:||Allocation: Non-Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
|Official Title:||Drug Interactions Between ATOvaquone Used in MAlaria Prophylaxis and Antiretroviral Agents in HIV-1 Infected Patients (ATOMA)|
- Pharmacokinetic blood samples will be taken just before dosing Malarone, and 12 samples in the time between 0,5 hour and 168 hours after dosing.
- Blood will be taken for genotyping of CYP2C19 at study day 1.
- HIV-1 RNA and CD4 determination will be done (HIV patients only) at inclusion screening
|Study Start Date:||March 2007|
|Study Completion Date:||December 2008|
|Primary Completion Date:||December 2008 (Final data collection date for primary outcome measure)|
Please refer to this study by its ClinicalTrials.gov identifier: NCT00421473
|Tilburg, Brabant, Netherlands, 5022 GC|
|Alysis Zorggroep loc. Rijnstate|
|Arnhem, Gelderland, Netherlands, 6800 TA|
|Radboud University Medical Centre Nijmegen|
|Nijmegen, Gelderland, Netherlands, 6525 GA|
|Leids Universitair Medisch Centrum|
|Leiden, Zuid Holland, Netherlands, 2300 RC|
|Rotterdam, Zuid Holland, Netherlands, 3000 CA|
|Principal Investigator:||D.M. Burger, Dr.||Radboud University Medical Centre Nijmegen|