Safety, adherence, and HIV-1 seroconversion among women using the dapivirine vaginal ring (DREAM): an open-label, extension study

作者：Annaléne Nel, Neliëtte van Niekerk, Ben Van Baelen, Mariëtte Malherbe, Winél Mans, Allison Carter, John Steytler, Elna van der Ryst, Charles Craig, Cheryl Louw, Thando Gwetu, Zonke Mabude, Philip Kotze, Robert Moraba, Hugo Tempelman, Katherine Gill, Sylvia Kusemererwa, Linda‐Gail Bekker, Bríd Devlin, Zeda Rosenberg · 发表于：The Lancet HIV · 年份：2021 · DOI：10.1016/s2352-3018(20)30300-3 · 被引用次数：98 · 研究领域：HIV/AIDS Research and Interventions、HIV Research and Treatment、Reproductive tract infections research

BACKGROUND: The Ring Study, a phase 3 trial in 1959 sexually active women (randomised 2:1), showed a favourable safety profile and a 31% HIV-1 infection risk reduction for a vaginal ring containing 25 mg of dapivirine, compared with a placebo ring. We report here the DREAM study, which aimed to evaluate safety, adherence, and HIV-1 incidence in those using the dapivirine vaginal ring (DVR) in open-label use. METHODS: The DREAM study is an open-label extension of The Ring Study, done at five research centres in South Africa and one research centre in Uganda. Former participants from The Ring Study, who remained HIV-negative and who did not discontinue the study due to an adverse event or safety concern that was considered to be related to the investigational product, were eligible. Women who were pregnant, planning to become pregnant, or breastfeeding at screening for DREAM were excluded. All participants received the DVR for insertion at the enrolment visit. Participants attended a 1-month follow-up visit and could either proceed with visits once every 3 months or attend monthly visits up to month 3 and then continue with visits once every 3 months. At each visit, HIV testing and safety evaluations were done, and residual dapivirine measured in used rings (approximately 4 mg is released from the DVR over 28 days of consistent use). HIV-1 incidence was compared descriptively with the simulated incidence rate obtained from bootstrap sampling of participants in the placebo group...