Clinical Trial: 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.

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

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 Ge

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, 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.

Detailed Summary:
Sponsor: GlaxoSmithKline

Current Primary Outcome: 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.


Original Primary Outcome: To determine the efficacy of administering valaciclovir 1 gram once daily for 6 months vs. placebo for genital herpes suppressive therapy in immunocompetent newly diagnosed subjects, the primary endpoint is time to first genital herpes recurrence.

Current Secondary Outcome:

  • 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.


Original Secondary Outcome: Secondary measures include: adverse events, serious adverse events, etc.; number of genital herpes recurrences within the study period; time to first oral HSV outbreak; collection of HSV-2 culture isolates to assess for resistance to acyclovir.

Information By: GlaxoSmithKline

Dates:
Date Received: September 8, 2005
Date Started: June 21, 2004
Date Completion:
Last Updated: April 12, 2017
Last Verified: April 2017