Botswana Study of UC-781 Vaginal Microbicide

This study has been withdrawn prior to enrollment.
(Study product is no longer being considered for further development.)
Sponsor:
Collaborator:
CONRAD
Information provided by:
Centers for Disease Control and Prevention
ClinicalTrials.gov Identifier:
NCT00385554
First received: October 5, 2006
Last updated: August 15, 2012
Last verified: August 2012
  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 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
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 NLM:


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

Enrollment: 0
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00385554

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: Christine K Mauck, MD, MPH CONRAD
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00385554     History of Changes
Other Study ID Numbers: CDC-NCHSTP 4885, BOTUSA MB05
Study First Received: October 5, 2006
Last Updated: August 15, 2012
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

Additional relevant MeSH terms:
HIV Infections
Acquired Immunodeficiency Syndrome
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Slow Virus Diseases
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on July 26, 2014