Status:
COMPLETED
Asymptomatic Bacterial Vaginosis and Herpes Simplex Virus Type 2 (BV/HSV-2) Shedding Study
Lead Sponsor:
University of Pittsburgh
Conditions:
Bacterial Vaginosis
Eligibility:
FEMALE
18-26 years
Phase:
PHASE4
Brief 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.
Detailed Description
An important contributor to the epidemic spread of herpes simplex virus type 2 (HSV-2) is its high frequency of asymptomatic shedding in the genital tract, as transmission usually occurs during these ...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
December 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2010
Estimated Enrollment :
12 Patients enrolled
Trial Details
Trial ID
NCT00464542
Start Date
December 1 2007
End Date
March 1 2010
Last Update
May 11 2017
Active Locations (2)
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1
University of Pittsburgh
Pittsburgh, Pennsylvania, United States, 15213
2
University of Pittsburgh, Magee Womens Hospital
Pittsburgh, Pennsylvania, United States, 15237