Vaccine Research Institute, Institut National de la Santé et de la Recherche médicale (INSERM), and Assistance Publique Hôpitaux de Paris (APHP), Hôpital H. Mondor, Créteil, France (Y.L., J.L.).
INSERM, Sorbonne Université, Institut Pierre Louis d'épidémiologie et de Santé Publique (IPLESP), Paris, France (L.A., R.L., L.B., D.C.).
Ann Intern Med. 2020 Mar 3;172(5):297-305. doi: 10.7326/M19-2133. Epub 2020 Feb 11.
Patients diagnosed with advanced HIV infection have a poor prognosis despite initiation of combined antiretroviral therapy (c-ART).
To assess the benefit of adding maraviroc, an antiretroviral drug with immunologic effects, to standard c-ART for patients with advanced disease at HIV diagnosis.
Randomized controlled trial. (ClinicalTrials.gov: NCT01348308).
Clinical sites in France (n = 25), Italy (n = 5), and Spain (n = 20).
416 HIV-positive, antiretroviral-naive adults with CD4 counts less than 0.200 × 109 cells/L and/or a previous AIDS-defining event (ADE).
C-ART plus placebo or maraviroc (300 mg twice daily with dose modification) for 72 weeks.
The primary end point was first occurrence of severe morbidity (new ADE, selected serious infections, serious non-ADE, immune reconstitution inflammatory syndrome, or death). Prespecified secondary outcomes included primary outcome components, biological and pharmacokinetic measures, and adverse events graded 2 or higher.
409 randomly assigned participants (207 in the placebo group and 202 in the maraviroc group) who received more than 1 dose were included in the analysis. During 72 weeks of follow-up, incidence of severe morbidity was 11.1 per 100 person-years in the maraviroc group and 11.2 per 100 person-years in the placebo group (hazard ratio, 0.97 [95% CI, 0.57 to 1.67]). Incidence of adverse events graded 2 or higher was 36.1 versus 41.5 per 100 person-years (incidence rate ratio, 0.87 [CI, 0.65 to 1.15]).
Sixty-four participants discontinued therapy during follow-up. The study was not designed to evaluate time-dependent outcomes or effect modification.
Addition of maraviroc to standard c-ART does not improve clinical outcomes of patients initiating therapy for advanced HIV infection.
INSERM-ANRS (French National Agency for Research on AIDS).
尽管接受了联合抗逆转录病毒治疗（c-ART），但诊断为晚期 HIV 感染的患者预后仍然较差。
评估在 HIV 诊断时患有晚期疾病的患者中，加用具有免疫作用的抗逆转录病毒药物马拉维若（maraviroc）对标准 c-ART 的益处。
随机对照试验。（ClinicalTrials.gov：NCT01348308）。
法国（n=25）、意大利（n=5）和西班牙（n=20）的临床站点。
416 名 HIV 阳性、初治的成年人，CD4 计数小于 0.200×109 个细胞/L 且/或之前有 AIDS 定义性事件（ADE）。
c-ART 加安慰剂或马拉维若（300mg，每日两次，剂量调整）治疗 72 周。
主要终点是首次发生严重的发病率（新的 ADE、选定的严重感染、严重非 ADE、免疫重建炎症综合征或死亡）。预先指定的次要结局包括主要结局成分、生物学和药代动力学指标以及 2 级或更高的不良事件。
409 名随机分配的参与者（安慰剂组 207 名，马拉维若组 202 名）接受了超过 1 剂治疗，纳入分析。在 72 周的随访期间，马拉维若组的严重发病率为每 100 人年 11.1 例，安慰剂组为每 100 人年 11.2 例（风险比，0.97 [95%CI，0.57 至 1.67]）。2 级或更高不良事件的发生率分别为每 100 人年 36.1 例和 41.5 例（发病率比，0.87 [CI，0.65 至 1.15]）。
64 名参与者在随访期间停止了治疗。该研究的设计不旨在评估时间依赖性结局或效应修饰。
在开始治疗晚期 HIV 感染的患者中，加用马拉维若并不能改善临床结局。
法国国家艾滋病研究署（INSERM-ANRS）。
