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Trial record 27 of 126 for:    HSV-2

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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ClinicalTrials.gov Identifier: NCT00158860
Recruitment Status : Completed
First Posted : September 12, 2005
Results First Posted : February 15, 2019
Last Update Posted : February 15, 2019
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Single (Investigator);   Primary Purpose: Treatment
Condition Herpes Genitalis
Interventions Drug: Valaciclovir
Drug: Placebo
Enrollment 384
Recruitment Details The study was conducted in 74 centers in the Unites States, Canada, Argentina, Brazil, and Chile.
Pre-assignment Details A total of 384 participants with first recognized episode of genital herpes (GH) were randomized in this study, out of which one participant did not take the study medication, hence, the Intent-to-treat (ITT) population consisted of 383 participants.
Arm/Group Title Placebo Valaciclovir 1g QD
Hide Arm/Group 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). Participants with GH recurrences during the study temporarily discontinued their blinded treatment assignment and received open label valaciclovir 500 mg twice a day (BID) for 3 days after which the double-blind therapy was resumed. 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 with GH recurrences during the study temporarily discontinued their blinded treatment assignment and received open label valaciclovir 500 mg BID for 3 days after which the double-blind therapy was resumed.
Period Title: Overall Study
Started 128 255
Completed 93 184
Not Completed 35 71
Reason Not Completed
Adverse Event             3             6
Lost to Follow-up             11             17
Protocol Violation             8             23
Withdrawal by Subject             7             17
MOVING OUT OF STATE             1             0
Pregnancy             3             3
SPONSOR STOPPED STUDY             2             2
SPONSOR REQUEST             0             1
Lost to Follow up but returned per GSK             0             1
Closed per sponsor             0             1
Arm/Group Title Placebo Valaciclovir 1g QD Total
Hide Arm/Group Description Participants randomized to this treatment arm received matching placebo to valacyclovir 1 g given as 2 x 500 mg caplets QD for 6 months (24 weeks). Participants with GH recurrences during the study temporarily discontinued their blinded treatment assignment and received open label valaciclovir 500 mg BID for 3 days after which the double-blind therapy was resumed. 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 with GH recurrences during the study temporarily discontinued their blinded treatment assignment and received open label valaciclovir 500mg BID for 3 days after which the double-blind therapy was resumed. Total of all reporting groups
Overall Number of Baseline Participants 128 255 383
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 128 participants 255 participants 383 participants
32.2  (11.52) 30.9  (10.48) 31.3  (10.84)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 128 participants 255 participants 383 participants
Female
92
  71.9%
176
  69.0%
268
  70.0%
Male
36
  28.1%
79
  31.0%
115
  30.0%
Race/Ethnicity, Customized  
Measure Type: Count of Participants
Unit of measure:  Participants
Race Number Analyzed 128 participants 255 participants 383 participants
American Hispanic
17
  13.3%
34
  13.3%
51
  13.3%
Arabic/North African
0
   0.0%
2
   0.8%
2
   0.5%
Black
39
  30.5%
84
  32.9%
123
  32.1%
East & South East Asian
0
   0.0%
2
   0.8%
2
   0.5%
White/Caucasian
68
  53.1%
125
  49.0%
193
  50.4%
Unknown
4
   3.1%
8
   3.1%
12
   3.1%
1.Primary Outcome
Title Percentage of Participants With Time to First GH Recurrence
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population was defined as all participants randomized to treatment who were administered at least one dose of investigational product.
Arm/Group Title Placebo Valaciclovir 1g QD
Hide Arm/Group Description:
Participants received double blinded treatment of oral dose of matching placebo to Valacyclovir 1 g given as 2 x 500 mg caplets QD for 6 months (24 weeks). Participants with GH recurrences during the study temporarily discontinued their blinded treatment assignment and received open label valaciclovir 500 mg BID for 3 days after which the double-blind therapy was resumed.
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 with GH recurrences during the study temporarily discontinued their blinded treatment assignment and received open label valaciclovir 500 mg BID for 3 days after which the double-blind therapy was resumed.
Overall Number of Participants Analyzed 128 255
Measure Type: Number
Unit of Measure: Percentage of participants
43 71
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Valaciclovir 1g QD
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method Log Rank
Comments [Not Specified]
Method of Estimation Estimation Parameter Kaplan-Meier estimates
Estimated Value 27.3
Confidence Interval (2-Sided) 95%
16.0 to 38.6
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Placebo, Valaciclovir 1g QD
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method Log Rank
Comments [Not Specified]
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 0.401
Confidence Interval (2-Sided) 95%
0.282 to 0.570
Estimation Comments [Not Specified]
2.Secondary Outcome
Title Mean Number of GH Recurrences Per Month Within the 6-month Study Period
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population. Only those participants available at the specified time points were analyzed.
Arm/Group Title Placebo Valaciclovir 1g QD
Hide Arm/Group Description:
Participants received double blinded treatment of oral dose of matching placebo to valacyclovir 1 g given as 2 x 500 mg caplets QD for 6 months (24 weeks). Participants with GH recurrences during the study temporarily discontinued their blinded treatment assignment and received open label valaciclovir 500 mg BID for 3 days after which the double-blind therapy was resumed.
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 with GH recurrences during the study temporarily discontinued their blinded treatment assignment and received open label valaciclovir 500 mg BID for 3 days after which the double-blind therapy was resumed.
Overall Number of Participants Analyzed 122 227
Mean (Standard Deviation)
Unit of Measure: Number of recurrences
0.48  (1.860) 0.11  (0.254)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Valaciclovir 1g QD
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method Wilcoxon rank sum test
Comments [Not Specified]
3.Secondary Outcome
Title Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population
Arm/Group Title Placebo Valaciclovir 1g QD
Hide Arm/Group Description:
Participants received double blinded treatment of oral dose of matching placebo to valacyclovir 1 g given as 2 x 500 mg caplets QD for 6 months (24 weeks). Participants with GH recurrences during the study temporarily discontinued their blinded treatment assignment and received open label valaciclovir 500 mg BID for 3 days after which the double-blind therapy was resumed.
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 with GH recurrences during the study temporarily discontinued their blinded treatment assignment and received open label valaciclovir 500 mg BID for 3 days after which the double-blind therapy was resumed.
Overall Number of Participants Analyzed 128 255
Measure Type: Count of Participants
Unit of Measure: Participants
Any AEs
98
  76.6%
185
  72.5%
Any SAEs
4
   3.1%
3
   1.2%
4.Secondary Outcome
Title Percentage of Participants With Time to First Oral Herpes Simplex Virus (HSV) Outbreak Within 6-months
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population
Arm/Group Title Placebo Valaciclovir 1g QD
Hide Arm/Group Description:
Participants received double blinded treatment of oral dose of matching placebo to valacyclovir 1 g given as 2 x 500 mg caplets QD for 6 months (24 weeks). Participants with GH recurrences during the study temporarily discontinued their blinded treatment assignment and received open label valaciclovir 500 mg BID for 3 days after which the double-blind therapy was resumed.
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 with GH recurrences during the study temporarily discontinued their blinded treatment assignment and received open label valaciclovir 500 mg BID for 3 days after which the double-blind therapy was resumed.
Overall Number of Participants Analyzed 128 255
Measure Type: Number
Unit of Measure: Percentage of participants
11 14
5.Secondary Outcome
Title Number of Isolates With Resistance to Acyclovir (ACV)
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population.
Arm/Group Title Placebo Valaciclovir 1g QD
Hide Arm/Group Description:
Participants received double blinded treatment of oral dose of matching placebo to valacyclovir 1 g given as 2 x 500 mg caplets QD for 6 months (24 weeks). Participants with GH recurrences during the study temporarily discontinued their blinded treatment assignment and received open label valaciclovir 500 mg BID for 3 days after which the double-blind therapy was resumed.
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 with GH recurrences during the study temporarily discontinued their blinded treatment assignment and received open label valaciclovir 500 mg BID for 3 days after which the double-blind therapy was resumed.
Overall Number of Participants Analyzed 128 255
Measure Type: Number
Unit of Measure: Number of isolates
0 0
Time Frame AEs were collected up to end of study (Day 168).
Adverse Event Reporting Description ITT population was defined as all participants randomized to treatment who were administered at least one dose of investigational product. ITT population was used for reporting adverse event.
 
Arm/Group Title Placebo Valaciclovir 1g QD
Hide Arm/Group Description Participants received double blinded treatment of oral dose of matching placebo to Valacyclovir 1 g given as 2 x 500 mg caplets QD for 6 months (24 weeks). Participants with GH recurrences during the study temporarily discontinued their blinded treatment assignment and received open label valaciclovir 500 mg BID for 3 days after which the double-blind therapy was resumed. 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 with GH recurrences during the study temporarily discontinued their blinded treatment assignment and received open label valaciclovir 500 mg BID for 3 days after which the double-blind therapy was resumed.
All-Cause Mortality
Placebo Valaciclovir 1g QD
Affected / at Risk (%) Affected / at Risk (%)
Total   0/128 (0.00%)   1/255 (0.39%) 
Show Serious Adverse Events Hide Serious Adverse Events
Placebo Valaciclovir 1g QD
Affected / at Risk (%) Affected / at Risk (%)
Total   4/128 (3.13%)   3/255 (1.18%) 
Infections and infestations     
Appendicitis  1  0/128 (0.00%)  1/255 (0.39%) 
Injury, poisoning and procedural complications     
Gun shot wound  1  0/128 (0.00%)  1/255 (0.39%) 
Metabolism and nutrition disorders     
Hypokalaemia  1  1/128 (0.78%)  0/255 (0.00%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
Lymphoma  1  1/128 (0.78%)  0/255 (0.00%) 
Pregnancy, puerperium and perinatal conditions     
Abortion spontaneous  1  2/128 (1.56%)  1/255 (0.39%) 
1
Term from vocabulary, MedDRA version 9.1
Indicates events were collected by systematic assessment
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Placebo Valaciclovir 1g QD
Affected / at Risk (%) Affected / at Risk (%)
Total   75/128 (58.59%)   138/255 (54.12%) 
Gastrointestinal disorders     
Nausea  1  10/128 (7.81%)  11/255 (4.31%) 
Infections and infestations     
Nasopharyngitis  1  13/128 (10.16%)  35/255 (13.73%) 
Herpes simplex  1  8/128 (6.25%)  22/255 (8.63%) 
Vulvovaginal mycotic infection  1  12/128 (9.38%)  16/255 (6.27%) 
Urinary tract infection  1  9/128 (7.03%)  7/255 (2.75%) 
Influenza  1  7/128 (5.47%)  7/255 (2.75%) 
Musculoskeletal and connective tissue disorders     
Back pain  1  6/128 (4.69%)  13/255 (5.10%) 
Nervous system disorders     
Headache  1  39/128 (30.47%)  59/255 (23.14%) 
Reproductive system and breast disorders     
Dysmenorrhoea  1  11/128 (8.59%)  16/255 (6.27%) 
Respiratory, thoracic and mediastinal disorders     
Pharyngolaryngeal pain  1  4/128 (3.13%)  14/255 (5.49%) 
1
Term from vocabulary, MedDRA version 9.1
Indicates events were collected by systematic assessment
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
GSK agreements may vary with individual investigators, but will not prohibit any investigator from publishing. GSK supports the publication of results from all centers of a multi-center trial but requests that reports based on single-site data not precede the primary publication of the entire clinical trial.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: GSK Response Center
Organization: GlaxoSmithKline
Phone: 866-435-7343
Layout table for additonal information
Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT00158860     History of Changes
Other Study ID Numbers: HS2100275
First Submitted: September 8, 2005
First Posted: September 12, 2005
Results First Submitted: July 6, 2017
Results First Posted: February 15, 2019
Last Update Posted: February 15, 2019