A Phase IIIb Study of the Safety, Efficacy, and Tolerability of Switching to a Fixed-dose Combination of Abacavir/Dolutegravir/ Lamivudine From Current Antiretroviral Regimen

Inclusion Criteria:

- Be able to understand and comply with protocol requirements, instructions, and
restrictions;

- Be likely to complete the study as planned;

- Be considered appropriate candidates for participation in an investigative clinical
trial with oral medication (e.g., no active substance abuse, acute major organ
disease, or planned long-term work assignments out of the country, etc.).

- Signed and dated written informed consent is obtained from the subject or the
subject's legal representative prior to screening

- HIV-1 infected men or women >=18 years of age;

- A female may be eligible to enter and participate in the study if she: a. Is of
non-childbearing potential either defined as post-menopausal (12 months of
spontaneous amenorrhea and >=45 years of age) or physically incapable of becoming
pregnant with documented tubal ligation, hysterectomy, or bilateral oophorectomy or,

- A female may be eligible to enter and participate in the study if she: b. Is of
childbearing potential with a negative pregnancy test at both Screening and Day 1 and
agrees to use one of the following methods of contraception to avoid pregnancy:
Complete abstinence from intercourse from 2 weeks prior to administration of study
drug, throughout the study, and for at least 2 weeks after discontinuation of all
study drugs; Double barrier method (e.g., male condom/spermicide, male
condom/diaphragm, diaphragm/spermicide); Any intrauterine device (IUD) with published
data showing that the expected failure rate is <1% per year ; Male partner
sterilization prior to the female subject's entry into the study and this male is the
sole partner for that subject; Approved hormonal contraception for subjects randomly
assigned to the ABC/DTG/3TC arm or approved hormonal contraception plus a barrier
method for subjects assigned to continued antiretroviral therapy arm; Any other
method with published data showing that the expected failure rate is <1% per year.

- Any contraception method must be used consistently, in accordance with the approved
product label and for at least 2 weeks after discontinuation of study drug. A
childbearing potential female subject who starts the study using complete abstinence
as her contraceptive method and decides to become sexually active must use the double
barrier method either as a bridge to an approved hormonal contraception (if possible)
or as a method of choice to be maintained from that moment onwards.

- All subjects participating in the study should be counselled on safer sexual
practices including the use of effective barrier methods (e.g., male
condom/spermicide).

- Within the last year, 2 consecutive plasma HIV-1 Ribonucleic acid (RNA) measurements
<50 copies/millilitres (c/mL) and plasma HIV-1 RNA<50 c/mL at Screening (<75 b
Deoxyribonucleic acid [bDNA] is considered equal to <50 c/mL); Subjects who present
at initial screening with a viral load between 50 to 200 c/mL can be retested once
within the screening period.

- Must be on current regimen (whether first or second line Combination antiretroviral
therapy [cART]) for at least 6 months prior to Screening;

- Acceptable stable cART regimens prior to Screening include: • Boosted PI (or
Atazanavir [ATV]) unboosted) + 2 NRTIs, NNRTI + 2 NRTIs, • INI + 2 NRTIs. For
subjects on an INI, their INI at Screening must be RAL or Elvitegravir (EVG)

- Any switch to a second line regimen, defined as change of a single drug or multiple
drugs simultaneously, must have occurred due to tolerability and/or safety concerns.

- Subject must have achieved plasma HIV-1 RNA level <50 c/mL within 6 months of start
of initial cART regimen with no plasma HIV-1 RNA level >200 c/mL following initial
suppression;

- Documentation that the subject is negative for the human leukocyte antigen (HLA)
B*5701 allele;

Exclusion Criteria:

Exclusionary Medical Conditions

- Women who are breastfeeding;

- Any evidence of an active (Centers for Disease Control and Prevention [CDC] Category
C) disease. Exceptions include cutaneous Kaposi's sarcoma not requiring systemic
therapy and historic CD4+ cell counts of <200 cells/cubic millimeter (mm).

- Subjects with any degree of hepatic impairment;

- Subjects positive for hepatitis B virus surface antigen (+HBsAg) at Screening or with
an anticipated need for hepatitis C virus (HCV) therapy during the study;

- History or presence of allergy to the study drugs or their components or drugs of
their class;

- Ongoing malignancy other than cutaneous Kaposi's sarcoma, basal cell carcinoma, or
resected, non-invasive cutaneous squamous cell carcinoma, or cervical intraepithelial
neoplasia; other localized malignancies require agreement between the investigator
and the study medical monitor for inclusion of the subject;

- Subjects who, in the investigator's judgment, pose a significant suicidality risk.
Recent history of suicidal behavior and/or suicidal ideation may be considered as
evidence of serious suicide risk;

Exclusionary Treatments Prior to Screening or Day 1

- Treatment with an HIV-1 immunotherapeutic vaccine within 90 days of Screening;

- Treatment with any of the following agents within 28 days of Screening: radiation
therapy, cytotoxic chemotherapeutic agents, any immunomodulators that alter immune
responses;

- Exposure to an experimental drug or experimental vaccine within either 28 days, 5
half-lives of the test agent, or twice the duration of the biological effect of the
test agent, whichever is longer, prior to the first dose of study drug;

- A history of use of only mono or dual NRTI therapy prior to starting cART;

- Use of etravirine at time of switch;

- Use of DTG at time of switch;

- Subjects receiving any prohibited medication listed in the protocol and who are
unwilling or unable to switch to an alternate medication

Exclusionary Laboratory Values or Clinical Assessments at Screening

- Evidence of primary viral resistance based on the presence of any
resistance-associated major PI or any NRTI, NNRTI, or INI mutation in any prior
resistance genotype assay result;

- Any verified Grade 4 laboratory abnormality, with the exception of Grade 4
triglyceride abnormalities. A single repeat test is allowed during the screening
period to verify a result;

- Any acute laboratory abnormality at Screening, which, in the opinion of the
investigator, would preclude the subject's participation in the study of an
investigational compound;

- Alanine aminotransferase (ALT) >=5 times the upper limit of normal (ULN), or ALT >=3
× ULN and bilirubin >=1.5 × ULN (with >35% direct bilirubin);

- Subject has CrCl of <50 mL/min using Modification of Diet in Renal Disease (MDRD);

- QTc (Bazett) >=450 msec or QTc (Bazett) >=480 msec for subjects with bundle branch
block. The QTc is the QT interval corrected for heart rate according to Bazett's
formula (QTcB). The QTc should be based on a single QTc value electrocardiogram (ECG)
obtained.

- Eligibility of subjects for study participation will be decided by the investigators
after taking into consideration various country specific guidelines, and
notwithstanding the above mentioned minimum inclusion and exclusion criteria.