Asymptomatic Bacterial Vaginosis and Herpes Simplex Virus Type 2 (BV/HSV-2) Shedding Study

• Status: Completed
• Trial end date: 2010-03-01
• Target enrollment: 0
• Participant gender: Female

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: University of Pittsburgh
• Treatments: Metronidazole

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