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 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 =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 =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.