Clinical trial NCT02227238 (phase 3, status: active, not recruiting)
Conditions: hiv infections
ICD codes: Z21
Drugs: dtg, lpv/rtv, two nrtis
SMILES: [H][C@]12CN3C=C(C(=O)NCC4=CC=C(F)C=C4F)C(=O)C(O)=C3C(=O)N1[C@H](C)CCO2, CC(C)[C@H](N1CCCNC1=O)C(=O)N[C@H](C[C@H](O)[C@H](CC1=CC=CC=C1)NC(=O)COC1=C(C)C=CC=C1C)CC1=CC=CC=C1
Eligibility criteria:

        Inclusion Criteria:

          -  HIV-1 infected subjects >=18 years of age.

          -  A female subject may be eligible to enter and participate in the study if she:

        is of non-childbearing potential defined as either 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, is of
        child-bearing potential, with a negative pregnancy test at both Screening and Day 1 and
        agrees to use one of the protocol-defined methods of contraception to avoid pregnancy
        throughout the study and for at least 2 weeks after discontinuation of all study
        medication.

          -  HIV-1 infection as documented by HIV-1 RNA >=400 c/mL at Screening.

          -  Subject has been on a first-line treatment regimen consisting of an NNRTI plus two
             NRTIs for at least 6 months and is currently experiencing virologic failure to this
             first-line regimen defined as two consecutive (>=7 days apart) HIV-1 RNA results of
             >=400 c/mL.

          -  Subjects must receive at least one fully active agent within the dual-NRTI background
             regimen for second line treatment. Fully active is defined by the Screening genotypic
             resistance report of the central laboratory (or a laboratory contracted by the central
             laboratory) showing no evidence of full or of partial resistance for a given NRTI
             which will be taken on study.

          -  Subject is PI-naïve and Integrase inhibitor (INI)-naïve, defined as no prior or
             current exposure to any PI or INI.

          -  Subject or the subject's legal representative is willing and able to understand and
             provide signed and dated written informed consent prior to screening.

        Exclusion Criteria:

          -  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 or current CD4+ cell levels <200 cells per cubic millimeter

          -  Subjects with severe hepatic impairment (Class C) as determined by Child-Pugh
             classification

          -  Unstable liver disease (as defined by the presence of ascites, encephalopathy,
             coagulopathy, hypoalbuminaemia, oesophageal or gastric varices, or persistent
             jaundice), cirrhosis, known biliary abnormalities (with the exception of Gilbert's
             syndrome or asymptomatic gallstones).

          -  Anticipated need for hepatitis C virus (HCV) therapy during the Randomized Phase of
             the study.

          -  History or presence of allergy or intolerance 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, poses a significant suicidality risk.
             Recent history of suicidal behavior and/or suicidal ideation may be considered as
             evidence of serious suicide risk.

          -  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, systemically administered
             immunomodulators.

          -  Treatment with any agent, other than licensed ART as allowed above with documented
             activity against HIV-1 in vitro/vivo within 28 days of first dose of IP. The exception
             is use of entecavir, in appropriate clinical situations, for treatment of hepatitis B
             [e.g. prior intolerance to Tenofovir (TDF), viral resistance to lamivudine (3TC) /
             Emtricitabine (FTC)] after discussion and agreement between the investigator and the
             medical monitor.

          -  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 IP.

          -  Any evidence of primary viral resistance to PIs or INIs based on the presence of any
             major resistance-associated mutation.

          -  The subject's virus does not yield results using genotype at Screening (assay data is
             essential for eligibility determination).

          -  Any verified Grade 4 laboratory abnormality, with the exception of Grade 4
             triglycerides. 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
             >=3xULN and bilirubin >=1.5xULN (with >35% direct bilirubin)