CL Item

Yes (Y)

CL Item

No (N)

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)

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)