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

Completed · Phase 4

Conditions studied: Bacterial Vaginosis

In brief

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.

Key facts

Study ID

NCT00464542

Run by

University of Pittsburgh

People needed

12

Starts

2007-12-01

Expected to finish

2010-03-01

Last updated by the study team

2017-05-11

Who can join

Age: 18 and older, up to 26. Sex: female. Healthy volunteers: accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• University of Pittsburgh — Pittsburgh, Pennsylvania, United States
• University of Pittsburgh, Magee Womens Hospital — Pittsburgh, Pennsylvania, United States

Full record on ClinicalTrials.gov

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