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) (onceMRK)

Merck Sharp & Dohme (MSD)

Status and phase: Completed; Phase 3

Conditions: HIV Infection

Treatments: Drug: Placebo to Raltegravir; Drug: Raltegravir; Drug: TRUVADA™; Drug: Reformulated Raltegravir; Drug: Placebo to Reformulated Raltegravir

Study type: Interventional

Funder types: Industry

Identifiers

NCT02131233

2013-001939-47 (EudraCT Number)

0518-292

Details and patient eligibility

About

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.

Enrollment: 802 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

---

802 participants in 2 patient groups

Reformulated Raltegravir

Experimental group

Description:

Reformulated raltegravir 1200 mg (2x 600 mg tablets) orally once daily plus placebo to raltegravir 1 tablet orally twice daily plus TRUVADA™ orally once daily for 96 weeks

Treatment:

Drug: Reformulated Raltegravir

Drug: Placebo to Raltegravir

Drug: TRUVADA™

Raltegravir

Active Comparator group

Description:

Raltegravir 400 mg tablet orally twice daily plus placebo to reformulated raltegravir 2 tablets orally once daily plus TRUVADA™ orally once daily for 96 weeks

Treatment:

Drug: Placebo to Reformulated Raltegravir

Drug: Raltegravir

Drug: TRUVADA™