Browsing by Author "Jefferys, Richard"
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Item A Landscape Analysis of HIV Cure-Related Clinical Research in 2019(Elsevier, 2020-09-02) Barr, Liz; Jefferys, RichardObjectives In 2018, we surveyed investigators conducting HIV cure-related clinical research, drawing on information from the online listing established by Treatment Action Group (TAG). The purpose of the survey was to facilitate a landscape analysis of the field. In 2019, we fielded a second survey in order to provide updated information and assess any shifts in the landscape. Methods Trials and observational studies listed as of August 16, 2019 formed the sample set. Survey questions addressed funding, trial development, recruitment, enrollment, participant demographics, antiretroviral therapy status, HIV reservoir assays, invasive procedures, study completion, data sharing and dissemination plans. A survey was sent to the contact(s) for each study. Supplemental information was collected from clinicaltrials.gov and available presentations/publications of study results. Results A total of 97 interventional trials and 36 observational studies were identified, with 30 including analytical treatment interruptions. Total projected enrollment is 13,732 participants, with observational studies contributing the majority (8,325). Most interventional trials are in early phases. The majority of current research is located in the USA, involves predominately male participants and is limited in racial and ethnic diversity. Prespecified demographic enrollment targets are rare. Two thirds of respondents to our previous survey reported that enrollment is progressing more slowly than anticipated. Conclusions A diverse range of interventions are being evaluated in HIV cure research, but participant diversity is far from optimal with a continuing underrepresentation of women. Broadening inclusion and geographic reach will be necessary to achieve the goal of developing widely effective, safe and accessible curative interventions.Item A landscape analysis of HIV cure-related clinical trials and observational studies in 2018(2019-11) Barr, Liz; Jefferys, RichardObjectives: The community-based organisation Treatment Action Group has established an online listing of HIV curerelated 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. Methods: 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. Results: 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 underrepresentation of women. Conclusions: 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.