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

University of Pittsburgh

Status and phase

Completed

Phase 4

Conditions

Bacterial Vaginosis

Treatments

Drug: Metronidazole

Study type

Interventional

Funder types

Other

Identifiers

NCT00464542

PRO07030124

Details and patient eligibility

About

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.

Full 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.

Enrollment

12 patients

Sex

Female

Ages

18 to 26 years old

Volunteers

Accepts Healthy Volunteers

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