GSK1349572 Drug Interaction Study With Efavirenz

ViiV Healthcare is the new sponsor of this study, and GlaxoSmithKline is in the process of
updating systems to reflect the change in sponsorship.

Inclusion Criteria:

- AST, ALT, alkaline phosphatase and bilirubin less than or equal to 1.5xULN (isolated
bilirubin >1.5xULN is acceptable if bilirubin is fractionated and direct bilirubin
<35%).

- Healthy as determined by a responsible and experienced physician, based on a medical
evaluation including medical history, physical examination, laboratory tests and
cardiac monitoring.

- Male or female between 18 and 65 years of age inclusive, at the time of signing the
informed consent.

- A female subject is eligible to participate if she is of: Non-childbearing potential
defined as pre-menopausal females with a documented tubal ligation or hysterectomy; or
postmenopausal defined as 12 months of spontaneous amenorrhea [in questionable cases a
blood sample with simultaneous follicle stimulating hormone (FSH) > 40 MlU/ml and
estradiol < 40 pg/ml (<147 pmol/L) is confirmatory].

- Body weight greater than or equal to 50 kg for males and 45 kg for females and BMI
within the range 18.5- 31.0 kg/m2 (inclusive).

- Capable of giving written informed consent, which includes compliance with the
requirements and restrictions listed in the consent form.

Exclusion Criteria:

- The subject has a positive pre-study drug/alcohol screen. A minimum list of drugs that
will be screened for include amphetamines, barbiturates, cocaine, opiates,
cannabinoids and benzodiazepines.

- The subject has participated in a clinical trial and has received an investigational
product within the following time period prior to the first dosing day in the current
study: 30 days, 5 half-lives or twice the duration of the biological effect of the
investigational product (whichever is longer).

- History of sensitivity to any of the study medications, or components thereof, or a
history of drug or other allergy that, in the opinion of the investigator or GSK
Medical Monitor, contraindicates their participation.

- Use of prescription or non-prescription drugs, including vitamins, herbal and dietary
supplements (including St John's Wort) within 7 days (or 14 days if the drug is a
potential enzyme inducer) or 5 half-lives (whichever is longer) prior to the first
dose of study medication, unless in the opinion of the Investigator and GSK Medical
Monitor the medication will not interfere with the study procedures or compromise
subject safety.

- If heparin is used during PK sampling, subjects with a history of sensitivity to
heparin or heparin-induced thrombocytopenia should not be enrolled.

- History of regular alcohol consumption within 6 months of the study defined as an
average weekly intake of >14 drinks/week for men or >7 drinks/week for women. One
drink is equivalent to (12 g alcohol) = 5 ounces (150 ml) of wine or 12 ounces (360
ml) of beer or 1.5 ounces (45 ml) of 80 proof distilled spirits.

- Has a history or regular use of tobacco- or nicotine-containing products within 3
months prior to screening.

- Consumption of red wine, seville oranges, grapefruit or grapefruit juice from 7 days
prior to the first dose of study medication.

- Pregnant females as determined by positive serum or urine human chorionic
gonadotrophin (hCG) test at screening or prior to dosing.

- Lactating females.

- Unwillingness or inability to follow the procedures outlined in the protocol.

- Subjects with a pre-existing condition interfering with normal gastrointestinal
anatomy or motility, hepatic and/or renal function, that could interfere with the
absorption, metabolism, and/or excretion of the study drugs. Subjects with a history
of cholecystectomy, peptic ulceration, inflammatory bowel disease or pancreatitis
should be excluded.

- History/evidence of symptomatic arrhythmia, angina/ischemia, coronary artery bypass
grafting (CABG) surgery or percutaneous transluminal coronary angioplasty (PCTA) or
any clinically significant cardiac disease.

- History/evidence of clinically significant pulmonary disease.

- History of significant renal or hepatobiliary diseases. Subjects with a history of
nephrolithiasis will be excluded.

- History of severe or serious psychiatric disease ever requiring hospitalization,
history of suicidal ideation or suicidal attempt, or undergoing psychiatric treatment
will be excluded from study participation.

- A positive pre-study Hepatitis B surface antigen or positive Hepatitis C antibody
result within 3 months of screening.

- A positive test for HIV antibody.

- History of 2nd degree or higher AV block.

- History of Gilbert's disease.

- Where participation in the study would result in donation of blood or blood products
in excess of 500 mL within a 56 day period.

- The subject's systolic blood pressure is outside the range of 90-140mmHg, or diastolic
blood pressure is outside the range of 45-90mmHg or heart rate is outside the range of
50-100bpm for female subjects or 45-100 bpm for male subjects.

- Exclusion criteria for screening ECG per protocol