Improving Maternal heAlth by Reducing Malaria in African HIV Women

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.

Timeline

Start

2019-09-18

Primary completion

2022-07-19

Completion

2023-06-19

Outcome

Missed primary endpoint

paper pregnant women with HIV did not reduce peripheral parasitaemia at delivery. PMID 38224706 ↗

Publications

• Results Gonzalez R, Nhampossa T, Mombo-Ngoma G, Mischlinger J, Esen M, Tchouatieu AM, Mendes A, Figueroa-Romero A, Zoleko-Manego R, Lell B, Lagler H, Stoeger L, Dimessa LB, El Gaaloul M, Sanz S, Mendez S, Piqueras M, Sevene E, Ramharter M, Saute F, Menendez C; MAMAH study group. Safety and efficacy of dihydroartemisinin-piperaquine for intermittent preventive treatment of malaria in pregnant women with HIV from Gabon and Mozambique: a randomised, double-blind, placebo-controlled trial. Lancet Infect Dis. 2024 May;24(5):476-487. doi: 10.1016/S1473-3099(23)00738-7. Epub 2024 Jan 12.
• Results Gonzalez R, Nhampossa T, Mombo-Ngoma G, Mischlinger J, Esen M, Tchouatieu AM, Pons-Duran C, Dimessa LB, Lell B, Lagler H, Garcia-Otero L, Zoleko Manego R, El Gaaloul M, Sanz S, Piqueras M, Sevene E, Ramharter M, Saute F, Menendez C. Evaluation of the safety and efficacy of dihydroartemisinin-piperaquine for intermittent preventive treatment of malaria in HIV-infected pregnant women: protocol of a multicentre, two-arm, randomised, placebo-controlled, superiority clinical trial (MAMAH project). BMJ Open. 2021 Nov 23;11(11):e053197. doi: 10.1136/bmjopen-2021-053197.
• Stoger L, Mischlinger J, Nhampossa T, Mombo-Ngoma G, Esen M, Tchouatieu A-M, Brunet M, Mendes A, Dimessa Mbadinga LB, Gamberini S, Ndzebe Ndoumba W, Figueroa-Romero A, Lell B, Lagler H, Zoleko-Manego R, El Gaaloul M, Mendez S, Botella N, Sanz S, Piqueras M, Sevene E, Saute F, Wicha SG, Soy D, Menendez C, Ramharter M, Gonzalez R; MAMAH Study Group. Effects of malaria intermittent preventive treatment with dihydroartemisinin-piperaquine on antiretroviral drug concentrations in African pregnant women living with HIV. Antimicrob Agents Chemother. 2026 Jul;70(7):e0033726. doi: 10.1128/aac.00337-26. Epub 2026 Jun 12.
• Pons-Duran C, Wassenaar MJ, Yovo KE, Marin-Carballo C, Briand V, Gonzalez R. Intermittent preventive treatment regimens for malaria in HIV-positive pregnant women. Cochrane Database Syst Rev. 2024 Sep 26;9(9):CD006689. doi: 10.1002/14651858.CD006689.pub3.

Drugs

Indications