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Botswana Study of UC-781 Vaginal Microbicide

Primary Purpose

HIV Infections

Status
Withdrawn
Phase
Phase 1
Locations
International
Study Type
Interventional
Intervention
UC-781 carbomer gel, 0.1% and 0.25%
Sponsored by
Centers for Disease Control and Prevention
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional prevention trial for HIV Infections focused on measuring Microbicide, HIV prevention, Botswana, Preventing acquisition of HIV infection, HIV Seronegativity

Eligibility Criteria

21 Years - 45 Years (Adult)All SexesAccepts 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

Sites / Locations

  • Centers for Disease Control and Prevention
  • CONRAD
  • BOTUSA HIV Prevention Research Unit

Outcomes

Primary Outcome Measures

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

Effects on vaginal microflora
Systemic absorption
Use acceptability in trial populations

Full Information

First Posted
October 5, 2006
Last Updated
August 15, 2012
Sponsor
Centers for Disease Control and Prevention
Collaborators
CONRAD
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1. Study Identification

Unique Protocol Identification Number
NCT00385554
Brief Title
Botswana Study of UC-781 Vaginal Microbicide
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
August 2012
Overall Recruitment Status
Withdrawn
Why Stopped
Study product is no longer being considered for further development.
Study Start Date
undefined (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
Centers for Disease Control and Prevention
Collaborators
CONRAD

4. Oversight

5. Study Description

Brief 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.
Detailed 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
HIV Infections
Keywords
Microbicide, HIV prevention, Botswana, Preventing acquisition of HIV infection, HIV Seronegativity

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
Double
Allocation
Randomized
Enrollment
0 (Actual)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
UC-781 carbomer gel, 0.1% and 0.25%
Primary Outcome Measure Information:
Title
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 Measure Information:
Title
Effects on vaginal microflora
Title
Systemic absorption
Title
Use acceptability in trial populations

10. Eligibility

Sex
All
Minimum Age & Unit of Time
21 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Dawn K Smith, MD, MPH
Organizational Affiliation
BOTUSA/CDC
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Christine K Mauck, MD, MPH
Organizational Affiliation
CONRAD
Official's Role
Study Director
Facility Information:
Facility Name
Centers for Disease Control and Prevention
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30333
Country
United States
Facility Name
CONRAD
City
Arlington
State/Province
Virginia
ZIP/Postal Code
22209
Country
United States
Facility Name
BOTUSA HIV Prevention Research Unit
City
Gaborone and Francistown
Country
Botswana

12. IPD Sharing Statement

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Botswana Study of UC-781 Vaginal Microbicide

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