Botswana Study of UC-781 Vaginal Microbicide

Status:

WITHDRAWN

Botswana Study of UC-781 Vaginal Microbicide

Lead Sponsor:

Centers for Disease Control and Prevention

Collaborating Sponsors:

CONRAD

Conditions:

HIV Infections

Eligibility:

All Genders

21-45 years

Phase:

PHASE1

Brief Summary

This study will test the safety, side effects, and acceptability of two strengths of UC-781 gel when used by women and men in Botswana for two weeks.

Detailed Description

45 women and 45 men, all healthy and sexually active, 21-45 years old, without HIV infection, will be enrolled in Francistown and Gaborone, Botswana. Volunteers will be randomized to receive either 0....

Eligibility Criteria

Inclusion

21-45 years old
citizen of Botswana
willing to use condoms for 14 days
PAP smear (normal, inflammation, ASCUS)
regular menses or amenorrhea
lives within 1 hour of a study clinic
pass comprehension test
provide written informed consent

Exclusion

genital mucosal disruption at screening
genital surgery within past 8 weeks
pregnant within past 8 weeks
currently breastfeeding
prior hysterectomy
plans to move within 2 months
ALT, AST, total bilirubin, or creatinine Grade 2 or above
Prothrombin or partial thromboplastin time Grade 2 or above
In other drug/vaccine safety trial
Has more than one sexual partner in past month
Unwilling/unsure they can have sex at least twice weekly for 2 weeks
Any other condition that investigator believes will interfere with the evaluation of study objectives

Key Trial Info

Start Date :

Trial Type :

INTERVENTIONAL

Allocation :

ACTUAL

End Date :

Estimated Enrollment :

Patients enrolled

Trial Details

Trial ID

NCT00385554

Last Update

August 16 2012

Active Locations (3)

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Page 1 of 1 (3 locations)

Centers for Disease Control and Prevention

Atlanta, Georgia, United States, 30333