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Completed Phase 4 Interventional Results available

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.

ClinicalTrials.gov ID: NCT00158860

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.

ClinicalTrials.gov public records Last synced Oct 23, 2026, 8:45 AM EDT

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
Lead sponsor
GlaxoSmithKline
Industry
Enrollment
384 participants

Conditions and interventions

Interventions

Drug

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 21, 2004 (Actual)
Primary completion
Jul 26, 2006 (Actual)
Completion
Jul 26, 2006 (Actual)
Last update posted
Feb 15, 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 15, 2019 · Synced Oct 23, 2026

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Open the official record

The complete public registry record, listed eligibility criteria, and available contact information for NCT00158860 live on ClinicalTrials.gov.

View official ClinicalTrials.gov record →