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Trial record 35 of 126 for:    HSV-2

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00464542
Recruitment Status : Completed
First Posted : April 23, 2007
Results First Posted : October 4, 2011
Last Update Posted : May 11, 2017
Sponsor:
Information provided by (Responsible Party):
University of Pittsburgh

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Bacterial Vaginosis
Intervention Drug: Metronidazole
Enrollment 12
Recruitment Details Twelve HSV-2 seropositive women with asymptomatic BV were enrolled. Two of these women were lost to follow-up within 2 weeks of enrollment. A third woman was lost to follow-up after initiating metronidazole therapy at study midpoint.
Pre-assignment Details  
Arm/Group Title MASH Cohort
Hide Arm/Group Description This cohort consisted of women who were seropositive for Herpes Simplex Virus type 2 (HSV-2)and who had asymptomatic bacterial vaginosis as assessed by Amsel's criteria at enrollment
Period Title: Pre-treatment
Started 12
Completed 10
Not Completed 2
Reason Not Completed
Withdrawal by Subject             2
Period Title: Post-treatment
Started 10
Completed 10
Not Completed 0
Arm/Group Title MASH Cohort
Hide Arm/Group Description This cohort consisted of women who were seropositive for Herpes Simplex Virus type 2 (HSV-2)and who had asymptomatic bacterial vaginosis as assessed by Amsel's criteria at enrollment
Overall Number of Baseline Participants 12
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 12 participants
<=18 years
0
   0.0%
Between 18 and 65 years
12
 100.0%
>=65 years
0
   0.0%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 12 participants
24  (2.5)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 12 participants
Female
12
 100.0%
Male
0
   0.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 12 participants
12
1.Primary Outcome
Title Number of Participants With Bacterial Vaginosis Recurrence
Hide Description Bacterial vaginosis, defined as any vaginal smear with a Nugent score of 7-10 during the 30 day period following cessation of metronidazole therapy.
Time Frame 30 days after cessation of metronidazole therapy
Hide Outcome Measure Data
Hide Analysis Population Description
per protocol
Arm/Group Title Post-treatment MASH Cohort
Hide Arm/Group Description:
Women who were seropositive for Herpes Simplex Virus type 2 (HSV-2)and had asymptomatic bacterial vaginosis as assessed by Amsel's criteria at enrollment and who provided daily vaginal smears for 30 days following cessation of metronidazole therapy
Overall Number of Participants Analyzed 9
Measure Type: Number
Unit of Measure: Participants
8
2.Secondary Outcome
Title Median Time to Bacterial Vaginosis During the 30 Days After Cessation of Metronidazole Therapy
Hide Description 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
Time Frame 30 days after cessation of metronidazole therapy
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Post-treatment MASH Cohort
Hide Arm/Group Description:
Women who were seropositive for Herpes Simplex Virus type 2 (HSV-2)and had asymptomatic bacterial vaginosis as assessed by Amsel's criteria at enrollment and who provided daily vaginal smears for 30 days following cessation of metronidazole therapy
Overall Number of Participants Analyzed 9
Median (Full Range)
Unit of Measure: Days
14
(7 to 24)
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title MASH Cohort
Hide Arm/Group Description This cohort consisted of women who were seropositive for Herpes Simplex Virus type 2 (HSV-2)and who had asymptomatic bacterial vaginosis as assessed by Amsel's criteria at enrollment
All-Cause Mortality
MASH Cohort
Affected / at Risk (%)
Total   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
MASH Cohort
Affected / at Risk (%)
Total   0/12 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 3%
MASH Cohort
Affected / at Risk (%)
Total   0/12 (0.00%) 
Inadequate controls (study would have been improved by inclusion of women without herpes simplex virus type 2 infection) to better determine the strength of the association between recalcitrance of BV and HSV-2 infection.
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Thomas Cherpes
Organization: University of Pittsburgh
Phone: 412 692 5930
EMail: cherpestl@upmc.edu
Layout table for additonal information
Responsible Party: University of Pittsburgh
ClinicalTrials.gov Identifier: NCT00464542     History of Changes
Other Study ID Numbers: PRO07030124
First Submitted: April 19, 2007
First Posted: April 23, 2007
Results First Submitted: March 22, 2011
Results First Posted: October 4, 2011
Last Update Posted: May 11, 2017