Drug Interaction Study Between Atovaquone and Antiretroviral Agents in HIV-1 Infected Patients
|ClinicalTrials.gov Identifier: NCT00421473|
Recruitment Status : Completed
First Posted : January 12, 2007
Last Update Posted : February 25, 2009
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.
|Condition or disease||Intervention/treatment||Phase|
|HIV Infections Malaria||Drug: Atovaquone / Proguanil||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||79 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Drug Interactions Between ATOvaquone Used in MAlaria Prophylaxis and Antiretroviral Agents in HIV-1 Infected Patients (ATOMA)|
|Study Start Date :||March 2007|
|Actual Primary Completion Date :||December 2008|
|Actual Study Completion Date :||December 2008|
- 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
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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|