Clinical trial NCT00464542: Asymptomatic Bacterial Vaginosis and Herpes Simplex Virus Type 2 (BV/HSV-2) Shedding Study
Official title: Asymptomatic Bacterial Vaginosis and Herpes Simplex Virus Type 2 Shedding
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Bacterial Vaginosis
Keywords: herpes simplex virus
Lead sponsor: University of Pittsburgh
Sponsor class: OTHER
First posted: 2007-04-23
Enrollment: 12
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 26
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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 periods of subclinical reactivation of the virus. Therefore, an improved understanding of the risk factors associated with HSV-2 shedding is needed.

Preliminary data suggests that bacterial vaginosis (BV) may be associated with increased genital tract shedding of HSV-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.

This study 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. Twelve HSV-2 seropositive women with asymptomatic BV were enrolled. These women were instructed to self-collect daily swab specimens for HSV-2 deoxyribonucleic acid (DNA) polymerase chain reaction (PCR) analysis from the lower genital tract for one month. At the end of the one month follow-up visit, each participant completed a one week course of oral metronidazole for treatment of BV. This was followed by daily home collection of genital tract swab specimens for an additional one month.

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

Primary outcomes:
measure: Number of Participants With Bacterial Vaginosis Recurrence
timeFrame: 30 days after cessation of metronidazole therapy
Secondary outcomes:
measure: Median Time to Bacterial Vaginosis During the 30 Days After Cessation of Metronidazole Therapy
timeFrame: 30 days after cessation of metronidazole therapy
Other outcomes:
Locations:
city: Pittsburgh
country: United States
facility: University of Pittsburgh
state: Pennsylvania
city: Pittsburgh
country: United States
facility: University of Pittsburgh, Magee Womens Hospital
state: Pennsylvania
Study officials:
affiliation: Univerisity of Pittsburgh
name: Thomas L Cherpes
role: PRINCIPAL_INVESTIGATOR
References: