Comparison of Doravirine, Tenofovir, Lamivudine (MK-1439A) and ATRIPLA™ in Treatment-Naive Human Immunodeficiency Virus Type 1 (HIV-1)-Infected Participants (MK-1439A-021)
Condition: Human Immunodeficiency Virus (HIV)
MeSH terms: Acquired Immunodeficiency Syndrome; HIV Infections; Immunologic Deficiency Syndromes
Intervention: Doravirine, Tenofovir, Lamivudine; ATRIPLA™; Placebo
Intervention description: One doravirine, tenofovir, lamivudine tablet taken q.d. by mouth.; One ATRIPLA™ tablet taken q.d. by mouth; Placebo tablets matched to ATRIPLA® or Doravirine, Tenofovir, Lamivudine.
Intervention MeSH terms: Tenofovir; Lamivudine; Efavirenz, Emtricitabine, Tenofovir Disoproxil Fumarate Drug Combination
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 734.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The purpose of this study is to compare the antiretroviral activity of doravirine, tenofovir,
      lamivudine (MK-1439A), a single-tablet, once-daily (q.d.) fixed-dose combination (FDC)
      containing doravirine (MK-1439) 100 mg + lamivudine 300 mg + tenofovir disoproxil fumarate
      300 mg, with ATRIPLA™, a single-tablet FDC containing efavirenz 600 mg + emtricitabine 200 mg
      + tenofovir disoproxil fumarate 300 mg, in treatment-naive participants infected with human
      immunodeficiency virus (HIV). The primary hypothesis is that doravirine, tenofovir,
      lamivudine q.d. is non-inferior to ATRIPLA™ q.d. as assessed by the proportion of
      participants with HIV-1 ribonucleic acid (RNA) <50 copies/mL (by the Abbott RealTime HIV-1
      Assay) at Week 48. This study has a total duration of 192 weeks, including a 96-week
      double-blind period and a 96-week open-label period. The present results are based on the
      first 48 weeks of this ongoing study.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Is HIV-1 positive as determined by a positive result on an enzyme-immunoassay, has
             screening plasma HIV-1 RNA (determined by the central laboratory) ≥1000 copies/mL
             within 45 days prior to the treatment phase of this study, and has HIV treatment
             indicated based on physician assessment

          -  Has never received antiretroviral therapy (ART)

          -  Is highly unlikely to either become pregnant or impregnate a partner

        Exclusion Criteria:

          -  Has a history or current evidence of any condition, therapy, laboratory abnormality,
             or other circumstance that might confound results of the study

          -  Is a user of recreational or illicit drugs or has a recent history of alcohol/drug
             abuse

          -  Has been treated for a viral infection other than HIV-1 (e.g., hepatitis B) with an
             agent that is active against HIV-1

          -  Has participated in a study with an investigational drug/device within 30 days prior
             to Screening

          -  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

          -  Has a current (active) diagnosis of acute hepatitis due to any cause (note:
             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 synthetic function)

          -  Is a female who is pregnant, breastfeeding, or expecting to conceive

          -  Is a female and is expecting to donate eggs or is male and is expecting to donate
             sperm (investigators will provide appropriate guidance regarding egg and/or sperm
             donation after completion of the study treatment regimen)

          -  Has evidence of decompensated liver disease manifested by the presence of or a history
             of ascites, esophageal or gastric variceal bleeding, hepatic encephalopathy or other
             signs or symptoms of advanced liver diseases, or has liver cirrhosis and a Child-Pugh
             Class C score or Pugh-Turcotte (CPT) score > 9