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


ABSTRACT: 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.

SUBMITTER: Cranston RD 

PROVIDER: S-EPMC5850518 | biostudies-literature | 2017 Mar

REPOSITORIES: biostudies-literature

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

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  

Clinical infectious diseases : an official publication of the Infectious Diseases Society of America 20170301 5


<h4>Background</h4>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.<h4>Methods</h4>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  ...[more]

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