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Trial record 18 of 126 for:    HSV-2

Randomized Trial to Evaluate Suppressive Effect of High-Dose Valacyclovir Versus Once-Daily Valacyclovir on Persons With HSV-2

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01346475
Recruitment Status : Completed
First Posted : May 3, 2011
Results First Posted : March 9, 2017
Last Update Posted : March 9, 2017
Sponsor:
Collaborator:
GlaxoSmithKline
Information provided by (Responsible Party):
Christine Johnston, University of Washington

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Crossover Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Genital Herpes
Interventions Drug: valacyclovir
Drug: Valacyclovir
Enrollment 50
Recruitment Details Participants recruited from October 2008 to April 2010. Participants recruited at the University of Washington Virology Research Clinic in Seattle, WA.
Pre-assignment Details  
Arm/Group Title Standard-dose Valacyclovir First Then High-dose Valacyclovir High-dose Valacyclovir First Then Standard-dose Valacyclovir
Hide Arm/Group Description Standard-dose valacyclovir (500 mg daily) for 5 weeks followed by 1 week wash-out and then high-dose valacyclovir (1 gram three times daily) for 5 weeks High-dose valacyclovir (1 gram three times daily) for 5 weeks followed by 1 week wash-out and then standard-dose valacyclovir (500 mg daily) for 5 weeks
Period Title: First Intervention
Started 22 28
Completed 18 25
Not Completed 4 3
Reason Not Completed
Lost to Follow-up             4             3
Period Title: Second Intervention
Started 18 25
Completed 18 25
Not Completed 0 0
Arm/Group Title Valacyclovir High Dose Valacyclovir Total
Hide Arm/Group Description [Not Specified] [Not Specified] Total of all reporting groups
Overall Number of Baseline Participants 22 28 50
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 22 participants 28 participants 50 participants
43.9  (9.5) 37.7  (12.8) 40.4  (11.8)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 22 participants 28 participants 50 participants
Female
13
  59.1%
15
  53.6%
28
  56.0%
Male
9
  40.9%
13
  46.4%
22
  44.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 22 participants 28 participants 50 participants
American Indian or Alaska Native
1
   4.5%
0
   0.0%
1
   2.0%
Asian
0
   0.0%
0
   0.0%
0
   0.0%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
3
  13.6%
3
  10.7%
6
  12.0%
White
18
  81.8%
25
  89.3%
43
  86.0%
More than one race
0
   0.0%
0
   0.0%
0
   0.0%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
1.Primary Outcome
Title Frequency of HSV-2 Total Shedding From the Genital Tract as Measured by PCR, Calculated Using a Per-day Shedding Rate in Participants Treated With High-dose Valacyclovir as Compared to Once-daily Valacyclovir.
Hide Description [Not Specified]
Time Frame 11 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Participants who collected at least one swab on each arm of the cross-over were included in the analysis.
Arm/Group Title Standard-dose Valacyclovir (500 mg Daily) High-dose Valacyclovir (1 gm Three Times Daily)
Hide Arm/Group Description:
[Not Specified]
[Not Specified]
Overall Number of Participants Analyzed 43 43
Overall Number of Units Analyzed
Type of Units Analyzed: Swabs
5008 4973
Measure Type: Number
Unit of Measure: percentage of swabs with HSV detected
5 3
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Standard-dose Valacyclovir (500 mg Daily), High-dose Valacyclovir (1 gm Three Times Daily)
Comments This study had 80% power to detect a 50% reduction in HSV genital shedding rates for high-dose valacyclovir compared to standard dose valacyclovir.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method Incident risk ratio
Comments The model is adjusted for period effects.
Method of Estimation Estimation Parameter Incident Risk Ratio
Estimated Value 0.54
Confidence Interval (2-Sided) 95%
0.44 to 0.66
Estimation Comments [Not Specified]
2.Secondary Outcome
Title Quantity of HSV Detected, Median
Hide Description Median quantity of HSV detected, among swabs with any HSV detected
Time Frame 11 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Standard-dose Valacyclovir (500 mg Daily) High-dose Valacyclovir (1 gm Three Times Daily)
Hide Arm/Group Description:
[Not Specified]
[Not Specified]
Overall Number of Participants Analyzed 43 43
Overall Number of Units Analyzed
Type of Units Analyzed: Swabs
292 164
Median (Inter-Quartile Range)
Unit of Measure: log 10 copies/ml
3.0
(2.4 to 4.5)
2.5
(2.3 to 2.7)
3.Secondary Outcome
Title Number of Genital HSV Shedding Episodes
Hide Description The number of HSV shedding episodes. A shedding episode is defined as any number of positive swabs preceded and followed by 2 negative swabs.
Time Frame 11 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Standard-dose Valacyclovir (500 mg Daily) High-dose Valacyclovir (1 gm Three Times Daily)
Hide Arm/Group Description:
[Not Specified]
[Not Specified]
Overall Number of Participants Analyzed 43 43
Measure Type: Number
Unit of Measure: Episodes
58 65
4.Secondary Outcome
Title Duration of Genital HSV Shedding Episodes
Hide Description Median duration of HSV shedding episodes, in hours, among episodes of known duration
Time Frame 11 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Standard-dose Valacyclovir (500 mg Daily) High-dose Valacyclovir (1 gm Three Times Daily)
Hide Arm/Group Description:
[Not Specified]
[Not Specified]
Overall Number of Participants Analyzed 43 43
Overall Number of Units Analyzed
Type of Units Analyzed: Episodes
42 41
Median (Inter-Quartile Range)
Unit of Measure: Hours
10
(7 to 42)
7
(6 to 9)
Time Frame Adverse event data was collected for the 11 week study period.
Adverse Event Reporting Description Adverse event data was collected on 43 participants who completed the trial. In addition, 1 participant who withdrew during the standard dose valacyclovir arm and 1 participant who withdrew during the high dose valacyclovir arm had adverse events, and these data are included in the total number of AEs and participants included.
 
Arm/Group Title Valacyclovir High Dose Valacyclovir
Hide Arm/Group Description [Not Specified] [Not Specified]
All-Cause Mortality
Valacyclovir High Dose Valacyclovir
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Valacyclovir High Dose Valacyclovir
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/44 (0.00%)      0/44 (0.00%)    
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 1%
Valacyclovir High Dose Valacyclovir
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   2/44 (4.55%)      20/44 (45.45%)    
Blood and lymphatic system disorders     
Neutropenia  2/44 (4.55%)  2 2/44 (4.55%)  2
Gastrointestinal disorders     
Nausea  0/44 (0.00%)  0 3/44 (6.82%) 
Musculoskeletal and connective tissue disorders     
myalgia  0/44 (0.00%)  0 2/44 (4.55%)  2
Nervous system disorders     
Headache  0/44 (0.00%)  0 13/44 (29.55%) 
This trial was performed at a single site and enrolled healthy, mostly white adults with frequent genital herpes outbreaks. Whether these finding are generalizable to other populations is unknown.
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.
The only disclosure restriction on the PI is that the sponsor can review and comment on any proposed publication, and all Study results and data reasonably necessary for a meaningful review of the proposed publication are submitted to the sponsor for a period of at least thirty (30) days prior to submitting the publication to any third party.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Dr. Christine Johnston
Organization: University of Washington
Phone: 206-520-4340
EMail: cjohnsto@u.washington.edu
Layout table for additonal information
Responsible Party: Christine Johnston, University of Washington
ClinicalTrials.gov Identifier: NCT01346475     History of Changes
Other Study ID Numbers: 30520-D - Phase 2
First Submitted: April 29, 2011
First Posted: May 3, 2011
Results First Submitted: March 23, 2012
Results First Posted: March 9, 2017
Last Update Posted: March 9, 2017