Overview

This trial is active, not recruiting.

Condition human immunodeficiency virus (hiv)
Treatments mk-1439a, atripla™
Phase phase 3
Sponsor Merck Sharp & Dohme Corp.
Start date June 2015
End date March 2017
Trial size 680 participants
Trial identifier NCT02403674, 1439A-021, 2014-003382-17

Summary

The purpose of this study is to compare the antiretroviral activity of MK-1439A, a single-tablet, once-daily (q.d.) fixed-dose combination (FDC) containing MK-1439 100 mg + lamivudine 300 mg + tenofovir disoproxil fumarate 300 mg, with ATRIPLA™, a single-tablet FDC containing efavirenz 600 mg + emtricitabine 200 mg + tenofovir disoproxil fumarate 300 mg, in treatment-naive participants infected with HIV. The primary hypothesis is that MK-1439A q.d. is non-inferior to ATRIPLA™ q.d. as assessed by the proportion of participants with HIV-1 ribonucleic acid (RNA) <50 copies/mL (by the Abbott RealTime HIV-1 Assay) at Week 48.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking double blind (subject, investigator)
Primary purpose treatment
Arm
(Experimental)
Treatment-naive HIV-infected participants will receive MK-1439A, a single-tablet FDC containing MK-1439 100 mg + lamivudine 300 mg + tenofovir disoproxil fumarate 300 mg, q.d. by mouth for 96 weeks. Participants will also take 1 placebo tablet matched to ATRIPLA™ q.d. by mouth for 96 weeks in order to maintain blinding.
mk-1439a
One MK-1439A tablet taken by mouth
(Active Comparator)
Treatment-naive HIV-infected participants will receive ATRIPLA™, a single-tablet FDC containing efavirenz 600 mg + emtricitabine 200 mg + tenofovir disoproxil fumarate 300 mg (equivalent to 245 mg tenofovir disoproxil), q.d. by mouth for 96 weeks. Participants will also take 1 placebo tablet matched to MK-1439A q.d. by mouth for 96 weeks in order to maintain blinding.
atripla™
One ATRIPLA™ tablet taken by mouth

Primary Outcomes

Measure
Proportion of participants with HIV-1 RNA <50 copies/mL at Week 48
time frame: Week 48
Proportion of participants with neuropsychiatric adverse events (AEs)
time frame: Up to Week 48

Secondary Outcomes

Measure
Proportion of participants with HIV-1 RNA <50 copies/mL at Week 96
time frame: Week 96
Change in cluster of differentiation 4 (CD4) cell counts at Week 48
time frame: Baseline and Week 48
Change in CD4 cell counts at Week 96
time frame: Baseline and Week 96
Proportion of participants with HIV-1 RNA <40 copies/mL at Week 48
time frame: Week 48
Proportion of participants with HIV-1 RNA <40 copies/mL at Week 96
time frame: Week 96

Eligibility Criteria

Male or female participants at least 18 years old.

Inclusion Criteria: - Is HIV-1 positive as determined by a positive result on an enzyme-immunoassay, has screening plasma HIV-1 RNA (determined by the central laboratory) ≥1000 copies/mL within 45 days prior to the treatment phase of this study, and has HIV treatment indicated based on physician assessment - Has never received antiretroviral therapy (ART) - Is highly unlikely to either become pregnant or impregnate a partner Exclusion Criteria: - Has a history or current evidence of any condition, therapy, laboratory abnormality, or other circumstance that might confound results of the study - Is a user of recreational or illicit drugs or has a recent history of alcohol/drug abuse - Has been treated for a viral infection other than HIV-1 (e.g., hepatitis B) with an agent that is active against HIV-1 - Has participated in a study with an investigational drug/device within 30 days prior to Screening - Has used systemic immunosuppressive therapy or immune modulators within 30 days prior to treatment in this study or is anticipated to need them during the course of the study - Has a current (active) diagnosis of acute hepatitis due to any cause (note: participants with chronic hepatitis B and C may enter the study as long as they fulfill all entry criteria, have stable liver function tests, and have no significant impairment of hepatic synthetic function) - Is a female who is pregnant, breastfeeding, or expecting to conceive - Is a female and is expecting to donate eggs or is male and is expecting to donate sperm (investigators will provide appropriate guidance regarding egg and/or sperm donation after completion of the study treatment regimen) - Has evidence of decompensated liver disease manifested by the presence of or a history of ascites, esophageal or gastric variceal bleeding, hepatic encephalopathy or other signs or symptoms of advanced liver diseases, or has liver cirrhosis and a Child-Pugh Class C score or Pugh-Turcotte (CPT) score > 9

Additional Information

Official title A Phase III Multicenter, Double-Blind, Randomized, Active Comparator-Controlled Clinical Trial to Evaluate the Safety and Efficacy of MK-1439A Once-Daily Versus ATRIPLA™ Once-Daily in Treatment-Naïve HIV-1 Infected Subjects
Trial information was received from ClinicalTrials.gov and was last updated in November 2016.
Information provided to ClinicalTrials.gov by Merck Sharp & Dohme Corp..