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

Bacterial Vaginosis Clinical Trial

— MASH  

Official title:

Asymptomatic Bacterial Vaginosis and Herpes Simplex Virus Type 2 Shedding

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00464542
• Other study ID #: PRO07030124
• Status: Completed
• Phase: Phase 4
• First received: April 19, 2007
• Last updated: August 31, 2011
• Start date: December 2007
• Est. completion date: March 2010

Study information

• Verified date: August 2011
• Source: University of Pittsburgh
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

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 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 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 12
• Est. completion date: March 2010
• Est. primary completion date: March 2010
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 26 Years

Eligibility

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

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 (biokit HSV-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

Study Design

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Bacterial Vaginosis
• Herpes Simplex
• Vaginal Diseases
• Vaginosis, Bacterial

Intervention

Drug:
• Metronidazole
500 mg, taken by mouth, two times a day, 7 days

Locations

Country	Name	City	State
United States	University of Pittsburgh	Pittsburgh	Pennsylvania
United States	University of Pittsburgh, Magee Womens Hospital	Pittsburgh	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
University of Pittsburgh

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Participants With Bacterial Vaginosis Recurrence	Bacterial vaginosis, defined as any vaginal smear with a Nugent score of 7-10 during the 30 day period following cessation of metronidazole therapy.	30 days after cessation of metronidazole therapy	No
Secondary	Median Time to Bacterial Vaginosis During the 30 Days After Cessation of Metronidazole Therapy	The time by which half of the participants were diagnosed with bacterial vaginosis, defined as any vaginal smear with a Nugent score of 7-10 during the 30 day period following cessation of metronidazole therapy	30 days after cessation of metronidazole therapy	No