RELIEF: Randomized Episodic Versus Long-Term Suppression Experience With Famciclovir
Phase 4
Completed
- Conditions
- Recurrent Genital Herpes (RGH)
- Registration Number
- NCT00219310
- Lead Sponsor
- Novartis
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- Not specified
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/exclusion criteria may apply.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method Time (days from randomizations) to first recurrence of symptoms of recurrent genital herpes confirmed by PCR.
- Secondary Outcome Measures
Name Time Method 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.
Trial Locations
- Locations (1)
Novartis Pharmaceuticals
🇺🇸East Hanover, New Jersey, United States