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Trial record 16 of 126 for:    HSV-2

VALTREX(Valacyclovir) Once Daily for Viral Shedding In Subjects Newly Diagnosed With HSV-2

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ClinicalTrials.gov Identifier: NCT00306293
Recruitment Status : Completed
First Posted : March 23, 2006
Results First Posted : March 23, 2018
Last Update Posted : March 23, 2018
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Crossover Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Treatment
Condition Herpes Labialis
Intervention Drug: valacyclovir
Enrollment 70
Recruitment Details Seventy participants were enrolled at 14 centers in the United States. The study was conducted between 20 February 2006 and 28 November 2006.
Pre-assignment Details Out of the 70 participants 35 participants were randomized to the VALTREX 1 g First then Placebo treatment sequence (VAL-PBO) and 35 participants were randomized to the Placebo first then VALTREX 1 g treatment sequence (PBO-VAL).
Arm/Group Title VALTREX 1 g First Then Placebo Placebo First Then VALTREX 1 g
Hide Arm/Group Description Participants received VALTREX 1 g (2 x500 mg caplets), OD, orally, for 60 days in first period followed by matching placebo 2 caplets, OD, orally, for 60 days in period second period. The two treatment periods were separated by washout period of seven days. Participants received matching placebo 2 caplets, OD, orally, for 60 days in first period followed by VALTREX 1 g (2 x500 mg caplets), OD, orally, for 60 days in second period. The two treatment periods were separated by washout period of seven days.
Period Title: Period 1 (Day 1 to Day 60)
Started 35 35
Completed 27 27
Not Completed 8 8
Reason Not Completed
Adverse Event             1             0
Lost to Follow-up             3             4
Withdrawal by Subject             2             2
Positive pregnancy Test             2             2
Period Title: Washout (Day 61 to Day 66)
Started 27 27
Completed 27 27
Not Completed 0 0
Period Title: Period 2 (Day 67 to Day 126 )
Started 27 27
Completed 24 26
Not Completed 3 1
Reason Not Completed
Adverse Event             1             0
Lost to Follow-up             1             0
Participant determined HSV-2 negative             0             1
Pregnancy             1             0
Arm/Group Title Overall Study
Hide Arm/Group Description Participants received VALTREX 1 g (2 x500 mg caplets) and matching placebo 2 caplets, orally, OD, for 60 days in a two-way crossover design either in sequence VAL-PBO or PBO-VAL. The two treatment periods were separated by washout period of seven days.
Overall Number of Baseline Participants 70
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Year
Number Analyzed 70 participants
30.9  (9.64)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 70 participants
Female
49
  70.0%
Male
21
  30.0%
Race/Ethnicity, Customized  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 70 participants
African American/African Heritage
28
  40.0%
American Indian or Alaska Native
2
   2.9%
Asian - East Asian Heritage
2
   2.9%
White - Arabic/North African Heritage
1
   1.4%
White - White/Caucasian/European Heritage
36
  51.4%
Mixed Race
1
   1.4%
1.Primary Outcome
Title Mean Percent Days of Total Shedding (Clinical and Subclinical) as Determined by Type-specific Polymerase Chain Reaction (PCR) Assay for Herpes Simplex Virus Type 2 (HSV-2)
Hide Description Each participant’s study day were classified as either ‘shedding’ (positive HSV-2 result), ‘no shedding’ (negative HSV-2 result), or ‘unknown’ (swabbing not done or assay result not available) confirmed by PCR. If either the daily genital swab or a lesion swab are positive, the day was classified as ‘shedding’. Study shedding day was classified as either ‘clinical’ (investigator-confirmed presence of genital lesions) or ‘subclinical’ (no genital lesions) by the investigator during recurrence visits. Percent of days with HSV-2 shedding was defined for each participant as the percent of days with PCR data for which HSV-2 shedding was detected by a positive PCR result, i.e., the number of days with HSV-2 PCR shedding divided by total number of days with PCR data, multiplied by 100. Sum of the percent clinical and nonclinical shedding days was reported as total shedding. Mean percent of days with HSV-2 shedding was reported for each treatment group.
Time Frame Up to 60 days in each treatment period (Up to 148 days)
Hide Outcome Measure Data
Hide Analysis Population Description
Intent to Treat Crossover population comprised of all participants in the Intent to Treat population who had at least one PCR swabbing result in each Treatment Period. Intent to Treat population comprised of all participants who received at least one dose of investigational product.
Arm/Group Title VALTREX 1 g, OD Placebo
Hide Arm/Group Description:
Participants received VALTREX 1 g (2 x500 mg caplets), OD, orally, for 60 days in a two-way crossover design either in sequence VAL-PBO or PBO-VAL. The two treatment periods were separated by washout period of seven days.
Participants received matching placebo 2 caplets, OD, orally, for 60 days in a two-way crossover design either in sequence VAL-PBO or PBO-VAL. The two treatment periods were separated by washout period of seven days.
Overall Number of Participants Analyzed 52 52
Mean (Standard Deviation)
Unit of Measure: Percent of days
2.9  (5.6) 13.5  (16.9)
2.Secondary Outcome
Title Mean Percent Days Subclinical Shedding (no Genital Lesions Present)
Hide Description The percent of days with subclinical HSV-2 shedding was defined as the percent of all days with PCR data for which subclinical HSV-2 shedding was detected (shedding in the absence of a genital lesion). Mean percent of days with subclinical HSV-2 shedding was reported for each treatment group. Each participant’s study day was classified as either ‘shedding’ (positive HSV-2 result), ‘no shedding’ (negative HSV-2 result), or ‘unknown’ (swabbing not done or assay result not available) confirmed by PCR. If either the daily genital swab or a lesion swab was positive, the day was classified as ‘shedding’. Study shedding day was classified as either ‘clinical’ (investigator-confirmed presence of genital lesions) or ‘subclinical’ (no genital lesions) by the investigator during recurrence visits.
Time Frame Up to 60 days in each treatment period (Up to 148 days)
Hide Outcome Measure Data
Hide Analysis Population Description
Intent-to-Treat Crossover
Arm/Group Title VALTREX 1 g, OD Placebo
Hide Arm/Group Description:
Participants received VALTREX 1 g (2 x500 mg caplets), OD, orally, for 60 days in a two-way crossover design either in sequence VAL-PBO or PBO-VAL. The two treatment periods were separated by washout period of seven days.
Participants received matching placebo 2 caplets, OD, orally, for 60 days in a two-way crossover design either in sequence VAL-PBO or PBO-VAL. The two treatment periods were separated by washout period of seven days.
Overall Number of Participants Analyzed 52 52
Mean (Standard Deviation)
Unit of Measure: Percentage of days
2.4  (4.8) 11  (15.1)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection VALTREX 1 g, OD, Placebo
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]
Method of Estimation Estimation Parameter Percent change from Placebo
Estimated Value -78
Estimation Comments Percent change in days with Subclinical HSV-2 Viral Shedding after VALTREX 1g treatment from the placebo
3.Secondary Outcome
Title Mean Percent Days Clinical Shedding (Presence of Genital Lesions)
Hide Description The percent of days with clinical HSV-2 shedding was defined as the percent of all days with PCR data for which clinical HSV-2 shedding was detected (shedding in the presence of a genital lesion). Each participant’s study day was classified as either ‘shedding’ (positive HSV-2 result), ‘no shedding’ (negative HSV-2 result), or ‘unknown’ (swabbing not done or assay result not available) confirmed by PCR. If either the daily genital swab or a lesion swab was positive, the day was classified as ‘shedding’. Study shedding day was classified as either ‘clinical’ (investigator-confirmed presence of genital lesions) or ‘subclinical’ (no genital lesions) by the investigator during recurrence visits. Mean percent of days with clinical HSV-2 shedding was reported for each treatment group.
Time Frame Up to 60 days in each treatment period (Up to 148 days)
Hide Outcome Measure Data
Hide Analysis Population Description
Intent-to-Treat Crossover
Arm/Group Title VALTREX 1 g, OD Placebo
Hide Arm/Group Description:
Participants received VALTREX 1 g (2 x500 mg caplets), OD, orally, for 60 days in a two-way crossover design either in sequence VAL-PBO or PBO-VAL. The two treatment periods were separated by washout period of seven days.
Participants received matching placebo 2 caplets, OD, orally, for 60 days in a two-way crossover design either in sequence VAL-PBO or PBO-VAL. The two treatment periods were separated by washout period of seven days.
Overall Number of Participants Analyzed 52 52
Mean (Standard Deviation)
Unit of Measure: Percentage of Days
0.6  (1.7) 2.4  (4.4)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection VALTREX 1 g, OD, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.014
Comments [Not Specified]
Method Wilcoxon Rank Sum
Comments [Not Specified]
Method of Estimation Estimation Parameter Percent change from Baseline
Estimated Value -77
Estimation Comments Percent change in ‘percentage of days with clinical HSV-2 viral shedding', after VALTREX 1g treatment from the placebo
4.Secondary Outcome
Title Percentage of Participants With no Shedding
Hide Description The proportion of participants with no shedding was defined as the number of participants with no HSV-2 shedding detected by PCR divided by the total number of participants with PCR data in the Treatment Period. Each participant’s study day was classified as either ‘shedding’ (positive HSV-2 result), ‘no shedding’ (negative HSV-2 result), or ‘unknown’ (swabbing not done or assay result not available) confirmed by PCR. If either the daily genital swab or a lesion swab was positive, the day was classified as ‘shedding’. Study shedding day was classified as either ‘clinical’ (investigator-confirmed presence of genital lesions) or ‘subclinical’ (no genital lesions) by the investigator during recurrence visits. Mean percent of days with no shedding was reported for each treatment group.
Time Frame Up to 60 days in each treatment period (Up to 148 days)
Hide Outcome Measure Data
Hide Analysis Population Description
Intent-to-Treat Crossover
Arm/Group Title VALTREX 1 g, OD Placebo
Hide Arm/Group Description:
Participants received VALTREX 1 g (2 x500 mg caplets), OD, orally, for 60 days in a two-way crossover design either in sequence VAL-PBO or PBO-VAL. The two treatment periods were separated by washout period of seven days.
Participants received matching placebo 2 caplets, OD, orally, for 60 days in a two-way crossover design either in sequence VAL-PBO or PBO-VAL. The two treatment periods were separated by washout period of seven days.
Overall Number of Participants Analyzed 52 52
Measure Type: Number
Unit of Measure: Percentage of participants
60 29
5.Secondary Outcome
Title Percentage of Participants With at Least One Genital Herpes Recurrence
Hide Description The proportion of participants with at least one genital herpes recurrence was defined as the number of participants with at least one investigator-confirmed genital herpes recurrence divided by the total number of participants with at least one clinic visit in the treatment period.
Time Frame Up to 60 days in each treatment period (Up to 148 days)
Hide Outcome Measure Data
Hide Analysis Population Description
Intent-to-Treat Crossover
Arm/Group Title VALTREX 1 g, OD Placebo
Hide Arm/Group Description:
Participants received VALTREX 1 g (2 x500 mg caplets), OD, orally, for 60 days in a two-way crossover design either in sequence VAL-PBO or PBO-VAL. The two treatment periods were separated by washout period of seven days.
Participants received matching placebo 2 caplets, OD, orally, for 60 days in a two-way crossover design either in sequence VAL-PBO or PBO-VAL. The two treatment periods were separated by washout period of seven days.
Overall Number of Participants Analyzed 52 52
Measure Type: Number
Unit of Measure: Percetage of participants
21 48
6.Secondary Outcome
Title Median Time to First Genital Herpes Recurrence (Days)
Hide Description Time to first genital herpes recurrence was evaluated using Kaplan-Meier estimates of investigator-confirmed genital herpes recurrences censoring the data from participants who prematurely discontinue the study at the time of discontinuation.
Time Frame Up to Day 68
Hide Outcome Measure Data
Hide Analysis Population Description
First Period Efficacy Population included participants in the Intent to Treat Exposed Population and was used for efficacy analyses restricted to the First Treatment Period.
Arm/Group Title VALTREX 1 g First Then Placebo Placebo First Then VALTREX 1 g
Hide Arm/Group Description:
Participants received VALTREX 1 g (2 x500 mg caplets), OD, orally, for 60 days in first period followed by matching placebo 2 caplets, OD, orally, for 60 days in period second period. The two treatment periods were separated by washout period of seven days.
Participants received matching placebo 2 caplets, OD, orally, for 60 days in first period followed by VALTREX 1 g (2 x500 mg caplets), OD, orally, for 60 days in second period. The two treatment periods were separated by washout period of seven days.
Overall Number of Participants Analyzed 33 35
Median (Full Range)
Unit of Measure: Days
NA [1] 
(11 to NA)
61
(4 to 61)
[1]
Genital herpes did not recur in more than half of participants within the first treatment period. The analysis was restricted to Treatment Period I (60 days) + 7 days of Washout Period. Therefore the median and upper limit could not be estimated.
7.Secondary Outcome
Title Number of Participants With Any Adverse Event (AE) and Serious Adverse Event (SAE)
Hide Description 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. SAE include adverse events that result in death, a life-threatening adverse event, inpatient hospitalization or prolongation of existing hospitalization, a persistent or significant incapacity or substantial disruption of the ability to conduct normal functions, or a congenital anomaly/birth defect. Important medical events that may not result in death, be life-threatening, or require hospitalization may be considered serious when, based upon appropriate medical judgment, they may jeopardize the participant and may require medical or surgical intervention to prevent one of the outcomes listed in this definition. No SAEs were reported in this study.
Time Frame Up to 148 days
Hide Outcome Measure Data
Hide Analysis Population Description
Intent to treat exposed population comprised of all participants who received at least one dose of investigational product.
Arm/Group Title VALTREX 1 g, OD Placebo
Hide Arm/Group Description:
Participants received VALTREX 1 g (2 x500 mg caplets), OD, orally, for 60 days in a two-way crossover design either in sequence VAL-PBO or PBO-VAL. The two treatment periods were separated by washout period of seven days.
Participants received matching placebo 2 caplets, OD, orally, for 60 days in a two-way crossover design either in sequence VAL-PBO or PBO-VAL. The two treatment periods were separated by washout period of seven days.
Overall Number of Participants Analyzed 62 62
Measure Type: Count of Participants
Unit of Measure: Participants
Any AE
19
  30.6%
26
  41.9%
Any SAE
0
   0.0%
0
   0.0%
Time Frame AE and SAE were collected from randomization visit (Day 1) until the recurrence visit (Day 148)
Adverse Event Reporting Description Intent-to-Treat Exposed population was used to collect the AEs and SAEs.
 
Arm/Group Title VALTREX 1 g, OD Placebo
Hide Arm/Group Description Participants received VALTREX 1 g (2 x500 mg caplets), OD, orally, for 60 days in a two-way crossover design either in sequence VAL-PBO or PBO-VAL. The two treatment periods were separated by washout period of seven days. Participants received matching placebo 2 caplets, OD, orally, for 60 days in a two-way crossover design either in sequence VAL-PBO or PBO-VAL. The two treatment periods were separated by washout period of seven days.
All-Cause Mortality
VALTREX 1 g, OD Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   0/62 (0.00%)   0/62 (0.00%) 
Show Serious Adverse Events Hide Serious Adverse Events
VALTREX 1 g, OD Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   0/62 (0.00%)   0/62 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
VALTREX 1 g, OD Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   19/62 (30.65%)   26/62 (41.94%) 
Eye disorders     
Abnormal sensation in eye  1  0/62 (0.00%)  1/62 (1.61%) 
Gastrointestinal disorders     
Diarrhoea  1  1/62 (1.61%)  2/62 (3.23%) 
Abdominal pain  1  0/62 (0.00%)  1/62 (1.61%) 
Dental caries  1  0/62 (0.00%)  1/62 (1.61%) 
Paraesthesia oral  1  0/62 (0.00%)  1/62 (1.61%) 
Toothache  1  0/62 (0.00%)  1/62 (1.61%) 
Infections and infestations     
Fungal infection  1  3/62 (4.84%)  6/62 (9.68%) 
Upper respiratory tract infection  1  3/62 (4.84%)  1/62 (1.61%) 
Sinusitis  1  2/62 (3.23%)  1/62 (1.61%) 
Vaginitis bacterial  1  2/62 (3.23%)  1/62 (1.61%) 
Bronchitis  1  2/62 (3.23%)  0/62 (0.00%) 
Ear infection  1  2/62 (3.23%)  0/62 (0.00%) 
Folliculitis  1  1/62 (1.61%)  1/62 (1.61%) 
Urinary tract infection  1  1/62 (1.61%)  1/62 (1.61%) 
Vulvovaginal mycotic infection  1  2/62 (3.23%)  0/62 (0.00%) 
Vulvovaginitis trichomonal  1  0/62 (0.00%)  2/62 (3.23%) 
Anogenital warts  1  0/62 (0.00%)  1/62 (1.61%) 
Cervicitis human papilloma virus  1  0/62 (0.00%)  1/62 (1.61%) 
Hordeolum  1  0/62 (0.00%)  1/62 (1.61%) 
Labyrinthitis  1  1/62 (1.61%)  0/62 (0.00%) 
Onychomycosis  1  1/62 (1.61%)  0/62 (0.00%) 
Pelvic inflammatory disease  1  0/62 (0.00%)  1/62 (1.61%) 
Sialoadenitis  1  0/62 (0.00%)  1/62 (1.61%) 
Injury, poisoning and procedural complications     
Contusion  1  0/62 (0.00%)  2/62 (3.23%) 
Concussion  1  0/62 (0.00%)  1/62 (1.61%) 
Fall  1  0/62 (0.00%)  1/62 (1.61%) 
Muscle strain  1  0/62 (0.00%)  1/62 (1.61%) 
Procedural pain  1  0/62 (0.00%)  1/62 (1.61%) 
Tendon injury  1  1/62 (1.61%)  0/62 (0.00%) 
Investigations     
Alanine aminotransferase increased  1  1/62 (1.61%)  0/62 (0.00%) 
Aspartate aminotransferase increased  1  1/62 (1.61%)  0/62 (0.00%) 
Blood pressure increased  1  1/62 (1.61%)  0/62 (0.00%) 
Smear cervix abnormal  1  1/62 (1.61%)  0/62 (0.00%) 
Metabolism and nutrition disorders     
Anorexia  1  0/62 (0.00%)  1/62 (1.61%) 
Hypercholesterolaemia  1  0/62 (0.00%)  1/62 (1.61%) 
Musculoskeletal and connective tissue disorders     
Muscle spasms  1  0/62 (0.00%)  2/62 (3.23%) 
Pain in extremity  1  0/62 (0.00%)  2/62 (3.23%) 
Back pain  1  0/62 (0.00%)  1/62 (1.61%) 
Musculoskeletal pain  1  0/62 (0.00%)  1/62 (1.61%) 
Neck pain  1  0/62 (0.00%)  1/62 (1.61%) 
Nervous system disorders     
Headache  1  1/62 (1.61%)  2/62 (3.23%) 
Migraine  1  0/62 (0.00%)  1/62 (1.61%) 
Paraesthesia  1  0/62 (0.00%)  1/62 (1.61%) 
Psychiatric disorders     
Depression  1  0/62 (0.00%)  2/62 (3.23%) 
Sleep disorder  1  0/62 (0.00%)  1/62 (1.61%) 
Stress  1  0/62 (0.00%)  1/62 (1.61%) 
Renal and urinary disorders     
Pollakiuria  1  1/62 (1.61%)  0/62 (0.00%) 
Urinary tract disorder  1  0/62 (0.00%)  1/62 (1.61%) 
Reproductive system and breast disorders     
Vulvovaginal discomfort  1  0/62 (0.00%)  1/62 (1.61%) 
Vulvovaginal dryness  1  1/62 (1.61%)  0/62 (0.00%) 
Respiratory, thoracic and mediastinal disorders     
Pharyngolaryngeal pain  1  1/62 (1.61%)  1/62 (1.61%) 
Sinus congestion  1  2/62 (3.23%)  0/62 (0.00%) 
Cough  1  0/62 (0.00%)  1/62 (1.61%) 
Skin and subcutaneous tissue disorders     
Rash  1  0/62 (0.00%)  1/62 (1.61%) 
1
Term from vocabulary, MedDRA
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: NCT00306293     History of Changes
Other Study ID Numbers: VLX105832
First Submitted: March 21, 2006
First Posted: March 23, 2006
Results First Submitted: April 14, 2017
Results First Posted: March 23, 2018
Last Update Posted: March 23, 2018