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)

NCT ID: NCT02131233

Last Updated: 2019-01-30

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 802 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-05-23
• Study Completion Date: 2016-12-19

Brief 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.

Conditions

HIV Infection

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

Reformulated Raltegravir

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

Group Type: EXPERIMENTAL

Reformulated Raltegravir

Intervention Type: DRUG

Reformulated raltegravir 1200 mg (2x 600 mg tablets) orally once daily

TRUVADA™

Intervention Type: DRUG

Emtricitabine / tenofovir disoproxil fumarate 200 / 300 mg tablet administered once-daily with food (open-label)

Placebo to Raltegravir

Intervention Type: DRUG

Placebo to raltegravir 1 tablet orally twice daily

Raltegravir

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

Group Type: ACTIVE_COMPARATOR

Raltegravir

Intervention Type: DRUG

Raltegravir 400 mg tablet orally twice daily

TRUVADA™

Intervention Type: DRUG

Emtricitabine / tenofovir disoproxil fumarate 200 / 300 mg tablet administered once-daily with food (open-label)

Placebo to Reformulated Raltegravir

Intervention Type: DRUG

Placebo to reformulated raltegravir 2 tablets orally once daily

Interventions

Reformulated Raltegravir

Reformulated raltegravir 1200 mg (2x 600 mg tablets) orally once daily

Intervention Type: DRUG

Raltegravir

Raltegravir 400 mg tablet orally twice daily

Intervention Type: DRUG

TRUVADA™

Emtricitabine / tenofovir disoproxil fumarate 200 / 300 mg tablet administered once-daily with food (open-label)

Intervention Type: DRUG

Placebo to Reformulated Raltegravir

Placebo to reformulated raltegravir 2 tablets orally once daily

Intervention Type: DRUG

Placebo to Raltegravir

Placebo to raltegravir 1 tablet orally twice daily

Intervention Type: DRUG

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Merck Sharp & Dohme LLC

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Medical Director

Role: STUDY_DIRECTOR

Merck Sharp & Dohme LLC

References

Cahn P, Kaplan R, Sax PE, Squires K, Molina JM, Avihingsanon A, Ratanasuwan W, Rojas E, Rassool M, Bloch M, Vandekerckhove L, Ruane P, Yazdanpanah Y, Katlama C, Xu X, Rodgers A, East L, Wenning L, Rawlins S, Homony B, Sklar P, Nguyen BY, Leavitt R, Teppler H; ONCEMRK Study Group. Raltegravir 1200 mg once daily versus raltegravir 400 mg twice daily, with tenofovir disoproxil fumarate and emtricitabine, for previously untreated HIV-1 infection: a randomised, double-blind, parallel-group, phase 3, non-inferiority trial. Lancet HIV. 2017 Nov;4(11):e486-e494. doi: 10.1016/S2352-3018(17)30128-5. Epub 2017 Sep 11.

Reference Type: RESULT

PMID: 28918877 (View on PubMed)

Cahn P, Sax PE, Squires K, Molina JM, Ratanasuwan W, Rassool M, Bloch M, Xu X, Zhou Y, Homony B, Hepler D, Teppler H, Hanna GJ, Nguyen BY, Greaves W; ONCEMRK Study Group. Raltegravir 1200 mg Once Daily vs 400 mg Twice Daily, With Emtricitabine and Tenofovir Disoproxil Fumarate, for Previously Untreated HIV-1 Infection: Week 96 Results From ONCEMRK, a Randomized, Double-Blind, Noninferiority Trial. J Acquir Immune Defic Syndr. 2018 Aug 15;78(5):589-598. doi: 10.1097/QAI.0000000000001723.

Reference Type: RESULT

PMID: 29771789 (View on PubMed)

Other Identifiers

2013-001939-47

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

0518-292

Identifier Type: -

Identifier Source: org_study_id