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J Acquir Immune Defic Syndr. 2014 Feb 1;65(2):198-206. doi: 10.1097/QAI.0000000000000058.

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

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  • 1*UMR 216, Institut de Recherche pour le Développement, Paris, France; †Faculté de Pharmacie, Université Paris Descartes, Paris, France; ‡Centre de Traitement Ambulatoire, Centre National Hospitalier Universitaire Hubert Koutoukou Maga, Cotonou, Benin; §Faculté des Sciences de la Santé, Université d'Abomey-Calavi, Abomey-Calavi, Benin; ‖Inserm U717, Hôpital Saint-Louis, Paris, France; ¶Service de Médecine Interne, Hôpital d'Instructions des Armées, Cotonou, Benin; #Service de gynécologie, Hôpital de la Mère et de l'Enfant Lagune, Cotonou, Benin; **Clinique Louis Pasteur, Porto-Novo, Benin; ††Centre de Traitement Ambulatoire, Hôpital de zone de Suru Léré, Cotonou, Benin; ‡‡Service des Maladies Infectieuses et Tropicales, Hôpital Saint-Antoine, APHP, Paris, France; §§Inserm U707, Université Pierre et Marie Curie, Paris, France.

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/mm), 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.

PMID:
24220287
[PubMed - indexed for MEDLINE]
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