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

Mcgowan, I and Hoesley, C and Cranston, RD and Andrew, P and Janocko, L and Dai, JY and Carballo-Dieguez, A and Ayudhya, RKN and Piper, J and Hladik, F and Mayer, K (2013) A Phase 1 Randomized, Double Blind, Placebo Controlled Rectal Safety and Acceptability Study of Tenofovir 1% Gel (MTN-007). PLoS ONE, 8 (4).

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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.

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Details

Item Type:	Article
Status:	Published
Creators/Authors:	Creators Email Pitt Username ORCID Mcgowan, I imcgowan@pitt.edu IMCGOWAN Hoesley, C Cranston, RD rdc27@pitt.edu RDC27 Andrew, P Janocko, L Dai, JY Carballo-Dieguez, A Ayudhya, RKN Piper, J Hladik, F Mayer, K
Date:	3 April 2013
Date Type:	Publication
Journal or Publication Title:	PLoS ONE
Volume:	8
Number:	4
DOI or Unique Handle:	10.1371/journal.pone.0060147
Schools and Programs:	School of Medicine > Medicine
Refereed:	Yes
PubMed ID:	23573238
Date Deposited:	22 Apr 2013 16:11
Last Modified:	13 Oct 2017 18:55
URI:	http://d-scholarship.pitt.edu/id/eprint/18323

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