Topical Metronidazole and Miconazole Co-formulated Vaginal Suppositories for Preventing Vaginal Infections in HIV-seronegative Women
Condition: Bacterial Vaginosis; Candidiasis; Trichomoniasis
MeSH terms: Candidiasis; Vaginosis, Bacterial; Trichomonas Infections; Vaginal Diseases
Study type: Interventional
Phase: Phase 2

Summary: 
      This research study is about vaginal infections such as bacterial vaginosis, yeast
      infections, and trichomoniasis. Usually, these infections can be treated with medication, but
      sometimes they come back after treatment. Researchers want to know if using vaginal
      suppositories can decrease the risk of vaginal infections. Participants will include 234
      women who are sexually active (greater than or equal to 4 episodes of sex with men during the
      past month), HIV-negative, 18 to 45 years old, with bacterial infection [vaginosis and/or
      vulvovaginal candidiasis (VVC) and/or Trichomonas vaginalis] detected by laboratory testing
      at a screening visit. Women will receive vaginal suppositories containing drug or inactive
      ingredients (placebo). Participation in the study will be about 12 months. Study procedures
      include: urine and blood tests, physical exams, and questionnaires.
    

Detailed description: 
      Vaginal infections including bacterial vaginosis (BV), vulvovaginal candidiasis (VVC), and
      Trichomonas (T.) vaginalis are common and have been associated with increased risk of HIV and
      other sexually transmitted infections (STIs) in multiple prospective studies. Effective
      interventions for prevention of vaginal infections could substantially reduce the risk of HIV
      and other STIs in women. A recently completed trial has demonstrated that monthly periodic
      presumptive treatment (PPT) can reduce vaginal infections and promote Lactobacillus
      colonization. However, the oral regimen of metronidazole 2 grams plus fluconazole 150 mg was
      not sufficiently effective to warrant moving to Phase III HIV/STI prevention trials using
      this intervention. The identification of more efficacious regimens for reducing vaginal
      infections is a crucial step towards the development of inexpensive, female-controlled,
      non-coitally dependent HIV/STI risk reduction interventions for women. There is growing
      evidence that higher doses and longer courses may be more effective for treatment of vaginal
      infections than single-dose therapy. The overall goal of this protocol is to conduct a
      randomized, double-blind, placebo-controlled trial to test the efficacy of monthly PPT with
      topical metronidazole 750 mg plus miconazole 200 mg (co-formulated suppositories) versus
      matching placebo suppositories nightly for five nights each month for reducing the rates of
      BV and VVC among HIV-seronegative women. This regimen could produce sufficient reductions in
      vaginal infections to support its use in Phase III HIV and STI prevention trials. The study
      participants will include 234 women who are sexually active (greater than or equal to 4
      episodes of heterosexual intercourse during the past month), HIV-seronegative, 18 to 45 years
      old, with BV and/or VVC and/or T. vaginalis detected by laboratory testing at a screening
      visit. There will be two study arms. The treatment arm (117 subjects) will receive PPT with
      intravaginal metronidazole 750 mg plus miconazole 200 mg (co-formulated suppositories) for
      five consecutive nights each month. The placebo arm (117 subjects) will receive PPT with
      identical placebo intravaginal suppositories for five consecutive nights each month.
      Individual participants will be in the study for one year.
    

Intervention name(s): Neo-Penotran® Forte (active ingredient Metronidazole & Miconazole Nitrate); Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Neo-Penotran® Forte (active ingredient Metronidazole & Miconazole Nitrate), co-formulated vaginal suppositories containing metronidazole 750 mg with miconazole 200 mg and excipients (Witepsol S 55). Witepsol S 55 is a hard fat suppository base. Such bases consist mainly of triglyceride esters of the higher saturated fatty acids along with varying proportions of mono- and diglycerides. 117 subjects receive nightly for 5 consecutive night each month.; Placebo vaginal suppositories, identical in appearance to the active product; contains Witepsol S 55, Titanium Dioxide and D+C yellow #10 with no metronidazole or miconazole.117 subjects receive nightly for 5 consecutive nights each month.
Intervention MeSH terms: Metronidazole; Miconazole; Clotrimazole
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Prevention
Keywords: Bacterial vaginosis, metronidazole, miconazole, vulvovaginal candidiasis, trichomonas vaginalis, women, Kenya