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Botswana Study of UC-781 Vaginal Microbicide
This study is not yet open for participant recruitment.
Verified by Centers for Disease Control and Prevention, October 2006
Sponsors and Collaborators: Centers for Disease Control and Prevention
CONRAD
Information provided by: Centers for Disease Control and Prevention
ClinicalTrials.gov Identifier: NCT00385554
  Purpose

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.


Condition Intervention Phase
HIV Infections
Drug: UC-781 carbomer gel, 0.1% and 0.25%
Phase I

MedlinePlus related topics: AIDS
U.S. FDA Resources
Study Type: Interventional
Study Design: Prevention, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety Study
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

Further study details as provided by Centers for Disease Control and Prevention:

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

Estimated Enrollment: 90
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.

  Eligibility

Ages Eligible for Study:   21 Years to 45 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00385554

Contacts
Contact: Dawn K Smith, MD, MS, MPH +267-390-1696 ext 210 dks0@cdc.gov
Contact: Poloko M Kebaabetswe, PhD +267-390-1696 ext 264 kebaabetsweP@bw.cdc.gov

Locations
United States, Georgia
Centers for Disease Control and Prevention
Atlanta, Georgia, United States, 30333
United States, Virginia
CONRAD
Arlington, Virginia, United States, 22209
Botswana
BOTUSA HIV Prevention Research Unit
Gaborone and Francistown, Botswana
Sponsors and Collaborators
CONRAD
Investigators
Principal Investigator: Dawn K Smith, MD, MPH BOTUSA/CDC
Study Director: Lisa A Grohskopf, MD, MPH Centers for Disease Control and Prevention
Study Director: Christine K Mauck, MD, MPH CONRAD
  More Information

Study ID Numbers: CDC-NCHSTP 4885, BOTUSA MB05
Study First Received: October 5, 2006
Last Updated: January 10, 2007
ClinicalTrials.gov Identifier: NCT00385554  
Health Authority: United States: Food and Drug Administration;   Botswana: Drug Regulatory Unit Ministry of Health

Keywords provided by Centers for Disease Control and Prevention:
Microbicide
HIV prevention
Botswana
Preventing acquisition of HIV infection
HIV Seronegativity

Study placed in the following topic categories:
Virus Diseases
Sexually Transmitted Diseases, Viral
HIV Infections
Sexually Transmitted Diseases
Acquired Immunodeficiency Syndrome
Retroviridae Infections
Immunologic Deficiency Syndromes

Additional relevant MeSH terms:
RNA Virus Infections
Slow Virus Diseases
Immune System Diseases
Lentivirus Infections
Infection

ClinicalTrials.gov processed this record on January 16, 2009