NCT00385554

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.

Trial Health

40
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Geographic Reach
2 countries

3 active sites

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 5, 2006

Completed
4 days until next milestone

First Posted

Study publicly available on registry

October 9, 2006

Completed
Last Updated

August 16, 2012

Status Verified

August 1, 2012

First QC Date

October 5, 2006

Last Update Submit

August 15, 2012

Conditions

HIV Infections

Keywords

MicrobicideHIV preventionBotswanaPreventing acquisition of HIV infectionHIV Seronegativity

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (3)

  • Effects on vaginal microflora

  • Systemic absorption

  • Use acceptability in trial populations

Interventions

UC-781 carbomer gel, 0.1% and 0.25%DRUG

Eligibility Criteria

Age21 Years - 45 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Centers for Disease Control and Prevention

Atlanta, Georgia, 30333, United States

Location

CONRAD

Arlington, Virginia, 22209, United States

Location

BOTUSA HIV Prevention Research Unit

Gaborone and Francistown, Botswana

Location

MeSH Terms

Conditions

HIV Infections

Condition Hierarchy (Ancestors)

Blood-Borne InfectionsCommunicable DiseasesInfectionsSexually Transmitted Diseases, ViralSexually Transmitted DiseasesLentivirus InfectionsRetroviridae InfectionsRNA Virus InfectionsVirus DiseasesGenital DiseasesUrogenital DiseasesImmunologic Deficiency SyndromesImmune System Diseases

Study Officials

  • Dawn K Smith, MD, MPH

    BOTUSA/CDC

    PRINCIPAL INVESTIGATOR

  • Christine K Mauck, MD, MPH

    CONRAD

    STUDY DIRECTOR
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Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
FED

Study Record Dates

First Submitted

October 5, 2006

First Posted

October 9, 2006

Last Updated

August 16, 2012

Record last verified: 2012-08

Locations

US(2)BO(1)