MTN 007

Status:Completed
Phase:I
Principal Investigator(s):Ian McGowan, Ken Mayer
Objective:The primary objective of this study is to assess the safety of vaginally formulated tenofovir 1% gel when applied rectally.   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
Prevention Option(s):Microbicides
Study Design:Blind, Controlled, Randomized
Arms and Assigned Interventions
DescriptionRectal application of HEC placebo gel
Mode of DeliveryGel
ARMsPlacebo Comparator
Descriptionrectal application of Tenofovir 1% gel
Mode of DeliveryGel
ARMs
Results: A phase 1 randomized, double blind, placebo controlled rectal safety and acceptability study of tenofovir 1% gel
Official Code: NCT01232803
Trial Sponsors: CONRAD, NIAID
Start Date
End Date
October 31, 2010
July 31, 2011
Enrollment:65
Age range: 18 Years ↔ any
Population:Cisgender Men, Cisgender Women