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Trial record 6 of 126 for:    HSV-2

Evaluating Three Grams Daily Valacyclovir in Patients With Chronic Hepatitis C and HSV-2 Infection (Phase I)

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: NCT01453075
Recruitment Status : Completed
First Posted : October 17, 2011
Results First Posted : November 22, 2016
Last Update Posted : November 22, 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: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition Chronic Hepatitis C Infection
Interventions Drug: Valacyclovir
Drug: Placebo
Enrollment 31
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Arm 1: Valacyclovir Arm 2: Placebo
Hide Arm/Group Description

Assigned patients will take 1.5 mg po valacyclovir twice daily

Valacyclovir: Valacyclovir 1.5 mg po bid

Assigned patients will receiving matching placebo twice daily

Placebo: Matching placebo twice daily

Period Title: Overall Study
Started 16 15
Completed 11 14
Not Completed 5 1
Arm/Group Title Arm 1: Valacyclovir Arm 2: Placebo Total
Hide Arm/Group Description

Assigned patients will take 1.5 mg po valacyclovir twice daily

Valacyclovir: Valacyclovir 1.5 mg po bid

Assigned patients will receiving matching placebo twice daily

Placebo: Matching placebo twice daily

Total of all reporting groups
Overall Number of Baseline Participants 16 15 31
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 16 participants 15 participants 31 participants
58.8  (3.5) 58.8  (3.5) 58.8  (3.5)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 16 participants 15 participants 31 participants
Female
1
   6.3%
2
  13.3%
3
   9.7%
Male
15
  93.8%
13
  86.7%
28
  90.3%
1.Primary Outcome
Title Effect of HSV-2 Suppression on HCV Viral Load.
Hide Description Measure the change in serum HCV viral load at baseline and 12 weeks in patients who have chronic hepatitis C and HSV-2 infection who receive the 3 grams daily valacyclovir versus placebo
Time Frame baseline; 12 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Analyzed patients who completed study
Arm/Group Title Arm 1: Valacyclovir Arm 2: Placebo
Hide Arm/Group Description:

Assigned patients will take 1.5 mg po valacyclovir twice daily

Valacyclovir: Valacyclovir 1.5 mg po bid

Assigned patients will receiving matching placebo twice daily

Placebo: Matching placebo twice daily

Overall Number of Participants Analyzed 11 14
Mean (Standard Error)
Unit of Measure: log(IU/mL)
.18  (.104) .03  (.75)
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Arm 1: Valacyclovir Arm 2: Placebo
Hide Arm/Group Description

Assigned patients will take 1.5 mg po valacyclovir twice daily

Valacyclovir: Valacyclovir 1.5 mg po bid

Assigned patients will receiving matching placebo twice daily

Placebo: Matching placebo twice daily

All-Cause Mortality
Arm 1: Valacyclovir Arm 2: Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Arm 1: Valacyclovir Arm 2: Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   0/16 (0.00%)   0/15 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Arm 1: Valacyclovir Arm 2: Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   0/16 (0.00%)   0/15 (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: VA ORD
Phone: 6013624471 ext 1251
EMail: mary.burton2@va.gov
Layout table for additonal information
Responsible Party: VA Office of Research and Development
ClinicalTrials.gov Identifier: NCT01453075     History of Changes
Obsolete Identifiers: NCT01525342
Other Study ID Numbers: CLIN-001A-10F
1lK2CX00536 ( Other Identifier: VA CSR&D )
VAL115610 ( Other Identifier: VS CSR&D )
First Submitted: October 7, 2011
First Posted: October 17, 2011
Results First Submitted: June 13, 2016
Results First Posted: November 22, 2016
Last Update Posted: November 22, 2016