VALTREX Once Daily For Viral Shedding In Herpes Simplex Virus 2 (HSV-2) Seropositive Subjects. VALTREX® Tablet is a Trademark of GlaxoSmithKline Group of Companies.
This study has been completed.
Sponsor:
GlaxoSmithKline
Information provided by (Responsible Party):
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT00116844
First received: June 30, 2005
Last updated: September 22, 2016
Last verified: September 2016
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
Purpose
Eligible subjects will be randomized to receive VALTREX® tablet 1g or placebo once daily for 60 days in a two-way crossover study with a washout period of 7 days between treatment periods.
| Condition | Intervention | Phase |
|---|---|---|
|
Infections, Herpesviridae |
Drug: Valaciclovir |
Phase 4 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Crossover Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Treatment |
| Official Title: | A Randomized, Double-Blind, Placebo-Controlled, Multicenter, Two-Way Crossover Study to Investigate the Effect of VALTREX 1g Once Daily for 60 Days on Viral Shedding in HSV-2 Seropositive Subjects With No Previous History of Symptomatic Genital Herpes Infection. |
Resource links provided by NLM:
Further study details as provided by GlaxoSmithKline:
Primary Outcome Measures:
- To determine the effect of valaciclovir 1g once daily for 60 days on HSV-2 viral shedding. [ Time Frame: 60 days ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- To determine the safety of valaciclovir 1g once daily for 60 days in healthy subjects with no previous history of symptomatic genital herpes infection. [ Time Frame: 60 days ] [ Designated as safety issue: No ]
| Enrollment: | 73 |
| Study Start Date: | March 2005 |
| Study Completion Date: | January 2006 |
| Primary Completion Date: | January 2006 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Placebo Comparator: Placebo
Val vs Placebo
|
Drug: Valaciclovir
Valtrex 1g QD
|
|
Active Comparator: 1g QD
Valtrex
|
Drug: Valaciclovir
Valtrex 1g QD
|
Eligibility| Ages Eligible for Study: | 18 Years and older (Adult, Senior) |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
Criteria
Inclusion Criteria:
- In overall general good health.
- HSV-2 (Herpes Simplex Virus-2) seropositive at screening.
Exclusion criteria:
- have active lesions consistent with genital herpes.
- previous history of symptomatic genital herpes.
- history of recurrent, undiagnosed symptoms consistent with genital herpes.
Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00116844
Please refer to this study by its ClinicalTrials.gov identifier: NCT00116844
Locations
| United States, California | |
| GSK Investigational Site | |
| Carmichael, California, United States, 95608 | |
| GSK Investigational Site | |
| Davis, California, United States, 95616 | |
| GSK Investigational Site | |
| Riverside, California, United States, 92506 | |
| GSK Investigational Site | |
| Sacramento, California, United States, 92585 | |
| United States, Indiana | |
| GSK Investigational Site | |
| Fort Wayne, Indiana, United States, 46804 | |
| GSK Investigational Site | |
| Indianapolis, Indiana, United States, 46202 | |
| United States, Massachusetts | |
| GSK Investigational Site | |
| Boston, Massachusetts, United States, 02115 | |
| United States, New York | |
| GSK Investigational Site | |
| Bronx, New York, United States, 10461 | |
| GSK Investigational Site | |
| New York, New York, United States, 10011 | |
| GSK Investigational Site | |
| New York, New York, United States, 10029 | |
| GSK Investigational Site | |
| Stony Brook, New York, United States, 11794 | |
| United States, North Carolina | |
| GSK Investigational Site | |
| Chapel Hill, North Carolina, United States, 27599 | |
| United States, Oklahoma | |
| GSK Investigational Site | |
| Tulsa, Oklahoma, United States, 74104 | |
| United States, Oregon | |
| GSK Investigational Site | |
| Portland, Oregon, United States, 97210 | |
| United States, Texas | |
| GSK Investigational Site | |
| Houston, Texas, United States, 77030 | |
| United States, Utah | |
| GSK Investigational Site | |
| Salt Lake City, Utah, United States, 84132 | |
| United States, Washington | |
| GSK Investigational Site | |
| Seattle, Washington, United States, 98104 | |
Sponsors and Collaborators
GlaxoSmithKline
Investigators
| Study Director: | GSK Clinical Trials | GlaxoSmithKline |
More Information
Additional Information:
Study Data/Documents: Dataset Specification
Identifier: VLX103596
For additional information about this study please refer to the GSK Clinical Study Register
For additional information about this study please refer to the GSK Clinical Study Register
Study Protocol
Identifier: VLX103596
For additional information about this study please refer to the GSK Clinical Study Register
For additional information about this study please refer to the GSK Clinical Study Register
Annotated Case Report Form
Identifier: VLX103596
For additional information about this study please refer to the GSK Clinical Study Register
For additional information about this study please refer to the GSK Clinical Study Register
Individual Participant Data Set
Identifier: VLX103596
For additional information about this study please refer to the GSK Clinical Study Register
For additional information about this study please refer to the GSK Clinical Study Register
Statistical Analysis Plan
Identifier: VLX103596
For additional information about this study please refer to the GSK Clinical Study Register
For additional information about this study please refer to the GSK Clinical Study Register
Clinical Study Report
Identifier: VLX103596
For additional information about this study please refer to the GSK Clinical Study Register
For additional information about this study please refer to the GSK Clinical Study Register
Informed Consent Form
Identifier: VLX103596
For additional information about this study please refer to the GSK Clinical Study Register
For additional information about this study please refer to the GSK Clinical Study Register
| Responsible Party: | GlaxoSmithKline |
| ClinicalTrials.gov Identifier: | NCT00116844 History of Changes |
| Obsolete Identifiers: | NCT00268190 |
| Other Study ID Numbers: | VLX103596 |
| Study First Received: | June 30, 2005 |
| Last Updated: | September 22, 2016 |
| Health Authority: | United States: Food and Drug Administration |
| Individual Participant Data | |
| Plan to Share IPD: | Yes |
| Plan Description: | Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site. |
Keywords provided by GlaxoSmithKline:
|
viral shedding Recurrent herpes genital herpes |
Additional relevant MeSH terms:
|
Infection Herpesviridae Infections DNA Virus Infections Virus Diseases |
Valacyclovir Antiviral Agents Anti-Infective Agents |
ClinicalTrials.gov processed this record on September 26, 2016