Clinical trial NCT02397096 (phase 3, status: active, not recruiting)
Conditions: hiv-1 infection
ICD codes: B20, Z71.7, O98.72, Z21, O98.73, R75, Z11.4
Drugs: doravirine, tenofovir, lamivudine, baseline regimen of ritonavir- or cobicistat-boosted protease inhibitor, baseline regimen of cobicistat-boosted elvitegravir, baseline regimen of a non-nucleoside reverse transcriptase inhibitor, baseline regimen of two nucleoside reverse transcriptase inhibitors
SMILES: CC1=CN([C@H]2C[C@H](N=[N+]=[N-])[C@@H](CO)O2)C(=O)NC1=O, CCO, CCO, CCO, CCO
Eligibility criteria:

        Inclusion Criteria:

          -  At least 18 years of age on the day of signing the informed consent.

          -  Understand the study procedures and voluntarily agree to participate by giving written
             informed consent for the trial.

          -  Have plasma HIV-1 RNA levels below the limit of quantification (BLoQ) (<40 copies/mL
             by the Abbott RealTime HIV-1 Assay as determined by the central laboratory) at the
             screening visit.

          -  Receiving antiretroviral therapy with a ritonavir- or cobicistat-boosted protease
             inhibitor (atazanavir, darunavir, or lopinavir) or cobicistat-boosted elvitegravir or
             a NNRTI (specifically, efavirenz, nevirapine, or rilpivirine) in combination with 2
             NRTIs (and no other antiretroviral therapy) continuously for >= 6 months.

          -  Receiving first or second retroviral regimen (participants receiving a NNRTI at
             Screening must be on their first retroviral regimen)

          -  No history of using an experimental NNRTI

          -  Has a genotype prior to starting his/her initial antiretroviral regimen and no known
             resistance to any of the study agents

          -  Not receiving lipid lowering therapy or on a stable dose of lipid lowering therapy at
             the time of enrollment

          -  Has the following laboratory values at screening within 30 days prior to the treatment
             phase of this study: Alkaline phosphatase ≤ 3.0 x upper limit of normal (ULN), Serum
             aspartate aminotransferase (AST) and serum alanine aminotransferase (ALT) ≤ 5.0 x ULN,
             and Hemoglobin ≥9.0 g/dL (if female) or ≥10.0 g/dL (if male)

          -  Has a calculated creatinine clearance at the time of screening ≥ 50 mL/min, based on
             the Cockcroft-Gault equation

          -  Male or female participant not of reproductive potential or, if of reproductive
             potential, agrees to avoid becoming pregnant or impregnating a partner while receiving
             study drug and for 14 days after the last dose of study drug by complying with one of
             the following: 1) practice abstinence from heterosexual activity, or 2) use acceptable
             contraception during heterosexual activity

          -  For inclusion in Study Extension 1 (optional): completed the Week 48 visit; considered
             to have derived benefit from study participation up to Week 48; considered to be a
             clinically appropriate candidate for an additional 2 years treatment with study drug

          -  For inclusion in Study Extension 2 (optional): completed the Week 144 visit;
             considered to have derived benefit from study participation up to Week 144; considered
             to be a clinically appropriate candidate for an additional 2 years treatment with
             study drug

        Exclusion Criteria:

          -  Uses recreational or illicit drugs or has a recent history of drug or alcohol abuse or
             dependence

          -  Received treatment for a viral infection other than HIV-1, such as hepatitis B, with
             an agent that is active against HIV-1 such as adefovir, emtricitabine, lamivudine, or
             tenofovir

          -  Has documented or known resistance to study drugs including doravirine, lamivudine,
             and/or tenofovir

          -  Participated in a study with an investigational compound or device within 30 days or
             anticipates doing so during the course of this study

          -  Used systemic immunosuppressive therapy or immune modulators within 30 days or
             anticipates needing them during the course of this study (short courses of
             corticosteroids will be allowed)

          -  Current, active diagnosis of acute hepatitis due to any cause (participants with
             chronic hepatitis B and C may enter the study as long as they fulfill all entry
             criteria, have stable liver function tests, and have no significant impairment of
             hepatic function)

          -  Has evidence of decompensated liver disease or has liver cirrhosis and a Child-Pugh
             Class C score or Pugh-Turcotte score >9

          -  Pregnant, breastfeeding, or expecting to conceive at any time during the study

          -  Female and is expecting to donate eggs or male and is expecting to donate sperm during
             the study