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母婴人类免疫缺陷病毒临床试验网络的发展历程。

Maternal-Child Human Immunodeficiency Virus Clinical Trials Networks across the Ages.

机构信息

Pediatric Infectious Disease, Department of Pediatrics, Renaissance School of Medicine, State University of New York at Stony Brook, 101 Nicholls Road, Stony Brook, NY 11794-8111, USA.

出版信息

Clin Perinatol. 2024 Dec;51(4):935-949. doi: 10.1016/j.clp.2024.08.009. Epub 2024 Sep 20.

DOI:10.1016/j.clp.2024.08.009
Abstract

The clinical trial networks that included a maternal-child focus have evolved since first funded by NIH in the 1990s. Since then, US domestic and international sites were combined into one network, with a focused agenda on therapeutics (for both prevention and treatment), human immunodeficiency virus (HIV) cure, tuberculosis, and complications of HIV, largely specific to the brain. Key to the success of the network has been a strong partnership with the community, collaborations with industry and other strategic partners, and recognition that one size does not fit all when it comes to antiretrovirals, diagnosing and treating TB, and other treatments for our populations.

摘要

自 20 世纪 90 年代首次由美国国立卫生研究院(NIH)资助以来,包含母婴重点的临床试验网络已经发展。从那时起,美国国内和国际的试验点合并成一个网络,重点关注治疗方法(包括预防和治疗)、人类免疫缺陷病毒(HIV)治愈、结核病和 HIV 并发症,主要针对大脑。该网络的成功关键在于与社区建立了强有力的伙伴关系,与行业和其他战略伙伴合作,并认识到在抗逆转录病毒药物、诊断和治疗结核病以及针对我们人群的其他治疗方面,一刀切并不适用。

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Prevalence of detectable HIV-DNA and HIV-RNA in cerebrospinal fluid of youth with perinatal HIV and impaired cognition on antiretroviral therapy.在接受抗逆转录病毒治疗的围生期 HIV 感染且认知功能受损的青少年的脑脊液中可检测到 HIV-DNA 和 HIV-RNA 的流行情况。
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将孕妇和哺乳期妇女纳入研究 - 努力和举措。
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Randomized trial of stopping or continuing ART among postpartum women with pre-ART CD4 ≥ 400 cells/mm3.产后抗逆转录病毒治疗前CD4≥400个细胞/mm³的女性中停止或继续抗逆转录病毒治疗的随机试验。
PLoS One. 2017 May 10;12(5):e0176009. doi: 10.1371/journal.pone.0176009. eCollection 2017.
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Benefits and Risks of Antiretroviral Therapy for Perinatal HIV Prevention.抗逆转录病毒疗法用于预防围产期HIV感染的益处与风险
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Immunogenicity of ALVAC-HIV vCP1521 in infants of HIV-1-infected women in Uganda (HPTN 027): the first pediatric HIV vaccine trial in Africa.在乌干达感染 HIV-1 的妇女的婴儿中,ALVAC-HIV vCP1521 的免疫原性(HPTN 027):这是非洲首例儿科 HIV 疫苗试验。
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