Overview

This trial is active, not recruiting.

Condition hiv infection
Treatments reformulated raltegravir, raltegravir, truvada™, placebo to reformulated raltegravir, placebo to raltegravir
Phase phase 3
Sponsor Merck Sharp & Dohme Corp.
Start date May 2014
End date December 2015
Trial size 750 participants
Trial identifier NCT02131233, 0518-292, 2013-001939-47

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking double blind (subject, investigator, outcomes assessor)
Primary purpose treatment
Arm
(Experimental)
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
reformulated raltegravir
Reformulated raltegravir for once-daily administration
truvada™
Emtricitabine / tenofovir disoproxil fumarate 200 / 300 mg tablet administered once-daily with food (open-label)
placebo to raltegravir
(Active Comparator)
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
raltegravir
Raltegravir for twice-daily administration
truvada™
Emtricitabine / tenofovir disoproxil fumarate 200 / 300 mg tablet administered once-daily with food (open-label)
placebo to reformulated raltegravir

Primary Outcomes

Measure
Percentage of Participants Achieving <40 copies/mL HIV-1 Ribonucleic Acid (RNA) at Week 48
time frame: Week 48

Secondary Outcomes

Measure
Change from Baseline in Cluster of Differentiation (CD4) Cell Count at Week 48
time frame: Baseline and Week 48
Percentage of Participants Achieving <40 copies/mL HIV-1 RNA at Week 96
time frame: Week 96
Change from Baseline in CD4 Cell Count at Week 96
time frame: Baseline and Week 96
Percentage of Participants with an Adverse Experience
time frame: Up to Week 48
Percentage of Participants with a Drug-Related Adverse Experience
time frame: Up to Week 48
Percentage of Participants with a Serious Adverse Experience
time frame: Up to Week 48
Percentage of Participants with a Serious and Drug-Related Adverse Experience
time frame: Up to Week 48
Percentage of Participants Discontinued from Drug Therapy Due to an Adverse Experience
time frame: Up to Week 48
Percentage of Participants with an Adverse Experience
time frame: Up to Week 96
Percentage of Participants with a Drug-Related Adverse Experience
time frame: Up to Week 96
Percentage of Participants with a Serious Adverse Experience
time frame: Up to Week 96
Percentage of Participants with a Serious and Drug-Related Adverse Experience
time frame: Up to Week 96
Percentage of Participants Discontinued from Drug Therapy Due to an Adverse Experience
time frame: Up to Week 96

Eligibility Criteria

Male or female participants at least 18 years old.

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

Additional Information

Official title A Phase III Multicenter, Double-Blind, Randomized, Active Comparator-Controlled Clinical Trial to Evaluate the Safety and Efficacy of Reformulated Raltegravir 1200 mg Once Daily Versus Raltegravir 400 mg Twice Daily, Each in Combination With TRUVADA™, in Treatment-Naïve HIV-1 Infected Subjects
Trial information was received from ClinicalTrials.gov and was last updated in March 2016.
Information provided to ClinicalTrials.gov by Merck Sharp & Dohme Corp..