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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	Summary
NCT00421473	Drug Interaction Study Between Atovaquone and Antiretroviral Agents in HIV-1 Infected Patients	Completed	Radboud University	Phase 4	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	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	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	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.
NCT01479361	Antiretroviral Drug Interaction Study in Volunteers With HIV	Completed	National Institutes of Health Clinical Center (CC)	Phase 1	Background: - People who are infected with the human immunodeficiency virus (HIV) are at risk of getting certain diseases. Two of these diseases are a type of pneumonia known as PCP and a brain infection called toxoplasmosis. Most people with HIV take antiretroviral (ARV) drugs to treat HIV and lower the risk of infections. However, some ARV drugs may make other drugs used to treat PCP and toxoplasmosis less effective. Researchers want to test specific ARV drugs to see if they affect atovaquone, a drug used to treat PCP and toxoplasmosis. Objectives: - To see if ARV drugs atazanavir-ritonavir or efavirenz lower the blood levels of atovaquone. Eligibility: - Individuals between 18 and 70 years of age who have HIV. - Participants must be taking efavirenz or atazanavir-ritonavir, or not taking any ARV drugs. Design: - Participants will be screened with a physical exam and medical history. They will also have blood and urine tests. - This study has a screening visit and five study visits. Two of the study visits will last about 12 hours; the other three visits will last about 1 hour each. - Participants will receive either a low dose or high dose of atovaquone to take for 14 days. They will record doses and any symptoms on a diary card at home. - After 14 days, participants will have a 12-hour visit to provide blood samples. There will be a wash-out period with no doses for up to 6 weeks. - After the wash-out period, participants will switch dose levels to either the high or low dose. - After 14 days, participants will have a 12-hour visit to provide blood samples.
Trial ID	Title	Status	Sponsor	Phase	Summary