Clinical trial NCT03272347 (phase 2, status: active, not recruiting)
Conditions: hiv-1 infection
ICD codes: B20, Z71.7, O98.72, Z21, O98.73, R75, Z11.4
Drugs: islatravir, placebo to islatravir, doravirine, placebo to doravirine, lamivudine, placebo to lamivudine, doravirine, tenofovir, lamivudine, placebo to doravirine, tenofovir, lamivudine, doravirine/islatravir
SMILES: CN1C(=O)C=C(N2CCC[C@@H](N)C2)N(CC2=C(C=CC=C2)C#N)C1=O, CN1C(O)=NN=C1CN1C=CC(=C(OC2=CC(=CC(Cl)=C2)C#N)C1=O)C(F)(F)F, CN1C(O)=NN=C1CN1C=CC(=C(OC2=CC(=CC(Cl)=C2)C#N)C1=O)C(F)(F)F, CC1=CN([C@H]2C[C@H](N=[N+]=[N-])[C@@H](CO)O2)C(=O)NC1=O, NC1=NC(=O)N(C=C1)[C@@H]1CS[C@H](CO)O1, CC1=CN([C@H]2C[C@H](N=[N+]=[N-])[C@@H](CO)O2)C(=O)NC1=O, CN1C(=O)C=C(N2CCC[C@@H](N)C2)N(CC2=C(C=CC=C2)C#N)C1=O
Eligibility criteria:

        Inclusion Criteria:

          -  Has HIV-1 infection

          -  Is naïve to anti-retroviral therapy (ART).

          -  Is clinically stable, with no signs or symptoms of acute infection, at the time of
             entry into the study

          -  Female is not pregnant, not breastfeeding, not a woman of childbearing potential
             (WOCBP); but if WOCBP agrees to follow the contraceptive guidance

          -  All participants, male and female, agree to use barrier methods of contraception when
             engaged in any sexual activity during treatment and for 6 weeks following treatment.

        Exclusion Criteria:

          -  Is a user of recreational or illicit drugs or has had a history of drug or alcohol
             abuse or dependence that may interfere with trial participation

          -  Has significant hypersensitivity or other contraindication to any of the components of
             the study drugs

          -  Has a history of malignancy ≤5 years prior

          -  Female expects to donate eggs at any time during the study

          -  Is breastfeeding or expecting to conceive

          -  A WOCBP who has a positive urine pregnancy test on Day 1 before the first dose of
             study treatment

          -  Has been treated for a viral infection other than HIV-1, such as hepatitis B, with an
             agent that is active against HIV-1

          -  Has used systemic immunosuppressive therapy or immune modulators within 30 days prior
             to treatment in this study or is anticipated to need them during the course of the
             study

          -  Requires any of the following prohibited medications: Carbamazepine, Phenobarbital,
             Phenytoin, Rifabutin, Rifampin, Herbal remedies, St. John's Wort, Modafinil, Bosentan,
             Nafcillin, Pentostatin

          -  Is currently participating in or has participated in an interventional clinical trial
             with an investigational compound or device within 30 days of signing informed consent
             to participate in this current trial

          -  Has a documented or known virologic resistance to any approved HIV-1 reverse
             transcriptase inhibitor, protease inhibitor, integrase inhibitor

          -  Has active hepatitis C virus (HCV) coinfection defined as detectable HCV RNA or HBV
             co-infection defined as hepatitis B surface antigen [HBsAg]-positive

          -  Has a current (active) diagnosis of acute hepatitis due to any cause

          -  Has previously been randomized in a study and received islatravir (MK-8591), DOR,
             Doravirine, Tenofovir, Lamivudine, or 3TC.