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Safety and Acceptability Study of the UC-781 Microbicide Gel Applied Rectally

NCT00408538 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 36

Last updated 2009-05-04

No results posted yet for this study

Summary

This study is the first to try this product in the rectum of humans. This study is only to find out if the gel is safe for use in the rectum, not to see if the gel works. Information gathered from this study will help investigators decide whether this gel is safe enough to move onto the next phase of studies.

Information gathered from this study will also help investigators determine what participants did and did not like about the product and what types of products people might want to use in the future. Currently condoms and abstinence are the only methods proven to prevent the spread of HIV sexually.

Conditions

  • HIV Infections

Interventions

DRUG

UC-781 microbicide gel (0.1% and 0.25%)

DRUG

placebo

Sponsors & Collaborators

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2006-12-31
Completion
2008-04-30

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00408538 on ClinicalTrials.gov