Botswana Study of UC-781 Vaginal Microbicide

• Status: Withdrawn
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Centers for Disease Control and Prevention
• Collaborator: CONRAD
• Treatments: Anti-Infective Agents; UC-781

Criteria

Inclusion Criteria:

• 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 Criteria:

• 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