Baseline characteristics of a rectal phase 2 extended safety and acceptability microbicide study of tenofovir reduced-glycerin 1% gel: MTN-017
Background: Men who have sex with men (MSM), and transgender women (TGW), are disproportionately affected by human immunodeficiency virus (HIV) infection worldwide. MTN-007 previously demonstrated that the reduced-glycerin formulation of 1% tenofovir gel (RGT) is safe and acceptable when applied rectally for up to 7 consecutive days. MTN-017 is a Phase-2, 3-period, randomized sequence, open label, expanded safety and acceptability crossover study evaluating RGT when used either daily or before and after receptive anal intercourse (RAI), compared to daily oral emtricitabine/tenofovir disoproxil fumarate (FTC/TDF). Baseline study participant (ppt) characteristics are presented here.
Methods: MTN-017 recruited ppts through social media, online advertising, flyers, community events and engagement, and word of mouth. Healthy HIV-1 uninfected MSM and TGW >18 years of age were enrolled at 8 clinical research sites in the United States (4), Peru (1), South Africa (1) and Thailand (2).
Results: Between September 2013 and November 2014, 347 ppts were screened and 195 enrolled. Reasons for screen outs were mostly for laboratory criteria (including sexually transmitted infections) and investigator discretion, with 7 individuals diagnosed as HIV-infected. The mean ppt age was 31.1 years (range 18-64). The race/ethnic composition was predominantly white: 64 (33%), Thai: 54 (28%), or mixed race: 29 (15%). Twenty three ppts (12.1%) self-identified as TGW/women, and 156 (80%) had a college education. At enrollment 29 (15%) and 32 (16%) had a perianal or rectal mucosal abnormality detected, respectively. Of those who reported having RAI in the past 8 weeks, 95% reported some lubricant use. Most ppts (67%) considered themselves at some risk for HIV infection, and nearly half (49%) had condomless RAI within the previous 8 weeks. Only a few ppts said they would be unlikely to use the daily gel (7%) or oral medication (6%), with fewer (3%) unlikely to use gel before and after RAI to prevent HIV were it available and effective.
Conclusions: An international cohort of MSM and TGW at risk for HIV infection and who may potentially benefit from rectal microbicides, if shown to be effective, was successfully engaged into research and enrolled into a Phase 2 rectal microbicide study.
R. Cranston1, J. Lama2, B. Richardson3, A. Carballo-Diéguez4, R.P. Kunjara Na Ayudhya5, B. Galaska5, C. Jacobson5, M. Marzinke6, S. Johnson7, J. Piper8, C. Grossman9, K. Ho1, T. Holtz10, S. Chariyalertsak11, L.-G. Bekker12, P. Gonzales2, K. Mayer13, A. Liu14, C. Zorrilla15, I. McGowan1
1University of Pittsburgh, Pittsburgh, United States, 2Impacta, Lima, Peru, 3University of Washington, Seattle, United States, 4HIV Center for Clinical and Behavioral Studies, New York City, United States, 5Magee-Womens Research Institute, Pittsburgh, United States, 6Johns Hopkins University, Baltimore, United States, 7FHI360, Durham, United States, 8National Institute of Allergy and Infectious Diseases, Bethesda, United States, 9National Institute of Mental Health, Bethesda, United States, 10Thailand MOPH - US CDC Collaboration, Bangkok, Thailand, 11Chiang Mai University, Chiang Mai, Thailand, 12Institute of Infectious Disease and Molecular Medicine, Cape Town, South Africa, 13Fenway Health/The Fenway Institute, Boston, United States, 14Bridge HIV at the San Franciso Department of Public Health, San Francisco, United States, 15University of Puerto Rico, San Juan, Puerto Rico