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Comparison of MK-1439A and ATRIPLA™ in Treatment-Naive Human Immunodeficiency Virus (HIV)-Infected Participants (MK-1439A-021)

This study is ongoing, but not recruiting participants.
Sponsor:
ClinicalTrials.gov Identifier:
NCT02403674
First Posted: March 31, 2015
Last Update Posted: October 20, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
  Purpose
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.

Condition Intervention Phase
Human Immunodeficiency Virus (HIV) Drug: MK-1439A Drug: ATRIPLA™ Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Merck Sharp & Dohme Corp.:

Primary Outcome Measures:
  • 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 Outcome Measures:
  • 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 ]

Enrollment: 734
Actual Study Start Date: June 5, 2015
Estimated Study Completion Date: February 25, 2020
Primary Completion Date: March 20, 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: MK-1439A
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.
Drug: MK-1439A
One MK-1439A tablet taken by mouth
Active Comparator: ATRIPLA™
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.
Drug: ATRIPLA™
One ATRIPLA™ tablet taken by mouth

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02403674


Sponsors and Collaborators
Merck Sharp & Dohme Corp.
Investigators
Study Director: Medical Director Merck Sharp & Dohme Corp.
  More Information

Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT02403674     History of Changes
Other Study ID Numbers: 1439A-021
2014-003382-17 ( EudraCT Number )
First Submitted: March 26, 2015
First Posted: March 31, 2015
Last Update Posted: October 20, 2017
Last Verified: October 2017

Additional relevant MeSH terms:
Immunologic Deficiency Syndromes
Acquired Immunodeficiency Syndrome
HIV Infections
Immune System Diseases
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Slow Virus Diseases
Tenofovir
Efavirenz, Emtricitabine, Tenofovir Disoproxil Fumarate Drug Combination
Antiviral Agents
Anti-Infective Agents
Reverse Transcriptase Inhibitors
Nucleic Acid Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anti-Retroviral Agents
Anti-HIV Agents