Asymptomatic Bacterial Vaginosis and Herpes Simplex Virus Type 2 (BV/HSV-2) Shedding Study (MASH)
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.
|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|
- 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.
- 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
|Study Start Date:||December 2007|
|Study Completion Date:||March 2010|
|Primary Completion Date:||March 2010 (Final data collection date for primary outcome measure)|
|Experimental: MASH cohort||
500 mg, taken by mouth, two times a day, 7 days
Other Name: Flagyl
Please refer to this study by its ClinicalTrials.gov identifier: NCT00464542
|United States, Pennsylvania|
|University of Pittsburgh|
|Pittsburgh, Pennsylvania, United States, 15213|
|University of Pittsburgh, Magee Womens Hospital|
|Pittsburgh, Pennsylvania, United States, 15237|
|Principal Investigator:||Thomas L Cherpes||Univerisity of Pittsburgh|