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Completed

NCT Number: NCT00477334

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

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

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Key information

Conditions

Genital Herpes Communicable Diseases DNA Virus Infections Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Genital Diseases, Female Genital Diseases, Male Herpes Genitalis Herpes Simplex Herpesviridae Infections Infections Male Urogenital Diseases Sexually Transmitted Diseases Sexually Transmitted Diseases, Viral Urogenital Diseases Virus Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Josha Research, Bloemfontein, South Africa

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Famciclovir

Drug

oral; two 500 mg tablets twice a day; single day treatment

Other names: Famvir

Placebo

Drug

oral; two tablets twice a day; single day treatment

Primary outcomes

  1. 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).

Secondary outcomes

  1. Percentage of Participants With Aborted and Non-aborted Genital Herpes Lesions During the Treatment Period

    Time frame: 21 days

  2. Investigator Assessed Time to Healing of All Non-aborted and Aborted Genital Herpes Lesions

    Time frame: 21 days

    Kaplan-Meier estimation.

  3. 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.

  4. 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.

  5. 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.

  6. 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.

  7. 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)

Sponsors and collaborators

Lead sponsor

Novartis

Industry

Registry information

Official study 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

Important dates

Study start
2007
Primary completion
2009
Study completion
2009
First posted
May 23, 2007
Registry last updated
Mar 28, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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