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
Intervention model parallel assignment
Primary purpose treatment
Masking participant, investigator
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

All 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 January 2017.
Information provided to ClinicalTrials.gov by Merck Sharp & Dohme Corp..