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Botswana Study of UC-781 Vaginal Microbicide

NCT ID: NCT00385554

Last Updated: 2012-08-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

PHASE1

Study Classification

INTERVENTIONAL

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.

Conditions

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HIV Infections

Keywords

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Microbicide HIV prevention Botswana Preventing acquisition of HIV infection HIV Seronegativity

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Interventions

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UC-781 carbomer gel, 0.1% and 0.25%

Intervention Type DRUG

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
Minimum Eligible Age

21 Years

Maximum Eligible Age

45 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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CONRAD

OTHER

Sponsor Role collaborator

Centers for Disease Control and Prevention

FED

Sponsor Role lead

Principal Investigators

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Dawn K Smith, MD, MPH

Role: PRINCIPAL_INVESTIGATOR

BOTUSA/CDC

Christine K Mauck, MD, MPH

Role: STUDY_DIRECTOR

CONRAD

Locations

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Centers for Disease Control and Prevention

Atlanta, Georgia, United States

Site Status

CONRAD

Arlington, Virginia, United States

Site Status

BOTUSA HIV Prevention Research Unit

Gaborone and Francistown, , Botswana

Site Status

Countries

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United States Botswana

Other Identifiers

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BOTUSA MB05

Identifier Type: -

Identifier Source: secondary_id

CDC-NCHSTP 4885

Identifier Type: -

Identifier Source: org_study_id