Dionne Jodie A, Anchang-Kimbi Judith, Hao Jiaying, Long Dustin, Apinjoh Tobias, Tih Pius, Mbah Rahel, Ngah Edward Ndze, Juliano Jonathan J, Kahn Mauricio, Bruxvoort Katia, Van Der Pol Barbara, Tita Alan T N, Marrazzo Jeanne, Achidi Eric
Department of Medicine, Division of Infectious Diseases, University of Alabama at Birmingham, Birmingham, Alabama, USA.
Center for Women's Reproductive Health, University of Alabama at Birmingham, Birmingham, Alabama, USA.
Open Forum Infect Dis. 2024 May 8;11(5):ofae274. doi: 10.1093/ofid/ofae274. eCollection 2024 May.
This trial tested the effectiveness of a novel regimen to prevent malaria and sexually transmitted infections (STIs) among pregnant women with HIV in Cameroon. Our hypothesis was that the addition of azithromycin (AZ) to standard daily trimethoprim-sulfamethoxazole (TMP-SMX) prophylaxis would reduce malaria and STI infection rates at delivery.
Pregnant women with HIV at gestational age <28 weeks were randomized to adjunctive monthly oral AZ 1 g daily or placebo for 3 days and both groups received daily standard oral TMP-SMX through delivery. Primary outcomes were (1) positive peripheral malaria infection by microscopy or polymerase chain reaction and (2) composite bacterial genital STI (, or syphilis) at delivery. Relative risk and 95% confidence intervals were estimated using 2 × 2 tables with significance as < .05.
Pregnant women with HIV (n = 308) were enrolled between March 2018 and August 2020: 155 women were randomized to TMP-SMX-AZ and 153 women to TMP-SMX-placebo. Groups were similar at baseline and loss to follow up was 3.2%. There was no difference in the proportion with malaria (16.3% in TMP-SMX-AZ vs 13.2% in TMP-SMX; relative risk, 1.24 [95% confidence interval, .71-2.16]) or STI at delivery (4.2% in TMP-SMX-AZ vs 5.8% in TMP-SMX; relative risk, 0.72 [95% confidence interval, .26-2.03]). Adverse birth outcomes were not significantly different, albeit lower in the TMP-SMX-AZ arm (preterm delivery 6.7% vs 10.7% [ = .3]; low birthweight 3.4% vs 5.4% [ = .6]).
The addition of monthly azithromycin to daily TMP-SMX prophylaxis in pregnant women living with HIV in Cameroon did not reduce the risk of malaria or bacterial STI at delivery.
本试验测试了一种新方案在喀麦隆预防感染HIV的孕妇感染疟疾和性传播感染（STIs）的有效性。我们的假设是，在标准每日服用甲氧苄啶-磺胺甲恶唑（TMP-SMX）预防用药的基础上加用阿奇霉素（AZ）可降低分娩时疟疾和STIs感染率。
孕龄小于28周的感染HIV的孕妇被随机分为两组，一组每月口服1克AZ，连服3天，另一组服用安慰剂，两组均在分娩前每日口服标准剂量的TMP-SMX。主要结局指标为：（1）通过显微镜检查或聚合酶链反应检测外周血疟疾感染呈阳性；（2）分娩时复合细菌性生殖系统STI（、或梅毒）。使用2×2列联表估计相对风险和95%置信区间，以P < 0.05为有统计学意义。
2018年3月至2020年8月期间招募了感染HIV的孕妇（n = 308）：155名妇女被随机分配至TMP-SMX-AZ组，153名妇女被随机分配至TMP-SMX-安慰剂组。两组在基线时相似，失访率为3.2%。分娩时疟疾感染比例（TMP-SMX-AZ组为16.3%，TMP-SMX组为13.2%；相对风险，1.24 [95%置信区间，0.71 - 2.16]）或STIs感染比例（TMP-SMX-AZ组为4.2%，TMP-SMX组为5.8%；相对风险，0.72 [95%置信区间，0.26 - 2.03]）无差异。不良分娩结局无显著差异，尽管TMP-SMX-AZ组较低（早产率6.7% 对10.7% [P = 0.3]；低出生体重率3.4% 对5.4% [P = 0.6]）。
在喀麦隆，对感染HIV的孕妇在每日服用TMP-SMX预防用药的基础上每月加用阿奇霉素，并未降低分娩时疟疾或细菌性STIs的风险。
