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A Phase 1 Randomized, Double Blind, Placebo Controlled Rectal Safety and Acceptability Study of Tenofovir 1% Gel (MTN-007)

Author

Listed:
  • Ian Mcgowan
  • Craig Hoesley
  • Ross D Cranston
  • Philip Andrew
  • Laura Janocko
  • James Y Dai
  • Alex Carballo-Dieguez
  • Ratiya Kunjara Na Ayudhya
  • Jeanna Piper
  • Florian Hladik
  • Ken Mayer

Abstract

Objective: Rectal microbicides are needed to reduce the risk of HIV acquisition associated with unprotected receptive anal intercourse. The MTN-007 study was designed to assess the safety (general and mucosal), adherence, and acceptability of a new reduced glycerin formulation of tenofovir 1% gel. Methods: Participants were randomized 1∶1:1∶1 to receive the reduced glycerin formulation of tenofovir 1% gel, a hydroxyethyl cellulose placebo gel, a 2% nonoxynol-9 gel, or no treatment. Each gel was administered as a single dose followed by 7 daily doses. Mucosal safety evaluation included histology, fecal calprotectin, epithelial sloughing, cytokine expression (mRNA and protein), microarrays, flow cytometry of mucosal T cell phenotype, and rectal microflora. Acceptability and adherence were determined by computer-administered questionnaires and interactive telephone response, respectively. Results: Sixty-five participants (45 men and 20 women) were recruited into the study. There were no significant differences between the numbers of ≥ Grade 2 adverse events across the arms of the study. Likelihood of future product use (acceptability) was 87% (reduced glycerin formulation of tenofovir 1% gel), 93% (hydroxyethyl cellulose placebo gel), and 63% (nonoxynol-9 gel). Fecal calprotectin, rectal microflora, and epithelial sloughing did not differ by treatment arms during the study. Suggestive evidence of differences was seen in histology, mucosal gene expression, protein expression, and T cell phenotype. These changes were mostly confined to comparisons between the nonoxynol-9 gel and other study arms. Conclusions: The reduced glycerin formulation of tenofovir 1% gel was safe and well tolerated rectally and should be advanced to Phase 2 development. Trial Registration: ClinicalTrials.gov NCT01232803.

Suggested Citation

  • Ian Mcgowan & Craig Hoesley & Ross D Cranston & Philip Andrew & Laura Janocko & James Y Dai & Alex Carballo-Dieguez & Ratiya Kunjara Na Ayudhya & Jeanna Piper & Florian Hladik & Ken Mayer, 2013. "A Phase 1 Randomized, Double Blind, Placebo Controlled Rectal Safety and Acceptability Study of Tenofovir 1% Gel (MTN-007)," PLOS ONE, Public Library of Science, vol. 8(4), pages 1-9, April.
  • Handle: RePEc:plo:pone00:0060147
    DOI: 10.1371/journal.pone.0060147
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    1. Stefan Baral & Frangiscos Sifakis & Farley Cleghorn & Chris Beyrer, 2007. "Elevated Risk for HIV Infection among Men Who Have Sex with Men in Low- and Middle-Income Countries 2000–2006: A Systematic Review," PLOS Medicine, Public Library of Science, vol. 4(12), pages 1-11, December.
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