Lise Denoeud-Ndam1, Djimon-Marcel Zannou, Camille Fourcade, Clément Taron-Brocard, Raphaël Porcher, Felix Atadokpede, Didier G Komongui, Lucien Dossou-Gbete, Aldric Afangnihoun, Nicaise T Ndam, Pierre-Marie Girard, Michel Cot. 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 includecotrimoxazole (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.
RCT Entities:
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-infectedwomen 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.
Authors: Krishanthi S Subramaniam; Jeff Skinner; Emil Ivan; Eugene Mutimura; Ryung S Kim; Catherine M Feintuch; Silvia Portugal; Kathryn Anastos; Peter D Crompton; Johanna P Daily Journal: PLoS One Date: 2015-04-30 Impact factor: 3.240
Authors: Alexandre Manirakiza; Eugène Serdouma; Richard Norbert Ngbalé; Sandrine Moussa; Samuel Gondjé; Rock Mbetid Degana; Gislain Géraud Banthas Bata; Jean Methode Moyen; Jean Delmont; Gérard Grésenguet; Abdoulaye Sepou Journal: J Public Health Afr Date: 2017-12-31