drugset / Trial / NCT01107145

Efficacy of Artemisinin Combination Therapies for the Treatment of Uncomplicated P. Vivax in Pregnancy in Brazil (PAACT-PV)

NCT01107145

Phase 4 Terminated 16 enrolled Centers for Disease Control and Prevention
RandomizedParallel-groupOpen-labelTreatment

Summary

The current treatment recommendations for P. vivax in pregnant and non-pregnant individuals are to use chloroquine; in non-pregnant patients this is followed by primaquine to prevent relapse. As primaquine can not be used in pregnant women, these women remain at risk of relapse. As there is increasing concern about chloroquine resistant P. vivax in this region, there is a need to identify alternative treatment options. The artemisinin combination therapies are recommended for use against P. falciparum infections in pregnant women after the 1st trimester; additional data are needed to support the use of these drugs against P. vivax.

Timeline

Start
2011-02
Primary completion
2012-01
Completion
2012-01

Drugs

EvaluationDrugModalityDoseRoute
Subject Artemether-lumefantrine Unknown 80 mg
Subject Artemether-lumefantrine Unknown 480 mg
Comparator Chloroquine Small molecule 7.5 mg/kg
Comparator Chloroquine Small molecule 750 mg
Subject Mefloquine Artesunate Unknown 100 mg
Subject Mefloquine Artesunate Unknown 220 mg