Patient-initiated Episodic Treatment of Recurrent Genital Herpes in Black Patients
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
1 other identifier
interventional
463
2 countries
43
Brief Summary
This study will evaluate the safety and efficacy of single-day famciclovir episodic treatment in Black patients with recurrent genital herpes
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_4
Started Jun 2007
43 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 22, 2007
CompletedFirst Posted
Study publicly available on registry
May 23, 2007
CompletedStudy Start
First participant enrolled
June 1, 2007
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2009
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2009
CompletedResults Posted
Study results publicly available
March 16, 2011
CompletedMarch 28, 2011
March 1, 2011
1.8 years
May 22, 2007
December 15, 2010
March 24, 2011
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Investigator Assessed Time to Healing of All Non-aborted Genital Herpes Lesions
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).
21 days
Secondary Outcomes (7)
Percentage of Participants With Aborted and Non-aborted Genital Herpes Lesions During the Treatment Period
21 days
Investigator Assessed Time to Healing of All Non-aborted and Aborted Genital Herpes Lesions
21 days
Time to Resolution of Symptoms Associated With Recurrent Genital Herpes
72 hour after initiation of study medication up to 21 days
Number of Participants With a Second Recurrence of Genital Herpes in the Follow-up Period
6 months
Time to Second Recurrence of Genital Herpes
6 months
- +2 more secondary outcomes
Study Arms (2)
1
EXPERIMENTALFamciclovir 1000 mg; twice a day for one day.
2
PLACEBO COMPARATORPlacebo; twice a day for one day.
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Novartislead
Study Sites (43)
Providence Clinical Research
Burbank, California, 91505, United States
Alia Clinical Research, INC
Huntington Park, California, 90255, United States
Dermatology Research Associates
Los Angeles, California, 90045, United States
The Conant Foundation Quest Diagnostics
San Francisco, California, 94114, United States
Medical Research Centers of South Florida, Inc.
Hollywood, Florida, 33021, United States
First Coast Primary Care Minority Physicians Research Alliance
Jacksonville, Florida, 32208, United States
AppleMed Research Inc.
Miami, Florida, 33155, United States
International Research Associates, LLC
Miami, Florida, 33156, United States
Segal Institute for Clinical Research Heathcare Clinical Data, Inc
North Miami, Florida, 33161, United States
Perimeter Institute for Clinical Research Inc. ("PICR")
Atlanta, Georgia, 30338, United States
Medical College of Georgia Hospital and Clinics
Augusta, Georgia, 30912, United States
Soapstone Center for Clinical Research
Decatur, Georgia, 30034, United States
Mount Vernon Clinical Research, LLC
Sandy Springs, Georgia, 30328, United States
Clinical Trials Management LLC
Covington, Louisiana, 70433, United States
Tulane University Health Sciences Center
New Orleans, Louisiana, 70112, United States
Omni Fertility and Laser Institute
Shreveport, Louisiana, 71118, United States
International Research Center
Towson, Maryland, 21286, United States
Miray Medical Center
Brockton, Massachusetts, 02301, United States
Pearl Medical Group, PLLC
Southfield, Michigan, 48075, United States
Dr. Mohammed
St Louis, Missouri, 63117, United States
Nevada Alliance Against Diabetes
Las Vegas, Nevada, 89101, United States
Metrolina Internal Medicine Internal Medicine Research
Charlotte, North Carolina, 28204, United States
Peters Medical Research
High Point, North Carolina, 27262, United States
UNC Clinical Research
Raleigh, North Carolina, 27607, United States
Hawthorne Medical Research, Inc.
Winston-Salem, North Carolina, 27103, United States
Planned Parenthood of Arkansas and Eastern Oklahoma
Tulsa, Oklahoma, 74105, United States
The Clinical Trial Center, LLC
Jenkintown, Pennsylvania, 19046, United States
Magee-Womens Hospital of UPMC
Pittsburgh, Pennsylvania, 15213, United States
Women's Care Center, PLC: Research Memphis Associates
Memphis, Tennessee, 38119, United States
Private Practice
Fort Worth, Texas, 76110, United States
R/D Clinical Research, Inc
Houston, Texas, 77074, United States
Sun Research Institute
San Antonio, Texas, 78205, United States
Millennium Clinical Trials, LLC
Arlington, Virginia, 22203, United States
Josha Research
Bloemfontein, South Africa
Prime Cure Medicentre
Durban, South Africa
Umkomaas Clinical Research Site
eMkhomazi, South Africa
Drs. Essack and Mitha
Johannesburg, South Africa
Medunsa Clinical Research Unit (MeCRU)
Medunsa, South Africa
Bertoni Mercy Clinic
Mmakau Village GA Rankuwa, South Africa
Global Clinical Trials
Port Elizabeth, South Africa
Eastmed Clinical Trial Centre/Eastmed Medical Centre
Pretoria, South Africa
Setshaba Research Centre
Shoshanguve, South Africa
Drs. AE and QE Bhorat
Soweto, South Africa
Related Publications (1)
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.
PMID: 20070143DERIVED
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Study Director
- Organization
- Novartis Pharmaceuticals
Study Officials
- PRINCIPAL INVESTIGATOR
Dalu Mohammed, Dr
Clayton Research Institute
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
May 22, 2007
First Posted
May 23, 2007
Study Start
June 1, 2007
Primary Completion
March 1, 2009
Study Completion
March 1, 2009
Last Updated
March 28, 2011
Results First Posted
March 16, 2011
Record last verified: 2011-03