A Dose-Ranging Study to Compare Doravirine (MK-1439) Plus TRUVADA® Versus Efavirenz Plus TRUVADA® in Human Immunodeficiency Virus (HIV)-1 Infected Participants (MK-1439-007)
Condition: HIV Infections
MeSH terms: HIV Infections
Intervention: Doravirine; Efavirenz; TRUVADA®; Placebo for Doravirine; Placebo for Efavirenz
Intervention description: Part I: Doravirine 25 mg, 50 mg (25 mg X 2), 100 mg, or 200 mg (100 mg X 2) depending upon randomization, taken orally every morning with or without food for at least 24 weeks. Part II: Selected dose of doravirine depending upon randomization (either 25 mg, 50 mg, 100 mg, or 200 mg) tablet orally every morning with or without food for 96 weeks.; Efavirenz 600 mg tablet orally at bedtime taken without food on an empty stomach for 96 weeks; Open-label TRUVADA® (fixed combination 200 mg emtricitabine and 300 mg tenofovir disoproxil fumarate) tablet taken orally with food in the morning for 96 weeks; Placebo tablets matching doravirine; Placebo tablets matching efavirenz
Intervention MeSH terms: Efavirenz; Emtricitabine, Tenofovir Disoproxil Fumarate Drug Combination
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 342.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The hypothesis tested in this study is that doravirine (MK-1439) at the final dose selected
      is superior to efavirenz, each given in combination with TRUVADA®, as measured by the
      percentage of participants with CNS events by Week 8. If superiority is established at Week
      8, the same hypothesis will be tested for Week 24.
    

Eligibility criteria:

        Inclusion Criteria:

          -  HIV-1 positive

          -  No previous use of antiretroviral therapy (ART)

          -  No signs of active pulmonary disease within 45 days before the start of study
             treatment

          -  Clinically stable with no signs or symptoms of acute infection

          -  No change in clinical status or chronic medications for at least 2 weeks before the
             start of study treatment

          -  Participants of reproductive potential agree to remain abstinent in line with their
             preferred and usual lifestyle or use (or have their partner use) 2 acceptable methods
             of birth control throughout the study and for 12 weeks post study.

          -  Participants not of reproductive potential, not sexually active, whose current
             partner(s) is not of reproductive potential, or whose sexual activity is exclusively
             homosexual are eligible without requiring the use of contraception.

        Exclusion Criteria:

          -  Males planning to impregnate or provide sperm donation for the duration of the study
             plus an additional 12 weeks. Females pregnant or breast-feeding or expecting to
             conceive or donate eggs for the duration of the study plus an additional 12 weeks.

          -  Received any approved or experimental antiretroviral agents or is anticipated to
             receive such medications during the study.

          -  Use of any immunomodulators or immunosuppressive therapy within one month before the
             study. Short courses of corticosteroids (e.g., for asthma exacerbation) are allowed.

          -  Treatment for a viral infection other than HIV, such as hepatitis B, with an agent
             that is active against HIV

          -  HIV resistance to emtricitabine, tenofovir disoproxil fumarate, and/or efavirenz.

          -  History of renal or urinary obstructive disease or requires dialysis

          -  Active Hepatitis C virus (HCV) or Hepatitis B virus (HBV) co-infection

          -  History of alcohol or other substance abuse

          -  Participation in a study with an investigational compound/device within one month or
             is anticipating to participate in such a study during this study