Safety Study of UC-781 Vaginal Microbicide

Phase 1

Completed

• Conditions: HIV Infections
• Interventions: Drug: Placebo gel; Drug: UC 781

• Registration Number: NCT00446979
• Lead Sponsor: Centers for Disease Control and Prevention

Brief Summary

This study will help determine whether UC-781 gel is safe when applied to the vagina twice daily for 14 days, and will assess whether women and men find the gel acceptable to use.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2007-03-12
• Study First Submitted QC: 2007-03-12
• Study First Posted: 2007-03-13
• Study Start: 2007-06
• Study Completion: 2007-10
• Status Verified: 2013-04
• Last Update Submitted: 2013-04-18
• Last Update Posted: 2013-04-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 90

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
3	Placebo gel	Placebo vaginal gel
1	UC 781	UC 781 0.1% carbomer gel
2	UC 781	UC 781 0.25% carbomer gel

Primary Outcome Measures

Name	Time	Method
Genital tract inflammation or epithelial disruption as assessed by naked eye and colposcopic inspection according to established guidelines	2 weeks
Symptoms of irritation	two weeks
Changes in vaginal flora	Two weeks
Assessment of pro-inflammatory cytokines in the genital tract	Two weeks
Other product-related adverse events	Two weeks

Secondary Outcome Measures

Name	Time	Method
acceptability of UC-781 gel use	Two weeks
systemic absorption of UC-781	Two weeks
anti-HIV activity of genital secretions in the presence of UC-781 gel	Two weeks

Trial Locations

Locations (1)

Chiang Rai Health Club; 🇹🇭 Chiang Rai, Thailand