NCT00385554

Botswana Study of UC-781 Vaginal Microbicide

Phase I Trial of the Safety, Toxicity, and Acceptability of the Microbicide UC-781 When Topically Applied by HIV-uninfected Women and Men in Botswana

• Status: Withdrawn
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Centers for Disease Control and Prevention · Federal
• Sex: All
• Age: 21 Years – 45 Years
• Healthy volunteers: Accepted

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 0.1% or 0.25% UC-781 carbomer gel or placebo gel (3 arms. Women will be instructed to apply gel intravaginally, morning and evening, and prior to sex (always with male condom use) for 14 consecutive days. Men will be instructed to apply gel topically for 14 consecutive nights, before bed, allow to dry overnight, and wash it off in the morning. Additionally instructed never to use gel during sex but always to use condoms. Volunteers will be seen weekly for evaluation of symptoms, laboratory toxicities, genital exam findings (with colposcopy for women, and plasma drug levels. Acceptability will be assessed in focus groups in the month after completing gel use.

Conditions

• HIV Infections

Interventions

Type	Name	Description
DRUG	UC-781 carbomer gel, 0.1% and 0.25%

Timeline

• First posted: 2006-10-09
• Last updated: 2012-08-16

Locations

3 sites across 2 countries: United States, Botswana