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
- Inclusion criteria:
- In overall general good health.
Inclusion and exclusion criteria
Inclusion 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
Showing 1 - 6 of 71 Results
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
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