Bacterial VaginosisNCT00682721
Valacyclovir Suppression to Improve the Stability of Vaginal Flora Among HSV-2 Seropositive Women
A study testing Valacyclovir in people with Bacterial Vaginosis and Herpes Simplex Virus Type II, run by University of Pittsburgh at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 40 years, women only
- Conditions the study is for
- Bacterial Vaginosis, Herpes Simplex Virus Type II
- What is being tested?
- Valacyclovir
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2009to Sep 2010
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 40 years
- Women only
- No healthy volunteers
- Adult
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
Trial locations and contacts
1 site in 1 country.
United States1 site
Magee-Womens Hospital of UPMC
Pittsburgh, Pennsylvania, 15213
About this study
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.
- Conditions
- Bacterial Vaginosis, Herpes Simplex Virus Type II
- Being tested
- Placebo, Valacyclovir
- Keywords
- Bacterial Vaginosis, Herpes Simplex Virus Type II
- Medical subject headings
- Vaginosis, Bacterial
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PlaceboDrug
Matching placebo two pills once daily
ValacyclovirDrug
1 gram daily x number of days active in the study
| Study group | Role | What they receive |
|---|---|---|
| 2 | Active comparator | Valacyclovir 1 gm daily x number of days active in the study Receives: Drug: Valacyclovir |
| 1 | Placebo comparator | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
The primary endpoint of this study will be a determination of the ability of valacyclovir suppressive therapy to stabilize the vaginal flora.
Measured: within 90 days of enrollment
Secondary outcomes (1)
The frequency of detection of HSV-2 in the lower genital tract at the follow up visits.
Measured: within 90 days of enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 May 2008 (estimated)
- Study startFeb 2009
- Primary completionSep 2010
- Study completionSep 2010
Why it stopped: Sponsor has withdrawn support for this study and it will not be performed
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bacterial VaginosisStudies of the same condition, open and under way.
- More trials run by University of PittsburghThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Pittsburgh
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Thomas L. Cherpes, MD, University of Pittsburgh
- Investigators
- Thomas L Cherpes, MD, Principal investigator, University of Pittsburgh
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00682721
- Sponsor's protocol ID
- PRO 08090230
- Status last verified
- Feb 2012
- First submitted
- 16 May 2008
- Last updated
- 2 Mar 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Mar 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Valacyclovir Suppression to Improve the Stability of Vaginal Flora Among HSV-2 Seropositive Women
- ClinicalTrials.gov ID
- NCT00682721
- Acronym / sponsor ID
- PRO 08090230
- Conditions
- Bacterial Vaginosis, Herpes Simplex Virus Type II
- Keywords
- Bacterial Vaginosis, Herpes Simplex Virus Type II
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Sponsor has withdrawn support for this study and it will not be performed
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University of PittsburghUniversity, hospital or other
- Study start
- Feb 2009
- Primary completion
- Sep 2010 (actual)
- Study completion
- Sep 2010 (actual)
- First posted
- 22 May 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 2 | Active comparator | Drug: ValacyclovirValacyclovir 1 gm daily x number of days active in the study |
| 1 | Placebo comparator | Drug: Placebo |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PlaceboMatching placebo two pills once daily | Drug | 1 |
| Valacyclovir1 gram daily x number of days active in the study | Drug | 2 |
Primary outcome
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
1 secondary outcome
The frequency of detection of HSV-2 in the lower genital tract at the follow up visits.
Time frame: within 90 days of enrollment
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Mar 2012.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Thomas L Cherpes, MD principal investigator
University of Pittsburgh
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Valacyclovir in people with Bacterial Vaginosis and Herpes Simplex Virus Type II, run by University of Pittsburgh at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 2 Mar 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Mar 2012.