MTN-017: A rectal phase 2 extended safety and acceptability study of tenofovir reduced-glycerin 1% gel

Ross D. Cranston, Javier R. Lama, Barbra A. Richardson, Alex Carballo-Diéguez, Ratiya Pamela Kunjara Na Ayudhya, Karen Liu, Karen B. Patterson, Cheng Shiun Leu, Beth Galaska, Cindy E. Jacobson, Urvi M. Parikh, Mark A Marzinke, Craig Hendrix, Sherri Johnson, Jeanna M. Piper, Cynthia Grossman, Ken S. Ho, Jonathan Lucas, Jim Pickett, Linda Gail BekkerSuwat Chariyalertsak, Anupong Chitwarakorn, Pedro Gonzales, Timothy H. Holtz, Albert Y. Liu, Kenneth H. Mayer, Carmen Zorrilla, Jill L. Schwartz, James Rooney, Ian McGowan

Research output: Contribution to journalArticle

Abstract

Background. 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. Methods. 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. Results. 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). Conclusions. 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.

Original languageEnglish (US)
Pages (from-to)614-620
Number of pages7
JournalClinical Infectious Diseases
Volume64
Issue number5
DOIs
Publication statusPublished - 2017

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Keywords

  • HIV
  • Microbicide
  • Prevention
  • Rectal
  • Tenofovir

ASJC Scopus subject areas

  • Microbiology (medical)
  • Infectious Diseases

Cite this

Cranston, R. D., Lama, J. R., Richardson, B. A., Carballo-Diéguez, A., Na Ayudhya, R. P. K., Liu, K., ... McGowan, I. (2017). MTN-017: A rectal phase 2 extended safety and acceptability study of tenofovir reduced-glycerin 1% gel. Clinical Infectious Diseases, 64(5), 614-620. https://doi.org/10.1093/cid/ciw832