ID

23718

Beskrivning

NCT00079911 Study ID 100181 Clinical Study ID HS2100181 Study Title: An International, Randomized, Double-Blind, Placebo-Controlled Study of Valaciclovir for the Suppression and Episodic Treatment of Genital HSV Infection in HIV-Infected Persons with CD4+ lymphocyte count <100 cells/mm3. Patient Level Data Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00079911 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 4 Study Recruitment Status: Terminated Generic Name: valaciclovir Trade Name: ZELITREX,Valtrex,RAPIVIR,Novirus Study Indication: Genital Herpes; HIV infection

Nyckelord

Versioner (1)
  1. 2017-07-11 2017-07-11 -
Rättsinnehavare

GlaxoSmithKline

Uppladdad den

11 juli 2017

DOI

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Creative Commons BY-NC 3.0
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GSK Valaciclovir for the Suppression and Episodic Treatment of Genital HSV Infection in HIV-Infected Persons Randomisation Visit INCLUSION AND EXCLUSION CRITERIA NCT00079911

Engelsk

GSK Study Randomisation Visit INCLUSION AND EXCLUSION CRITERIA NCT00079911

1 Formulär  
Study administration
Beskrivning

Study administration

Subject Identifier
Beskrivning

Subject Identifier

Datatyp

integer

Alias
UMLS CUI [1]
C2348585
Visit Date
Beskrivning

Visit Date

Datatyp

date

Måttenheter
  • DD/MMM/YY
Alias
UMLS CUI [1]
C1320303
DD/MMM/YY
ELIGIBILITY QUESTION
Beskrivning

ELIGIBILITY QUESTION

Did the subject meet all the entry criteria?
Beskrivning

If No, v all boxes corresponding to violations of any inclusion/exclusion criteria. Do not enter the subject into the study if they failed any inclusion or exclusion criteria below.

Datatyp

boolean

Alias
UMLS CUI [1]
C1516637
INCLUSION CRITERIA
Beskrivning

INCLUSION CRITERIA

1. Subjects 18 years of age or older.
Beskrivning

full-aged

Datatyp

boolean

Alias
UMLS CUI [1]
C0001779
2. a) nonchildbearing potential
Beskrivning

nonchildbearing potential

Datatyp

boolean

Alias
UMLS CUI [1,1]
C3831118
UMLS CUI [1,2]
C0332197
2. 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 elimination 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 labeling, in peer reviewed studies.
Beskrivning

negative pregnancy test

Datatyp

boolean

Alias
UMLS CUI [1]
C0427780
3. CD4+ lymphocyte count <100cells/mm3 at the screening visit.
Beskrivning

CD4+ lymphocyte count

Datatyp

partialDate

Alias
UMLS CUI [1]
C1277776
4. Documented history of HIV infection.
Beskrivning

human immunodeficiency virus

Datatyp

boolean

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

positive HSV-2 serum antibody

Datatyp

boolean

Alias
UMLS CUI [1]
C1291921
6. 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).
Beskrivning

recurrences of genital HSV or suppressive therapy

Datatyp

boolean

Alias
UMLS CUI [1]
C1274323
UMLS CUI [2,1]
C0319232
UMLS CUI [2,2]
C0013216
7. A signed and dated written informed consent is obtained from the subject or subject's legally acceptable representative prior to study participation.
Beskrivning

informed consent

Datatyp

boolean

Alias
UMLS CUI [1]
C0021430
EXCLUSION CRITERIA
Beskrivning

EXCLUSION CRITERIA

1. Subjects with impaired renal function defined as creatinine clearance <30 ml/min (calculated via central laboratory and/or with the Cockcroft-Gault formula) [Cockcroft, 1976] (see Appendix 2 of the protocol).
Beskrivning

impaired renal function

Datatyp

boolean

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

impaired hepatic function

Datatyp

boolean

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

thrombotic microangiopathies thrombocytopenia purpura hemolytic uremic syndrome

Datatyp

boolean

Alias
UMLS CUI [1]
C2717961
UMLS CUI [2]
C0857305
UMLS CUI [3,1]
C0019061
4. Subjects known to be hypersensitive to VALTREX, ZOVIRAxt (acyclovir), Famvirt (famciclovir), or Cytovenet (ganciclovir).
Beskrivning

hypersensitivity

Datatyp

boolean

Alias
UMLS CUI [1]
C0020517
5. Subjects with HSV-2 isolates known to be resistant to VALTREX, ZOVIRAX (acyclovir), Famvir (famciclovir), or Cytovene (ganciclovir).
Beskrivning

HSV-2 isolates

Datatyp

boolean

Alias
UMLS CUI [1]
C1989245
6. Subjects with malabsorption or vomiting syndrome that might impair pharmacokinetics.
Beskrivning

malabsorption or vomiting syndrome

Datatyp

boolean

Alias
UMLS CUI [1]
C0024523
UMLS CUI [2]
C0014498
7. Females contemplating pregnancy within the duration of the study drug dosing period or 1 week after completion or premature discontinuation from the study.
Beskrivning

child wish

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0032961
UMLS CUI [1,2]
C0747309
8. Females who are pregnant and/or nursing mothers.
Beskrivning

pregnancy

Datatyp

boolean

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

herpes therapy

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0019342
UMLS CUI [1,2]
C0013216
10. Subjects with non-healed genital lesions at randomization.
Beskrivning

genital lesions

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0744369
11. Subjects receiving systemic immunomodulators with anti-herpetic effects. To be el igible for enrollment, subjects receiving such therapy must stop therapy at least 1 week prior to randomization.
Beskrivning

systemic immunomodulators

Datatyp

boolean

Alias
UMLS CUI [1]
C1527392
12. Subjects with active AIDS-indicator conditions, as defined by CDC Category C [Morbidity and Mortality Weekly Report, 1992] (See Appendix 3 of the protocol).
Beskrivning

active AIDS-indicator conditions

Datatyp

boolean

Alias
UMLS CUI [1]
C2368571
13. Subjects with lactose-intolerance enrolled at sites outside North and South America.
Beskrivning

lactose intolerance

Datatyp

boolean

Alias
UMLS CUI [1]
C0022951
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Similar models

GSK Study Randomisation Visit INCLUSION AND EXCLUSION CRITERIA NCT00079911

1 Formulär
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
Alias
Item Group
Study administration
Subject Identifier
Item
Subject Identifier
integer
C2348585 (UMLS CUI [1])
Visit Date
Item
Visit Date
date
C1320303 (UMLS CUI [1])
Item Group
ELIGIBILITY QUESTION
eligibility criteria
Item
Did the subject meet all the entry criteria?
boolean
C1516637 (UMLS CUI [1])
Item Group
INCLUSION CRITERIA
full-aged
Item
1. Subjects 18 years of age or older.
boolean
C0001779 (UMLS CUI [1])
nonchildbearing potential
Item
2. a) nonchildbearing potential
boolean
C3831118 (UMLS CUI [1,1])
C0332197 (UMLS CUI [1,2])
negative pregnancy test
Item
2. 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 elimination 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 labeling, in peer reviewed studies.
boolean
C0427780 (UMLS CUI [1])
CD4+ lymphocyte count
Item
3. CD4+ lymphocyte count <100cells/mm3 at the screening visit.
partialDate
C1277776 (UMLS CUI [1])
human immunodeficiency virus
Item
4. Documented history of HIV infection.
boolean
C0019693 (UMLS CUI [1])
positive HSV-2 serum antibody
Item
5. 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])
recurrences of genital HSV or suppressive therapy
Item
6. 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])
C0319232 (UMLS CUI [2,1])
C0013216 (UMLS CUI [2,2])
informed consent
Item
7. 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
impaired renal function
Item
1. Subjects with impaired renal function defined as creatinine clearance <30 ml/min (calculated via central laboratory and/or with the Cockcroft-Gault formula) [Cockcroft, 1976] (see Appendix 2 of the protocol).
boolean
C1565489 (UMLS CUI [1])
impaired hepatic function
Item
2. Subjects with impaired hepatic function defined as an alanine transaminase (ALT) level >5 times the upper limit of normal.
boolean
C0086565 (UMLS CUI [1])
thrombotic microangiopathies thrombocytopenia purpura hemolytic uremic syndrome
Item
3. 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 [3,1])
hypersensitivity
Item
4. Subjects known to be hypersensitive to VALTREX, ZOVIRAxt (acyclovir), Famvirt (famciclovir), or Cytovenet (ganciclovir).
boolean
C0020517 (UMLS CUI [1])
HSV-2 isolates
Item
5. Subjects with HSV-2 isolates known to be resistant to VALTREX, ZOVIRAX (acyclovir), Famvir (famciclovir), or Cytovene (ganciclovir).
boolean
C1989245 (UMLS CUI [1])
malabsorption or vomiting syndrome
Item
6. Subjects with malabsorption or vomiting syndrome that might impair pharmacokinetics.
boolean
C0024523 (UMLS CUI [1])
C0014498 (UMLS CUI [2])
child wish
Item
7. 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])
C0747309 (UMLS CUI [1,2])
pregnancy
Item
8. Females who are pregnant and/or nursing mothers.
boolean
C0032961 (UMLS CUI [1])
herpes therapy
Item
9. Subjects receiving systemic anti-herpetic therapies. To be eligible for enrollment, subjects on antiherpetic therapy must stop therapy at least 1 week prior to randomization.
boolean
C0019342 (UMLS CUI [1,1])
C0013216 (UMLS CUI [1,2])
genital lesions
Item
10. Subjects with non-healed genital lesions at randomization.
boolean
C0744369 (UMLS CUI [1,1])
systemic immunomodulators
Item
11. Subjects receiving systemic immunomodulators with anti-herpetic effects. To be el igible for enrollment, subjects receiving such therapy must stop therapy at least 1 week prior to randomization.
boolean
C1527392 (UMLS CUI [1])
active AIDS-indicator conditions
Item
12. Subjects with active AIDS-indicator conditions, as defined by CDC Category C [Morbidity and Mortality Weekly Report, 1992] (See Appendix 3 of the protocol).
boolean
C2368571 (UMLS CUI [1])
lactose intolerance
Item
13. Subjects with lactose-intolerance enrolled at sites outside North and South America.
boolean
C0022951 (UMLS CUI [1])
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