Evaluation of the safety and efficacy of dihydroartemisinin-piperaquine for intermittent preventive treatment of malaria in HIV-infected pregnant women: protocol of a multicentre, two-arm, randomised, placebo-controlled, superiority clinical trial (MAMAH project).
Evaluation of the safety and efficacy of dihydroartemisinin-piperaquine for intermittent preventive treatment of malaria in HIV-infected pregnant women: protocol of a multicentre, two-arm, randomised, placebo-controlled, superiority clinical trial (MAMAH project).
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DOI：
10.1136/bmjopen-2021-053197
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发表时间：
2021-11-23
期刊：
影响因子：
2.9
通讯作者：
Menendez C
中科院分区：
文献类型：
--
作者：
González R;Nhampossa T;Mombo-Ngoma G;Mischlinger J;Esen M;Tchouatieu AM;Pons-Duran C;Dimessa LB;Lell B;Lagler H;Garcia-Otero L;Zoleko Manego R;El Gaaloul M;Sanz S;Piqueras M;Sevene E;Ramharter M;Saute F;Menendez C
怀孕期间感染疟疾是孕产妇和新生儿健康的一个重要驱动因素，特别是在感染艾滋病毒的妇女中。建议在未感染艾滋病毒的妇女中使用磺胺嘧啶-乙胺嘧啶间歇预防治疗（IPTp）预防疟疾，但由于潜在的不良反应，对使用复方新诺明预防（CTXp）的艾滋病毒感染者禁用该治疗。双氢青蒿素-哌喹（DHA-PPQ）已被证明具有增强抗疟疾保护作用，是一种有前景的IPTp候选药物。该试验的目的是确定在每日CTXp的基础上添加每月3天的DHA-PPQ IPTp疗程是否安全，并且在降低妊娠末期外周疟疾寄生虫病的比例方面是否优于单独CTXp。这是一项多中心、双组、安慰剂对照、单独随机试验，在接受CTXp和抗逆转录病毒治疗的感染艾滋病毒的孕妇中进行。在加蓬和莫桑比克的第一次产前保健诊所就诊时，总共将登记664名妇女。参与者将收到一个经杀虫剂处理的蚊帐，并从妊娠中期开始每月使用DHA-PPQ或安慰剂（1:1比例）作为直接观察治疗。主要研究结果是分娩时母体寄生虫病的患病率。次要结局包括与疟疾相关的孕产妇和婴儿结局的流行率以及不良围产期结局的比例。参与者将被跟踪到怀孕结束后6周，他们的婴儿将被跟踪到1岁，以评估DHA-PPQ对艾滋病毒母婴传播的影响。分析将根据治疗意向和协议队列进行，并根据重力、国家、季节性和与疟疾有关的其他变量进行调整。加蓬和莫桑比克的机构和国家伦理委员会以及巴塞罗那医院诊所对议定书进行了审查和批准。项目结果将提交给所有利益相关者，并在开放获取期刊上发表。NCT03671109。
Malaria infection during pregnancy is an important driver of maternal and neonatal health especially among HIV-infected women. Intermittent preventive treatment in pregnancy (IPTp) with sulphadoxine–pyrimethamine is recommended for malaria prevention in HIV-uninfected women, but it is contraindicated in those HIV-infected on cotrimoxazole prophylaxis (CTXp) due to potential adverse effects. Dihydroartemisinin–piperaquine (DHA–PPQ) has been shown to improve antimalarial protection, constituting a promising IPTp candidate. This trial’s objective is to determine if monthly 3-day IPTp courses of DHA–PPQ added to daily CTXp are safe and superior to CTXp alone in decreasing the proportion of peripheral malaria parasitaemia at the end of pregnancy. This is a multicentre, two-arm, placebo-controlled, individually randomised trial in HIV-infected pregnant women receiving CTXp and antiretroviral treatment. A total of 664 women will be enrolled at the first antenatal care clinic visit in sites from Gabon and Mozambique. Participants will receive an insecticide-treated net, and they will be administered monthly IPTp with DHA-PPQ or placebo (1:1 ratio) as directly observed therapy from the second trimester of pregnancy. Primary study outcome is the prevalence of maternal parasitaemia at delivery. Secondary outcomes include prevalence of malaria-related maternal and infant outcomes and proportion of adverse perinatal outcomes. Participants will be followed until 6 weeks after the end of pregnancy and their infants until 1 year of age to also evaluate the impact of DHA–PPQ on mother-to-child transmission of HIV. The analysis will be done in the intention to treat and according to protocol cohorts, adjusted by gravidity, country, seasonality and other variables associated with malaria. The protocol was reviewed and approved by the institutional and national ethics committees of Gabon and Mozambique and the Hospital Clinic of Barcelona. Project results will be presented to all stakeholders and published in open-access journals. NCT03671109.
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DOI：
10.1016/s1473-3099(16)30378-4
发表时间：
2017-02
期刊：
The Lancet. Infectious diseases
影响因子：
--
作者：
Gutman J;Kovacs S;Dorsey G;Stergachis A;Ter Kuile FO
通讯作者：
Ter Kuile FO
影响因子：
2.9
作者：
Mombo-Ngoma, Ghyslain;Mackanga, Jean Rodolphe;Ramharter, Michael
通讯作者：
Ramharter, Michael
影响因子：
4.5
作者：
Manego, R. Zoleko;Mombo-Ngoma, G.;Matsiegui, P. B.
通讯作者：
Matsiegui, P. B.
DOI：
10.1097/dbp.0b013e31829d211c
发表时间：
2013-09-01
影响因子：
2.4
作者：
Koura, Kobto G.;Boivin, Michael J.;Bodeau-Livinec, Florence
通讯作者：
Bodeau-Livinec, Florence
影响因子：
15.8
作者：
González R;Sevene E;Jagoe G;Slutsker L;Menéndez C
通讯作者：
Menéndez C