At a glance
ClinicalIndex Comparison Record- ✓First recognized episode of genital herpes diagnosed at screening or within 3 months prior
- ✓Overall general good health
- ✓Females of childbearing potential must have negative pregnancy test and agree to GSK stipulated contraceptive methods
- ✕Known or suspected immunocompromise including HIV seropositivity, immunosuppressive therapy, or chemotherapy
- ✕Receiving systemic antiviral or immunomodulatory treatments
- ✕Systemic antiviral therapy within 3 days or immunomodulatory therapy within 30 days of starting study drug
- ✕Creatinine clearance <30 ml/min by Cockcroft-Gault
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
An International, Randomized, Double-Blind, Placebo-Controlled, Multicenter, 6-Month Study of the Efficacy and Safety of Valtrex 1g QD vs. Placebo for the Suppression of HSV-2 Genital Herpes in Newly Diagnosed Immunocompetent Patients
In Brief
A Phase 4 clinical trial evaluating Valaciclovir and Placebo for Herpes Genitalis. Completed, enrolled 384 participants across 72 sites in 5 countries.
Detailed Summary
Genital herpes (GH) is a commonly occurring sexually transmitted disease caused by herpes simplex virus (HSV). There are two types of HSV, type 1 (HSV-1) and type 2 (HSV-2); both can cause GH, although the latter is much more likely to produce frequent recurrences of GH lesions. Evidence suggests that there are advantages to using suppressive vs. episodic treatment, which include increased intervals between the pain and discomfort of genital herpes recurrences. Therefore, this study will collect safety and efficacy data on suppressive therapy with valaciclovir in subjects newly diagnosed with HSV-2 genital herpes.
Study Details
Timeline
Interventions
1g once daily
placebo