Clinical trial NCT02831764 (phase 3, status: active, not recruiting)
Conditions: infection, human immunodeficiency virus, hiv infections
ICD codes: Z21, Z21
Drugs: dolutegravir (dtg), lamivudine (3tc), tenofovir disoproxil fumarate/emtricitabine (tdf/ftc fdc)
SMILES: [H][C@]12CN3C=C(C(=O)NCC4=CC=C(F)C=C4F)C(=O)C(O)=C3C(=O)N1[C@H](C)CCO2, NC1=NC(=O)N(C=C1)[C@@H]1CS[C@H](CO)O1, C[C@H](CN1C=NC2=C1N=CN=C2N)OCP(O)(O)=O
Eligibility criteria:

        Inclusion Criteria:

          -  Must be an HIV 1 infected adult >=18 years of age (or older, if required by local
             regulations) at the time of signing the informed consent

          -  An eligible female subject should not be pregnant (as confirmed by a negative serum
             human chorionic gonadotrophin (hCG) test at Screening and negative urine test at
             Baseline), not lactating, and at least one of the following conditions applies

               -  Non reproductive premenopausal women are those that have undergone documented
                  tubal ligation or documented hysteroscopic tubal occlusion procedure with follow
                  up confirmation of bilateral tubal occlusion or documented bilateral oophorectomy
                  or hysterectomy

               -  Non reproductive premenopausal women are those with 12 months of spontaneous
                  amenorrhea and >=45 years of age

               -  Women with reproductive potential agree to follow one of the protocol-defined
                  methods for avoiding pregnancy

          -  Should have screening plasma HIV 1 RNA levels of 1000 c/mL to <=100,000 c/mL. If an
             independent review of accumulated data from other clinical trials investigating the
             DTG plus 3TC dual regimen is supportive of the DTG plus 3TC treatment regimen,
             enrolment will be opened to subjects with Screening plasma HIV 1 RNA of 1000 c/mL to
             <=500,000 c/mL

          -  Subject should be antiretroviral naïve (defined as <=10 days of prior therapy with any
             antiretroviral agent following a diagnosis of HIV 1 infection). Subjects who received
             HIV post exposure prophylaxis (PEP) or pre exposure prophylaxis (PrEP) in the past are
             allowed as long as the last PEP/PrEP dose was >1 year from HIV diagnosis or there is
             documented HIV seronegativity between the last prophylactic dose and the date of HIV
             diagnosis

          -  Subject or the subject's legal representative capable of giving signed informed
             consent which includes compliance with the requirements and restrictions listed in the
             consent form and the protocol

          -  Subjects enrolled in France: a subject will be eligible for inclusion in this study
             only if either affiliated to or a beneficiary of a social security category

        Exclusion Criteria

          -  Women who are breastfeeding or plan to become pregnant or breastfeed during the study

          -  Any evidence of an active centers for disease control and prevention (CDC) Stage 3
             disease (CDC, 2014), except cutaneous Kaposi's sarcoma not requiring systemic therapy
             and historical or current CD4 cell counts less than 200 cells/mm^3

          -  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

          -  Evidence of hepatitis B virus (HBV) infection or HBV surface antibody (anti-HBs or
             HBsAb) based on:

        Subjects positive for HBV surface antigen (HBsAg) at screening will be excluded Subjects
        negative for HBV core antibody (anti HBs) but positive for anti HBc (negative HBsAg status)
        and positive for HBV deoxyribose nucleic acid (DNA) will be excluded; however, subjects
        positive for anti HBc (negative HBsAg status) and positive for anti HBs (past and/or
        current evidence) are immune to HBV and will not be excluded

          -  Anticipated need for any hepatitis B virus (HCV) therapy during the first 48 weeks of
             the study and for HCV therapy based on interferon or any drugs that have a potential
             for adverse drug:drug interactions with study treatment throughout the entire study
             period

          -  Untreated syphilis infection positive RPR at Screening without clear documentation of
             treatment. Subjects who are at least 14 days post completed treatment are eligible

          -  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, anal or penile
             intraepithelial neoplasia; other localised 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 behaviour 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,

               -  Any systemic immune suppressant

          -  Treatment with any agent, except recognised ART as allowed above, with documented
             activity against HIV 1 in vitro within 28 days of first dose of study treatment

          -  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 treatment

          -  Subjects enrolled in France: the subject has participated in any study using an
             investigational drug during the previous 60 days or 5 half lives, or twice the
             duration of the biological effect of the experimental drug or vaccine, whichever is
             longer, prior to screening for the study or the subject will participate
             simultaneously in another clinical study

          -  Any evidence of pre existing viral resistance based on the presence of any major
             resistance associated mutation in the Screening result or, if known, in any historical
             resistance test result

          -  Any verified Grade 4 laboratory abnormality. 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)

          -  Creatinine clearance of <50 mL/min per 1.73 m^2 via the chronic kidney disease
             epidemiology collaboration (CKD EPI) method