RMP 02/MTN 006

Status:Completed
Phase:I
Principal Investigator(s):Peter Anton
Objective:The primary objective of this study is to evaluate the systemic safety of 1% vaginally formulated tenofovir gel applied rectally
Prevention Option(s):Microbicides
Study Design:Controlled, Double-blind, Randomized
Arms and Assigned Interventions
DescriptionTopical gel applied rectally
Mode of DeliveryGel
ARMsExperimental
DescriptionPlacebo gel applied rectally
Mode of DeliveryGel
ARMsPlacebo Comparator
DescriptionAll participants will undergo an open label tenofovir tablet single dose administration (i.e. Tenofovir Disoproxil Fumarate 300 mg, aka Viread®)
Mode of DeliveryTablet
ARMs
Results: A phase 1 randomized, double blind, placebo controlled rectal safety and acceptability study of tenofovir 1% gel
Official Code: NCT00984971
Trial Sponsors: CONRAD, MTN, NIAID
Start Date
End Date
September 30, 2009
July 31, 2010
Enrollment:18
Age range: 18 Years ↔ any
Population:Cisgender Men, Cisgender Women