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)

• Status: Completed
• Trial end date: 2016-12-19
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Merck Sharp & Dohme Corp.
• Treatments: Emtricitabine, Tenofovir Disoproxil Fumarate Drug Combination; Raltegravir Potassium

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