Genetic Screening For HLA-B*5701 in Patients with HIV Inclusion and Exclusion Criteria NCT00340080

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Yes (Y)

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No (N)

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Male or female subjects infected with documented HIV-1 aged 18 years or older. (1)

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Subjects are ABC-naïve (subjects can be antiretroviral therapy (ART)-naïve or experienced) (2)

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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)

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If subjects are therapy naïve they must meet the criteria for commencing HAART according to local guidelines. (4)

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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)

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Ability to understand and comply with protocol requirements, instructions and protocol-stated restrictions. (6)

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Subject is willing and able to understand and provide written informed consent prior to participation in this study (7)

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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)

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Note: All subjects participating in the study should be counselled on the practice of safer sex. (9)

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Has previously received ABC-containing therapy. (1)

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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)

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The subject or any of their healthcare providers is aware of the subjects HLA type. (3)

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Has undergone an allogeneic bone marrow transplant. (4)

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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)

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NA (6)

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Any laboratory abnormality at Screening which, in the opinion of the Investigator, should preclude the subject’s participation in the study. (7)

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Any laboratory abnormality at Screening which, in the opinion of the Investigator, should preclude the subject’s participation in the study. (7)

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Pregnant women or women who are breastfeeding. (8)

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Any immunisation within 30 days prior to Day 1. (9)

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Subject is, in the opinion of the Investigator, unable to complete the 6 week observation period and the EPT assessments as required. (10)

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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)

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Subject is enrolled in one or more investigational drug/vaccine protocols. (12)

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In France, an eligible subject is neither affiliated with nor beneficiary of a social security category (13)