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Trial record 14 of 126 for:    HSV-2

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

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ClinicalTrials.gov Identifier: NCT00682721
Recruitment Status : Withdrawn (Sponsor has withdrawn support for this study and it will not be performed)
First Posted : May 22, 2008
Last Update Posted : March 2, 2012
Sponsor:
Information provided by (Responsible Party):
Thomas L. Cherpes, MD, University of Pittsburgh

Tracking Information
First Submitted Date  ICMJE May 16, 2008
First Posted Date  ICMJE May 22, 2008
Last Update Posted Date March 2, 2012
Study Start Date  ICMJE February 2009
Actual Primary Completion Date September 2010   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 3, 2009)
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 ]
Original Primary Outcome Measures  ICMJE
 (submitted: May 21, 2008)
The presence of genital lesions consistent with a clinical recurrence of HSV-2. [ Time Frame: within 90 days of enrollment ]
Change History Complete list of historical versions of study NCT00682721 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: May 21, 2008)
The frequency of detection of HSV-2 in the lower genital tract at the follow up visits. [ Time Frame: within 90 days of enrollment ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Valacyclovir Suppression to Improve the Stability of Vaginal Flora Among HSV-2 Seropositive Women
Official Title  ICMJE Valacyclovir Suppression to Improve the Stability of Vaginal Flora Among HSV-2 Seropositive Women
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Prevention
Condition  ICMJE
  • Bacterial Vaginosis
  • Herpes Simplex Virus Type II
Intervention  ICMJE
  • Drug: Placebo
    Matching placebo two pills once daily
  • Drug: Valacyclovir
    1 gram daily x number of days active in the study
Study Arms  ICMJE
  • Active Comparator: 2
    Valacyclovir 1 gm daily x number of days active in the study
    Intervention: Drug: Valacyclovir
  • Placebo Comparator: 1
    Intervention: Drug: Placebo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Withdrawn
Actual Enrollment  ICMJE
 (submitted: February 29, 2012)
0
Original Estimated Enrollment  ICMJE
 (submitted: May 21, 2008)
270
Actual Study Completion Date  ICMJE September 2010
Actual Primary Completion Date September 2010   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 18 Years to 40 Years   (Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00682721
Other Study ID Numbers  ICMJE PRO 08090230
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Thomas L. Cherpes, MD, University of Pittsburgh
Study Sponsor  ICMJE University of Pittsburgh
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Thomas L Cherpes, MD University of Pittsburgh
PRS Account University of Pittsburgh
Verification Date February 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP