Trials / Completed
CompletedNCT00158860
A Study Comparing Daily Treatment With Valaciclovir To Placebo For Suppression Of Herpes Simplex Virus HSV-2 Genital Herpes In Newly Diagnosed Patients. VALTREX® Tablet is a Trademark of the GlaxoSmithKline Group of Companies.
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
- Status
- Completed
- Phase
- Phase 4
- Study type
- Interventional
- Enrollment
- 384 (actual)
- Sponsor
- GlaxoSmithKline · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Valaciclovir | 1g once daily |
| DRUG | Placebo | placebo |
Timeline
- Start date
- 2004-06-21
- Primary completion
- 2006-07-26
- Completion
- 2006-07-26
- First posted
- 2005-09-12
- Last updated
- 2019-02-15
- Results posted
- 2019-02-15
Locations
72 sites across 5 countries: United States, Argentina, Brazil, Canada, Chile
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT00158860. Inclusion in this directory is not an endorsement.