Barr Liz, Jefferys Richard
Women's HIV Research Collaborative (WHRC), AIDS Clinical Trials Group Community Scientific Subcommittee (ACTG CSS), Baltimore, MD, USA.
Department of Gender, Women's, and Sexuality Studies University of Maryland, Baltimore County (UMBC), Baltimore, MD, USA.
J Virus Erad. 2019 Nov 4;5(4):212-219. doi: 10.1016/S2055-6640(20)30030-3.
The community-based organisation Treatment Action Group has established an online listing of HIV cure-related trials and observational studies derived from trial registries. Our objective was to use the listing as a basis for a landscape analysis of the current status of HIV cure-related clinical research.
Trials and observational studies listed as of August 2018 formed the sample set. Survey questions were developed on trial development, trial design, recruitment, enrolment, study completion and dissemination plans. A survey was sent to the contact(s) for each study. Supplemental information was collected from clinicaltrials.gov. The full dataset was then analysed.
A total of 99 interventional trials and 29 observational studies were included. Diverse interventions are under evaluation, including combinations of experimental candidates. Current studies plan to enrol over 7000 participants. Projected completion dates for ~90% of the sample fell between the fourth quarter of 2018 and the end of 2020. Potential obstacles to enrolment that were reported included concerns over invasive procedures and lack of potential benefit to participants. Data on the sex and ethnicity of enrollees were limited but sufficient to note a significant under-representation of women.
A considerable amount of HIV cure-related clinical research is under way. The results from these studies, which should help shape the future of the field, will become available over the next 2-4 years. Diversity both geographically and in terms of enrollees remains limited, particularly in terms of the participation of women, a concern that could significantly affect the generalisability of the findings.
社区组织治疗行动组织建立了一个源自试验注册库的与HIV治愈相关试验和观察性研究的在线列表。我们的目标是以该列表为基础，对与HIV治愈相关的临床研究现状进行态势分析。
截至2018年8月列出的试验和观察性研究构成样本集。针对试验开展、试验设计、招募、入组、研究完成及传播计划制定了调查问卷。向每项研究的联系人发送了调查问卷。从美国国立医学图书馆临床试验数据库收集了补充信息。然后对完整数据集进行分析。
共纳入99项干预性试验和29项观察性研究。正在评估多种干预措施，包括实验候选药物的组合。当前研究计划招募7000多名参与者。约90%的样本预计完成日期在2018年第四季度至2020年底之间。报告的潜在招募障碍包括对侵入性程序的担忧以及对参与者缺乏潜在益处。关于入组者性别和种族的数据有限，但足以注意到女性代表性严重不足。
大量与HIV治愈相关的临床研究正在进行。这些研究的结果将在未来2至4年内得出，应有助于塑造该领域的未来。地域和入组者方面存在的多样性仍然有限，尤其是女性的参与情况，这一问题可能会严重影响研究结果的普遍性。
