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This study has been withdrawn prior to enrollment.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

October 5, 2006
August 15, 2012
Not Provided
Not Provided
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
Same as current
Complete list of historical versions of study NCT00385554 on ClinicalTrials.gov Archive Site
  • Effects on vaginal microflora
  • Systemic absorption
  • Use acceptability in trial populations
Same as current
Not Provided
Not Provided
 
Botswana Study of UC-781 Vaginal Microbicide
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

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.

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.

Interventional
Phase 1
Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Prevention
HIV Infections
Drug: UC-781 carbomer gel, 0.1% and 0.25%
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Withdrawn
0
Not Provided
Not Provided

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
Both
21 Years to 45 Years
Yes
Contact information is only displayed when the study is recruiting subjects
Botswana,   United States
 
NCT00385554
CDC-NCHSTP 4885, BOTUSA MB05
Not Provided
Not Provided
Centers for Disease Control and Prevention
CONRAD
Principal Investigator: Dawn K Smith, MD, MPH BOTUSA/CDC
Study Director: Christine K Mauck, MD, MPH CONRAD
Centers for Disease Control and Prevention
August 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP