At a glance
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Evaluation of the Safety and Efficacy of Dihydroartemisinin-piperaquine for Intermittent Preventive Treatment of Malaria in HIV-infected Pregnant Women
In Brief
A Phase 3 clinical trial evaluating Dihydroartemisinin-piperaquine (DHA-PPQ) and Placebo Oral Tablet for Malaria and 2 related conditions. Completed, enrolled 666 participants across 2 sites in 2 countries.
Detailed Summary
Trial to evaluate the safety and efficacy of DHA-PPQ for Intermittent Preventive Treatment (IPTp) in HIV-infected pregnant women receiving cotrimoxazole prophylaxis (CTXp) and antiretroviral (ARV) drugs and using long lasting insecticide treated nets will be conducted in Mozambique and Gabon where malaria and HIV infection are moderate to highly prevalent. In addition, the possibility for a PK interaction between DHA-PPQ and ARV drugs will be assessed in a sub-sample of participants. Women will receive ARV therapy according to national guidelines and their infants will be followed until one year of age to evaluate the impact of DHA-PPQ on MTCT-HIV.
Study Details
Timeline
Interventions
Following physical examination, recruited women with more than 13 weeks of gestational age will receive IPTp-DHA-PPQ under supervision
Following physical examination, recruited women with more than 13 weeks of gestational age will receive IPTp-Placebo under supervision