Improving Maternal and Infant Health by reducing malaria risks in African women: evaluation of the safety and efficacy of dihydroartemisinin-piperaquine for intermittent preventive treatment of malaria in HIV-infected pregnant women (MAMAH)

Malaria infection during pregnancy is an important driver of maternal and neonatal health, especially among HIV infected women. In Africa, at least one million pregnancies are co-infected with malaria and HIV annually. The interaction between the two infections is particularly deleterious in pregnancy, leading to increased risk of malaria and HIV viral load, which may increase the frequency of mother to child transmission of HIV (MTCTHIV).

IPTp with sulphadoxine-pyrimethamine (SP) is recommended for malaria prevention in HIV-uninfected women but it is contraindicated in those HIV-infected on CTXp due to potential adverse effects. A recent EDCTP-funded trial showed that although an effective antimalarial (mefloquine) added to CTXp and long-lasting insecticide-treated nets (LLITNs) in HIV-infected pregnant women improves malaria prevention and maternal health, it was not well tolerated and it was associated with an increase in HIV viral load at delivery and a two-fold increased risk of MTCT-HIV. Thus, this highlights the need to find alternative drugs with better tolerability and safety profile to prevent malaria in this vulnerable group and to further study the pharmacological interactions between antimalarial and ARV drugs.

DHA-PPQ has been shown to improve antimalarial protection in HIV-uninfected women constituting the most promising candidate for IPTp in HIV-infected pregnant women. However, there is limited information on the pharmacokinetics of DHA-PPQ with concomitant use of ARV drugs and CTX.

ClinicalTrials.gov Identifier: NCT03671109
Study Phase: Phase 3
Allocation: Randomized double blind placebo controlled trial
Intervention Model: Parallel Assignment
Intervention Model Description:
Superiority clinical trial
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking Description:
Double blind placebo-controlled
Primary Purpose: Prevention

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 mother to child transmission of HIV (MTCT-HIV).

MAMAHClinical trial registrationEDCTP Grants

Impact of Interventions
Vulnerable Populations

Mar 2018 — Feb 2023

$3.65M

Austria
Gabon
Mozambique
Spain

Intermittent preventive treatment in pregnancy (IPTp)