Clinical trial NCT00477334: Patient-initiated Episodic Treatment of Recurrent Genital Herpes in Black Patients
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Genital Herpes
Keywords: Recurrent genital herpes
Black population
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2007-05-23
Enrollment: 463
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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


Eligibility 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

Primary outcomes:
measure: Investigator Assessed Time to Healing of All Non-aborted Genital Herpes Lesions
timeFrame: 21 days
Secondary outcomes:
measure: Percentage of Participants With Aborted and Non-aborted Genital Herpes Lesions During the Treatment Period
timeFrame: 21 days
measure: Investigator Assessed Time to Healing of All Non-aborted and Aborted Genital Herpes Lesions
timeFrame: 21 days
measure: Time to Resolution of Symptoms Associated With Recurrent Genital Herpes
timeFrame: 72 hour after initiation of study medication up to 21 days
measure: Number of Participants With a Second Recurrence of Genital Herpes in the Follow-up Period
timeFrame: 6 months
measure: Time to Second Recurrence of Genital Herpes
timeFrame: 6 months
measure: The Number of Participants With Clinically Notable Shifts From Normal at Baseline by Hematology Test and Treatment
timeFrame: Baseline, Day 2
measure: The Number of Participants With Clinically Notable Shifts From Normal at Baseline by Chemistry Test and Treatment
timeFrame: Baseline, Day 2
Other outcomes:
Locations:
city: Burbank
country: United States
facility: Providence Clinical Research
state: California
city: Huntington Park
country: United States
facility: Alia Clinical Research, INC
state: California
city: Los Angeles
country: United States
facility: Dermatology Research Associates
state: California
city: San Francisco
country: United States
facility: The Conant Foundation Quest Diagnostics
state: California
city: Hollywood
country: United States
facility: Medical Research Centers of South Florida, Inc.
state: Florida
city: Jacksonville
country: United States
facility: First Coast Primary Care Minority Physicians Research Alliance
state: Florida
city: Miami
country: United States
facility: AppleMed Research Inc.
state: Florida
city: Miami
country: United States
facility: International Research Associates, LLC
state: Florida
city: North Miami
country: United States
facility: Segal Institute for Clinical Research Heathcare Clinical Data, Inc
state: Florida
city: Atlanta
country: United States
facility: Perimeter Institute for Clinical Research Inc. ("PICR")
state: Georgia
city: Augusta
country: United States
facility: Medical College of Georgia Hospital and Clinics
state: Georgia
city: Decatur
country: United States
facility: Soapstone Center for Clinical Research
state: Georgia
city: Sandy Springs
country: United States
facility: Mount Vernon Clinical Research, LLC
state: Georgia
city: Covington
country: United States
facility: Clinical Trials Management LLC
state: Louisiana
city: New Orleans
country: United States
facility: Tulane University Health Sciences Center
state: Louisiana
city: Shreveport
country: United States
facility: Omni Fertility and Laser Institute
state: Louisiana
city: Towson
country: United States
facility: International Research Center
state: Maryland
city: Brockton
country: United States
facility: Miray Medical Center
state: Massachusetts
city: Southfield
country: United States
facility: Pearl Medical Group, PLLC
state: Michigan
city: St. Louis
country: United States
facility: Dr. Mohammed
state: Missouri
city: Las Vegas
country: United States
facility: Nevada Alliance Against Diabetes
state: Nevada
city: Charlotte
country: United States
facility: Metrolina Internal Medicine Internal Medicine Research
state: North Carolina
city: High Point
country: United States
facility: Peters Medical Research
state: North Carolina
city: Raleigh
country: United States
facility: UNC Clinical Research
state: North Carolina
city: Winston-Salem
country: United States
facility: Hawthorne Medical Research, Inc.
state: North Carolina
city: Tulsa
country: United States
facility: Planned Parenthood of Arkansas and Eastern Oklahoma
state: Oklahoma
city: Jenkintown
country: United States
facility: The Clinical Trial Center, LLC
state: Pennsylvania
city: Pittsburgh
country: United States
facility: Magee-Womens Hospital of UPMC
state: Pennsylvania
city: Memphis
country: United States
facility: Women's Care Center, PLC: Research Memphis Associates
state: Tennessee
city: Fort Worth
country: United States
facility: Private Practice
state: Texas
city: Houston
country: United States
facility: R/D Clinical Research, Inc
state: Texas
city: San Antonio
country: United States
facility: Sun Research Institute
state: Texas
city: Arlington
country: United States
facility: Millennium Clinical Trials, LLC
state: Virginia
city: Bloemfontein
country: South Africa
facility: Josha Research
city: Durban
country: South Africa
facility: Prime Cure Medicentre
city: Johannesburg
country: South Africa
facility: Drs. Essack and Mitha
city: Medunsa
country: South Africa
facility: Medunsa Clinical Research Unit (MeCRU)
city: Mmakau Village GA Rankuwa
country: South Africa
facility: Bertoni Mercy Clinic
city: Port Elizabeth
country: South Africa
facility: Global Clinical Trials
city: Pretoria
country: South Africa
facility: Eastmed Clinical Trial Centre/Eastmed Medical Centre
city: Shoshanguve
country: South Africa
facility: Setshaba Research Centre
city: Soweto
country: South Africa
facility: Drs. AE and QE Bhorat
city: Umkomaas
country: South Africa
facility: Umkomaas Clinical Research Site
Study officials:
affiliation: Clayton Research Institute
name: Dalu Mohammed, Dr
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.