Asymptomatic Bacterial Vaginosis and Herpes Simplex Virus Type 2 (BV/HSV-2) Shedding Study
Condition: Bacterial Vaginosis
MeSH terms: Herpes Simplex; Vaginosis, Bacterial; Vaginal Diseases
Intervention: Metronidazole
Intervention description: 500 mg, taken by mouth, two times a day, 7 days
Intervention MeSH terms: Metronidazole
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 12.0
Sex: Female
Minimum age: 18 Years
Maximum age: 26 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: herpes simplex virus

Summary:

      This investigation assessed the effects of asymptomatic BV on daily genital tract shedding of
      HSV-2 by determining shedding frequency before and after treatment of asymptomatic BV.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Women 18-26 years old of age

          -  Only those women who deny symptoms of vaginal discharge and odor but who meet Amsel
             and Gram stain criteria for the diagnosis of BV will be eligible

          -  Amsel criteria (3 of the following 4 conditions) (10):

          -  Homogenous vaginal discharge

          -  Vaginal pH > 4.5

          -  Positive amine (sniff) test

          -  Presence of clue cells in the vaginal fluid

          -  Gram stain criteria (11):

          -  Score: 0-3; classification: normal; vaginal bacteria morphotype: Lactobacillus
             predominant

          -  Score: 4-6; classification: intermediate; vaginal bacteria morphotype: Lactobacilli
             reduced

          -  Score: 7-10; classification: BV; vaginal bacteria morphotype: Lactobacillus replaced
             by Gardnerella and anaerobes

          -  Eligible women will need to test positive for HSV-2 type-specific antibodies.
             Determination of HSV-2 serostatus will be determined by a point-of-care type-specific
             immunoassay kit.

          -  Patients capable of providing written informed consent

          -  Patients willing to refrain from the use of intravaginal products (i.e., contraceptive
             creams, gels, foams, sponges, lubricants, douches, etc.) during the study period

          -  Patients willing to refrain from the use of any systemic or topical genital antiviral
             medication during the study period

          -  Patients willing and capable of cooperating to the extent and degree required by this
             protocol

        Exclusion Criteria:

          -  HSV-2 seronegativity (as determined by the point-of-care immunoassay)

          -  Pregnancy (all women will receive a pregnancy test prior to enrollment) or those women
             currently not practicing an effective method of birth control

          -  Current Chlamydia trachomatis, Neisseria gonorrhea, or Trichomonas vaginalis infection

          -  Use of prescriptive antiviral treatment for presumed HSV reactivation within the 14
             days prior to enrollment

          -  Use of systemic antimicrobials within the past 14 days

          -  History of hypersensitivity or inability to tolerate systemic metronidazole therapy

          -  Nursing mother

          -  Patients with intrauterine devices

          -  Unwillingness to refrain from initiation of antiviral medication during study period

          -  Unwillingness to refrain from use of douche products during study period

          -  Unwillingness to refrain from the ingestion of any alcoholic beverages during the
             one-week course of oral metronidazole therapy