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

NCT ID: NCT00464542

Last Updated: 2017-05-11

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 12 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2007-12-31
• Study Completion Date: 2010-03-31

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.

Conditions

Bacterial Vaginosis

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Metronidazole

Observational before and after treatment Drug: Metronidazole 500 mg, taken by mouth, two times a day, 7 days

Group Type: OTHER

Metronidazole

Intervention Type: DRUG

500 mg, taken by mouth, two times a day, 7 days

Interventions

Metronidazole

500 mg, taken by mouth, two times a day, 7 days

Intervention Type: DRUG

Other Intervention Names

Flagyl

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 26 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

University of Pittsburgh

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Thomas L Cherpes

Role: PRINCIPAL_INVESTIGATOR

Univerisity of Pittsburgh

Locations

University of Pittsburgh

Pittsburgh, Pennsylvania, United States

University of Pittsburgh, Magee Womens Hospital

Pittsburgh, Pennsylvania, United States

Countries

United States

Other Identifiers

PRO07030124

Identifier Type: -

Identifier Source: org_study_id