Safety, Tolerance and Acceptability Trial of the Invisible Condom® in Healthy Women
Condition: HIV Infections; Sexually Transmitted Diseases
MeSH terms: Sexually Transmitted Diseases
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      The objectives of this clinical study are to evaluate the extended safety, tolerance and
      acceptability of a vaginal gel formulation when applied in 452 healthy women volunteers. This
      vaginal formulation was shown to be well tolerated in a previous smaller clinical study. The
      formulation is being developed as a microbicide for the prevention of sexually transmitted
      infections (STIs) including HIV.
    

Detailed description: 
      Objectives: The objectives of this Phase I/II clinical trial are to evaluate the safety,
      tolerance and acceptability of a gel formulation containing sodium lauryl sulfate (SLS)
      (compared to gel alone and placebo) when applied intravaginally in healthy volunteers.

      Design: In part A of the protocol, three groups: gel alone, gel plus SLS, and placebo will be
      tested for safety, tolerance and acceptability when applied intravaginally once, twice or
      three times daily for 14 days in 252 healthy subjects. The volunteers will be divided as
      follow: 36 sexually abstinent healthy subjects (12 per group) will apply the gel, gel plus
      SLS or the placebo once daily for 14 days; 72 sexually active healthy subjects (24 per group)
      will apply the gel, gel plus SLS or the placebo once daily for 14 days; 72 sexually active
      healthy subjects (24 per group) will apply the gel, gel plus SLS or the placebo twice daily
      for 14 days and 72 sexually active healthy subjects (24 per group) will apply the gel, gel
      plus SLS or the placebo three times daily for 14 days. The gel will be applied between
      menses. For the sexually active group, the gel should be applied less than 1 hour before
      sexual intercourse, if planned. Subjects will have vaginal intercourse a minimum of 4 times
      in a 2-week period of gel application.

      In part B of the protocol, the extended safety of the gel alone, gel plus SLS and placebo
      will be studied when applied intravaginally twice daily for 8 weeks in sexually active
      healthy subjects. In this part B (actually represents Phase II of the trial), 80 healthy
      sexually active subjects for the gel alone group and 80 subjects for the gel + SLS group and
      40 subjects for the placebo group, will be studied. The part B involves the participation of
      a total of 200 subjects. Subjects will have vaginal intercourse a minimum of 4 times in a
      2-week period of gel application. The gel will be applied between menses. The gel should be
      applied less than 1 hour before sexual intercourse, if planned, but no more than twice a day.
    

Intervention name(s): Invisible Condom®
Intervention type(s): Drug
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Prevention
Keywords: microbicide; Women; Prevention; HIV; STIs; HIV Seronegativity; prevention of sexually transmitted infections including HIV.