Ignite Creation Date:
2024-05-05 @ 5:28 PM
Last Modification Date:
2024-10-26 @ 9:32 AM
Study NCT ID:
NCT00464542
Status:
COMPLETED
Last Update Posted:
2017-05-11
First Post:
2007-04-19
Brief Title:
Asymptomatic Bacterial Vaginosis and Herpes Simplex Virus Type 2 BVHSV-2 Shedding Study
Sponsor:
University of Pittsburgh
Organization:
University of Pittsburgh
Study Overview
Official Title:
Asymptomatic Bacterial Vaginosis and Herpes Simplex Virus Type 2 Shedding
Status:
COMPLETED
Status Verified Date:
2017-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
MASH
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
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None