Botswana Study of UC-781 Vaginal Microbicide

Withdrawn before enrolling · Phase 1

Conditions studied: HIV Infections

In brief

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.

Key facts

Study ID

NCT00385554

Run by

Centers for Disease Control and Prevention

People needed

0

Last updated by the study team

2012-08-16

Who can join

Age: 21 and older, up to 45. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Centers for Disease Control and Prevention — Atlanta, Georgia, United States
• CONRAD — Arlington, Virginia, United States
• BOTUSA HIV Prevention Research Unit — Gaborone and Francistown, Botswana

Full record on ClinicalTrials.gov

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