MTN-017: A Rectal Phase 2 Extended Safety and Acceptability Study of Tenofovir Reduced-Glycerin 1% Gel.

Journal: Clinical infectious diseases : an official publication of the Infectious Diseases Society of America

Volume: 64

Issue: 5

Year of Publication: 2017

Affiliated Institutions:  University of Pittsburgh, Pennsylvania, USA. Asociación Civil Impacta Salud y Educación, Lima, Peru. Department of Biostatistics, University of Washington, Box , Seattle, WA, USA. New York State Psychiatry Institute and Columbia University, New York, USA. Magee-Womens Research Institute, Pittsburgh, Pennsylvania, USA. Fred Hutchinson Cancer Research Center-Statistical Center for HIV/AIDS Research and Prevention, Seattle, Washington, USA. Department of Medicine, Johns Hopkins University, Baltimore, Maryland, USA. FHI , Durham, North Carolina, USA. National Institute of Allergy and Infectious Disease/DAIDS, Rockville, MD, USA.. National Institute of Mental Health, Bethesda, Maryland, USA. AIDS Foundation of Chicago, Illinois, USA. Desmond Tutu HIV Centre, University of Cape Town, South Africa. Research Institute for Health Sciences, Chiang Mai University, Chiang Mai, Thailand. Thailand Ministry of Public Health-US Centers for Disease Control and Prevention Collaboration, Bangkok, Thailand. Bridge HIV, San Francisco Department of Public Health, California, USA. Fenway Institute, Boston, Massachusetts, USA. Department of Obstetrics and Gynecology, University of Puerto Rico School of Medicine, San Juan, USA. CONRAD/Eastern Virginia Medical School, Arlington, Virginia, USA. Gilead Sciences, Foster City, California, USA.

Abstract summary 

Human immunodeficiency virus (HIV) disproportionately affects men who have sex with men (MSM) and transgender women (TGW). Safe and acceptable topical HIV prevention methods that target the rectum are needed.MTN-017 was a phase 2, 3-period, randomized sequence, open-label, expanded safety and acceptability crossover study comparing rectally applied reduced-glycerin (RG) 1% tenofovir (TFV) and oral emtricitabine/TFV disoproxil fumarate (FTC/TDF). In each 8-week study period participants were randomized to RG-TFV rectal gel daily, or RG-TFV rectal gel before and after receptive anal intercourse (RAI; or at least twice weekly in the event of no RAI), or daily oral FTC/TDF.MSM and TGW (n = 195) were enrolled from 8 sites in the United States, Thailand, Peru, and South Africa with mean age of 31.1 years (range 18-64). There were no differences in ≥grade 2 adverse event rates between daily gel (incidence rate ratio [IRR], 1.09; P = .59) or RAI gel (IRR, 0.90; P = .51) compared to FTC/TDF. High adherence (≥80% of prescribed doses assessed by unused product return and Short Message System reports) was less likely in the daily gel regimen (odds ratio [OR], 0.35; P < .001), and participants reported less likelihood of future daily gel use for HIV protection compared to FTC/TDF (OR, 0.38; P < .001).Rectal application of RG TFV gel was safe in MSM and TGW. Adherence and product use likelihood were similar for the intermittent gel and daily oral FTC/TDF regimens, but lower for the daily gel regimen.NCT01687218.

Authors & Co-authors:  Cranston Ross D RD Lama Javier R JR Richardson Barbra A BA Carballo-Diéguez Alex A Kunjara Na Ayudhya Ratiya Pamela RP Liu Karen K Patterson Karen B KB Leu Cheng-Shiun CS Galaska Beth B Jacobson Cindy E CE Parikh Urvi M UM Marzinke Mark A MA Hendrix Craig W CW Johnson Sherri S Piper Jeanna M JM Grossman Cynthia C Ho Ken S KS Lucas Jonathan J Pickett Jim J Bekker Linda-Gail LG Chariyalertsak Suwat S Chitwarakorn Anupong A Gonzales Pedro P Holtz Timothy H TH Liu Albert Y AY Mayer Kenneth H KH Zorrilla Carmen C Schwartz Jill L JL Rooney James J McGowan Ian I

Study Outcome 

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Statistics
Citations :  Beyrer C, Sullivan P, Sanchez J, et al. The increase in global HIV epidemics in MSM. AIDS 2013; 27:2665–78.
Authors :  31
Identifiers
Doi : 10.1093/cid/ciw832
SSN : 1537-6591
Study Population
Men,Women
Mesh Terms
Adolescent
Other Terms
HIV;microbicide;prevention;rectal;tenofovir
Study Design
Randomized Control Trial,Cross Sectional Study
Study Approach
Country of Study
South Africa
Publication Country
United States