Evaluation of the Safety and Efficacy of Reformulated Raltegravir (MK-0518) 1200 mg Once Daily in Combination With TRUVADA™ in Human Immunodeficiency Virus (HIV)-1 Infected, Treatment-Naive Participants (MK-0518-292)
Condition: HIV Infection
MeSH terms: HIV Infections
Intervention: Reformulated Raltegravir; Raltegravir; TRUVADA™; Placebo to Reformulated Raltegravir; Placebo to Raltegravir
Intervention description: Reformulated raltegravir 1200 mg (2x 600 mg tablets) orally once daily; Raltegravir 400 mg tablet orally twice daily; Emtricitabine / tenofovir disoproxil fumarate 200 / 300 mg tablet administered once-daily with food (open-label); Placebo to reformulated raltegravir 2 tablets orally once daily; Placebo to raltegravir 1 tablet orally twice daily
Intervention MeSH terms: Raltegravir Potassium; Emtricitabine, Tenofovir Disoproxil Fumarate Drug Combination
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Enrollment: 802.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      To evaluate the safety and efficacy of reformulated raltegravir (MK-0518) 1200 mg once daily
      in combination with TRUVADA™ versus raltegravir 400 mg twice daily in combination with
      TRUVADA™ in HIV-1 infected, treatment-naive participants. The primary hypothesis being tested
      is that reformulated raltegravir 1200 mg once-daily is non-inferior to raltegravir 400 mg
      twice-daily, each in combination therapy with TRUVADA™, as assessed by the proportion of
      participants achieving HIV-1 ribonucleic acid (RNA) <40 copies/mL at Week 48.
    

Eligibility criteria:

        Inclusion Criteria:

          -  HIV-1 positive

          -  Naïve to antiretroviral therapy including investigational antiretroviral agents

          -  Not of reproductive potential or, if of reproductive potential agrees to 1) true
             abstinence, or 2) use of an acceptable method of birth control during the study

        Exclusion Criteria:

          -  Use of recreational or illicit drugs or has 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 raltegravir, emtricitabine, and/or tenofovir
             before the first dose of study drug

          -  Has participated in a study with an investigational compound or device within 30 days
             or anticipates participating in such a study during this study

          -  Has used systemic immunosuppressive therapy or immune modulators within 30 days or is
             anticipated to need them during the study (short courses of corticosteroids are
             allowed)

          -  Requires or is anticipated to require any of the following prohibited medications
             while in the study: phenobarbital, phenytoin, rifampin, rifabutin, or calcium,
             magnesium and aluminum containing antacids, such as TUMS™, Maalox™ and Milk of
             Magnesia™

          -  Has significant hypersensitivity or other contraindication to any of the components of
             the study drugs

          -  Has current, active diagnosis of acute hepatitis due to any cause

          -  Is pregnant, breastfeeding, or expecting to conceive during the study

          -  Female participant expecting to donate eggs or male participant expecting to donate
             sperm during the study

          -  Is or has a family member (spouse or children) who is investigational staff or sponsor
             staff directly involved in this trial