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

This study has been completed.
Sponsor:
Information provided by:
Novartis
ClinicalTrials.gov Identifier:
NCT00477334
First received: May 22, 2007
Last updated: March 24, 2011
Last verified: March 2011
  Purpose

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


Condition Intervention Phase
Genital Herpes
Drug: Famciclovir
Drug: Placebo
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
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 Recurrent Genital Herpes in Immunocompetent Black Patients

Resource links provided by NLM:


Further study details as provided by Novartis:

Primary Outcome Measures:
  • Investigator Assessed Time to Healing of All Non-aborted Genital Herpes Lesions [ Time Frame: 21 days ] [ Designated as safety issue: No ]
    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).


Secondary Outcome Measures:
  • Percentage of Participants With Aborted and Non-aborted Genital Herpes Lesions During the Treatment Period [ Time Frame: 21 days ] [ Designated as safety issue: No ]
  • Investigator Assessed Time to Healing of All Non-aborted and Aborted Genital Herpes Lesions [ Time Frame: 21 days ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]

    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)



Enrollment: 463
Study Start Date: June 2007
Study Completion Date: March 2009
Primary Completion Date: March 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
Famciclovir 1000 mg; twice a day for one day.
Drug: Famciclovir
oral; two 500 mg tablets twice a day; single day treatment
Other Name: Famvir
Placebo Comparator: 2
Placebo; twice a day for one day.
Drug: Placebo
oral; two tablets twice a day; single day treatment

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00477334

  Show 43 Study Locations
Sponsors and Collaborators
Novartis
Investigators
Principal Investigator: Dalu Mohammed, Dr Clayton Research Institute
  More Information

Additional Information:
No publications provided

Responsible Party: External Affairs, Novartis
ClinicalTrials.gov Identifier: NCT00477334     History of Changes
Other Study ID Numbers: CFAM810A2310
Study First Received: May 22, 2007
Results First Received: December 15, 2010
Last Updated: March 24, 2011
Health Authority: United States: Food and Drug Administration
South Africa: Medicines Control Council

Keywords provided by Novartis:
Recurrent genital herpes
Black population

Additional relevant MeSH terms:
Herpes Genitalis
Herpes Simplex
Herpesviridae Infections
DNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Genital Diseases, Male
Genital Diseases, Female
Famciclovir
Antiviral Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on July 10, 2014