Botswana Study of UC-781 Vaginal Microbicide

Centers for Disease Control and Prevention (CDC)

Status and phase

Withdrawn

Phase 1

Conditions

HIV Infections

Treatments

Drug: UC-781 carbomer gel, 0.1% and 0.25%

Study type

Interventional

Funder types

Other

Other U.S. Federal agency

Identifiers

NCT00385554

CDC-NCHSTP 4885

BOTUSA MB05

Details and patient eligibility

About

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.

Full 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.

Sex

All

Ages

21 to 45 years old

Volunteers

Accepts Healthy Volunteers

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