Comparison of MK-1439A and ATRIPLA™ in Treatment-Naive Human Immunodeficiency Virus (HIV)-Infected Participants (MK-1439A-021)
Merck Sharp & Dohme Corp.
Information provided by (Responsible Party)
Merck Sharp & Dohme Corp.
First received: March 26, 2015
Last updated: January 8, 2018
Last Verified: January 2018
History of Changes
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 doravirine (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.
Human Immunodeficiency Virus (HIV)
Drug : MK-1439A
Drug : ATRIPLA™
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|
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 ]
- 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 ]
|Study Start Date:||June 5, 2015|
|Estimated Study Completion Date:||February 25, 2020|
|Estimated Primary Completion Date:||March 20, 2017 (Final data collection date for primary outcome measure)|
Treatment-naive HIV-infected participants will receive MK-1439A, a single-tablet FDC containing doravirine 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.
One MK-1439A tablet taken by mouth
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.
One ATRIPLA™ tablet taken by mouth
|Ages Eligible for Study:||18 Years and older|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||No|
- 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
- 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
Contacts and LocationsChoosing to participate in a study is an important personal decision.Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.For general information, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT02403674
Sponsors and CollaboratorsMerck Sharp & Dohme Corp.
|Study Director:||Medical Director||Merck Sharp & Dohme Corp.|
|Responsible Party:||Merck Sharp & Dohme Corp.|
|ClinicalTrials.gov Identifier:||NCT02403674 History of Changes|
|Other Study ID Numbers:||1439A-021|
|Study First Received:||March 26, 2015|
|Last Updated:||January 8, 2018|
Additional relevant MeSH terms:
Immunologic Deficiency Syndromes
Acquired Immunodeficiency Syndrome
Efavirenz, Emtricitabine, Tenofovir Disoproxil Fumarate Drug Combination
ClinicalTrials.gov processed this data on March 23, 2018
This information is provided by ClinicalTrials.gov.