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

This study has been terminated.

( Sponsor has withdrawn support for this study and it will not be performed )

First Received on May 16, 2008. Last Updated on October 19, 2011 History of Changes

Sponsor:	University of Pittsburgh
Information provided by (Responsible Party):	Thomas L. Cherpes, MD, University of Pittsburgh
ClinicalTrials.gov Identifier:	NCT00682721

Purpose

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.

Condition	Intervention
Bacterial Vaginosis Herpes Simplex Virus Type II	Drug: Placebo Drug: Valacyclovir

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator) Primary Purpose: Prevention
Official Title:	Valacyclovir Suppression to Improve the Stability of Vaginal Flora Among HSV-2 Seropositive Women

Resource links provided by NLM:

MedlinePlus related topics: Herpes Simplex

Drug Information available for: Valaciclovir Valacyclovir hydrochloride

U.S. FDA Resources

Further study details as provided by University of Pittsburgh:

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. [ Time Frame: within 90 days of enrollment ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

The frequency of detection of HSV-2 in the lower genital tract at the follow up visits. [ Time Frame: within 90 days of enrollment ] [ Designated as safety issue: No ]

Estimated Enrollment:	1000
Study Start Date:	February 2009
Study Completion Date:	September 2010
Primary Completion Date:	September 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Active Comparator: 2 Valacyclovir 1 gm daily x number of days active in the study	Drug: Valacyclovir 1 gram daily x number of days active in the study
Placebo Comparator: 1	Drug: Placebo Matching placebo two pills once daily

Eligibility

Ages Eligible for Study:	18 Years to 40 Years
Genders Eligible for Study:	Female
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00682721

Locations

United States, Pennsylvania
Magee-Womens Hospital of UPMC
Pittsburgh, Pennsylvania, United States, 15213

Sponsors and Collaborators

University of Pittsburgh

Investigators

Principal Investigator:

Thomas L Cherpes, MD

University of Pittsburgh

More Information

No publications provided

Responsible Party:	Thomas L. Cherpes, MD, Assistant Professor, University of Pittsburgh
ClinicalTrials.gov Identifier:	NCT00682721 History of Changes
Other Study ID Numbers:	PRO 08090230
Study First Received:	May 16, 2008
Last Updated:	October 19, 2011
Health Authority:	United States: Institutional Review Board

Keywords provided by University of Pittsburgh:

Bacterial Vaginosis
Herpes Simplex Virus Type II

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
Valacyclovir
Acyclovir
Antiviral Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on February 09, 2012