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

Summary: 
      Vaginal microbicides are compounds that may protect women from HIV and other sexually
      transmitted infections (STIs). This study will determine the safety of the microbicide UC-781
      by comparing the effects of keeping the microbicide in the vagina for different lengths of
      time.
    

Detailed description: 
      Vaginal microbicides are compounds applied to the inside of the vagina that may protect women
      against vaginal transmission of HIV and other STIs. This study will evaluate the safety of
      the vaginal microbicide UC-781. Studies have shown UC-781 to be an effective inhibitor of
      HIV-1 reverse transcriptase. UC-781 has been tested in animal models and in Phase I and II
      studies in humans. The results of these studies indicated that cervical tissue was fully
      protected from different variants of HIV. The purpose of this study is to assess the
      incidence of epithelial disruption and inflammation in the cervix, vagina, and vulva of
      healthy HIV uninfected women after a single exposure to UC-781 vaginal gel. This study will
      compare the results of leaving the microbicide in the vagina for varying lengths of time.

      The duration of this study is approximately 35 days. Participants in this study will be
      randomly assigned to one of eight groups, and all participants will receive a single exposure
      of UC-781 or placebo gel. There will be five total study visits, including the screening and
      study entry visits. Screening will occur approximately 10 days prior to the study entry
      visit. At study entry, a single application of microbicide or placebo gel will be inserted
      for 0, 2, 4,or 8 hours in the vagina. Length of exposure time will differ, depending on which
      group a participant has been randomly assigned to. Following vaginal exposure to the
      microbicide, the microbicide will be rinsed off. Vaginal secretions will be collected to test
      antiviral activity against HIV and assess the amount of microbicide remaining in the vagina.
      Visits 3 through 5 occur at approximately 24 to 48 hours, 6 to 8 days, and 25 to 35 days
      following study entry.

      At all visits, participants will be asked to complete a questionnaire and undergo a pelvic
      exam, STI tests, and vital signs measurements. Blood and urine collection will occur at each
      visit. On selected visits, a colposcopy will be conducted and participants will be
      interviewed regarding product acceptability, in addition to other measures. Between selected
      visits, participants will be asked to maintain sexual abstinence or use condoms.
    

Intervention name(s): UC-781; UC-781 placebo
Intervention type(s): Drug; Drug
Intervention description(s): 0.1% UC-781 Vaginal Gel; Vaginal Gel Placebo
Intervention MeSH terms: UC-781
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Primary purpose: Prevention
Keywords: Anti-Infective Agents, Local; Healthy Women; Microbicides; UC-781; Vaginal Gel; HIV Seronegativity