Phase 4
N=463
Patient-initiated Episodic Treatment of Recurrent Genital Herpes in Black Patients
Genital Herpes
Bottom Line
View on ClinicalTrials.gov: NCT00477334 ↗Enrolled (actual)
463
Serious AEs
1.0%
Results posted
Mar 2011
Primary outcome: Primary: Investigator Assessed Time to Healing of All Non-aborted Genital Herpes Lesions — 5.38; 4.79 Days — p=0.4161
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Famciclovir (Drug); Placebo (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Novartis
- Primary completion
- Mar 2009
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Investigator Assessed Time to Healing of All Non-aborted Genital Herpes Lesions |
5.38; 4.79 | 0.4161 |
| SECONDARY Percentage of Participants With Aborted and Non-aborted Genital Herpes Lesions During the Treatment Period |
24.4; 20.4; 75.6; 79.6 | — |
| SECONDARY Investigator Assessed Time to Healing of All Non-aborted and Aborted Genital Herpes Lesions |
4.13; 4.06 | — |
| SECONDARY Time to Resolution of Symptoms Associated With Recurrent Genital Herpes |
4.5; 5.7; 3.0; 2.6; 2.3; 2.5 | — |
| SECONDARY Number of Participants With a Second Recurrence of Genital Herpes in the Follow-up Period |
141; 75 | — |
| SECONDARY Time to Second Recurrence of Genital Herpes |
69.0; 81.0; 63.0; 75.0 | — |
| SECONDARY The Number of Participants With Clinically Notable Shifts From Normal at Baseline by Hematology Test and Treatment |
0; 0; 0; 0; 0; 0 | — |
| SECONDARY The Number of Participants With Clinically Notable Shifts From Normal at Baseline by Chemistry Test and Treatment |
3; 0; 0; 0; 1; 1 | — |
Summary
This study will evaluate the safety and efficacy of single-day famciclovir episodic treatment in Black patients with recurrent genital herpes
Eligibility Criteria
Inclusion Criteria
- 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
Exclusion Criteria
- 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
- Other protocol-defined inclusion/exclusion criteria may apply
Data sourced from ClinicalTrials.gov (NCT00477334). 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.