ID
36445
Beskrivning
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.
Länk
https://clinicaltrials.gov/show/NCT01580995
Nyckelord
Versioner (2)
- 2019-01-15 2019-01-15 -
- 2019-05-14 2019-05-14 -
Rättsinnehavare
VA Office of Research and Development
Uppladdad den
14 maj 2019
DOI
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Licens
Creative Commons BY-NC 3.0
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Herpes Simplex Type 1 Suppression in Hepatitis C NCT01580995
Eligibility Criteria
- StudyEvent: Eligibility
Beskrivning
Exclusion Criteria
Alias
- UMLS CUI
- C0680251
Beskrivning
The participant should not have had antiherpes or immunomodulatory therapy during the past 30 day
Datatyp
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
Beskrivning
The participant should not have hiv or chronic hepatitis b infection
Datatyp
boolean
Alias
- UMLS CUI [1]
- C0019693
- UMLS CUI [2]
- C0524909
Beskrivning
The participant should not have decompensated liver disease (ascites, hepatic encephalopathy, coagulopathy, jaundice/icterus)
Datatyp
boolean
Alias
- UMLS CUI [1]
- C4075847
- UMLS CUI [2]
- C0003962
- UMLS CUI [3]
- C0019151
- UMLS CUI [4]
- C0005779
- UMLS CUI [5]
- C0022346
Beskrivning
The participant should not have a creatinine clearance <50 ml/min.
Datatyp
boolean
Alias
- UMLS CUI [1]
- C0373595
Beskrivning
The (female) participant should not be pregnant or nursing
Datatyp
boolean
Alias
- UMLS CUI [1]
- C0032961
- UMLS CUI [2]
- C0006147
Beskrivning
The participant should not have a gastrointestinal disorder which might result in malabsorption of valacyclovir
Datatyp
boolean
Alias
- UMLS CUI [1,1]
- C0017178
- UMLS CUI [1,2]
- C3714745
- UMLS CUI [1,3]
- C0249458
Beskrivning
The participant should not have a history of erythema multiforme major, thrombotic thrombocytopenia purpura or hemolytic uremic syndrome
Datatyp
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
Beskrivning
The participant should not have an allergy to valacyclovir or related drug
Datatyp
boolean
Alias
- UMLS CUI [1,1]
- C0249458
- UMLS CUI [1,2]
- C0020517
Similar models
Eligibility Criteria
- StudyEvent: Eligibility
C0855840 (UMLS CUI [1,2])
C0392762 (UMLS CUI [1,3])
C3830527 (UMLS CUI [1,4])
C0205160 (UMLS CUI [1,2])
C0206679 (UMLS CUI [2,1])
C1446409 (UMLS CUI [2,2])
C0019369 (UMLS CUI [1,2])
C0332185 (UMLS CUI [1,3])
C1963758 (UMLS CUI [2,1])
C0332185 (UMLS CUI [2,2])
C0524909 (UMLS CUI [2])
C0003962 (UMLS CUI [2])
C0019151 (UMLS CUI [3])
C0005779 (UMLS CUI [4])
C0022346 (UMLS CUI [5])
C0006147 (UMLS CUI [2])
C3714745 (UMLS CUI [1,2])
C0249458 (UMLS CUI [1,3])
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])
C0020517 (UMLS CUI [1,2])