Back to resultsA 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.
Primary Purpose
Herpes Genitalis
Status
Completed
Phase
Phase 4
Locations
International
Study Type
Interventional
Intervention
Valaciclovir
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Herpes Genitalis focused on measuring VALTREX®, valaciclovir, genital herpes, HSV-2, suppression
Eligibility Criteria
Inclusion criteria: In overall general good health. Females can enter and participate in this study if they are of non-childbearing potential (i.e., physiologically incapable of becoming pregnant) or if of childbearing potential, has a negative pregnancy test (urine) at screening and agrees to use GSK stipulated contraceptive methods. Must be newly diagnosed with a first recognized episode of GH at the time of the Screening Visit or within 3 months prior to the Screening Visit. Exclusion criteria: Known or suspected to be immunocompromised (e.g., subjects receiving immunosuppressive therapy or chemotherapy for malignancy, or are seropositive for HIV). Received an investigational drug in the 30 days prior to the study. Receiving systemic antiviral or immunomodulatory treatments. Must not have received systemic antiviral treatments (e.g., valaciclovir, Famvir (famciclovir), acyclovir, lysine) within 3 days of starting study drug or immunomodulatory treatments in the 30 days before starting study drug. Clinically significant impaired renal function as defined by a creatinine clearance <30 ml/min, calculated using the Cockcroft-Gault formula. Clinically significant impaired hepatic function defined as an ALT (alanine transaminase) level > 5 times the normal upper limit. Subjects with active liver disease. Known to be hypersensitive to acyclovir, famciclovir, ganciclovir or any component of valaciclovir formulations. Known resistance to acyclovir, valaciclovir, penciclovir, famciclovir, ganciclovir or valganciclovir. Subjects with malabsorption or vomiting syndrome or other gastrointestinal dysfunction that might impair drug pharmacokinetics. Women contemplating pregnancy within the duration of the study drug dosing period. Women who are pregnant and/or nursing mothers Current history of alcohol or drug abuse. Received suppressive (daily) therapy for genital herpes prior to enrollment.
Sites / Locations
- GSK Investigational Site
- GSK Investigational Site
- GSK Investigational Site
- GSK Investigational Site
- GSK Investigational Site
- GSK Investigational Site
- GSK Investigational Site
- GSK Investigational Site
- GSK Investigational Site
- GSK Investigational Site
- GSK Investigational Site
- GSK Investigational Site
- GSK Investigational Site
- GSK Investigational Site
- GSK Investigational Site
- GSK Investigational Site
- GSK Investigational Site
- GSK Investigational Site
- GSK Investigational Site
- GSK Investigational Site
- GSK Investigational Site
- GSK Investigational Site
- GSK Investigational Site
- GSK Investigational Site
- GSK Investigational Site
- GSK Investigational Site
- GSK Investigational Site
- GSK Investigational Site
- GSK Investigational Site
- GSK Investigational Site
- GSK Investigational Site
- GSK Investigational Site
- GSK Investigational Site
- GSK Investigational Site
- GSK Investigational Site
- GSK Investigational Site
- GSK Investigational Site
- GSK Investigational Site
- GSK Investigational Site
- GSK Investigational Site
- GSK Investigational Site
- GSK Investigational Site
- GSK Investigational Site
- GSK Investigational Site
- GSK Investigational Site
- GSK Investigational Site
- GSK Investigational Site
- GSK Investigational Site
- GSK Investigational Site
- GSK Investigational Site
- GSK Investigational Site
- GSK Investigational Site
- GSK Investigational Site
- GSK Investigational Site
- GSK Investigational Site
- GSK Investigational Site
- GSK Investigational Site
- GSK Investigational Site
- GSK Investigational Site
- GSK Investigational Site
- GSK Investigational Site
- GSK Investigational Site
- GSK Investigational Site
- GSK Investigational Site
- GSK Investigational Site
- GSK Investigational Site
- GSK Investigational Site
- GSK Investigational Site
- GSK Investigational Site
- GSK Investigational Site
- GSK Investigational Site
- GSK Investigational Site
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Valaciclovir
Placebo
Arm Description
Participants received double blinded treatment of oral dose of Valacyclovir 1 g given as 2 x 500 mg caplets QD for 6 months (24 weeks).
Participants received double blinded treatment of oral dose of matching placebo to Valacyclovir 1 gram (g) given as 2 x 500 milligram (mg) caplets once daily (QD) for 6 months (24 weeks).
Outcomes
Primary Outcome Measures
Percentage of Participants With Time to First GH Recurrence
Diary cards were issued to the participants during randomization visit for recording GH recurrences. HSV recurrences since the last visit was assessed after review of the diary card and discussion with the participant. The percentage of participants with time to first GH recurrence was based on Kaplan-Meier estimates. Confidence intervals for differences in proportions was calculated using the standard error for the Kaplan-Meier estimate derived using Greenwood's formula.
Secondary Outcome Measures
Mean Number of GH Recurrences Per Month Within the 6-month Study Period
Mean number of GH recurrence reaching macular/papular stage per month was reported. Diary cards were issued to the participants during randomization visit for the recording GH recurrences. HSV recurrences since the last visit was assessed after review of the diary card and discussion with the participant.
Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)
An AE was defined as any untoward medical occurrence in a participant temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An SAE was defined as any untoward medical occurrence that, at any dose results in death, was life-threatening, required hospitalization or prolongation of hospitalization, results in disability/incapacity, was a congenital anomaly/birth defect or medically significant.
Percentage of Participants With Time to First Oral Herpes Simplex Virus (HSV) Outbreak Within 6-months
Diary cards were issued to the participants during randomization visit for recording HSV outbreak within 6-momths. HSV outbreak was assessed after review of the diary card and discussion with the participant. The percentage of participants who had first oral HSV outbreak at 6-months was reported.
Number of Isolates With Resistance to Acyclovir (ACV)
Culture samples were tested for AVC-susceptibility by the analytical laboratory. Re-testing of the ACV resistant isolates was carried out to check if the half maximal inhibitory concentration (IC-50s) for all the ACV resistant isolates were within the expected errors of 2.0 microgram per milliliters (mcg/ml) cut-off for the plaque reduction assay. Those isolates that confirm to be resistant in repeat assays were considered as resistant to ACV.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00158860
Brief Title
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.
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
Study Type
Interventional
2. Study Status
Record Verification Date
December 2017
Overall Recruitment Status
Completed
Study Start Date
June 21, 2004 (Actual)
Primary Completion Date
July 26, 2006 (Actual)
Study Completion Date
July 26, 2006 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
GlaxoSmithKline
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Herpes Genitalis
Keywords
VALTREX®, valaciclovir, genital herpes, HSV-2, suppression
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
384 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Valaciclovir
Arm Type
Experimental
Arm Description
Participants received double blinded treatment of oral dose of Valacyclovir 1 g given as 2 x 500 mg caplets QD for 6 months (24 weeks).
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Participants received double blinded treatment of oral dose of matching placebo to Valacyclovir 1 gram (g) given as 2 x 500 milligram (mg) caplets once daily (QD) for 6 months (24 weeks).
Intervention Type
Drug
Intervention Name(s)
Valaciclovir
Intervention Description
1g once daily
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
placebo
Primary Outcome Measure Information:
Title
Percentage of Participants With Time to First GH Recurrence
Description
Diary cards were issued to the participants during randomization visit for recording GH recurrences. HSV recurrences since the last visit was assessed after review of the diary card and discussion with the participant. The percentage of participants with time to first GH recurrence was based on Kaplan-Meier estimates. Confidence intervals for differences in proportions was calculated using the standard error for the Kaplan-Meier estimate derived using Greenwood's formula.
Time Frame
Day 168
Secondary Outcome Measure Information:
Title
Mean Number of GH Recurrences Per Month Within the 6-month Study Period
Description
Mean number of GH recurrence reaching macular/papular stage per month was reported. Diary cards were issued to the participants during randomization visit for the recording GH recurrences. HSV recurrences since the last visit was assessed after review of the diary card and discussion with the participant.
Time Frame
Up to Day 168
Title
Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)
Description
An AE was defined as any untoward medical occurrence in a participant temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An SAE was defined as any untoward medical occurrence that, at any dose results in death, was life-threatening, required hospitalization or prolongation of hospitalization, results in disability/incapacity, was a congenital anomaly/birth defect or medically significant.
Time Frame
Upto Day 168
Title
Percentage of Participants With Time to First Oral Herpes Simplex Virus (HSV) Outbreak Within 6-months
Description
Diary cards were issued to the participants during randomization visit for recording HSV outbreak within 6-momths. HSV outbreak was assessed after review of the diary card and discussion with the participant. The percentage of participants who had first oral HSV outbreak at 6-months was reported.
Time Frame
Day 168
Title
Number of Isolates With Resistance to Acyclovir (ACV)
Description
Culture samples were tested for AVC-susceptibility by the analytical laboratory. Re-testing of the ACV resistant isolates was carried out to check if the half maximal inhibitory concentration (IC-50s) for all the ACV resistant isolates were within the expected errors of 2.0 microgram per milliliters (mcg/ml) cut-off for the plaque reduction assay. Those isolates that confirm to be resistant in repeat assays were considered as resistant to ACV.
Time Frame
Day 168
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion criteria:
In overall general good health.
Females can enter and participate in this study if they are of non-childbearing potential (i.e., physiologically incapable of becoming pregnant) or if of childbearing potential, has a negative pregnancy test (urine) at screening and agrees to use GSK stipulated contraceptive methods.
Must be newly diagnosed with a first recognized episode of GH at the time of the Screening Visit or within 3 months prior to the Screening Visit.
Exclusion criteria:
Known or suspected to be immunocompromised (e.g., subjects receiving immunosuppressive therapy or chemotherapy for malignancy, or are seropositive for HIV).
Received an investigational drug in the 30 days prior to the study.
Receiving systemic antiviral or immunomodulatory treatments.
Must not have received systemic antiviral treatments (e.g., valaciclovir, Famvir (famciclovir), acyclovir, lysine) within 3 days of starting study drug or immunomodulatory treatments in the 30 days before starting study drug.
Clinically significant impaired renal function as defined by a creatinine clearance <30 ml/min, calculated using the Cockcroft-Gault formula.
Clinically significant impaired hepatic function defined as an ALT (alanine transaminase) level > 5 times the normal upper limit.
Subjects with active liver disease.
Known to be hypersensitive to acyclovir, famciclovir, ganciclovir or any component of valaciclovir formulations.
Known resistance to acyclovir, valaciclovir, penciclovir, famciclovir, ganciclovir or valganciclovir.
Subjects with malabsorption or vomiting syndrome or other gastrointestinal dysfunction that might impair drug pharmacokinetics.
Women contemplating pregnancy within the duration of the study drug dosing period.
Women who are pregnant and/or nursing mothers
Current history of alcohol or drug abuse.
Received suppressive (daily) therapy for genital herpes prior to enrollment.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
GSK Clinical Trials
Organizational Affiliation
GlaxoSmithKline
Official's Role
Study Director
Facility Information:
Facility Name
GSK Investigational Site
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35294
Country
United States
Facility Name
GSK Investigational Site
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85016
Country
United States
Facility Name
GSK Investigational Site
City
Tucson
State/Province
Arizona
ZIP/Postal Code
85710
Country
United States
Facility Name
GSK Investigational Site
City
Anaheim
State/Province
California
ZIP/Postal Code
92805
Country
United States
Facility Name
GSK Investigational Site
City
Beverly Hills
State/Province
California
ZIP/Postal Code
90211
Country
United States
Facility Name
GSK Investigational Site
City
Davis
State/Province
California
ZIP/Postal Code
95616
Country
United States
Facility Name
GSK Investigational Site
City
Fair Oaks
State/Province
California
ZIP/Postal Code
95628
Country
United States
Facility Name
GSK Investigational Site
City
Los Angeles
State/Province
California
ZIP/Postal Code
90048
Country
United States
Facility Name
GSK Investigational Site
City
Sacramento
State/Province
California
ZIP/Postal Code
95816
Country
United States
Facility Name
GSK Investigational Site
City
Sacramento
State/Province
California
ZIP/Postal Code
95825
Country
United States
Facility Name
GSK Investigational Site
City
San Diego
State/Province
California
ZIP/Postal Code
92123
Country
United States
Facility Name
GSK Investigational Site
City
San Diego
State/Province
California
ZIP/Postal Code
92128
Country
United States
Facility Name
GSK Investigational Site
City
San Francisco
State/Province
California
ZIP/Postal Code
94102
Country
United States
Facility Name
GSK Investigational Site
City
Santa Ana
State/Province
California
ZIP/Postal Code
92704
Country
United States
Facility Name
GSK Investigational Site
City
Hartford
State/Province
Connecticut
ZIP/Postal Code
06012
Country
United States
Facility Name
GSK Investigational Site
City
New Britain
State/Province
Connecticut
ZIP/Postal Code
06052
Country
United States
Facility Name
GSK Investigational Site
City
Clearwater
State/Province
Florida
ZIP/Postal Code
33759
Country
United States
Facility Name
GSK Investigational Site
City
Coral Gables
State/Province
Florida
ZIP/Postal Code
33134
Country
United States
Facility Name
GSK Investigational Site
City
Melbourne
State/Province
Florida
ZIP/Postal Code
32901
Country
United States
Facility Name
GSK Investigational Site
City
Palm Springs
State/Province
Florida
ZIP/Postal Code
33461
Country
United States
Facility Name
GSK Investigational Site
City
Venice
State/Province
Florida
ZIP/Postal Code
34285
Country
United States
Facility Name
GSK Investigational Site
City
West Palm Beach
State/Province
Florida
ZIP/Postal Code
33407
Country
United States
Facility Name
GSK Investigational Site
City
Alpharetta
State/Province
Georgia
ZIP/Postal Code
30005
Country
United States
Facility Name
GSK Investigational Site
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30310
Country
United States
Facility Name
GSK Investigational Site
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30342
Country
United States
Facility Name
GSK Investigational Site
City
Decatur
State/Province
Georgia
ZIP/Postal Code
30033
Country
United States
Facility Name
GSK Investigational Site
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60612
Country
United States
Facility Name
GSK Investigational Site
City
Springfield
State/Province
Illinois
ZIP/Postal Code
62702
Country
United States
Facility Name
GSK Investigational Site
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46202 - 5124
Country
United States
Facility Name
GSK Investigational Site
City
South Bend
State/Province
Indiana
ZIP/Postal Code
46601
Country
United States
Facility Name
GSK Investigational Site
City
New Orleans
State/Province
Louisiana
ZIP/Postal Code
70114
Country
United States
Facility Name
GSK Investigational Site
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02114
Country
United States
Facility Name
GSK Investigational Site
City
Taunton
State/Province
Massachusetts
ZIP/Postal Code
02780
Country
United States
Facility Name
GSK Investigational Site
City
Portage
State/Province
Michigan
ZIP/Postal Code
49024
Country
United States
Facility Name
GSK Investigational Site
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89128
Country
United States
Facility Name
GSK Investigational Site
City
Bronx
State/Province
New York
ZIP/Postal Code
10461
Country
United States
Facility Name
GSK Investigational Site
City
Brooklyn
State/Province
New York
ZIP/Postal Code
11203
Country
United States
Facility Name
GSK Investigational Site
City
Endicott
State/Province
New York
ZIP/Postal Code
13760
Country
United States
Facility Name
GSK Investigational Site
City
Stony Brook
State/Province
New York
ZIP/Postal Code
11794-8091
Country
United States
Facility Name
GSK Investigational Site
City
Chapel Hill
State/Province
North Carolina
ZIP/Postal Code
27599
Country
United States
Facility Name
GSK Investigational Site
City
Winston-Salem
State/Province
North Carolina
ZIP/Postal Code
27103
Country
United States
Facility Name
GSK Investigational Site
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73112
Country
United States
Facility Name
GSK Investigational Site
City
Tulsa
State/Province
Oklahoma
ZIP/Postal Code
74104
Country
United States
Facility Name
GSK Investigational Site
City
Portland
State/Province
Oregon
ZIP/Postal Code
97210
Country
United States
Facility Name
GSK Investigational Site
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19103
Country
United States
Facility Name
GSK Investigational Site
City
East Providence
State/Province
Rhode Island
ZIP/Postal Code
02914
Country
United States
Facility Name
GSK Investigational Site
City
Memphis
State/Province
Tennessee
ZIP/Postal Code
38104
Country
United States
Facility Name
GSK Investigational Site
City
Memphis
State/Province
Tennessee
ZIP/Postal Code
38120
Country
United States
Facility Name
GSK Investigational Site
City
Austin
State/Province
Texas
ZIP/Postal Code
78746
Country
United States
Facility Name
GSK Investigational Site
City
Fort Worth
State/Province
Texas
ZIP/Postal Code
76104
Country
United States
Facility Name
GSK Investigational Site
City
Georgetown
State/Province
Texas
ZIP/Postal Code
78626
Country
United States
Facility Name
GSK Investigational Site
City
Houston
State/Province
Texas
ZIP/Postal Code
77058
Country
United States
Facility Name
GSK Investigational Site
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78205
Country
United States
Facility Name
GSK Investigational Site
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229
Country
United States
Facility Name
GSK Investigational Site
City
Spokane
State/Province
Washington
ZIP/Postal Code
99204
Country
United States
Facility Name
GSK Investigational Site
City
La Crosse
State/Province
Wisconsin
ZIP/Postal Code
54601
Country
United States
Facility Name
GSK Investigational Site
City
Milwaukee
State/Province
Wisconsin
ZIP/Postal Code
53209-0996
Country
United States
Facility Name
GSK Investigational Site
City
Waukesha
State/Province
Wisconsin
ZIP/Postal Code
53186
Country
United States
Facility Name
GSK Investigational Site
City
Buenos Aires
ZIP/Postal Code
1221
Country
Argentina
Facility Name
GSK Investigational Site
City
Buenos Aires
ZIP/Postal Code
C1114AAP
Country
Argentina
Facility Name
GSK Investigational Site
City
Porto Alegre
State/Province
Rio Grande Do Sul
ZIP/Postal Code
90035-903
Country
Brazil
Facility Name
GSK Investigational Site
City
Porto Alegre
State/Province
Rio Grande Do Sul
ZIP/Postal Code
90470-340
Country
Brazil
Facility Name
GSK Investigational Site
City
Rio de Janeiro
ZIP/Postal Code
20 551-030
Country
Brazil
Facility Name
GSK Investigational Site
City
Edmonton
State/Province
Alberta
ZIP/Postal Code
T6G 2C8
Country
Canada
Facility Name
GSK Investigational Site
City
Winnipeg
State/Province
Manitoba
ZIP/Postal Code
R3C 0N2
Country
Canada
Facility Name
GSK Investigational Site
City
Ottawa
State/Province
Ontario
ZIP/Postal Code
K1S 0G8
Country
Canada
Facility Name
GSK Investigational Site
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5V 2T3
Country
Canada
Facility Name
GSK Investigational Site
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H2L 4P9
Country
Canada
Facility Name
GSK Investigational Site
City
Sainte-Foy
State/Province
Quebec
ZIP/Postal Code
G1V 4G2
Country
Canada
Facility Name
GSK Investigational Site
City
Québec
ZIP/Postal Code
G1S 2L6
Country
Canada
Facility Name
GSK Investigational Site
City
Santiago
State/Province
Región Metro De Santiago
ZIP/Postal Code
7580206
Country
Chile
Facility Name
GSK Investigational Site
City
Santiago
State/Province
Región Metro De Santiago
ZIP/Postal Code
8380456
Country
Chile
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing 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.
Links:
URL
https://www.clinicalstudydatarequest.com
Description
Researchers can use this site to request access to anonymised patient level data and/or supporting documents from clinical studies to conduct further research.
Available IPD and Supporting Information:
Available IPD/Information Type
Dataset Specification
Available IPD/Information URL
https://www.clinicalstudydatarequest.com
Available IPD/Information Identifier
HS2100275
Available IPD/Information Comments
For additional information about this study please refer to the GSK Clinical Study Register
Available IPD/Information Type
Annotated Case Report Form
Available IPD/Information URL
https://www.clinicalstudydatarequest.com
Available IPD/Information Identifier
HS2100275
Available IPD/Information Comments
For additional information about this study please refer to the GSK Clinical Study Register
Available IPD/Information Type
Individual Participant Data Set
Available IPD/Information URL
https://www.clinicalstudydatarequest.com
Available IPD/Information Identifier
HS2100275
Available IPD/Information Comments
For additional information about this study please refer to the GSK Clinical Study Register
Available IPD/Information Type
Study Protocol
Available IPD/Information URL
https://www.clinicalstudydatarequest.com
Available IPD/Information Identifier
HS2100275
Available IPD/Information Comments
For additional information about this study please refer to the GSK Clinical Study Register
Available IPD/Information Type
Clinical Study Report
Available IPD/Information URL
https://www.clinicalstudydatarequest.com
Available IPD/Information Identifier
HS2100275
Available IPD/Information Comments
For additional information about this study please refer to the GSK Clinical Study Register
Available IPD/Information Type
Statistical Analysis Plan
Available IPD/Information URL
https://www.clinicalstudydatarequest.com
Available IPD/Information Identifier
HS2100275
Available IPD/Information Comments
For additional information about this study please refer to the GSK Clinical Study Register
Available IPD/Information Type
Informed Consent Form
Available IPD/Information URL
https://www.clinicalstudydatarequest.com
Available IPD/Information Identifier
HS2100275
Available IPD/Information Comments
For additional information about this study please refer to the GSK Clinical Study Register
Learn more about this trial
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.
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