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Trial record 61 of 126 for:    HSV-2

Herpes Simplex Type 1 Suppression in Hepatitis C (HSV1/HCV)

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: NCT01580995
Recruitment Status : Completed
First Posted : April 19, 2012
Results First Posted : September 21, 2016
Last Update Posted : September 21, 2016
Sponsor:
Collaborator:
GlaxoSmithKline
Information provided by (Responsible Party):
VA Office of Research and Development

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Treatment
Condition Chronic Hepatitis C Infection
Interventions Drug: Valacyclovir
Drug: Placebo
Enrollment 19
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Valacyclovir Placebo
Hide Arm/Group Description

Valacyclovir 500 mg po bid

Valacyclovir: Valacyclovir 500 mg po bid

Matching placebo twice daily

Placebo: Placebo tablet twice daily

Period Title: Overall Study
Started 10 9
Completed 8 7
Not Completed 2 2
Reason Not Completed
Lost to Follow-up             2             2
Arm/Group Title Valacyclovir Placebo Total
Hide Arm/Group Description

Valacyclovir 500 mg po bid

Valacyclovir: Valacyclovir 500 mg po bid

Matching placebo twice daily

Placebo: Placebo tablet twice daily

Total of all reporting groups
Overall Number of Baseline Participants 10 9 19
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 10 participants 9 participants 19 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
10
 100.0%
9
 100.0%
19
 100.0%
>=65 years
0
   0.0%
0
   0.0%
0
   0.0%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 10 participants 9 participants 19 participants
55  (2) 57  (3) 56  (2)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 10 participants 9 participants 19 participants
Female
0
   0.0%
0
   0.0%
0
   0.0%
Male
10
 100.0%
9
 100.0%
19
 100.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 10 participants 9 participants 19 participants
10 9 19
1.Primary Outcome
Title Change in HCV RNA Viral Load
Hide Description Measure change in HCV RNA viral load in treatment group as compared with placebo
Time Frame Baseline, 12 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
patients who completed 12 weeks of follow up
Arm/Group Title Valacyclovir Placebo
Hide Arm/Group Description:

Valacyclovir 500 mg po bid

Valacyclovir: Valacyclovir 500 mg po bid

Matching placebo twice daily

Placebo: Placebo tablet twice daily

Overall Number of Participants Analyzed 8 7
Mean (Standard Deviation)
Unit of Measure: log(IU/mL)
.24  (.20) .08  (.01)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Valacyclovir, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.05
Comments [Not Specified]
Method Fisher Exact
Comments [Not Specified]
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Valacyclovir Placebo
Hide Arm/Group Description

Valacyclovir 500 mg po bid

Valacyclovir: Valacyclovir 500 mg po bid

Matching placebo twice daily

Placebo: Placebo tablet twice daily

All-Cause Mortality
Valacyclovir Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Valacyclovir Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   0/10 (0.00%)   0/9 (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 Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   0/10 (0.00%)   0/9 (0.00%) 
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT 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.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Mary Jane Burton
Organization: VAORD
Phone: 6013624471
EMail: mary.burton2@va.gov
Layout table for additonal information
Responsible Party: VA Office of Research and Development
ClinicalTrials.gov Identifier: NCT01580995     History of Changes
Other Study ID Numbers: CLIN-001C-10F
First Submitted: April 13, 2012
First Posted: April 19, 2012
Results First Submitted: June 13, 2016
Results First Posted: September 21, 2016
Last Update Posted: September 21, 2016