Early versus Delayed Initiation of Antiretroviral Therapy for Concurrent HIV Infection and Cryptococcal Meningitis in Sub-Saharan Africa
Early versus Delayed Initiation of Antiretroviral Therapy for Concurrent HIV Infection and Cryptococcal Meningitis in Sub-Saharan Africa
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DOI：
10.1086/652652
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发表时间：
2010-06-01
影响因子：
11.8
通讯作者：
Hakim, James G.
中科院分区：
文献类型：
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作者：
Makadzange, Azure T.;Ndhlovu, Chiratidzo E.;Hakim, James G.
背景。隐球菌性脑膜炎（CM）仍然是撒哈拉以南非洲地区获得性免疫缺陷综合征相关死亡的主要原因。针对人类免疫缺陷病毒 (HIV) 相关 CM 开始抗逆转录病毒治疗 (ART) 的时机仍不确定。该研究旨在确定采用 CM.Methods 的 HIV 阳性个体开始 ART 的最佳时机。在津巴布韦的一家三级教学医院进行了一项前瞻性、开放标签、随机临床试验。参与者年龄 >= 18 岁，未接受过 ART，已接受过首次 CM 诊断，并随机接受早期 ART（CM 诊断后 72 小时内）或延迟 ART（单独使用氟康唑治疗 10 周后）。参与者每天接受 800 毫克氟康唑。使用的 ART 方案是司他夫定、拉米夫定和奈韦拉平，每日两次。随访时间长达3年。主要终点是全因死亡率。结果。 54 名参与者参加了这项研究（早期 ART 组 28 名，延迟 ART 组 26 名）。入组时的中位 CD4 细胞计数为 37 个细胞/mm(3)（四分位数范围，17-69 个细胞/mm(3)）。早期 ART 组和延迟 ART 组的 3 年死亡率存在显着差异（88% vs 54%；P
Background. Cryptococcal meningitis (CM) remains a leading cause of acquired immunodeficiency syndrome-related death in sub-Saharan Africa. The timing of the initiation of antiretroviral therapy (ART) for human immunodeficiency virus (HIV)-associated CM remains uncertain. The study aimed to determine the optimal timing for initiation of ART in HIV-positive individuals with CM.Methods. A prospective, open-label, randomized clinical trial was conducted at a tertiary teaching hospital in Zimbabwe. Participants were aged >= 18 years, were ART naive, had received a first CM diagnosis, and were randomized to receive early ART (within 72 h after CM diagnosis) or delayed ART (after 10 weeks of treatment with fluconazole alone). Participants received 800 mg of fluconazole per day. The ART regimen used was stavudine, lamivudine, and nevirapine given twice daily. The duration of follow-up was up to 3 years. The primary end point was all-cause mortality.Results. Fifty-four participants were enrolled in the study (28 in the early ART arm and 26 in the delayed ART arm). The median CD4 cell count at enrollment was 37 cells/mm(3) (interquartile range, 17-69 cells/mm(3)). The 3-year mortality rate differed significantly between the early and delayed ART groups (88% vs 54%; P