Genital HerpesPhase 4NCT01346475
Randomized Trial to Evaluate Suppressive Effect of High-Dose Valacyclovir Versus Once-Daily Valacyclovir on Persons With HSV-2
A Phase 4 study testing valacyclovir in people with Genital Herpes, run by University of Washington at 1 site in United States.
Trial summary
On 13 August 2008, this trial was submitted to ClinicalTrials.gov as modification to NCT00362297. On 28 April 2011, the two records were split for administrative purposes and each trial was given its own unique study record. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Genital Herpes
- What is being tested?
- valacyclovir
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2008to Sep 2011
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 18 years or older;
- HSV-2 seropositive by Western Blot;
- not receiving any drugs with known anti-HSV-2 activity for study duration;
- history of primary genital herpes infection within past 6 months OR history of 4 or more HSV recurrences per year during the past year OR 4 or more recurrences per year prior to initiation of suppressive antiviral therapy; or shedding HSV-2 from genital mucosa on >25% of days in shedding session performed at the VRC within the last 2 years.
- able to comply with the study protocol;
- women of child bearing potential who are sexually active with men must be using a medically accepted method of contraception as judged by the investigator;
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- women of child-bearing potential must have a negative pregnancy test (urine) at screening visit;
- in general good health, without other serious medical conditions and specifically with normal renal and hepatic function, as determined by the patient's medical history;
- planning to remain resident in the area of the study center for the duration of the study participation;
- HIV seronegative.
Who cannot join
- hypersensitivity to acyclovir or valacyclovir;
- pregnant women;
- HIV positive or other immunosuppressed state, including chronic steroid use. Intermittent nasal or topical steroids are acceptable
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Washington Virology Research Clinic
Seattle, Washington, 98104
About this study
Official title: A Randomized, Cross-Over Study to Evaluate the Suppressive Effect of High-Dose Valacyclovir Versus Once Daily Valacyclovir on Herpes Simplex Virus Type 2 Genital Shedding in Herpes Simplex Virus-2 Seropositive Adults
On 13 August 2008, this trial was submitted to ClinicalTrials.gov as modification to NCT00362297. On 28 April 2011, the two records were split for administrative purposes and each trial was given its own unique study record. Please refer to the "History of Changes" on posting NCT00362297 for a detailed summary of the modifications.
The purpose of the research study is to evaluate the effectiveness of high-dose valacyclovir compared to once daily valacyclovir for reduction of asymptomatic HSV-2 genital shedding in persons with genital herpes.
Read more
The study will enroll men and women who are 18 years or older, test positive to HSV-2 (by blood test) and have had a first outbreak of HSV-2 within the past 6 months or have had at least 4 genital herpes outbreaks in the past year. Participants must be HIV negative and willing to stop taking suppressive therapy for HSV for the one week wash out period. (Females only: You must not be pregnant or breast-feeding). Both men and women will be asked to use an effective form of birth control.
Involvement in the study will last 11-weeks and you will be asked to visit the clinic every 2-weeks. At each visit, you will be given medication to take daily (either once daily valacyclovir or high dose valacyclovir; you will receive both medications at some point during this study). We will ask you to give a blood sample for liver, kidney and blood count testing at each visit. There will be a total of 8 study visits and each visit will last approximately 30 minutes. We will ask that you complete a daily symptom diary and collected daily home swabs 4-times a day, everyday during the study. Each daily home swab will take less than 3 minutes to perform.
Read the detailed description
Screening Assessment
Patients will be assessed for their eligibility to enter the study at a screening visit. After signing informed consent they will undergo a medical history and the following information will be recorded in the Case Report Form (CRF):
- Demographic Data: Date of birth, sex, marital status, education and race
- Previous antiviral medication taken
- History of sexually transmitted infections and sexual history.
- Women of childbearing potential will undergo a urine pregnancy test. Serologic samples for HSV-2 and HIV will be obtained. Part of the blood sample will also be used for safety labs.
Start of Study Visit (Day 0) and Day 14, 28, 35, 42, 56, 70, and 77 Follow-Up Visits.
Eligible patients will return to clinic to be given study drug and a patient diary card on which to record concomitant medications, signs and symptoms, and adverse experiences. The investigator will instruct the patient on daily home viral sample collection, taking the study drug, and completing the diary card. The patient will be instructed to return to clinic in 2 weeks, +/- 2 days. Medication compliance will be assessed at each visit using pill counts. Safety labs will be performed on day 14, 28, 35, 56, 70 and 77.
Crossover Study Visit Prior To Washout Period (Day 35-41)
Participants will not be given study drug or placebo during the 7-day washout period. Participants will not be required to obtain swabs during the washout period.
Daily Home Viral Sample Collection
Participants will collect swabs from the genital mucosa four times per day and store the samples in PCR media with preprinted labels. Women will swab the cervicovaginal, vulvar and perianal areas, and men will swab the penile and perianal. Every two weeks, they will return the samples to the Virology Research Clinic when they present for additional study drug and assessment.
Final Study Visit (Day 77)
At the final study visit at Day 77 or for premature discontinuation, the investigator will perform the activities at the regular study visits, with the exception of the dispensation of study drug.
- Conditions
- Genital Herpes
- Being tested
- valacyclovir
- Medical subject headings
- Herpes Genitalis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
valacyclovirDrug
1000 mg orally three times daily for 5 weeks
ValacyclovirDrug
500 mg orally once daily for 5 weeks
| Study group | Role | What they receive |
|---|---|---|
| valacyclovir | Active comparator | Not described Receives: Drug: Valacyclovir |
| high dose valacyclovir | Experimental | Not described Receives: Drug: valacyclovir |
What is being measured
The primary outcome is the main question the study is designed to answer.
Frequency of HSV-2 Total Shedding From the Genital Tract as Measured by PCR, Calculated Using a Per-day Shedding Rate in Participants Treated With High-dose Valacyclovir as Compared to Once-daily Valacyclovir.
Measured: 11 weeks
Secondary outcomes (3)
Quantity of HSV Detected, Median
Median quantity of HSV detected, among swabs with any HSV detected
Measured: 11 weeks
Number of Genital HSV Shedding Episodes
The number of HSV shedding episodes. A shedding episode is defined as any number of positive swabs preceded and followed by 2 negative swabs.
Measured: 11 weeks
Duration of Genital HSV Shedding Episodes
Median duration of HSV shedding episodes, in hours, among episodes of known duration
Measured: 11 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 May 2011 (estimated)
- Study startNov 2008
- Primary completionJul 2010
- Study completionSep 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Genital HerpesStudies of the same condition, open and under way.
- More trials run by University of WashingtonThe 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Washington
- Sponsor type
- University, hospital or other
- Collaborators
- GlaxoSmithKline
- Responsible party
- Principal investigator, Christine Johnston, University of Washington
- Investigators
- Christine Johnston, MD, MPH, Principal investigator, University of Washington
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01346475
- Sponsor's protocol ID
- 30520-D - Phase 2
- Status last verified
- Mar 2017
- First submitted
- 29 Apr 2011
- Last updated
- 9 Mar 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Johnston C, Saracino M, Kuntz S, Magaret A, Selke S, Huang ML, Schiffer JT, Koelle DM, Corey L, Wald A. Standard-dose and high-dose daily antiviral therapy for short episodes of genital HSV-2 reactivation: three randomised, open-label, cross-over trials. Lancet. 2012 Feb 18;379(9816):641-7. doi: 10.1016/S0140-6736(11)61750-9. Epub 2012 Jan 4.
PubMed 22225814
Study at a glance
From the registry record, last updated by the sponsor on 9 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Cross-Over Study to Evaluate the Suppressive Effect of High-Dose Valacyclovir Versus Once Daily Valacyclovir on Herpes Simplex Virus Type 2 Genital Shedding in Herpes Simplex Virus-2 Seropositive Adults
- ClinicalTrials.gov ID
- NCT01346475
- Acronym / sponsor ID
- 30520-D - Phase 2
- Conditions
- Genital Herpes
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- University of WashingtonUniversity, hospital or other
- Collaborators
- GlaxoSmithKline
- Study start
- Nov 2008
- Primary completion
- Jul 2010 (actual)
- Study completion
- Sep 2011 (actual)
- First posted
- 3 May 2011 (estimated)
- Results
- Posted 9 Mar 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
On 13 August 2008, this trial was submitted to ClinicalTrials.gov as modification to NCT00362297. On 28 April 2011, the two records were split for administrative purposes and each trial was given its own unique study record. Please refer to the "History of Changes" on posting NCT00362297 for a detailed summary of the modifications.
The purpose of the research study is to evaluate the effectiveness of high-dose valacyclovir compared to once daily valacyclovir for reduction of asymptomatic HSV-2 genital shedding in persons with genital herpes.
The study will enroll men and women who are 18 years or older, test positive to HSV-2 (by blood test) and have had a first outbreak of HSV-2 within the past 6 months or have had at least 4 genital herpes outbreaks in the past year. Participants must be HIV negative and willing to stop taking suppressive therapy for HSV for the one week wash out period. (Females only: You must not be pregnant or breast-feeding). Both men and women will be asked to use an effective form of birth control.
Involvement in the study will last 11-weeks and you will be asked to visit the clinic every 2-weeks. At each visit, you will be given medication to take daily (either once daily valacyclovir or high dose valacyclovir; you will receive both medications at some point during this study). We will ask you to give a blood sample for liver, kidney and blood count testing at each visit. There will be a total of 8 study visits and each visit will last approximately 30 minutes. We will ask that you complete a daily symptom diary and collected daily home swabs 4-times a day, everyday during the study. Each daily home swab will take less than 3 minutes to perform.
Detailed description
Screening Assessment
Patients will be assessed for their eligibility to enter the study at a screening visit. After signing informed consent they will undergo a medical history and the following information will be recorded in the Case Report Form (CRF):
- Demographic Data: Date of birth, sex, marital status, education and race
- Previous antiviral medication taken
- History of sexually transmitted infections and sexual history.
- Women of childbearing potential will undergo a urine pregnancy test. Serologic samples for HSV-2 and HIV will be obtained. Part of the blood sample will also be used for safety labs.
Start of Study Visit (Day 0) and Day 14, 28, 35, 42, 56, 70, and 77 Follow-Up Visits.
Eligible patients will return to clinic to be given study drug and a patient diary card on which to record concomitant medications, signs and symptoms, and adverse experiences. The investigator will instruct the patient on daily home viral sample collection, taking the study drug, and completing the diary card. The patient will be instructed to return to clinic in 2 weeks, +/- 2 days. Medication compliance will be assessed at each visit using pill counts. Safety labs will be performed on day 14, 28, 35, 56, 70 and 77.
Crossover Study Visit Prior To Washout Period (Day 35-41)
Participants will not be given study drug or placebo during the 7-day washout period. Participants will not be required to obtain swabs during the washout period.
Daily Home Viral Sample Collection
Participants will collect swabs from the genital mucosa four times per day and store the samples in PCR media with preprinted labels. Women will swab the cervicovaginal, vulvar and perianal areas, and men will swab the penile and perianal. Every two weeks, they will return the samples to the Virology Research Clinic when they present for additional study drug and assessment.
Final Study Visit (Day 77)
At the final study visit at Day 77 or for premature discontinuation, the investigator will perform the activities at the regular study visits, with the exception of the dispensation of study drug.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| valacyclovir | Active comparator | Drug: Valacyclovir |
| high dose valacyclovir | Experimental | Drug: valacyclovir |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 18 years or older;
- HSV-2 seropositive by Western Blot;
- not receiving any drugs with known anti-HSV-2 activity for study duration;
- history of primary genital herpes infection within past 6 months OR history of 4 or more HSV recurrences per year during the past year OR 4 or more recurrences per year prior to initiation of suppressive antiviral therapy; or shedding HSV-2 from genital mucosa on >25% of days in shedding session performed at the VRC within the last 2 years.
- able to comply with the study protocol;
Key exclusion criteria (3 listed)
- hypersensitivity to acyclovir or valacyclovir;
- pregnant women;
- HIV positive or other immunosuppressed state, including chronic steroid use. Intermittent nasal or topical steroids are acceptable
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 |
|---|---|---|
| valacyclovir1000 mg orally three times daily for 5 weeks | Drug | high dose valacyclovir |
| Valacyclovir500 mg orally once daily for 5 weeks | Drug | valacyclovir |
Primary outcome
Frequency of HSV-2 Total Shedding From the Genital Tract as Measured by PCR, Calculated Using a Per-day Shedding Rate in Participants Treated With High-dose Valacyclovir as Compared to Once-daily Valacyclovir.
Time frame: 11 weeks
3 secondary outcomes
Quantity of HSV Detected, Median
Time frame: 11 weeks
Number of Genital HSV Shedding Episodes
Time frame: 11 weeks
Duration of Genital HSV Shedding Episodes
Time frame: 11 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Mar 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 22225814Johnston C, Saracino M, Kuntz S, Magaret A, Selke S, Huang ML, Schiffer JT, Koelle DM, Corey L, Wald A. Standard-dose and high-dose daily antiviral therapy for short episodes of genital HSV-2 reactivation: three randomised, open-label, cross-over trials. Lancet. 2012 Feb 18;379(9816):641-7. doi: 10.1016/S0140-6736(11)61750-9. Epub 2012 Jan 4.
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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.
Christine Johnston, MD, MPH principal investigator
University of Washington
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing valacyclovir in people with Genital Herpes, run by University of Washington 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?
The sponsor lists 10 inclusion and 3 exclusion criteria. 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: finished, as of the sponsor's last update on 9 Mar 2017. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 9 Mar 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Frequency of HSV-2 Total Shedding From the Genital Tract as Measured by PCR, Calculated Using a Per-day Shedding Rate in Participants Treated With High-dose Valacyclovir as Compared to Once-daily Valacyclovir. (time frame: 11 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01346475, which also lists 1 linked publication.
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 9 Mar 2017.