Study of UC-781 Vaginal Microbicide
Condition: HIV Infections
MeSH terms: HIV Infections
Study type: Interventional
Phase: Phase 1

Summary: 
      This study will help determine whether the agent UC-781, formulated as a gel, is safe when
      applied to the vagina twice daily for 14 days. It will also assess whether women find the gel
      acceptable to use.
    

Detailed description: 
      Purpose: To assess the safety and acceptability of vaginal use of 0.1% and 0.25% UC-781 gel
      in sexually active HIV-uninfected women, and their male partners, and sexually abstinent
      HIV-infected women

      Design: Single-center, phase I randomized, double-blind, controlled trial with 14 days of
      twice-daily product or control gel exposure

      Study population: Sexually active, HIV-uninfected women at low-risk for HIV and their male
      partners; sexually-abstinent HIV-infected women; all age 18-45

      Size: 36 sexually active HIV-uninfected women and up to 36 of their male partners; 18
      sexually abstinent HIV-infected women

      Treatment regimen:

      Stage 1: HIV-uninfected, sexually active women and 1 male partner per woman:

      12 women assigned to 0.1% UC-781 twice daily x 14 days; 12 women assigned to 0.25% UC-781
      twice daily x 14 days; 12 women assigned to control gel twice daily X 14 days.

      Stage 2: HIV-infected, abstinent women: 12 assigned to 0.25% UC-781 twice daily x 14 days; 6
      assigned to control gel twice daily x 14 days

      Study duration: Participant accrual will take 6 months. Each participant will be followed for
      14 days in Stage 1 and 21 days in Stage 2. Total study duration will be 9 months.

      Study Site: The Hope Clinic of Emory University, Decatur, GA

      Primary Objectives:

        -  To assess the safety and toxicity of 0.1% UC-781 gel and 0.25% UC-781 gel administered
           intravaginally twice-daily for 14 days on the vulvar and cervicovaginal mucosa of
           sexually active HIV-uninfected women

        -  To assess the safety and toxicity of 0.25% UC-781 gel administered intravaginally
           twice-daily for 14 days on the vulvar and cervicovaginal mucosa of sexually abstinent
           HIV-infected women

      Secondary Objectives:

        -  To assess the acceptability of 0.1% and 0.25% UC-781 gel administered intravaginally
           twice-daily for 14 days among HIV-uninfected, and the acceptability of 0.25% gel
           similarly administered to HIV-infected women

        -  To assess the effect of study product on vaginal microflora of HIV-uninfected and
           HIV-infected women

        -  To assess the systemic absorption of 0.1% and 0.25% UC-781 gel when administered
           intravaginally

        -  To assess HIV viral load in genital secretions in HIV-infected women during 0.25% UC-781
           gel use

        -  To assess the genotypic resistance patterns of HIV in genital secretions and peripheral
           blood in HIV-infected women during 0.25% UC-781 gel use

        -  To assess the acceptability of 0.1% and 0.25% UC-781 gel in male sexual partners of
           HIV-uninfected women

      Primary Endpoints:

      The safety and toxicity of 0.1% UC-781 gel and 0.25% UC-781 gel administered intravaginally
      twice-daily for 14 days in sexually-active HIV-uninfected women and 0.25% UC-781 gel
      administered in sexually-abstinent HIV-infected women will be assessed by:

        -  Macroscopic and/or microscopic evidence of vulvar and/or vaginal epithelium damage,
           including ulceration, abrasion, severe erythema, and/or severe edema

        -  Macroscopic and/or microscopic evidence of cervical mucosal damage including ulceration,
           abrasion, severe erythema, and/or severe edema

        -  Symptoms of genital irritation, including burning, itching or soreness

        -  Laboratory evidence of grade 3 or higher toxicity for hematology, liver or renal
           function which cannot be attributed to another cause

      Secondary Endpoints:

      Acceptability of 0.1% and 0.25% UC-781 gel use by HIV-uninfected and 0.25% UC-781 gel use by
      HIV-infected women will be assessed by:

        -  Proportion of participants who at Day 14 visit indicate they would be 'somewhat
           unlikely' or 'very unlikely' to use 0.1% and 0.25% UC-781 gel during sexual intercourse
           in the future compared to control gel users

        -  Reported positive aspects of using 0.1% and 0.25% UC-781 gel compared to control gel
           users

        -  Reported negative aspects of using 0.1% and 0.25% UC-781 gel compared to control gel
           users
    

Intervention name(s): topical vaginal application of UC-781 gel
Intervention type(s): Drug
Intervention description(s): UC-781 gel (arms 1 and 2) or placebo (arm 3) applied vaginally twice daily for 14 days
Intervention MeSH terms: UC-781
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Prevention
Keywords: HIV; topical microbicides