Safety and Efficacy of Doravirine, Tenofovir, Lamivudine (MK-1439A) in Participants Infected With Treatment-Naïve Human Immunodeficiency Virus (HIV) -1 With Transmitted Resistance (MK-1439A-030)
Condition: HIV-1 Infection
Intervention: Doravirine/lamivudine/tenofovir disoproxil fumarate
Intervention description: FDC tablet containing MK-1439 (doravirine) 100 mg / lamivudine 300 mg / tenofovir disoproxil fumarate 300 mg taken by mouth.
Intervention MeSH terms: Tenofovir; Lamivudine
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 10.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The primary objectives of this study are to evaluate the antiretroviral activity and the
      safety/tolerability of open-label doravirine/lamivudine/tenofovir disoproxil fumarate
      (DOR/3TC/TDF; MK-1439A; DELSTRIGO™) consisting of a single fixed-dose combination (FDC)
      tablet of DOR/3TC/TDF 100 mg/300 mg/300 mg in treatment-naïve HIV-1 infected participants
      with select non-nucleoside reverse transcriptase inhibitor (NNRTI) transmitted
      resistance-associated mutations.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Is HIV-1 positive within 45 days prior to the treatment phase of this study, and have
             HIV treatment indicated based on physician assessment.

          -  Is naïve to antiretroviral therapy (ART) including investigational antiretroviral
             agents.

          -  Prior to screening, have had a genotype performed confirming the presence of only one
             of the following NNRTI mutations: K103N, Y181C, or G190A.

          -  Is considered clinically stable with no signs or symptoms of active infection at time
             of entry into the study (i.e. clinical status and all chronic medications should be
             unchanged for at least 2 weeks prior to the start of treatment in this study).

          -  Is highly unlikely to become pregnant or to impregnate a partner

        Exclusion Criteria:

          -  Is a user of recreational or illicit drugs or has had a recent history of drug or
             alcohol abuse or dependence.

          -  Has been treated for a viral infection other than HIV-1, such as hepatitis B, with an
             agent that is active against HIV-1, including, but not limited to, adefovir,
             tenofovir, entecavir, emtricitabine, or lamivudine.

          -  Has documented or known resistance to study drugs (doravirine, lamivudine, and/or
             tenofovir)

          -  Has participated or anticipates participating in a study with an investigational
             compound/device within 30 days prior to signing informed consent

          -  Has any medical condition requiring, or likely to require, chronic systemic
             administration of corticosteroids, tumor necrosis factor (TNF) antagonists, or other
             immunosuppressant drugs during the course of the trial.

          -  Requires or anticipates requiring any of the prohibited medications

          -  Has significant hypersensitivity or other contraindication to any of the components of
             the study drug

          -  Has a current (active) diagnosis of acute hepatitis due to any cause

          -  Has evidence of decompensated liver disease or has liver cirrhosis and a Child-Pugh
             Class C score or Pugh-Turcotte (CPT) score > 9

          -  Is pregnant, breastfeeding, or expecting to conceive

          -  Is female and expecting to donate eggs, or is male and is expecting to donate sperm at
             any time during the study