Last updated: 11/04/2018 13:35:44
VALTREX(valacyclovir) Once Daily for Viral Shedding In Subjects Newly Diagnosed With HSV-2
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Completed
Completed
Trial overview
Official title: The Effect of Valacyclovir 1g Once Daily on HSV-2 Viral Shedding in Subjects Newly Diagnosed with Genital Herpes Infection
Trial description: Eligible subjects will be randomized to receive VALTREX 1g or placebo once daily for 60 days in a two-way crossover study with a washout period of 7 days in between.
Primary purpose:
Treatment
Trial design:
Crossover Assignment
Masking:
Double (Participant, Investigator)
Allocation:
Randomized
Primary outcomes:
Mean percent days of total shedding (clinical and subclinical) as determined by type-specific polymerase chain reaction (PCR) assay for Herpes Simplex Virus Type 2 (HSV-2)
Timeframe: Up to 60 days in each treatment period (Up to 148 days)
Secondary outcomes:
Mean percent days subclinical shedding (no genital lesions present)
Timeframe: Up to 60 days in each treatment period (Up to 148 days)
Mean percent days clinical shedding (presence of genital lesions)
Timeframe: Up to 60 days in each treatment period (Up to 148 days)
Percentage of participants with no shedding
Timeframe: Up to 60 days in each treatment period (Up to 148 days)
Percentage of participants with at least one genital herpes recurrence
Timeframe: Up to 60 days in each treatment period (Up to 148 days)
Median time to first genital herpes recurrence (days)
Timeframe: Up to Day 68
Number of participants with any adverse event (AE) and serious adverse event (SAE)
Timeframe: Up to 148 days
Interventions:
Drug: valacyclovir
Enrollment:
70
Observational study model:
Not applicable
Primary completion date:
2006-27-11
Time perspective:
Not applicable
Clinical publications:
Not applicable
Medical condition
Herpes Labialis
Product
valaciclovir
Collaborators
Not applicable
Study date(s)
February 2006 to November 2006
Type
Interventional
Phase
4
Participation criteria
Sex
Female & Male
Age
18+ years
Accepts healthy volunteers
No
- Subject is in overall general good health.
- If female, subject must be of:
- Subject is known or suspected to be immunocompromised (e.g., subjects receiving immunosuppressive therapy or chemotherapy for malignancy, or are seropositive for HIV).
- Subject received an investigational drug in the 30 days prior to the randomization visit.
Inclusion and exclusion criteria
Inclusion criteria:
- Subject is in overall general good health.
- If female, subject must be of: a. Non-childbearing potential (i.e., physiologically incapable of becoming pregnant, including any female who is pre-menarchial or post-menopausal or surgically sterile); or b.Childbearing potential, but must have a negative pregnancy test at randomization, and must be compliant with one of the following: Complete abstinence from intercourse for two weeks before exposure to the study drug, throughout the clinical trial, and for a period of 1 week after study completion or premature discontinuation from the study (to account for elimination of the drug); Have a male partner who is confirmed to be sterile prior to the female subject's entry into the study and is the sole sexual partner for that female subject; Use of contraceptive(s) with a documented failure rate of less than 1% per year, including but not limited to: implants of levonorgestrel, use of injectable progestogen, oral contraceptives (either combined or progestogen only), an intrauterine device (IUD) or spermicide plus a mechanical barrier (condom/diaphragm).
- Subjects must be newly diagnosed with a first recognized episode of genital herpes as described in (a) or (b) below (See Appendix 3): a.HSV-2 seropositive at screen, with documented clinical signs and symptoms consistent with genital herpes at screen or within 4 months prior to randomization or b.HSV-2 seronegative at screen, AND HSV-2 culture positive or HSV-2 PCR positive with documented clinical signs and symptoms consistent with genital herpes at screen or within 4 months prior to randomization.
- Subject must be willing and able to provide written informed consent and comply with the protocol.
Exclusion criteria:
- Subject is known or suspected to be immunocompromised (e.g., subjects receiving immunosuppressive therapy or chemotherapy for malignancy, or are seropositive for HIV).
- Subject received an investigational drug in the 30 days prior to the randomization visit.
- Subject is receiving systemic antiviral or immunomodulatory treatments.
- Subjects who have received systemic antiherpetic treatments (e.g., valacyclovir, acyclovir, ganciclovir, famciclovir) within 3 days of starting study drug, or immunomodulatory treatments in the 30 days before starting study drug.
- Subject has clinically significantly impaired renal function as defined by creatinine clearance less than 50ml/min (calculated using the Cockcroft-Gault formula).
- Subjects with a history or evidence of decompensated liver disease, or clinically significantly impaired hepatic function defined as an ALT (alanine transaminase) level >3 times the normal upper limit.
- Subject is known to be hypersensitive to valacyclovir, acyclovir, ganciclovir or famciclovir.
- Subject has malabsorption or vomiting syndrome or other gastrointestinal dysfunction that may impair drug pharmacokinetics.
- Female subject who is contemplating pregnancy within the duration of the study drug dosing period.
- Female subject who is pregnant and/or nursing.
- Subject with current alcohol or drug abuse.
- Subjects who have received suppressive (daily) therapy for genital herpes prior to randomization. Suppressive therapy is defined as daily antiherpetic therapy of at least 4 weeks duration.
- Subjects with a history of ocular HSV (herpes simplex virus) infection.
Trial location(s)
Location
GSK Investigational Site
St. Petersburg, Florida, United States, 33710
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Anaheim, California, United States, 92805
Status
Study Complete
Location
GSK Investigational Site
Indianapolis, Indiana, United States, 46202
Status
Study Complete
Location
GSK Investigational Site
Carmichael, California, United States, 95608
Status
Study Complete
Location
GSK Investigational Site
San Diego, California, United States, 92123
Status
Study Complete
Location
GSK Investigational Site
South Bend, Indiana, United States, 46601
Status
Study Complete
Location
GSK Investigational Site
Portage, Michigan, United States, 49024
Status
Study Complete
Location
GSK Investigational Site
Portland, Oregon, United States, 97210
Status
Study Complete
Location
GSK Investigational Site
Boynton Beach, Florida, United States, 33437
Status
Study Complete
Location
GSK Investigational Site
Sacramento, California, United States, 95816
Status
Study Complete
Location
GSK Investigational Site
Winston-Salem, North Carolina, United States, 27103
Status
Study Complete
Location
GSK Investigational Site
Philadelphia, Pennsylvania, United States, 19140
Status
Study Complete
Location
GSK Investigational Site
Memphis, Tennessee, United States, 38104
Status
Study Complete
Location
GSK Investigational Site
Fair Oaks, California, United States, 95628
Status
Terminated/Withdrawn
Location
GSK Investigational Site
New York, New York, United States, 10029
Status
Study Complete
Location
GSK Investigational Site
Memphis, Tennessee, United States, 38120
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Chapel Hill, North Carolina, United States, 27599
Status
Study Complete
Study documents
Clinical study report
Available language(s): English
Scientific result summary
Available language(s): English
If you wish to request for full study report, please contact - [email protected]
Results overview
Results posted on ClinicalTrials.gov
Recruitment status
Completed
Actual primary completion date
2006-27-11
Actual study completion date
2006-27-11
Plain language summaries
Plain language summaries of clinical trial results for Phase 2-4 clinical trials that were initiated on or after January 2022 will be posted by GSK within one year following study completion.
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