Botswana Study of UC-781 Vaginal Microbicide

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00385554
Recruitment Status : Withdrawn (Study product is no longer being considered for further development.)
First Posted : October 9, 2006
Last Update Posted : August 16, 2012
Information provided by:
Centers for Disease Control and Prevention

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.

Condition or disease Intervention/treatment Phase
HIV Infections Drug: UC-781 carbomer gel, 0.1% and 0.25% Phase 1

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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Prevention
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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS
U.S. FDA Resources

Primary Outcome Measures :
  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 Outcome Measures :
  1. Effects on vaginal microflora
  2. Systemic absorption
  3. Use acceptability in trial populations

Information from the National Library of Medicine

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Ages Eligible for Study:   21 Years to 45 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00385554

United States, Georgia
Centers for Disease Control and Prevention
Atlanta, Georgia, United States, 30333
United States, Virginia
Arlington, Virginia, United States, 22209
BOTUSA HIV Prevention Research Unit
Gaborone and Francistown, Botswana
Sponsors and Collaborators
Centers for Disease Control and Prevention
Principal Investigator: Dawn K Smith, MD, MPH BOTUSA/CDC
Study Director: Christine K Mauck, MD, MPH CONRAD Identifier: NCT00385554     History of Changes
Other Study ID Numbers: CDC-NCHSTP 4885
First Posted: October 9, 2006    Key Record Dates
Last Update Posted: August 16, 2012
Last Verified: August 2012

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

Additional relevant MeSH terms:
HIV Infections
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Anti-Infective Agents