McGowan Ian, Cranston Ross D, Mayer Kenneth H, Febo Irma, Duffill Kathryn, Siegel Aaron, Engstrom Jarret C, Nikiforov Alexyi, Park Seo-Young, Brand Rhonda M, Jacobson Cindy, Giguere Rebecca, Dolezal Curtis, Frasca Timothy, Leu Cheng-Shiun, Schwartz Jill L, Carballo-Diéguez Alex
University of Pittsburgh, Pittsburgh, Pennsylvania, United States of America.
Magee-Womens Research Institute, Pittsburgh, Pennsylvania, United States of America.
PLoS One. 2016 Jun 30;11(6):e0158310. doi: 10.1371/journal.pone.0158310. eCollection 2016.
The purpose of Project Gel was to determine the safety and acceptability of rectal microbicides in young men who have sex with men (MSM) and transgender women (TGW) at risk of HIV infection.
MSM and TGW aged 18-30 years were enrolled at three sites; Pittsburgh, PA; Boston, MA; and San Juan, PR. Stage 1A was a cross-sectional assessment of sexual health and behavior in MSM and TGW. A subset of participants from Stage 1A were then enrolled in Stage 1B, a 12-week evaluation of the safety and acceptability of a placebo rectal gel. This was followed by the final phase of the study (Stage 2) in which a subset of participants from Stage 1B were enrolled into a Phase 1 rectal safety and acceptability evaluation of tenofovir (TFV) 1% gel.
248 participants were enrolled into Stage 1A. Participants' average age was 23.3 years. The most common sexually transmitted infection (STIs) at baseline were Herpes simplex (HSV)-2 (16.1% by serology) and rectal Chlamydia trachomatis (CT) (10.1% by NAAT). 134 participants were enrolled into Stage 1B. During the 12 week period of follow-up 2 HIV, 5 rectal CT, and 5 rectal Neisseria gonorrhea infections were detected. The majority of adverse events (AEs) were infections (N = 56) or gastrointestinal (N = 46) and were mild (69.6%) or moderate (28.0%). Of the participants who completed Stage 1B, 24 were enrolled into Stage 2 and randomized (1:1) to receive TFV or placebo gel. All participants completed Stage 2. The majority of AEs were gastrointestinal (N = 10) and of mild (87.2%) or moderate (10.3%) severity.
In this study we were able to enroll a sexually active population of young MSM and TGW who were willing to use rectal microbicides. TFV gel was safe and acceptable and should be further developed as an alternative HIV prevention intervention for this population.
ClinicalTrials.gov NCT01283360.
凝胶项目的目的是确定直肠杀菌剂在有感染艾滋病毒风险的男男性行为者（MSM）和跨性别女性（TGW）中的安全性和可接受性。
18至30岁的男男性行为者和跨性别女性在三个地点入组；宾夕法尼亚州匹兹堡；马萨诸塞州波士顿；以及波多黎各圣胡安。1A阶段是对男男性行为者和跨性别女性的性健康和行为进行横断面评估。然后，1A阶段的一部分参与者被纳入1B阶段，这是一项为期12周的安慰剂直肠凝胶安全性和可接受性评估。接下来是研究的最后阶段（2阶段），其中1B阶段的一部分参与者被纳入替诺福韦（TFV）1%凝胶的1期直肠安全性和可接受性评估。
248名参与者被纳入1A阶段。参与者的平均年龄为23.3岁。基线时最常见的性传播感染（STIs）是单纯疱疹病毒2型（HSV-2）（血清学检测为16.1%）和直肠沙眼衣原体（CT）（核酸扩增检测为10.1%）。134名参与者被纳入1B阶段。在12周的随访期间，检测到2例艾滋病毒感染、5例直肠CT感染和5例直肠淋病奈瑟菌感染。大多数不良事件（AE）为感染（N = 56）或胃肠道事件（N = 46），且为轻度（69.6%）或中度（28.0%）。在完成1B阶段的参与者中，24人被纳入2阶段并随机分组（1:1）接受TFV或安慰剂凝胶。所有参与者均完成了2阶段。大多数不良事件为胃肠道事件（N = 10），且为轻度（87.2%）或中度（10.3%）严重程度。
在本研究中，我们能够招募到愿意使用直肠杀菌剂的性活跃的年轻男男性行为者和跨性别女性群体。TFV凝胶安全且可接受，应进一步开发作为该人群预防艾滋病毒的替代干预措施。
ClinicalTrials.gov NCT01283360。
