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Valacyclovir Suppression to Improve the Stability of Vaginal Flora Among HSV-2 Seropositive Women

Primary Purpose

Bacterial Vaginosis, Herpes Simplex Virus Type II

Status

Withdrawn

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Placebo

Valacyclovir

About this trial

This is an interventional prevention trial for Bacterial Vaginosis focused on measuring Bacterial Vaginosis, Herpes Simplex Virus Type II

Eligibility Criteria

18 Years - 40 Years (Adult)FemaleDoes not accept healthy volunteers

Screening Inclusion Criteria:

Women 18-40 years of age at the time of screening
Willing to be screened for HSV-2 using a rapid, FDA approved test
Using an effective method of birth control (examples of effective methods of birth control are: women practicing abstinence x 90 days, hormonal birth control, consistent condom use, bilateral tubal ligation, partner with a vasectomy)

Screening Exclusion Criteria:

Pregnant or nursing mother
Use of any antimicrobial agents (vaginal or systemic) for the treatment of any condition within 7 days
Presence of any intrauterine device
Allergy or hypersensitivity to valcyclovir or nucleoside analogues

Enrollment Inclusion Criteria:

Women 18-40 Years of age at the time of screening
HSV-2 seropositive as determined by rapid HSV-2 testing
Using an effective method of birth control (examples of effective methods of birth control are: women practicing abstinence x 90 days, hormonal birth control, consistent condom use, bilateral tubal ligation, partner with a vasectomy)
Willing to avoid use of any intravaginal products during study period
Capable of providing written informed consent
Capable of cooperating to the extent and degree required by this protocol

Enrollment Exclusion Criteria:

Pregnancy (all women will have a urine pregnancy test prior to randomization and treatment)
nursing mother
Menopausal women
Use of any antimicrobial agents (vaginal or systemic) for the treatment of any condition within 7 days of study enrollment
Known immunocompromised state
Significant Medical disorder that precludes accurate evaluation of participants condition
Presence of any intrauterine device
History of significant hepatic or renal impairment
Sensitivity/allergy to valacyclovir or nucleoside analogues
history of acyclovir or valacyclovir resistant HSV infection
Participation in a study using an investigational product in the past 30 days

Sites / Locations

Magee-Womens Hospital of UPMC

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Arm Description

Valacyclovir 1 gm daily x number of days active in the study

Outcomes

Primary Outcome Measures

The primary endpoint of this study will be a determination of the ability of valacyclovir suppressive therapy to stabilize the vaginal flora.

Secondary Outcome Measures

The frequency of detection of HSV-2 in the lower genital tract at the follow up visits.

Full Information

NCT ID

NCT00682721

First Posted

May 16, 2008

Last Updated

February 29, 2012

Sponsor

University of Pittsburgh

1. Study Identification

Unique Protocol Identification Number

NCT00682721

Brief Title

Valacyclovir Suppression to Improve the Stability of Vaginal Flora Among HSV-2 Seropositive Women

Official Title

Valacyclovir Suppression to Improve the Stability of Vaginal Flora Among HSV-2 Seropositive Women

Study Type

Interventional

2. Study Status

Record Verification Date

February 2012

Overall Recruitment Status

Withdrawn

Why Stopped

Sponsor has withdrawn support for this study and it will not be performed

Study Start Date

February 2009 (undefined)

Primary Completion Date

September 2010 (Actual)

Study Completion Date

September 2010 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

University of Pittsburgh

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

We will be examining the effects of suppressive valacyclovir therapy on the stability of vaginal flora in women who are seropositive for HSV-2. We have preliminary data that suggests the presence of HSV-2 increases the risk for Group B Streptococcus colonization as well as many other deleterious organisms (e.g. Streptococcus pseudoporcinus), in addition to increasing the risk for acquisition of BV-associated vaginal flora. We will be examining the effects of suppressive therapy on the vaginal flora of any HSV-2 seropositive woman.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Bacterial Vaginosis, Herpes Simplex Virus Type II

Keywords

Bacterial Vaginosis, Herpes Simplex Virus Type II

7. Study Design

Primary Purpose

Prevention

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigator

Allocation

Randomized

Enrollment

0 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Arm Type

Active Comparator

Arm Description

Valacyclovir 1 gm daily x number of days active in the study

Arm Title

Arm Type

Placebo Comparator

Intervention Type

Drug

Intervention Name(s)

Placebo

Intervention Description

Matching placebo two pills once daily

Intervention Type

Drug

Intervention Name(s)

Valacyclovir

Intervention Description

1 gram daily x number of days active in the study

Primary Outcome Measure Information:

Title

The primary endpoint of this study will be a determination of the ability of valacyclovir suppressive therapy to stabilize the vaginal flora.

Time Frame

within 90 days of enrollment

Secondary Outcome Measure Information:

Title

The frequency of detection of HSV-2 in the lower genital tract at the follow up visits.

Time Frame

within 90 days of enrollment

10. Eligibility

Sex

Female

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

40 Years

Accepts Healthy Volunteers

Eligibility Criteria

Screening Inclusion Criteria: Women 18-40 years of age at the time of screening Willing to be screened for HSV-2 using a rapid, FDA approved test Using an effective method of birth control (examples of effective methods of birth control are: women practicing abstinence x 90 days, hormonal birth control, consistent condom use, bilateral tubal ligation, partner with a vasectomy) Screening Exclusion Criteria: Pregnant or nursing mother Use of any antimicrobial agents (vaginal or systemic) for the treatment of any condition within 7 days Presence of any intrauterine device Allergy or hypersensitivity to valcyclovir or nucleoside analogues Enrollment Inclusion Criteria: Women 18-40 Years of age at the time of screening HSV-2 seropositive as determined by rapid HSV-2 testing Using an effective method of birth control (examples of effective methods of birth control are: women practicing abstinence x 90 days, hormonal birth control, consistent condom use, bilateral tubal ligation, partner with a vasectomy) Willing to avoid use of any intravaginal products during study period Capable of providing written informed consent Capable of cooperating to the extent and degree required by this protocol Enrollment Exclusion Criteria: Pregnancy (all women will have a urine pregnancy test prior to randomization and treatment) nursing mother Menopausal women Use of any antimicrobial agents (vaginal or systemic) for the treatment of any condition within 7 days of study enrollment Known immunocompromised state Significant Medical disorder that precludes accurate evaluation of participants condition Presence of any intrauterine device History of significant hepatic or renal impairment Sensitivity/allergy to valacyclovir or nucleoside analogues history of acyclovir or valacyclovir resistant HSV infection Participation in a study using an investigational product in the past 30 days

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Thomas L Cherpes, MD

Organizational Affiliation

University of Pittsburgh

Official's Role

Principal Investigator

Facility Information:

Facility Name

Magee-Womens Hospital of UPMC

City

Pittsburgh

State/Province

Pennsylvania

ZIP/Postal Code

15213

Country

United States

12. IPD Sharing Statement

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Valacyclovir Suppression to Improve the Stability of Vaginal Flora Among HSV-2 Seropositive Women

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