Phase 3
N=1,179
Efficacy and Safety of Famciclovir 1-day Treatment Compared to 3-day Treatment With Valacyclovir in Adults With Recurrent Genital Herpes
Genital Herpes
Bottom Line
View on ClinicalTrials.gov: NCT00306787 ↗Enrolled (actual)
1,179
Serious AEs
0.4%
Results posted
Jun 2011
Primary outcome: Primary: Investigator-assessed Time to Healing of All Non-aborted Genital Herpes Lesions — 4.25; 4.08 days
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Famciclovir (Drug); Valacyclovir (Drug); Placebo matching famciclovir (Drug); Placebo matching valacyclovir (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Novartis Pharmaceuticals
- Primary completion
- Feb 2008
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Investigator-assessed Time to Healing of All Non-aborted Genital Herpes Lesions |
4.25; 4.08 | — |
| SECONDARY Percentage of Participants With Aborted Genital Herpes Lesions |
32.7; 33.6; 67.3; 66.4 | — |
| SECONDARY Investigator-assessed Time to Healing of All (Non-aborted and Aborted) Genital Herpes Lesions |
3.07; 3.01 | — |
| SECONDARY Time to Resolution of Symptoms Associated With Recurrent Genital Herpes |
18.0; 20.3; 16.1; 12.6; 43.9; 43.5 | — |
| SECONDARY Number of Patients With a Second Recurrence of Genital Herpes |
324; 342; 226; 231 | — |
| SECONDARY Time to a Second Recurrence of Genital Herpes |
33.5; 38.0; 27.5; 32.0 | — |
Summary
This study will assess the safety and efficacy of one-day famciclovir (1000 mg twice a day (b.i.d)) in reducing the duration of genital herpes lesions and the associated symptoms compared to three-day treatment with valacyclovir (500 mg capsule b.i.d).
Eligibility Criteria
Inclusion Criteria
- At least 18 years old
- History of at least 4 recurrences of genital herpes in the preceding 12 months
- Lesions located on the external genitalia or anogenital region
- Willing to discontinue suppressive treatment
- Documented positive herpes simplex virus (HSV)
- General good health, and history of normal renal function
Exclusion Criteria
- Women of childbearing potential not using approved form of contraceptive
- Pregnant or nursing women
- History of hypersensitivity to famciclovir, valacyclovir, or acyclovir
- Known to be immunosuppressed
- Known to have renal dysfunction
- Receiving anti-herpes therapy
- Known to have other genital tract disorders
- Known to have condition which could interfere with drug absorption
Additional protocol-defined inclusion/exclusion criteria may apply.
Data sourced from ClinicalTrials.gov (NCT00306787). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.