Cotrimoxazole versus sulfadoxine-pyrimethamine for intermittent preventive treatment of malaria in HIV-infected pregnant women in Bangui, Central African Republic: a Pragmatic Randomized Controlled Trial

International audience; OBJECTIVE: The main objective of the MACOMBA (Maternity and Control of Malaria-HIV co-infection in Bangui) trial was to show that cotrimoxazole (CTX) is more effective than Sulphadoxine-Pyremethamine-IPTp (IPTp-SP) to prevent placental malaria infection (primary endpoint) among HIV-positive pregnant women with a CD4+ count ≥350 cells/mm(3) in Bangui, CAR.METHODS: MACOMBA is a multicenter, open-label randomized trial conducted in four maternity hospitals in Bangui. Between 2013 and 2017, 193 women were randomized and 112 (59 and 53 in CTX and IPTp-SP arms, respectively) were assessed for placental infection defined by microscopic parasitemia or PCR.RESULTS: Thirteen women had a placental infection: 5 in the CTX arm (1 by microscopic placental parasitemia and 4 by PCR) and 8 by PCR in the SP-IPTp (8.5% vs 15.1%, p = 0.28). The percentage of newborns with low birthweight (< 2500 g) did not differ statistically between the two arms. Self-reported compliance to CTX prophylaxis was good. There was a low overall rate of adverse events in both arms.CONCLUSION: Although our results do not allow us to conclude that CTX is more effective, drug safety and good compliance among women with this treatment favour its widespread use among HIV-infected pregnant women, as currently recommended by WHO.