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

Sponsor:	University of Pittsburgh
Information provided by (Responsible Party):	Thomas L. Cherpes, MD, University of Pittsburgh
ClinicalTrials.gov Identifier:	NCT00464542

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 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.

Condition	Intervention	Phase
Bacterial Vaginosis	Drug: Metronidazole	Phase IV

Study Type:	Interventional
Study Design:	Allocation: Non-Randomized Endpoint Classification: Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment
Official Title:	Asymptomatic Bacterial Vaginosis and Herpes Simplex Virus Type 2 Shedding

Resource links provided by NLM:

MedlinePlus related topics: Herpes Simplex

Drug Information available for: Metronidazole hydrochloride Metronidazole phosphate Metronidazole

U.S. FDA Resources

Further study details as provided by University of Pittsburgh:

Primary Outcome Measures:

Number of Participants With Bacterial Vaginosis Recurrence [ Time Frame: 30 days after cessation of metronidazole therapy ] [ Designated as safety issue: No ]
Bacterial vaginosis, defined as any vaginal smear with a Nugent score of 7-10 during the 30 day period following cessation of metronidazole therapy.

Secondary Outcome Measures:

Median Time to Bacterial Vaginosis During the 30 Days After Cessation of Metronidazole Therapy [ Time Frame: 30 days after cessation of metronidazole therapy ] [ Designated as safety issue: No ]
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

Enrollment:	12
Study Start Date:	December 2007
Study Completion Date:	March 2010
Primary Completion Date:	March 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: MASH cohort	Drug: Metronidazole 500 mg, taken by mouth, two times a day, 7 days Other Name: Flagyl

Eligibility

Ages Eligible for Study:	18 Years to 26 Years
Genders Eligible for Study:	Female
Accepts Healthy Volunteers:	Yes

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

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00464542

Locations

United States, Pennsylvania
University of Pittsburgh
Pittsburgh, Pennsylvania, United States, 15213
University of Pittsburgh, Magee Womens Hospital
Pittsburgh, Pennsylvania, United States, 15237

Sponsors and Collaborators

University of Pittsburgh

Investigators

Principal Investigator:

Thomas L Cherpes

Univerisity of Pittsburgh

More Information

No publications provided

Responsible Party:	Thomas L. Cherpes, MD, Assistant Professor, University of Pittsburgh
ClinicalTrials.gov Identifier:	NCT00464542 History of Changes
Other Study ID Numbers:	PRO07030124
Study First Received:	April 19, 2007
Results First Received:	March 22, 2011
Last Updated:	August 31, 2011
Health Authority:	United States: Institutional Review Board

Keywords provided by University of Pittsburgh:

herpes simplex virus

Additional relevant MeSH terms:

Herpes Simplex
Vaginosis, Bacterial
Herpesviridae Infections
DNA Virus Infections
Virus Diseases
Skin Diseases, Viral
Skin Diseases, Infectious
Skin Diseases
Bacterial Infections
Vaginitis

Vaginal Diseases
Genital Diseases, Female
Metronidazole
Radiation-Sensitizing Agents
Physiological Effects of Drugs
Pharmacologic Actions
Anti-Infective Agents
Therapeutic Uses
Antiprotozoal Agents
Antiparasitic Agents

ClinicalTrials.gov processed this record on February 09, 2012