中非共和国班吉地区抗疟叶酸预防策略对 HIV 阳性孕妇的有效性：一项随机对照试验（MACOMBA）的研究方案。

Effectiveness of two antifolate prophylactic strategies against malaria in HIV-positive pregnant women in Bangui, Central African Republic: study protocol for a randomized controlled trial (MACOMBA).

机构信息

Institut Pasteur of Bangui, International Network of Instituts Pasteur, PO Box 923, Pasteur Avenue, Bangui, Central African Republic.

出版信息

Trials. 2013 Aug 14;14:255. doi: 10.1186/1745-6215-14-255.

DOI:10.1186/1745-6215-14-255

PMID:23945130

原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC3751878/

Abstract

BACKGROUND

Co-infection with malaria parasite and HIV is an emerging public health problem in tropical areas, particularly in pregnant women, and management of the concurrent effects of these two infections is challenging. Co-trimoxazole is a sulfamide preparation used to prevent opportunistic infections in HIV-infected patients, and many studies have reported that it has significant activity against malaria. As the efficacy of intermittent preventive treatment (IPT) with sulfadoxine-pyrimethamine (SP) against malaria is decreasing, co-trimoxazole might be an alternative for preventing malaria among HIV-infected populations. The aim of this study is to compare the effectiveness of SP-IPT, which is recommended for the prevention of malaria during pregnancy in the Central African Republic, with that of a daily dose of co-trimoxazole against P. falciparum infections among HIV-infected pregnant women in Bangui, the capital of the Central African Republic.

METHODS/DESIGN: The MACOMBA study (MAternity and COntrol of Malaria-HIV co-infection in BAngui) is a multicentre open-label randomized clinical trial conducted at four maternity hospitals in Bangui. All HIV-infected pregnant women presenting for an antenatal clinic visit between the weeks 16 and 28 of amenorrhoea, with a CD4 count of more than 350 cells/mm3, will be eligible. All the women will provide written consent before being enrolled in the study and will then be randomly allocated to either SP-IPT (25 mg of sulfadoxine and 1.25 mg of pyrimethamine) or daily co-trimoxazole doses (960 mg per dose). The primary end-point is the placental malaria parasitaemia rate at delivery. Other main outcome measures include the number of malaria episodes during pregnancy, safety, and treatment compliance. Furthermore, the frequency of molecular resistance markers dhfr and dhps will be measured.

DISCUSSION

In this trial, we seek to confirm whether co-trimoxazole is operationally suitable to replace SP-IPT in order to prevent malaria among pregnant women infected with HIV in the Central African Republic.

TRIAL REGISTRATION

ClinicalTrials.gov Identifier: NCT01746199.

摘要

背景

疟疾寄生虫和 HIV 的合并感染是热带地区一个新出现的公共卫生问题，特别是在孕妇中，管理这两种感染的并发影响具有挑战性。复方磺胺甲噁唑是一种磺胺类制剂，用于预防 HIV 感染患者的机会性感染，许多研究报告称其对疟疾具有显著的活性。由于磺胺多辛-乙胺嘧啶（SP）间歇性预防治疗（IPT）对疟疾的疗效正在下降，复方磺胺甲噁唑可能是预防 HIV 感染人群疟疾的替代药物。本研究的目的是比较 SP-IPT 的有效性，SP-IPT 是建议在中非共和国怀孕期间预防疟疾的方法，与在中非共和国首都班吉的 HIV 感染孕妇中每天使用复方磺胺甲噁唑预防恶性疟原虫感染的效果。

方法/设计：MACOMBA 研究（中非共和国班吉母婴疟疾-HIV 合并感染控制）是在班吉的四家妇产医院进行的一项多中心开放性随机临床试验。所有在闭经 16 至 28 周内就诊的、CD4 计数超过 350 个细胞/mm3 的 HIV 感染孕妇都符合条件。所有妇女在参加研究前都将书面同意，并随后被随机分配到 SP-IPT（25 毫克磺胺多辛和 1.25 毫克乙胺嘧啶）或每日复方磺胺甲噁唑剂量（960 毫克/剂）组。主要终点是分娩时胎盘疟疾寄生虫血症率。其他主要结局指标包括怀孕期间的疟疾发作次数、安全性和治疗依从性。此外，还将测量 dhfr 和 dhps 的分子耐药标记的频率。