Study to Evaluate the Safety Tolerability and Acceptability of Long Acting Injections of the Human Immunodeficiency Virus (HIV) Integrase Inhibitor, GSK1265744, in HIV Uninfected Men (ECLAIR)

Inclusion Criteria:

- Non-reactive HIV test at screening or enrollment.

- Males 18 to 65 years old at the time of signing the informed consent.

- At risk of acquiring HIV, defined as having at least one casual sex partner in the
past 24 months.

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

- If participating in sexual activity with a female of child-bearing potential, men must
agree to use condoms. Subjects who are sexual partners of females with child bearing
potential must also agree to practice an acceptable method of contraception for the
duration of the study, such as double barrier (male condom/spermicide, male
condom/diaphragm) or female partner use of hormonal contraception, intrauterine device
(IUD) or other method with published data showing that the lowest expected failure
rate for that is less than 1% per year. All subjects participating in the study must
be counseled on safer sexual practices including the use of effective barrier methods
to minimize risk of HIV transmission.

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

- Willing to undergo all required study procedures

Exclusion Criteria:

- One or more reactive HIV test results at screening or enrollment, even if HIV
infection is not confirmed. Negative HIV Ribonucleic acid (RNA) must also be
documented at screening.

- Assessed by the Investigator of Record or designee as being at "high risk" for HIV
infection. This may include one or more of the following:

The negative partner in an HIV serodiscordant couple Men who exchange sex for goods or
money Men who have engaged in unprotected receptive anal intercourse within the past 6
months Men who have had greater than 3 sexual partners within the past 3 months Men who
have had a sexually transmitted disease within the past 6 months Any other behavior
assessed by the investigator as "high risk"

- Co-enrollment in any other HIV interventional research study (provided by self-report
or other available documentation) or prior enrollment and receipt of the active arm
(i.e., NOT a placebo) of a HIV vaccine trial (provided by available documentation).

- Use of antiretroviral (ARV) therapy (e.g., for Post exposure prophylaxis (PEP) or Pre
exposure prophylaxis (PrEP) in the past 30 days, five half-lives, or twice the
duration of the biological effect of the applied treatment (whichever is longer) prior
to study enrollment.

- Current or chronic history of liver disease, or known hepatic or biliary abnormalities
(with the exception of Gilbert's syndrome or asymptomatic gallstones).

- History of drug or alcohol consumption that in the opinion of the Principal
Investigator will interfere with study participation.

- 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 Medical
Monitor, contraindicates their participation.

- Any of the following laboratory values during the screening period. Positive Hepatitis
C antibody result Positive Hepatitis B surface antigen (HBsAg) Hemoglobin less than 11
gram (g)/deci liter (dL) Absolute neutrophil count less than 750 cells/mm^3 Platelet
count less than or equal to 100,000/mm^3 Presence of a coagulopathy as defined by an
INR greater than 1.5 or a PTT greater than 45sec Calculated creatinine clearance less
than 70 mL/minute using the Cockcroft-Gault equation A single repeat test is allowed
during the Screening period to verify a result, with the exception of HIV tests.

- Subjects with an alanine aminotransferase (ALT), alkaline phosphatase (ALP) or
bilirubin greater than or equal to1.5xULN (isolated bilirubin greater than 1.5xULN is
acceptable if bilirubin is fractionated and direct bilirubin less than 35%).

- History of the following cardiac diseases: myocardial infarction, congestive heart
failure, documented hypertrophic cardiomyopathy, sustained ventricular tachycardia.

- The subject's systolic blood pressure is outside the range of 90-160mmHg, or diastolic
blood pressure is outside the range of 45-90mmHg or heart rate is outside the range of
45-100 beats per minute (bpm).

- Exclusion criteria for screening (ECG (a single repeat is allowed for eligibility
determination) for Male Subjects:

Heart rate (A heart rate from 100 to 110 bpm can be rechecked within 30 minutes to verify
eligibility)-less than 45 and greater than 100 bpm.

QRS duration-greater than 120 msec. QTc interval (B or F)-greater than 450 msec. Evidence
of previous myocardial infarction (does not include ST segment changes associated with
repolarization).

Any conduction abnormality (including but not specific to left or right complete bundle
branch block, AV block [2nd degree or higher], Wolf Parkinson White [WPW] syndrome).

Sinus Pauses greater than 3 seconds. Any significant arrhythmia which, in the opinion of
the principal investigator and medical monitor, will interfere with the safety for the
individual subject.

Non-sustained or sustained ventricular tachycardia (greater than or equal to 3 consecutive
ventricular ectopic beats).

- Ongoing intravenous drug use - episodic use or any use in the past 90 days is
exclusionary (as assessed by the study investigator).

- The subject has a tattoo or other dermatological condition overlying the gluteus
region which may interfere with interpretation of ISRs.

- Use of high dose aspirin or any other anticoagulant or antiplatelet medication that
would interfere with the ability to receive intramuscular injections.

- Active skin disease or disorder (i.e., infection, inflammation, dermatitis, eczema,
drug rash, psoriasis, urticaria). Mild cases of localized acne or folliculitis or
other mild skin condition may not be exclusionary at the discretion of the
Investigator of Record or Medical Monitor).