Clinical Trials Directory

Trials / Withdrawn

WithdrawnNCT03044379

Dapivirine Gel Rectal Safety and PK Study

A Randomized, Double Blind, Placebo-Controlled, Phase 1 Safety and Pharmacokinetic Study of Dapivirine Gel (0.05%) Administered Rectally to HIV-1 Seronegative Adults

Status
Withdrawn
Phase
Phase 1
Study type
Interventional
Enrollment
0 (actual)
Sponsor
International Partnership for Microbicides, Inc. · Industry
Sex
All
Age
18 Years – 45 Years
Healthy volunteers
Accepted

Summary

Dapivirine Gel Rectal Safety and PK Study

Detailed description

A Randomized, Double Blind, Placebo-Controlled Phase 1 Safety and Pharmacokinetic Study of Dapivirine Gel (0.05%) Administered Rectally to HIV-1 Seronegative Adults

Conditions

Interventions

TypeNameDescription
DRUGDapivirine gel (0.05%)MTN-026/IPM 038 will use the HTI pre-filled applicator, the same applicator that has been utilized in other rectal studies.
OTHERUniversal HEC placebo gel

Timeline

Start date
2015-09-29
Primary completion
2017-09-01
Completion
2017-11-01
First posted
2017-02-07
Last updated
2017-02-08

Locations

1 site across 1 country: United States

Source: ClinicalTrials.gov record NCT03044379. Inclusion in this directory is not an endorsement.