Rectal Safety and Acceptability Study of Tenofovir 1% Gel
Status:
Completed
Trial end date:
2011-07-01
Target enrollment:
Participant gender:
Summary
MTN-007 is a Phase 1, randomized, blinded, placebo-controlled safety and acceptability study
of vaginally formulated tenofovir 1% gel (a reduced-glycerin formulation), when applied
rectally. The primary objective of this study is to assess the safety of vaginally formulated
tenofovir 1% gel when applied rectally.
After completing screening and baseline evaluation, eligible participants will be randomized
to receive tenofovir 1% gel, 2% nonoxynol-9 gel (N-9) or placebo gel. The study will also
include a no treatment arm. There will be 15 participants in each arm.
Participants will return to the clinic, where they will self-administer a single dose of the
study gel under observation. Within approximately 30 minutes, lavage, stool, and rectal
biopsy specimens will be obtained. After a one-week recovery period, participants will return
to the clinic for assessment. If no significant adverse events (AEs) are reported they will
begin to self-administer once-daily outpatient doses of the study gel for 7 days.
Participants will return to clinic for evaluation and specimen collection after completion of
7 days of daily dosing.
Phase:
Phase 1
Details
Lead Sponsor:
CONRAD
Collaborators:
National Institute of Allergy and Infectious Diseases (NIAID) National Institute of Mental Health (NIMH)