Recurrent Genital Herpes (RGH)
Conditions
Keywords
Recurrent Genital Herpes (RGH), famciclovir, episodic treatment, suppressive treatment, Polymerase Chain Reaction (PCR).
Brief summary
This trial will assess whether RGH patients who have two recurrent episodes within a three month period would benefit from suppressive treatment and whether patients prefer episodic therapy or suppressive therapy for the treatment of their RGH.
Interventions
DRUGFamciclovir
Sponsors
Novartis
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Inclusion criteria
* • Patients who are immunocompetent and who have had 4 or more episodes of Recurrent Genital Herpes (RGH) in the last 12 months. * Patients with active HSV-2 or HSV-1 infection as confirmed by Polymerase Chain Reaction (PCR). * Patients with active symptoms (i.e., itching, burning, tingling, aching, tenderness, rash or pain) associated with a recurrent episode of genital herpes
Exclusion criteria
* • Female patients who are pregnant or breast-feeding. * Current, history or suspicion of liver disease or kidney disease. * HIV infected (as confirmed by positive HIV serology). Other protocol-defined inclusion/
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Time (days from randomizations) to first recurrence of symptoms of recurrent genital herpes confirmed by PCR. | — |
Secondary
| Measure | Time frame |
|---|---|
| Change in total score of the Recurrent Genital Herpes Quality of Life. | — |
| Safety assessed by adverse events. | — |
| Time to first recurrence of genital herpes. | — |
| Number of genital herpes recurrences confirmed by PCR. | — |
Countries
United States
Outcome results
None listed