View clinical trials related to Drug Combination.
Filter by:This is an open-label pharmacokinetic study in 16 healthy Thai subjects. To assess the safety and tolerability and pharmacological interactions of the combination of artemether-lumefantrine and amodiaquine. This study is funded by Prof White's WT PRF. The Welcome Trust grant reference number is B9R04920.
Despite the implementation of a national strategy to prevent the transmission of the human immunodeficiency virus (HIV) combining prevention campaigns, condom use, early detection of HIV infections and recommendations for treatment as soon as possible, the number of new HIV-infected patients per year in France does not decrease. New HIV prevention strategies are therefore clearly needed. Since 2009, several studies have shown that tenofovir disoproxil fumarate and emtricitabine (TDF/FTC), an antiretroviral therapy combining two nucleoside reverse transcriptase inhibitors used for the treatment of patients seropositive for HIV, has preventive activity on HIV transmission. These results enabled the TDF/FTC to obtain in France an extension of the marketing authorization in March 2017 for preexposure prophylaxis (PrEP) of HIV transmission among patients at high risk of contamination. Since the approval, many studies around the world investigate the use of PrEP in routine practice, highlighting its effectiveness in real life. These studies describe the population of patients who benefit from PrEP in order to adapt their multidisciplinary care but also track the transmission of other sexually transmitted infections to prevent their emergence, given the observed decline in condom use. However, these studies are limited to big cities while PrEP is accessible in all territories. The Rhône-Alpes region is one of the three French regions that has been the most involved in the implementation of PrEP, one year after the FTC/TDF approval in France. Given the geographical position of the investigators, both in province and close to Switzerland, where the FTC/TDF is not authorized for PrEP, and the non-university nature of five of the six involved hospitals, the investigators would like to determine the profile of patients consulting in this region to benefit from PrEP. This analysis will also determine if the population at risk of the "Alpine Arc" region is similar to that observed in the other cohorts in order to adapt patient care.
Primary Objective - To characterize the potential pharmacokinetic interactions of artemether -lumefantrine, amodiaquine and primaquine in healthy adult subjects. Secondary Objectives - To characterize the pharmacokinetic properties of artemether-lumefantrine, amodiaquine and primaquine when given alone and in combination. - To evaluate the safety and tolerability of co-administered artemether-lumefantrine, amodiaquine and primaquine. - To investigate pharmacogenetic polymorphisms affecting drug levels of artemether-lumefantrine, amodiaquine and primaquine and their metabolites.
Primary Objective - To evaluate the safety and tolerability of co-administered single dose Dihydroartemisinin-Piperaquine (DHA-PQP), Ivermectin (IVM), Primaquine (PQ), and Albendazole (ABZ) in healthy subjects. Secondary Objectives - To characterize the potential pharmacokinetic interactions between DHA-PQP, IVM, PQ, and ABZ in healthy adult subjects. - To characterize the pharmacokinetic properties of PQ (and its major metabolite), DHA-PQP, IVM, and ABZ (and its major metabolite) when given alone and in combination. - To investigate pharmacogenetic polymorphisms affecting drug levels of PQ, DHA-PQP, IVM, ABZ and their metabolites. - To determine mosquito lethal efficacy of IVM, PQ, ABZ, and DHA-PQP combinations against Anopheles dirus and Anopheles minimus. - To determine if IVM concentrations in venous blood differs from capillary blood.