Clinical Trial: Patient-initiated Episodic Treatment of Recurrent Genital Herpes in Black Patients

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

Official Title: A Randomized, Multicenter, Double-blind Study to Compare the Efficacy of Single-day Treatment (1000 mg b.i.d.) With Famciclovir Compared to That of Placebo in Patient-initiated Episodic Treatment of R

Brief Summary: This study will evaluate the safety and efficacy of single-day famciclovir episodic treatment in Black patients with recurrent genital herpes

Detailed Summary:
Sponsor: Novartis

Current Primary Outcome: Investigator Assessed Time to Healing of All Non-aborted Genital Herpes Lesions [ Time Frame: 21 days ]

Time to healing of all non-aborted genital herpes lesions, defined as the time from the first dose of study medication to the investigator-assessed time of healing (i.e. loss of all crusts and re-epithelialization of lesions; erythema may be present).


Original Primary Outcome: Time to healing of non-aborted genital herpes lesions

Current Secondary Outcome:

  • Percentage of Participants With Aborted and Non-aborted Genital Herpes Lesions During the Treatment Period [ Time Frame: 21 days ]
  • Investigator Assessed Time to Healing of All Non-aborted and Aborted Genital Herpes Lesions [ Time Frame: 21 days ]
    Kaplan-Meier estimation.
  • Time to Resolution of Symptoms Associated With Recurrent Genital Herpes [ Time Frame: 72 hour after initiation of study medication up to 21 days ]
    Median time to resolution of symptoms: all symptoms, pain, burning, itching, tingling and tenderness associated with recurrent genital herpes estimated using Kaplan-Meier method.
  • Number of Participants With a Second Recurrence of Genital Herpes in the Follow-up Period [ Time Frame: 6 months ]
    Number of participants with a second recurrence of genital herpes in the follow-up period.
  • Time to Second Recurrence of Genital Herpes [ Time Frame: 6 months ]
    Kaplan Meier estimated time in days to second recurrent from treatment initiation and from the date of healing of aborted lesions.
  • The Number of Participants With Clinically Notable Shifts From Normal at Baseline by Hematology Test and Treatment [ Time Frame: Baseline, Day 2 ]
    The number of participants with clinically noted shifts in Hematology tests from normal at baseline are graded based on Division of Microbiology and Infectious Diseases (DMID) toxicity tables from Grade 1 toxicity (smallest change) to Grade 4 toxicity (largest change). Grade 3 and 4 toxicities are considered to be clinically meaningful.
  • The Number of Participants With Clinically Notable Shifts From Normal at Baseline by Chemistry Test and Treatment [ Time Frame: Baseline, Day 2 ]

    The number of participants with clinically noted shifts in Clinical Chemistry tests from normal at baseline are graded based on Division of Microbiology and Infectious Diseases (DMID) toxicity tables from Grade 1 toxicity (smallest change) to Grade 4 toxicity (largest change). Grade 3 and 4 toxicities are considered to be clinically meaningful.

    SGPT(ALT)= Serum Glutamic Pyruvate Transaminase (Alanine Aminotransferase) and SGOT(AST)= Serum Glutamic Oxalacetic Transaminase (Aspartate Aminotransferase)



Original Secondary Outcome: • Proportion of patients with aborted genital herpes lesions • Safety as assessed by adverse events and laboratory abnormalities [ Time Frame: Time to healing of all non-aborted and aborted genital herpes lesions ]

Information By: Novartis

Dates:
Date Received: May 22, 2007
Date Started: June 2007
Date Completion:
Last Updated: March 24, 2011
Last Verified: March 2011