Last updated: 11/04/2018 08:10:51
A Study Comparing Daily Treatment With Valaciclovir To Placebo For Suppression Of Herpes Simplex Virus HSV-2 Genital Herpes In Newly Diagnosed Patients. VALTREX® tablet is a trademark of the GlaxoSmithKline group of companies.
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Study complete
Study complete
Trial overview
Official title: An International, Randomized, Double-Blind, Placebo-Controlled, Multicenter, 6-Month Study of the Efficacy and Safety of Valtrex 1g QD vs. Placebo for the Suppression of HSV-2 Genital Herpes in Newly Diagnosed Immunocompetent Patients
Trial description: Genital herpes (GH) is a commonly occurring sexually transmitted disease caused by herpes simplex virus (HSV). There are two types of HSV, type 1 (HSV-1) and type 2 (HSV-2); both can cause GH, although the latter is much more likely to produce frequent recurrences of GH lesions. Evidence suggests that there are advantages to using suppressive vs. episodic treatment, which include increased intervals between the pain and discomfort of genital herpes recurrences. Therefore, this study will collect safety and efficacy data on suppressive therapy with valaciclovir in subjects newly diagnosedwith HSV-2 genital herpes.
Primary purpose:
Treatment
Trial design:
Parallel Assignment
Masking:
Single (Investigator)
Allocation:
Randomized
Primary outcomes:
Percentage of participants with time to first GH recurrence
Timeframe: Day 168
Secondary outcomes:
Mean number of GH recurrences per month within the 6-month study period
Timeframe: Up to Day 168
Number of participants with adverse events (AEs) and serious adverse events (SAEs)
Timeframe: Upto Day 168
Percentage of participants with time to first oral Herpes Simplex Virus (HSV) outbreak within 6-months
Timeframe: Day 168
Number of isolates with resistance to acyclovir (ACV)
Timeframe: Day 168
Interventions:
Enrollment:
384
Primary completion date:
2006-26-07
Observational study model:
Not applicable
Time perspective:
Not applicable
Clinical publications:
Not applicable
Medical condition
Herpes Genitalis
Product
valaciclovir
Collaborators
Not applicable
Study date(s)
June 2004 to July 2006
Type
Interventional
Phase
4
Participation criteria
Sex
Female & Male
Age
18+ years
Accepts healthy volunteers
No
- In overall general good health.
- Females can enter and participate in this study if they are of non-childbearing potential (i.e., physiologically incapable of becoming pregnant) or if of childbearing potential, has a negative pregnancy test (urine) at screening and agrees to use GSK stipulated contraceptive methods.
- Known or suspected to be immunocompromised (e.g., subjects receiving immunosuppressive therapy or chemotherapy for malignancy, or are seropositive for HIV).
- Received an investigational drug in the 30 days prior to the study.
Inclusion and exclusion criteria
Inclusion criteria:
- In overall general good health.
- Females can enter and participate in this study if they are of non-childbearing potential (i.e., physiologically incapable of becoming pregnant) or if of childbearing potential, has a negative pregnancy test (urine) at screening and agrees to use GSK stipulated contraceptive methods.
- Must be newly diagnosed with a first recognized episode of GH at the time of the Screening Visit or within 3 months prior to the Screening Visit.
Exclusion criteria:
- Known or suspected to be immunocompromised (e.g., subjects receiving immunosuppressive therapy or chemotherapy for malignancy, or are seropositive for HIV).
- Received an investigational drug in the 30 days prior to the study.
- Receiving systemic antiviral or immunomodulatory treatments.
- Must not have received systemic antiviral treatments (e.g., valaciclovir, Famvir (famciclovir), acyclovir, lysine) within 3 days of starting study drug or immunomodulatory treatments in the 30 days before starting study drug.
- Clinically significant impaired renal function as defined by a creatinine clearance <30 ml/min, calculated using the Cockcroft-Gault formula.
- Clinically significant impaired hepatic function defined as an ALT (alanine transaminase) level > 5 times the normal upper limit.
- Subjects with active liver disease.
- Known to be hypersensitive to acyclovir, famciclovir, ganciclovir or any component of valaciclovir formulations.
- Known resistance to acyclovir, valaciclovir, penciclovir, famciclovir, ganciclovir or valganciclovir.
- Subjects with malabsorption or vomiting syndrome or other gastrointestinal dysfunction that might impair drug pharmacokinetics.
- Women contemplating pregnancy within the duration of the study drug dosing period.
- Women who are pregnant and/or nursing mothers
- Current history of alcohol or drug abuse.
- Received suppressive (daily) therapy for genital herpes prior to enrollment.
Trial location(s)
Location
GSK Investigational Site
Venice, Florida, United States, 34285
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Atlanta, Georgia, United States, 30342
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Hartford, Connecticut, United States, 06012
Status
Study Complete
Location
GSK Investigational Site
Davis, California, United States, 95616
Status
Study Complete
Location
GSK Investigational Site
Stony Brook, New York, United States, 11794-8091
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, 19103
Status
Study Complete
Location
GSK Investigational Site
San Diego, California, United States, 92123
Status
Study Complete
Location
GSK Investigational Site
Palm Springs, Florida, United States, 33461
Status
Study Complete
Location
GSK Investigational Site
San Diego, California, United States, 92128
Status
Study Complete
Location
GSK Investigational Site
Santiago, Región Metro De Santiago, Chile, 7580206
Status
Study Complete
Location
GSK Investigational Site
Fort Worth, Texas, United States, 76104
Status
Study Complete
Location
GSK Investigational Site
Waukesha, Wisconsin, United States, 53186
Status
Study Complete
Location
GSK Investigational Site
La Crosse, Wisconsin, United States, 54601
Status
Study Complete
Location
GSK Investigational Site
Georgetown, Texas, United States, 78626
Status
Terminated/Withdrawn
Location
GSK Investigational Site
East Providence, Rhode Island, United States, 02914
Status
Study Complete
Location
GSK Investigational Site
Spokane, Washington, United States, 99204
Status
Study Complete
Location
GSK Investigational Site
Las Vegas, Nevada, United States, 89128
Status
Study Complete
Location
GSK Investigational Site
Santa Ana, California, United States, 92704
Status
Study Complete
Location
GSK Investigational Site
Clearwater, Florida, United States, 33759
Status
Study Complete
Location
GSK Investigational Site
Atlanta, Georgia, United States, 30310
Status
Study Complete
Location
GSK Investigational Site
Rio de Janeiro, Rio De Janeiro, Brazil, 20 551-030
Status
Recruiting
Location
GSK Investigational Site
Melbourne, Florida, United States, 32901
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Brooklyn, New York, United States, 11203
Status
Study Complete
Location
GSK Investigational Site
Fair Oaks, California, United States, 95628
Status
Study Complete
Location
GSK Investigational Site
Sacramento, California, United States, 95825
Status
Study Complete
Location
GSK Investigational Site
Taunton, Massachusetts, United States, 02780
Status
Study Complete
Location
GSK Investigational Site
Boston, Massachusetts, United States, 02114
Status
Study Complete
Location
GSK Investigational Site
West Palm Beach, Florida, United States, 33407
Status
Study Complete
Location
GSK Investigational Site
Buenos Aires, Buenos Aires, Argentina, 1221
Status
Terminated/Withdrawn
Location
GSK Investigational Site
San Francisco, California, United States, 94102
Status
Study Complete
Location
GSK Investigational Site
Phoenix, Arizona, United States, 85016
Status
Study Complete
Location
GSK Investigational Site
Anaheim, California, United States, 92805
Status
Study Complete
Location
GSK Investigational Site
Portage, Michigan, United States, 49024
Status
Study Complete
Location
GSK Investigational Site
Chapel Hill, North Carolina, United States, 27599
Status
Study Complete
Location
GSK Investigational Site
San Antonio, Texas, United States, 78205
Status
Study Complete
Location
GSK Investigational Site
Chicago, Illinois, United States, 60612
Status
Study Complete
Location
GSK Investigational Site
South Bend, Indiana, United States, 46601
Status
Study Complete
Location
GSK Investigational Site
San Antonio, Texas, United States, 78229
Status
Study Complete
Location
GSK Investigational Site
Oklahoma City, Oklahoma, United States, 73112
Status
Study Complete
Location
GSK Investigational Site
Springfield, Illinois, United States, 62702
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Memphis, Tennessee, United States, 38104
Status
Study Complete
Location
GSK Investigational Site
Beverly Hills, California, United States, 90211
Status
Study Complete
Location
GSK Investigational Site
Birmingham, Alabama, United States, 35294
Status
Study Complete
Location
GSK Investigational Site
New Britain, Connecticut, United States, 06052
Status
Study Complete
Location
GSK Investigational Site
Milwaukee, Wisconsin, United States, 53209-0996
Status
Study Complete
Location
GSK Investigational Site
Porto Alegre, Rio Grande Do Sul, Brazil, 90470-340
Status
Recruiting
Location
GSK Investigational Site
Sacramento, California, United States, 95816
Status
Study Complete
Location
GSK Investigational Site
Memphis, Tennessee, United States, 38120
Status
Study Complete
Location
GSK Investigational Site
Decatur, Georgia, United States, 30033
Status
Terminated/Withdrawn
Location
GSK Investigational Site
New Orleans, Louisiana, United States, 70114
Status
Study Complete
Location
GSK Investigational Site
Portland, Oregon, United States, 97210
Status
Study Complete
Location
GSK Investigational Site
Porto Alegre, Rio Grande Do Sul, Brazil, 90035-903
Status
Recruiting
Location
GSK Investigational Site
Coral Gables, Florida, United States, 33134
Status
Study Complete
Location
GSK Investigational Site
Indianapolis, Indiana, United States, 46202 - 5124
Status
Study Complete
Location
GSK Investigational Site
Alpharetta, Georgia, United States, 30005
Status
Study Complete
Location
GSK Investigational Site
Endicott, New York, United States, 13760
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Los Angeles, California, United States, 90048
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
Study complete
Actual primary completion date
2006-26-07
Actual study completion date
2006-26-07
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.
Additional information about the trial
Participate in clinical trial
Additional information
Researchers can use this site to request access to anonymised patient level data and/or supporting documents from clinical studies to conduct further research.
Click hereAccess to clinical trial data by researchers
Visit website