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

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ClinicalTrials.gov Identifier: NCT00477334
Recruitment Status : Completed
First Posted : May 23, 2007
Results First Posted : March 16, 2011
Last Update Posted : March 28, 2011
Sponsor:
Information provided by:
Novartis

Tracking Information
First Submitted Date  ICMJE May 22, 2007
First Posted Date  ICMJE May 23, 2007
Results First Submitted Date  ICMJE December 15, 2010
Results First Posted Date  ICMJE March 16, 2011
Last Update Posted Date March 28, 2011
Study Start Date  ICMJE June 2007
Actual Primary Completion Date March 2009   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 22, 2011)
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 Measures  ICMJE
 (submitted: May 22, 2007)
Time to healing of non-aborted genital herpes lesions
Change History Complete list of historical versions of study NCT00477334 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: March 24, 2011)
  • 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 Measures  ICMJE
 (submitted: May 22, 2007)
• 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 ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Patient-initiated Episodic Treatment of Recurrent Genital Herpes in Black Patients
Official Title  ICMJE 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 Recurrent Genital Herpes in Immunocompetent Black Patients
Brief Summary This study will evaluate the safety and efficacy of single-day famciclovir episodic treatment in Black patients with recurrent genital herpes
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Genital Herpes
Intervention  ICMJE
  • Drug: Famciclovir
    oral; two 500 mg tablets twice a day; single day treatment
    Other Name: Famvir
  • Drug: Placebo
    oral; two tablets twice a day; single day treatment
Study Arms  ICMJE
  • Experimental: 1
    Famciclovir 1000 mg; twice a day for one day.
    Intervention: Drug: Famciclovir
  • Placebo Comparator: 2
    Placebo; twice a day for one day.
    Intervention: Drug: Placebo
Publications * Leone P, Abudalu M, Mitha E, Gani M, Zhou W, Hamed K. One-day famciclovir vs. placebo in patient-initiated episodic treatment of recurrent genital herpes in immunocompetent Black patients. Curr Med Res Opin. 2010 Mar;26(3):653-61. doi: 10.1185/03007990903554471.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: October 29, 2008)
463
Original Enrollment  ICMJE Not Provided
Actual Study Completion Date  ICMJE March 2009
Actual Primary Completion Date March 2009   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Black men or women 18 years or older
  • History of recurrent genital herpes with at least 4 recurrences in preceding 12 months or in preceding 12 months prior to using suppressive antiviral therapy
  • Documented herpes simplex virus type 2 (HSV-2) seropositivity
  • Willingness to discontinue suppressive therapy during study, if applicable
  • Willingness and ability to comply with the study protocol

Exclusion Criteria:

  • Pregnant or breastfeeding women
  • Women of childbearing potential not using accepted methods of contraception
  • Hypersensitivity to famciclovir or drugs with similar chemical structures
  • Renal dysfunction
  • Known or suspected to have decompensated liver disease
  • Known to have gastrointestinal malabsorption
  • Known to be immunocompromised
  • Known to be hypersensitive to ingredients in study medication
  • Other protocol-defined inclusion/exclusion criteria may apply
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE South Africa,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00477334
Other Study ID Numbers  ICMJE CFAM810A2310
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party External Affairs, Novartis
Study Sponsor  ICMJE Novartis
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Dalu Mohammed, Dr Clayton Research Institute
PRS Account Novartis
Verification Date March 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP