Towards better anti-malaria Practices

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Cotrimoxazole prophylaxis versus mefloquine intermittent preventive treatment to prevent malaria in HIV-infected pregnant women: two randomized controlled trials

Denoeud-Ndam, Lise MD, PHD; Zannou, Djimon-Marcel MD; Fourcade, Camille MD, MPH; Taron-Brocard, Clément MD; Porcher, Raphaël PHD; Atadokpede, Felix MD; Komongui, Didier G. MD; Dossou-Gbete, Lucien MD; Afangnihoun, Aldric MD; Ndam, Nicaise T. PHD; Girard, Pierre-Marie MD, PHD; Cot, Michel MD, PHD

Published Ahead-of-Print
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Abstract

Background: Malaria during pregnancy has serious consequences, which are worsened by HIV infection. Malaria-preventive measures for HIV-infected pregnant women include cotrimoxazole (CTX) prophylaxis given to prevent HIV-related opportunistic infections and also protective against malaria, or intermittent preventive treatment (IPTp) with an anti-malarial drug. Here we present the first study evaluating CTX efficacy versus mefloquine (MQ)-IPTp, alone and in combination, in HIV-infected pregnant women.
Methods: We conducted two randomized, open-label, non-inferiority trials in Benin. In the CTX-mandatory (CM) trial, HIV-infected women with CD4<350/mm3 received CTX either alone or with MQ-IPTp (N=292). In the CTX not-mandatory (CNM) trial (CD4>350/mm3), CTX was compared to MQ-IPTp (N=140). In both trials the primary endpoint was microscopic placental parasitemia.
Results: At delivery, one woman in each CTX-alone treatment group exhibited placental parasitemia, versus no women in the groups receiving MQ. CTX alone demonstrated non-inferiority in the CM trial. However, PCR-detected placental parasitemia was markedly reduced in the CTX+MQ group compared with CTX alone (0/105 versus 5/103, P=0.03). Due to insufficient recruitment in the CNM trial, non-inferiority could not be conclusively assessed. Dizziness and vomiting of moderate intensity were reported by 34-37% of women receiving MQ in both trials, versus 0-3% in CTX groups (P<0.0001). No serious adverse events related to these drugs were found.
Conclusions: CTX alone provided adequate protection against malaria in HIV-infected pregnant women, although MQ-IPTp showed higher efficacy against placental infection. Although more frequently associated with dizziness and vomiting, MQ-IPTp may be an effective alternative given concerns about parasite resistance to CTX.
(C) 2013 by Lippincott Williams & Wilkins

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