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.
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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 diagnosed with HSV-2 genital herpes.
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
Actual Study Start Date
June 21, 2004
Primary Completion Date
July 26, 2006
Study Completion Date
July 26, 2006
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Median time to first GH recurrence [ Time Frame: Day 168 ]
Diary cards were issued to the participants during randomization visit for recording GH recurrences. HSV recurrences since the last visit was assessed after review of the diary card and discussion with the participant. The median recurrence-free time was defined as the time by which 50 percent of the participants had their first GH recurrence (reaching the macular/papular stage). A median time for valaciclovir could not be calculated due to the infrequency of recurrences in this group during the 6 months study period and also statistical analysis was not performed for median recurrence-free time.
Secondary Outcome Measures
Mean number of GH recurrences within the 6-month study period [ Time Frame: Up to Day 168 ]
Mean number of GH recurrence reaching macular/papular stage per month was reported. Diary cards were issued to the participants during randomization visit for the recording GH recurrences. HSV recurrences since the last visit was assessed after review of the diary card and discussion with the participant.
Number of participants with adverse events (AEs) and serious adverse events (SAEs) [ Time Frame: Upto Day 168 ]
An AE was defined as any untoward medical occurrence in a participant temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An SAE was defined as any untoward medical occurrence that, at any dose results in death, was life-threatening, required hospitalization or prolongation of hospitalization, results in disability/incapacity, was a congenital anomaly/birth defect or medically significant.
Percentage of participants with time to first oral Herpes Simplex Virus (HSV) outbreak within 6-months [ Time Frame: Day 168 ]
Time to first oral HSV outbreak was demonstrated to estimate recurrence free rates at 6-months. Diary cards were issued to the participants during randomization visit for recording GH recurrences. HSV recurrences since the last visit was assessed after review of the diary card and discussion with the participant. The percentage of participants who had first oral HSV outbreak at 6-months was reported.
Number of islotates with resistance to acyclovir (ACV) [ Time Frame: Day 168 ]
Culture samples were tested for AVC-susceptibility by the analytical laboratory. Re-testing of the ACV resistant isolates was carried out to check if the half maximal inhibitory concentration (IC-50s) for all the ACV resistant isolates were within the expected errors of 2.0 microgram per milliliters (mcg/ml) cut-off for the plaque reduction assay. Those isolates that confirm to be resistant in repeat assays were considered as resistant to ACV.
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Ages Eligible for Study:
18 Years and older (Adult, Senior)
Sexes Eligible for Study:
Accepts Healthy Volunteers:
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.
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.