Botswana Study of UC-781 Vaginal Microbicide

Study Overview
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Brief Summary
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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
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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.

Official Title
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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

Conditions
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HIV Infections

Intervention / Treatment
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* Drug: UC-781 carbomer gel, 0.1% and 0.25%


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 21 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: UC-781 carbomer gel, 0.1% and 0.25%|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The safety and toxicity of 0.1% and 0.25% UC-781 carbomer gel compared to placebo gel in HIV uninfected, sexually active women and men |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Effects on vaginal microflora |  |  | 
| Systemic absorption |  |  | 
| Use acceptability in trial populations |  |  | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Microbicide, HIV prevention, Botswana, Preventing acquisition of HIV infection, HIV Seronegativity