This study will evaluate the safety and efficacy of single-day famciclovir episodic treatment in Black patients with recurrent genital herpes
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
463
oral; two 500 mg tablets twice a day; single day treatment
oral; two tablets twice a day; single day treatment
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).
Time frame: 21 days
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
Kaplan-Meier estimation.
Time frame: 21 days
Time to Resolution of Symptoms Associated With Recurrent Genital Herpes
Median time to resolution of symptoms: all symptoms, pain, burning, itching, tingling and tenderness associated with recurrent genital herpes estimated using Kaplan-Meier method.
Time frame: 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
Number of participants with a second recurrence of genital herpes in the follow-up period.
Time frame: 6 months
Time to Second Recurrence of Genital Herpes
Kaplan Meier estimated time in days to second recurrent from treatment initiation and from the date of healing of aborted lesions.
Time frame: 6 months
The Number of Participants With Clinically Notable Shifts From Normal at Baseline by Hematology Test and Treatment
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Providence Clinical Research
Burbank, California, United States
Alia Clinical Research, INC
Huntington Park, California, United States
Dermatology Research Associates
Los Angeles, California, United States
The Conant Foundation Quest Diagnostics
San Francisco, California, United States
Medical Research Centers of South Florida, Inc.
Hollywood, Florida, United States
First Coast Primary Care Minority Physicians Research Alliance
Jacksonville, Florida, United States
AppleMed Research Inc.
Miami, Florida, United States
International Research Associates, LLC
Miami, Florida, United States
Segal Institute for Clinical Research Heathcare Clinical Data, Inc
North Miami, Florida, United States
Perimeter Institute for Clinical Research Inc. ("PICR")
Atlanta, Georgia, United States
...and 33 more locations
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.
Time frame: Baseline, Day 2
The Number of Participants With Clinically Notable Shifts From Normal at Baseline by Chemistry Test and Treatment
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)
Time frame: Baseline, Day 2