Informações:
Falhas:
ID
21402
Descrição
NCT00340080 / VIIV-CNA106030 A phase IV, randomised, multicentre, double-blind, study to evaluate the clinical utility of prospective genetic screening (HLA-B*5701) for susceptibility to abacavir hypersensitivity Assessment: Inclusion and Exclusion Criteria Medicine: abacavir, Condition: Infection, Human Immunodeficiency Virus, Phase: 4, Clinical Study ID: CNA106030, Sponsor: ViiV
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Versões (1)
- 19/04/2017 19/04/2017 -
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19 de abril de 2017
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Licença
Creative Commons BY-NC 3.0
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Genetic Screening For HLA-B*5701 in Patients with HIV Inclusion and Exclusion Criteria NCT00340080
Genetic Screening For HLA-B*5701 Inclusion and Exclusion Criteria NCT00340080
Similar models
Genetic Screening For HLA-B*5701 Inclusion and Exclusion Criteria NCT00340080
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de dados
Alias
Item Group
Inclusion and Exclusion Criteria
C0680251 (UMLS CUI-1)
C1512693 (UMLS CUI-2)
C1516637 (UMLS CUI-3)
C1512693 (UMLS CUI-2)
C1516637 (UMLS CUI-3)
Subject Identifier
Item
Subject Identifier
text
C2348585 (UMLS CUI [1])
Visit Date
Item
Visit Date
date
C1320303 (UMLS CUI [1])
Item
Eligibility Question: Did the subject meet all the entry criteria?
text
C1516637 (UMLS CUI [1])
CL Item
Yes (Y)
CL Item
No (N)
Item
Inclusion Criteria: check the boxes corresponding to any of the inclusion criteria the subject failed.
integer
C1512693 (UMLS CUI [1])
Code List
Inclusion Criteria: check the boxes corresponding to any of the inclusion criteria the subject failed.
CL Item
Male or female subjects infected with documented HIV-1 aged 18 years or older. (1)
CL Item
Subjects are ABC-naïve (subjects can be antiretroviral therapy (ART)-naïve or experienced) (2)
CL Item
All subjects must have a clinical need for treatment with ABC or an ABC-containing product that precedes the decision to participate in the study. (3)
CL Item
If subjects are therapy naïve they must meet the criteria for commencing HAART according to local guidelines. (4)
CL Item
ABC and ABC-containing products are not recommended during pregnancy. A female is eligible to enter and participate in the study if she is of: (5)
CL Item
Ability to understand and comply with protocol requirements, instructions and protocol-stated restrictions. (6)
CL Item
Subject is willing and able to understand and provide written informed consent prior to participation in this study (7)
CL Item
Complete abstinence from intercourse from 4 weeks prior to administration of the ABC- containing compound, throughout the study, and for at least 4 weeks after discontinuation of ABC or ABC-containing product. Double barrier method (e.g., male condom/spermicide, male condom/diaphragm, diaphragm/ spermicide). Hormonal contraceptives will not be considered sufficient forms of contraception for this study. Any intrauterine device with published data showing that the expected failure rate is <1% per year. Sterilization (male partner of female subject). (8)
CL Item
Note: All subjects participating in the study should be counselled on the practice of safer sex. (9)
Item
Exclusion Criteria:check the boxes corresponding to any of the exclusion criteria that disqualified the subject from entry.
integer
C0680251 (UMLS CUI [1])
Code List
Exclusion Criteria:check the boxes corresponding to any of the exclusion criteria that disqualified the subject from entry.
CL Item
Has previously received ABC-containing therapy. (1)
CL Item
Satisfies any contraindications or restrictions to ABC therapy as listed in the product labels. Treatment with ABC must be in line with the recommendations of the product label. (2)
CL Item
The subject or any of their healthcare providers is aware of the subjects HLA type. (3)
CL Item
Has undergone an allogeneic bone marrow transplant. (4)
CL Item
Has an active or acute CDC Clinical Category C event at screening. Treatment for the acute event must have been completed at least 30 days prior to Screening. (5)
CL Item
NA (6)
CL Item
Any laboratory abnormality at Screening which, in the opinion of the Investigator, should preclude the subject’s participation in the study. (7)
CL Item
Any laboratory abnormality at Screening which, in the opinion of the Investigator, should preclude the subject’s participation in the study. (7)
CL Item
Pregnant women or women who are breastfeeding. (8)
CL Item
Any immunisation within 30 days prior to Day 1. (9)
CL Item
Subject is, in the opinion of the Investigator, unable to complete the 6 week observation period and the EPT assessments as required. (10)
CL Item
Subject requires treatment with radiation therapy or cytotoxic chemotherapeutic agents within 28 days prior to Screening, or has an anticipated need for these agents within the study period. (11)
CL Item
Subject is enrolled in one or more investigational drug/vaccine protocols. (12)
CL Item
In France, an eligible subject is neither affiliated with nor beneficiary of a social security category (13)