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



Status:Recruiting
Conditions:HIV / AIDS, HIV / AIDS, HIV / AIDS
Therapuetic Areas:Immunology / Infectious Diseases
Healthy:No
Age Range:18 - Any
Updated:3/12/2016
Start Date:June 2015
End Date:February 2018
Contact:Toll Free Number
Phone:1-888-577-8839

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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

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.


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
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