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Asymptomatic Bacterial Vaginosis and Herpes Simplex Virus Type 2 (BV/HSV-2) Shedding Study - NCT00464542-15213(Clinical Trial 168843)



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City:  Pittsburgh
State:  
PA
Zip Code: 15213
Conditions: Bacterial Vaginosis
Purpose: 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 periods of subclinical reactivation of the virus (1). Therefore, an improved understanding of the risk factors associated with HSV-2 shedding is needed. The researchers' preliminary data suggests that bacterial vaginosis (BV) may be associated with increased genital tract shedding of HSV-2 (2). As BV is the most common cause of vaginal symptoms in reproductive age women, even modest associations with genital tract shedding of HSV-2 would result in substantial attributable risks for transmission of the virus. The researchers' investigation will assess the effects of asymptomatic BV on daily genital tract shedding of HSV-2 by determining shedding frequency before and after treatment of asymptomatic BV. To do this, the researchers will enroll 35 HSV-2 seropositive women with asymptomatic BV. These women will be instructed to self-collect daily swab specimens for HSV-2 DNA PCR analysis from the lower genital tract for one month. At the end of the one month follow-up visit, each participant will complete a one week course of oral metronidazole for treatment of BV. This will be followed by daily home collection of genital tract swab specimens for an additional one month.
Study summary:
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 morphophyte: Lactobacillus predominant - Score: 4-6; classification: intermediate; vaginal bacteria morphophyte: Lactobacilli reduced - Score: 7-10; classification: BV; vaginal bacteria morphophyte: Lactobacillus replaced by Gardnerella and anaerobes It has been reported that 50% of women who meet clinical criteria for BV will deny symptoms (12). In addition, routine antimicrobial treatment of women with asymptomatic BV is not currently recommended by the Centers for Disease Control (13). - 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 (biokitHSV-2 Rapid Test, biokit USA). - 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 POC 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
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Data Source: ClinicalTrials.gov
Date Processed: March 15, 2010
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