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.
Public ClinicalTrials.gov record NCT00158860. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
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
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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 identification
- NCT ID
- NCT00158860
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 4
- Enrollment
- 384 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 18 Years and older
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Jun 20, 2004
- Primary completion
- Jul 25, 2006
- Completion
- Jul 25, 2006
- Last update posted
- Feb 14, 2019
2004 – 2006
United States locations
- U.S. sites
- 58
- U.S. states
- 22
- U.S. cities
- 53
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| GSK Investigational Site | Birmingham | Alabama | 35294 | — |
| GSK Investigational Site | Phoenix | Arizona | 85016 | — |
| GSK Investigational Site | Tucson | Arizona | 85710 | — |
| GSK Investigational Site | Anaheim | California | 92805 | — |
| GSK Investigational Site | Beverly Hills | California | 90211 | — |
| GSK Investigational Site | Davis | California | 95616 | — |
| GSK Investigational Site | Fair Oaks | California | 95628 | — |
| GSK Investigational Site | Los Angeles | California | 90048 | — |
| GSK Investigational Site | Sacramento | California | 95816 | — |
| GSK Investigational Site | Sacramento | California | 95825 | — |
| GSK Investigational Site | San Diego | California | 92123 | — |
| GSK Investigational Site | San Diego | California | 92128 | — |
| GSK Investigational Site | San Francisco | California | 94102 | — |
| GSK Investigational Site | Santa Ana | California | 92704 | — |
| GSK Investigational Site | Hartford | Connecticut | 06012 | — |
| GSK Investigational Site | New Britain | Connecticut | 06052 | — |
| GSK Investigational Site | Clearwater | Florida | 33759 | — |
| GSK Investigational Site | Coral Gables | Florida | 33134 | — |
| GSK Investigational Site | Melbourne | Florida | 32901 | — |
| GSK Investigational Site | Palm Springs | Florida | 33461 | — |
| GSK Investigational Site | Venice | Florida | 34285 | — |
| GSK Investigational Site | West Palm Beach | Florida | 33407 | — |
| GSK Investigational Site | Alpharetta | Georgia | 30005 | — |
| GSK Investigational Site | Atlanta | Georgia | 30310 | — |
| GSK Investigational Site | Atlanta | Georgia | 30342 | — |
| GSK Investigational Site | Decatur | Georgia | 30033 | — |
| GSK Investigational Site | Chicago | Illinois | 60612 | — |
| GSK Investigational Site | Springfield | Illinois | 62702 | — |
| GSK Investigational Site | Indianapolis | Indiana | 46202 - 5124 | — |
| GSK Investigational Site | South Bend | Indiana | 46601 | — |
| GSK Investigational Site | New Orleans | Louisiana | 70114 | — |
| GSK Investigational Site | Boston | Massachusetts | 02114 | — |
| GSK Investigational Site | Taunton | Massachusetts | 02780 | — |
| GSK Investigational Site | Portage | Michigan | 49024 | — |
| GSK Investigational Site | Las Vegas | Nevada | 89128 | — |
| GSK Investigational Site | Brooklyn | New York | 11203 | — |
| GSK Investigational Site | Endicott | New York | 13760 | — |
| GSK Investigational Site | Stony Brook | New York | 11794-8091 | — |
| GSK Investigational Site | The Bronx | New York | 10461 | — |
| GSK Investigational Site | Chapel Hill | North Carolina | 27599 | — |
| GSK Investigational Site | Winston-Salem | North Carolina | 27103 | — |
| GSK Investigational Site | Oklahoma City | Oklahoma | 73112 | — |
| GSK Investigational Site | Tulsa | Oklahoma | 74104 | — |
| GSK Investigational Site | Portland | Oregon | 97210 | — |
| GSK Investigational Site | Philadelphia | Pennsylvania | 19103 | — |
| GSK Investigational Site | East Providence | Rhode Island | 02914 | — |
| GSK Investigational Site | Memphis | Tennessee | 38104 | — |
| GSK Investigational Site | Memphis | Tennessee | 38120 | — |
| GSK Investigational Site | Austin | Texas | 78746 | — |
| GSK Investigational Site | Fort Worth | Texas | 76104 | — |
| GSK Investigational Site | Georgetown | Texas | 78626 | — |
| GSK Investigational Site | Houston | Texas | 77058 | — |
| GSK Investigational Site | San Antonio | Texas | 78205 | — |
| GSK Investigational Site | San Antonio | Texas | 78229 | — |
| GSK Investigational Site | Spokane | Washington | 99204 | — |
| GSK Investigational Site | La Crosse | Wisconsin | 54601 | — |
| GSK Investigational Site | Milwaukee | Wisconsin | 53209-0996 | — |
| GSK Investigational Site | Waukesha | Wisconsin | 53186 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
Non-U.S. locations
This page focuses on the U.S. directory. The official record also lists 14 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT00158860, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Feb 14, 2019 · Synced Sep 6, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT00158860 live on ClinicalTrials.gov.