ID

23718

Descrizione

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

Keywords

versioni (1)
  1. 11/07/17 11/07/17 -
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GlaxoSmithKline

Caricato su

11 luglio 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

Inglese

GSK Study Randomisation Visit INCLUSION AND EXCLUSION CRITERIA NCT00079911

1 moduli  
Study administration
Descrizione

Study administration

Subject Identifier
Descrizione

Subject Identifier

Tipo di dati

integer

Alias
UMLS CUI [1]
C2348585
Visit Date
Descrizione

Visit Date

Tipo di dati

date

Unità di misura
  • DD/MMM/YY
Alias
UMLS CUI [1]
C1320303
DD/MMM/YY
ELIGIBILITY QUESTION
Descrizione

ELIGIBILITY QUESTION

Did the subject meet all the entry criteria?
Descrizione

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.

Tipo di dati

boolean

Alias
UMLS CUI [1]
C1516637
INCLUSION CRITERIA
Descrizione

INCLUSION CRITERIA

1. Subjects 18 years of age or older.
Descrizione

full-aged

Tipo di dati

boolean

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

nonchildbearing potential

Tipo di dati

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.
Descrizione

negative pregnancy test

Tipo di dati

boolean

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

CD4+ lymphocyte count

Tipo di dati

partialDate

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

human immunodeficiency virus

Tipo di dati

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.
Descrizione

positive HSV-2 serum antibody

Tipo di dati

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).
Descrizione

recurrences of genital HSV or suppressive therapy

Tipo di dati

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.
Descrizione

informed consent

Tipo di dati

boolean

Alias
UMLS CUI [1]
C0021430
EXCLUSION CRITERIA
Descrizione

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).
Descrizione

impaired renal function

Tipo di dati

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.
Descrizione

impaired hepatic function

Tipo di dati

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)].
Descrizione

thrombotic microangiopathies thrombocytopenia purpura hemolytic uremic syndrome

Tipo di dati

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).
Descrizione

hypersensitivity

Tipo di dati

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).
Descrizione

HSV-2 isolates

Tipo di dati

boolean

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

malabsorption or vomiting syndrome

Tipo di dati

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.
Descrizione

child wish

Tipo di dati

boolean

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

pregnancy

Tipo di dati

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.
Descrizione

herpes therapy

Tipo di dati

boolean

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

genital lesions

Tipo di dati

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.
Descrizione

systemic immunomodulators

Tipo di dati

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).
Descrizione

active AIDS-indicator conditions

Tipo di dati

boolean

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

lactose intolerance

Tipo di dati

boolean

Alias
UMLS CUI [1]
C0022951
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Similar models

GSK Study Randomisation Visit INCLUSION AND EXCLUSION CRITERIA NCT00079911

1 moduli
Name
genere
Description | Question | Decode (Coded Value)
Tipo di dati
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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