ID

36445

Description

Herpes Simplex Type 1 Suppression in Hepatitis C; ODM derived from: https://clinicaltrials.gov/show/NCT01580995 Brief Summary: The purpose of this study is to examine the effects of valacyclovir in patients who have chronic hepatitis C, antibodies to herpes simplex type 1 infection but do not have antibodies to herpes simplex type 2 infection. Herpes simplex type 1 infection commonly causes cold sores or fever blisters, also known as herpes labialis, but most persons do not have any symptoms at all. Valacyclovir is a medication which is approved by the Food and Drug administration to treat herpes labialis. Valacyclovir has not been approved to treat chronic hepatitis C infection. The study will take 16 weeks. Participants will be assigned to take either the study drug, valacyclovir, or a sugar pill that looks exactly like valacyclovir. The researchers and patients will not know which medication they are receiving. Study visits will occur every two weeks and will take approximately 30-45 minutes. All study visits will occur at the G.V. Sonny Montgomery VA Medical Center in Jackson, Mississippi.

Link

https://clinicaltrials.gov/show/NCT01580995

Keywords

Versions (2)
  1. 1/15/19 1/15/19 -
  2. 5/14/19 5/14/19 -
Copyright Holder

VA Office of Research and Development

Uploaded on

May 14, 2019

DOI

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License

Creative Commons BY-NC 3.0
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Herpes Simplex Type 1 Suppression in Hepatitis C NCT01580995

English

Eligibility Criteria

1 forms  
  1. StudyEvent: Eligibility
    1. Eligibility Criteria
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
Does the participant have a chronic hepatitis c infection with a detectable hcv rna in the serum on two occasions, 6 months apart?
Description

The participant has to have a chronic hepatitis c infection with a detectable hcv rna in the serum on two occasions, 6 months apart

Data type

boolean

Alias
UMLS CUI [1,1]
C0524910
UMLS CUI [1,2]
C0855840
UMLS CUI [1,3]
C0392762
UMLS CUI [1,4]
C3830527
Is the participant focus hsv-2 igg negative and focus hsv-1 igg positive, using manufacturer's cut-offs?
Description

The participant should be focus hsv-2 igg negative and focus hsv-1 igg positive, using manufacturer's cut-offs

Data type

boolean

Alias
UMLS CUI [1,1]
C0019351
UMLS CUI [1,2]
C0205160
UMLS CUI [2,1]
C0206679
UMLS CUI [2,2]
C1446409
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
Does the participant have had antiherpes or immunomodulatory therapy during the past 30 days?
Description

The participant should not have had antiherpes or immunomodulatory therapy during the past 30 day

Data type

boolean

Alias
UMLS CUI [1,1]
C1514463
UMLS CUI [1,2]
C0019369
UMLS CUI [1,3]
C0332185
UMLS CUI [2,1]
C1963758
UMLS CUI [2,2]
C0332185
Does the participant have hiv or chronic hepatitis b infection?
Description

The participant should not have hiv or chronic hepatitis b infection

Data type

boolean

Alias
UMLS CUI [1]
C0019693
UMLS CUI [2]
C0524909
Does the participant have decompensated liver disease (ascites, hepatic encephalopathy, coagulopathy, jaundice/icterus)?
Description

The participant should not have decompensated liver disease (ascites, hepatic encephalopathy, coagulopathy, jaundice/icterus)

Data type

boolean

Alias
UMLS CUI [1]
C4075847
UMLS CUI [2]
C0003962
UMLS CUI [3]
C0019151
UMLS CUI [4]
C0005779
UMLS CUI [5]
C0022346
Does the participant have a creatinine clearance <50 ml/min.?
Description

The participant should not have a creatinine clearance <50 ml/min.

Data type

boolean

Alias
UMLS CUI [1]
C0373595
Is the female participant is pregnant or nursing?
Description

The (female) participant should not be pregnant or nursing

Data type

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
Does the participant have a gastrointestinal disorder which might result in malabsorption of valacyclovir?
Description

The participant should not have a gastrointestinal disorder which might result in malabsorption of valacyclovir

Data type

boolean

Alias
UMLS CUI [1,1]
C0017178
UMLS CUI [1,2]
C3714745
UMLS CUI [1,3]
C0249458
Does the participant have a history of erythema multiforme major, thrombotic thrombocytopenia purpura or hemolytic uremic syndrome?
Description

The participant should not have a history of erythema multiforme major, thrombotic thrombocytopenia purpura or hemolytic uremic syndrome

Data type

boolean

Alias
UMLS CUI [1,1]
C0262926
UMLS CUI [1,2]
C0857305
UMLS CUI [2,1]
C0262926
UMLS CUI [2,2]
C0019061
UMLS CUI [3,1]
C0262926
UMLS CUI [3,2]
C3241919
Does the participant have an allergy to valacyclovir or related drug?
Description

The participant should not have an allergy to valacyclovir or related drug

Data type

boolean

Alias
UMLS CUI [1,1]
C0249458
UMLS CUI [1,2]
C0020517
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Similar models

Eligibility Criteria

1 forms
  1. StudyEvent: Eligibility
    1. Eligibility Criteria
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Chronic Hepatitis C
Item
Does the participant have a chronic hepatitis c infection with a detectable hcv rna in the serum on two occasions, 6 months apart?
boolean
C0524910 (UMLS CUI [1,1])
C0855840 (UMLS CUI [1,2])
C0392762 (UMLS CUI [1,3])
C3830527 (UMLS CUI [1,4])
HSV Status
Item
Is the participant focus hsv-2 igg negative and focus hsv-1 igg positive, using manufacturer's cut-offs?
boolean
C0019351 (UMLS CUI [1,1])
C0205160 (UMLS CUI [1,2])
C0206679 (UMLS CUI [2,1])
C1446409 (UMLS CUI [2,2])
Item Group
C0680251 (UMLS CUI)
Prior Treatment
Item
Does the participant have had antiherpes or immunomodulatory therapy during the past 30 days?
boolean
C1514463 (UMLS CUI [1,1])
C0019369 (UMLS CUI [1,2])
C0332185 (UMLS CUI [1,3])
C1963758 (UMLS CUI [2,1])
C0332185 (UMLS CUI [2,2])
HIV and chronic Hepatitis C
Item
Does the participant have hiv or chronic hepatitis b infection?
boolean
C0019693 (UMLS CUI [1])
C0524909 (UMLS CUI [2])
Decompensated liver disease
Item
Does the participant have decompensated liver disease (ascites, hepatic encephalopathy, coagulopathy, jaundice/icterus)?
boolean
C4075847 (UMLS CUI [1])
C0003962 (UMLS CUI [2])
C0019151 (UMLS CUI [3])
C0005779 (UMLS CUI [4])
C0022346 (UMLS CUI [5])
Creatinine Clearance
Item
Does the participant have a creatinine clearance <50 ml/min.?
boolean
C0373595 (UMLS CUI [1])
Pregnancy or Peripartum
Item
Is the female participant is pregnant or nursing?
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
Gastrointestinal disorder
Item
Does the participant have a gastrointestinal disorder which might result in malabsorption of valacyclovir?
boolean
C0017178 (UMLS CUI [1,1])
C3714745 (UMLS CUI [1,2])
C0249458 (UMLS CUI [1,3])
Erythema multiforme major, Thrombotic thrombocytopenia purpura or hemolytic uremic syndrome
Item
Does the participant have a history of erythema multiforme major, thrombotic thrombocytopenia purpura or hemolytic uremic syndrome?
boolean
C0262926 (UMLS CUI [1,1])
C0857305 (UMLS CUI [1,2])
C0262926 (UMLS CUI [2,1])
C0019061 (UMLS CUI [2,2])
C0262926 (UMLS CUI [3,1])
C3241919 (UMLS CUI [3,2])
Valacyclovir allergy
Item
Does the participant have an allergy to valacyclovir or related drug?
boolean
C0249458 (UMLS CUI [1,1])
C0020517 (UMLS CUI [1,2])
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