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JAIDS Journal of Acquired Immune Deficiency Syndromes:
doi: 10.1097/QAI.0000000000000058
Clinical Science

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*,†

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Abstract

Background: Malaria during pregnancy has serious consequences that 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 antimalarial 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 2 randomized, open-label, noninferiority trials in Benin. In the CTX-mandatory trial, HIV-infected women with CD4 counts of <350 per cubic millimeter received CTX either alone or with MQ-IPTp (N = 292). In the CTX-not-mandatory trial (CD4 count >350/mm3), CTX was compared with MQ-IPTp (N = 140). In both the trials, the primary end point was microscopic placental parasitemia.

Results: At delivery, 1 woman in each CTX-alone treatment group exhibited placental parasitemia, versus no women in the groups receiving MQ. CTX alone demonstrated noninferiority in the CTX-mandatory trial. However, polymerase chain reaction–detected placental parasitemia was markedly reduced in the CTX + MQ group compared with CTX alone (0/105 vs. 5/103, P = 0.03). Because of insufficient recruitment in the CTX-not-mandatory trial, noninferiority could not be conclusively assessed. Dizziness and vomiting of moderate intensity were reported by 34%–37% of women receiving MQ in both the 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.

© 2014 by Lippincott Williams & Wilkins

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