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CLINICAL TRIALS PROFILE FOR MALARONE PEDIATRIC

Clinical Trials for Malarone Pediatric

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Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00421473	Drug Interaction Study Between Atovaquone and Antiretroviral Agents in HIV-1 Infected Patients	Completed	Radboud University	Phase 4	2007-03-01	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.
NCT00444106	Evaluation of Potential Effect of Artemether - Lumefantrine and Malaria Drugs on Auditory Function	Completed	Novartis	Phase 4	2007-05-01	To evaluate the potential effects of artemether- lumefantrine on the auditory function
NCT00984256	Weekly Dosing of Malarone ® for Prevention of Malaria	Completed	U.S. Army Medical Research and Materiel Command	Phase 2	2009-09-01	The purpose of this study is to determine whether Malarone ®, which is a drug approved to prevent malaria when taken daily, will still effectively prevent malaria if taken weekly.
NCT01150344	Evaluation of the Riamet® Versus Malarone® in the Treatment of Uncomplicated Malaria	Completed	Assistance Publique - Hôpitaux de Paris	Phase 4	2010-07-01	Riamet® or Malarone® are both recommended as the first line treatment for uncomplicated malaria in France, according to the French consensus Conference revised in 2007 on the treatment of imported malaria. The aim of the study is to compare both tolerance and efficacy of Malarone® and Riamet® in the treatment of uncomplicated imported malaria and to determine clinical and parasitological predictive factors associated with a less effectiveness. It's a multicentric, randomised study in adults with uncomplicated malaria. Treatment will be administered for 3 days, and patients will be followed for 28 days, to evaluate the therapeutic evolution. 640 patients will be included among 15 centres.
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