ID

34859

Beschreibung

Study ID: 100181 Clinical Study ID: 100181 Study Title: A Clinical Research Study For The Suppression And Treatment Of Genital Herpes Infection In HIV-Infected Persons Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00079911 Sponsor: GlaxoSmithKline Phase: Phase 4 Study Recruitment Status: Completed Generic Name: valacyclovir hydrochloride Trade Name: Valaciclovir Study Indication: Herpes Simplex Virus (HSV)

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  1. 01.02.19 01.02.19 -
  2. 01.02.19 01.02.19 -
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GlaxoSmithKline

Hochgeladen am

1. Februar 2019

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Suppression And Treatment Of Genital Herpes Infection In HIV-Infected Persons 00079911

Englisch

Eligibility Question

1 Formulare  
  1. StudyEvent: ODM
    1. Eligibility Question
Administrative
Beschreibung

Administrative

Alias
UMLS CUI-1
C1320722
Subject Identifier
Beschreibung

Subject Identifier

Datentyp

integer

Alias
UMLS CUI [1]
C2348585
Visit Date
Beschreibung

Visit Date

Datentyp

date

Alias
UMLS CUI [1]
C1320303
Eligibility Question
Beschreibung

Eligibility Question

Alias
UMLS CUI-1
C1516637
Did the subject meet all the entry criteria?
Beschreibung

If No, check all boxes corresponding to violations of any inclusion/ exclusion criteria.

Datentyp

boolean

Alias
UMLS CUI [1]
C1516637
Inclusion Criteria
Beschreibung

Inclusion Criteria

Alias
UMLS CUI-1
C1512693
Subjects 18 years of age or older
Beschreibung

Subjects 18 years of age or older

Datentyp

boolean

Alias
UMLS CUI [1]
C0001779
A female is eligible to enter and participate in this study if she is of: a) nonchildbearing potential (i.e. physiologically incapable of becoming pregnant including any female who is post- menopausal) b) child- bearing potential, has a negative pregnancy test (urine or serum) at screen and randomization, and agrees with one of the following: - Complete abstinence from intercourse from 2 weeks prior to administration of the study drug, throughout the study, and for 1 week after completion or premature discontinuation from the study (to account for climination of the investigational drug) or, - Female sterilization; or, - Sterilization of male partner; or, - Contraceptive use, either hormonal, chemical or physical that has an accepted pregnancy rate of <1% per year as documented in the product labeling approved by regulatory agencies, or in absence of approved labelling, in peer reviewed studies
Beschreibung

Pregnancy, Childbearing Potential; Sterilization; Postmenopausal state; Contraceptive Use

Datentyp

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C3831118
UMLS CUI [3]
C0015787
UMLS CUI [4]
C0232970
UMLS CUI [5]
C1999124
CD4+ lymphocyte count <100cells/ mm3 at the creening visit
Beschreibung

CD4+ lymphocyte count

Datentyp

boolean

Alias
UMLS CUI [1]
C1277776
Documented history of HIV infection
Beschreibung

Documented history of HIV infection

Datentyp

boolean

Alias
UMLS CUI [1]
C0019693
Subjects with a positive HSV-2 serum antibody result, as determined by Western Blot or immunoblot at the screening visit
Beschreibung

Positive HSV-2 serum antibody result

Datentyp

boolean

Alias
UMLS CUI [1,1]
C1291921
UMLS CUI [1,2]
C1446409
UMLS CUI [2]
C0005863
UMLS CUI [3]
C0020985
UMLS CUI [4]
C0545082
Subjects experiencing 3 or more recurrences of genital HSV in the previous 12 months, or if the subject is on suppressive therapy for a herpes virus, then having experienced 3 or more recurrences of genital HSV per year in the period prior to the initiation of chronic suppressive therapy (chronic suppressive therapy is defined as therapy of at least 12 weeks duration)
Beschreibung

Recurrences of genital HSV; suppressive therapy

Datentyp

boolean

Alias
UMLS CUI [1]
C1274323
UMLS CUI [2,1]
C0087111
UMLS CUI [2,2]
C0205367
A signed and dated written informed consent is obtained from the subject or subject's legally acceptable representative prior to study participation.
Beschreibung

Signed and dated written informed consent

Datentyp

boolean

Alias
UMLS CUI [1]
C0021430
Exclusion criteria
Beschreibung

Exclusion criteria

Alias
UMLS CUI-1
C0680251
Subjects with impaired renal function defined as creatinine clearance <30 ml/min (calculated via central laboratory and/or with the Cockcroft- Gault formula)
Beschreibung

Impaired renal function; creatinine clearance

Datentyp

boolean

Alias
UMLS CUI [1,1]
C1565489
UMLS CUI [1,2]
C0373595
UMLS CUI [1,3]
C2711451
Subjects with impaired hepatic function defined as an alanine transaminase (ALT) level >5 times the upper limit of normal.
Beschreibung

Iimpaired hepatic function; alanine transaminase (ALT)

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0086565
UMLS CUI [1,2]
C0201836
Subjects who have or have had a diagnosis of thrombotic microangiopathies [e.g., thrombotic thrombocytopenia purpura (TTP) and/ or hemolytic uremic syndrome (HUS)]
Beschreibung

Thrombotic microangiopathies ; Thrombotic thrombocytopenia purpura; Hemolytic uremic syndrome

Datentyp

boolean

Alias
UMLS CUI [1]
C2717961
UMLS CUI [2]
C0857305
UMLS CUI [3]
C0019061
Subjects known to be hypersensitive to VALTREX, ZOVIRAX (acyclovir), Famvir (famciclovir), or Cytovene (ganciclovir).
Beschreibung

Hypersensitive to VALTREX, ZOVIRAX (acyclovir), Famvir (famciclovir), or Cytovene (ganciclovir)

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0020517
UMLS CUI [1,2]
C0001367
UMLS CUI [2,1]
C0020517
UMLS CUI [2,2]
C0209227
UMLS CUI [3,1]
C0020517
UMLS CUI [3,2]
C0017066
Subjects with HSV-2 isolates known to be resistent to VALTREX, ZOVIRAX (acyclovir), Famvir (famciclovir), or Cytovene (ganciclovir).
Beschreibung

HSV-2 isolates known to be resistent to VALTREX, ZOVIRAX (acyclovir), Famvir (famciclovir), or Cytovene (ganciclovir)

Datentyp

boolean

Alias
UMLS CUI [1,1]
C1989245
UMLS CUI [1,2]
C0205269
UMLS CUI [1,3]
C0001367
UMLS CUI [2,1]
C1989245
UMLS CUI [2,2]
C0205269
UMLS CUI [2,3]
C0209227
UMLS CUI [3,1]
C1989245
UMLS CUI [3,2]
C0205269
UMLS CUI [3,3]
C0017066
Subjects with malabsorption or vomiting syndrome that might impair pharmacokinetics.
Beschreibung

Subjects with malabsortion or vomiting syndrome that might impair pharmacokinetics.

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0024523
UMLS CUI [1,2]
C0031328
UMLS CUI [2,1]
C0042963
UMLS CUI [2,2]
C0031328
Females contemplating pregnancy within the duration of the study drug dosing period or 1 week after completion or premature discontinuation from the study
Beschreibung

Females contemplating pregnancy

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0032961
UMLS CUI [1,2]
C1277196
UMLS CUI [1,3]
C0678766
UMLS CUI [1,4]
C2347804
Females who are pregnant and/ or nursing mothers
Beschreibung

Females who are pregnant and/ or nursing mothers

Datentyp

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
Subjects receiving systemic anti- herpetic therapies. To be eligible for enrollment , subjects on anti- herpetic therapy must stop therapy at least 1 week prior to randomization.
Beschreibung

Systemic anti- herpetic therapies

Datentyp

boolean

Alias
UMLS CUI [1,1]
C1579418
UMLS CUI [1,2]
C1515119
Subjects with non- healed genital lesions at randomization.
Beschreibung

Subjects with non- healed genital lesions at randomization.

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0744369
UMLS CUI [1,2]
C0750433
UMLS CUI [2]
C0034656
Subjects receiving systemic immunomodulators with anti-herpetic effects. To be eligible for enrollment, subjects receiving such therapy must stop therapy at least 1 week prior to randomization.
Beschreibung

Systemic immunomodulators with anti-herpetic effects

Datentyp

boolean

Alias
UMLS CUI [1,1]
C1527392
UMLS CUI [1,2]
C1515119
UMLS CUI [1,3]
C1579418
Subjects with active AIDS- indicator conditions, as defined by CDC Category C.
Beschreibung

Subjects with active AIDS- indicator conditions, as defined by CDC Category C.

Datentyp

boolean

Alias
UMLS CUI [1]
C3888531
Subjects with lactose- intolerance enrolled at sites outside North and South America
Beschreibung

Subjects with lactose- intolerance enrolled at sites outside North and South America

Datentyp

boolean

Alias
UMLS CUI [1]
C0022951
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Ähnliche Modelle

Eligibility Question

1 Formulare
  1. StudyEvent: ODM
    1. Eligibility Question
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
Item Group
Administrative
C1320722 (UMLS CUI-1)
Subject Identifier
Item
Subject Identifier
integer
C2348585 (UMLS CUI [1])
Visit Date
Item
Visit Date
date
C1320303 (UMLS CUI [1])
Item Group
Eligibility Question
C1516637 (UMLS CUI-1)
Did the subject meet all the entry criteria?
Item
Did the subject meet all the entry criteria?
boolean
C1516637 (UMLS CUI [1])
Item Group
Inclusion Criteria
C1512693 (UMLS CUI-1)
Subjects 18 years of age or older
Item
Subjects 18 years of age or older
boolean
C0001779 (UMLS CUI [1])
Pregnancy, Childbearing Potential; Sterilization; Postmenopausal state; Contraceptive Use
Item
A female is eligible to enter and participate in this study if she is of: a) nonchildbearing potential (i.e. physiologically incapable of becoming pregnant including any female who is post- menopausal) b) child- bearing potential, has a negative pregnancy test (urine or serum) at screen and randomization, and agrees with one of the following: - Complete abstinence from intercourse from 2 weeks prior to administration of the study drug, throughout the study, and for 1 week after completion or premature discontinuation from the study (to account for climination of the investigational drug) or, - Female sterilization; or, - Sterilization of male partner; or, - Contraceptive use, either hormonal, chemical or physical that has an accepted pregnancy rate of <1% per year as documented in the product labeling approved by regulatory agencies, or in absence of approved labelling, in peer reviewed studies
boolean
C0032961 (UMLS CUI [1])
C3831118 (UMLS CUI [2])
C0015787 (UMLS CUI [3])
C0232970 (UMLS CUI [4])
C1999124 (UMLS CUI [5])
CD4+ lymphocyte count
Item
CD4+ lymphocyte count <100cells/ mm3 at the creening visit
boolean
C1277776 (UMLS CUI [1])
Documented history of HIV infection
Item
Documented history of HIV infection
boolean
C0019693 (UMLS CUI [1])
Positive HSV-2 serum antibody result
Item
Subjects with a positive HSV-2 serum antibody result, as determined by Western Blot or immunoblot at the screening visit
boolean
C1291921 (UMLS CUI [1,1])
C1446409 (UMLS CUI [1,2])
C0005863 (UMLS CUI [2])
C0020985 (UMLS CUI [3])
C0545082 (UMLS CUI [4])
Recurrences of genital HSV; suppressive therapy
Item
Subjects experiencing 3 or more recurrences of genital HSV in the previous 12 months, or if the subject is on suppressive therapy for a herpes virus, then having experienced 3 or more recurrences of genital HSV per year in the period prior to the initiation of chronic suppressive therapy (chronic suppressive therapy is defined as therapy of at least 12 weeks duration)
boolean
C1274323 (UMLS CUI [1])
C0087111 (UMLS CUI [2,1])
C0205367 (UMLS CUI [2,2])
Signed and dated written informed consent
Item
A signed and dated written informed consent is obtained from the subject or subject's legally acceptable representative prior to study participation.
boolean
C0021430 (UMLS CUI [1])
Item Group
Exclusion criteria
C0680251 (UMLS CUI-1)
Impaired renal function; creatinine clearance
Item
Subjects with impaired renal function defined as creatinine clearance <30 ml/min (calculated via central laboratory and/or with the Cockcroft- Gault formula)
boolean
C1565489 (UMLS CUI [1,1])
C0373595 (UMLS CUI [1,2])
C2711451 (UMLS CUI [1,3])
Iimpaired hepatic function; alanine transaminase (ALT)
Item
Subjects with impaired hepatic function defined as an alanine transaminase (ALT) level >5 times the upper limit of normal.
boolean
C0086565 (UMLS CUI [1,1])
C0201836 (UMLS CUI [1,2])
Thrombotic microangiopathies ; Thrombotic thrombocytopenia purpura; Hemolytic uremic syndrome
Item
Subjects who have or have had a diagnosis of thrombotic microangiopathies [e.g., thrombotic thrombocytopenia purpura (TTP) and/ or hemolytic uremic syndrome (HUS)]
boolean
C2717961 (UMLS CUI [1])
C0857305 (UMLS CUI [2])
C0019061 (UMLS CUI [3])
Hypersensitive to VALTREX, ZOVIRAX (acyclovir), Famvir (famciclovir), or Cytovene (ganciclovir)
Item
Subjects known to be hypersensitive to VALTREX, ZOVIRAX (acyclovir), Famvir (famciclovir), or Cytovene (ganciclovir).
boolean
C0020517 (UMLS CUI [1,1])
C0001367 (UMLS CUI [1,2])
C0020517 (UMLS CUI [2,1])
C0209227 (UMLS CUI [2,2])
C0020517 (UMLS CUI [3,1])
C0017066 (UMLS CUI [3,2])
HSV-2 isolates known to be resistent to VALTREX, ZOVIRAX (acyclovir), Famvir (famciclovir), or Cytovene (ganciclovir)
Item
Subjects with HSV-2 isolates known to be resistent to VALTREX, ZOVIRAX (acyclovir), Famvir (famciclovir), or Cytovene (ganciclovir).
boolean
C1989245 (UMLS CUI [1,1])
C0205269 (UMLS CUI [1,2])
C0001367 (UMLS CUI [1,3])
C1989245 (UMLS CUI [2,1])
C0205269 (UMLS CUI [2,2])
C0209227 (UMLS CUI [2,3])
C1989245 (UMLS CUI [3,1])
C0205269 (UMLS CUI [3,2])
C0017066 (UMLS CUI [3,3])
Subjects with malabsortion or vomiting syndrome that might impair pharmacokinetics.
Item
Subjects with malabsorption or vomiting syndrome that might impair pharmacokinetics.
boolean
C0024523 (UMLS CUI [1,1])
C0031328 (UMLS CUI [1,2])
C0042963 (UMLS CUI [2,1])
C0031328 (UMLS CUI [2,2])
Females contemplating pregnancy
Item
Females contemplating pregnancy within the duration of the study drug dosing period or 1 week after completion or premature discontinuation from the study
boolean
C0032961 (UMLS CUI [1,1])
C1277196 (UMLS CUI [1,2])
C0678766 (UMLS CUI [1,3])
C2347804 (UMLS CUI [1,4])
Females who are pregnant and/ or nursing mothers
Item
Females who are pregnant and/ or nursing mothers
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
Systemic anti- herpetic therapies
Item
Subjects receiving systemic anti- herpetic therapies. To be eligible for enrollment , subjects on anti- herpetic therapy must stop therapy at least 1 week prior to randomization.
boolean
C1579418 (UMLS CUI [1,1])
C1515119 (UMLS CUI [1,2])
Subjects with non- healed genital lesions at randomization.
Item
Subjects with non- healed genital lesions at randomization.
boolean
C0744369 (UMLS CUI [1,1])
C0750433 (UMLS CUI [1,2])
C0034656 (UMLS CUI [2])
Systemic immunomodulators with anti-herpetic effects
Item
Subjects receiving systemic immunomodulators with anti-herpetic effects. To be eligible for enrollment, subjects receiving such therapy must stop therapy at least 1 week prior to randomization.
boolean
C1527392 (UMLS CUI [1,1])
C1515119 (UMLS CUI [1,2])
C1579418 (UMLS CUI [1,3])
Subjects with active AIDS- indicator conditions, as defined by CDC Category C.
Item
Subjects with active AIDS- indicator conditions, as defined by CDC Category C.
boolean
C3888531 (UMLS CUI [1])
Subjects with lactose- intolerance enrolled at sites outside North and South America
Item
Subjects with lactose- intolerance enrolled at sites outside North and South America
boolean
C0022951 (UMLS CUI [1])
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