Status:
COMPLETED
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.
Lead Sponsor:
GlaxoSmithKline
Conditions:
Herpes Genitalis
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief Summary
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, althoug...
Eligibility Criteria
Inclusion
- 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.
Exclusion
Key Trial Info
Start Date :
June 21 2004
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 26 2006
Estimated Enrollment :
384 Patients enrolled
Trial Details
Trial ID
NCT00158860
Start Date
June 21 2004
End Date
July 26 2006
Last Update
February 15 2019
Active Locations (72)
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1
GSK Investigational Site
Birmingham, Alabama, United States, 35294
2
GSK Investigational Site
Phoenix, Arizona, United States, 85016
3
GSK Investigational Site
Tucson, Arizona, United States, 85710
4
GSK Investigational Site
Anaheim, California, United States, 92805