Safety and Efficacy of Doravirine (MK-1439) in Participants With Human Immunodeficiency Virus 1 (HIV-1) (MK-1439-018)



Status:Recruiting
Conditions:HIV / AIDS, HIV / AIDS
Therapuetic Areas:Immunology / Infectious Diseases
Healthy:No
Age Range:18 - Any
Updated:10/31/2015
Start Date:December 2014
End Date:September 2017
Contact:Toll Free Number
Phone:1-888-577-8839

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A Phase 3 Multicenter, Double-Blind, Randomized, Active Comparator-Controlled Clinical Trial to Evaluate the Safety and Efficacy of Doravirine (MK-1439) 100 mg Once Daily Versus Darunavir 800 mg Once Daily Plus Ritonavir 100 mg Once Daily, Each in Combination With TRUVADA™ or EPZICOM™/KIVEXA™, in Treatment-Naïve HIV-1 Infected Subjects

To establish a new treatment option for treatment-naïve participants with HIV-1, the
efficacy and safety of doravirine will be determined relative to a protease inhibitor (PI).
The primary hypothesis is that doravirine 100 mg once a day (q.d.) is non-inferior to
darunavir/ritonavir (800 mg/100 mg) q.d., each in combination with TRUVADA™ or
EPZICOM™/KIVEXA™, as assessed by the proportion of participants with HIV-1 ribonucleic acid
(RNA) <50 copies/mL at Week 48. If non-inferiority is established, then the superiority of
doravirine 100 mg q.d. compared to darunavir/ ritonavir (800 mg/100 mg) q.d. will be
assessed.


Inclusion Criteria:

- Is HIV-1 positive and has HIV treatment indicated based on physician assessment.

- Has received no (0 days of) antiretroviral therapy (ART), including investigational
antiretroviral agents.

- Is considered clinically stable with no signs or symptoms of active infection for at
least 2 weeks prior to the start of treatment.

- Female is highly unlikely to become pregnant, or male is highly unlikely to
impregnate a partner because they are not of reproductive potential, or agree to
practice abstinence or use acceptable contraception for up to 14 days after the last
dose of study drug.

Exclusion Criteria:

- Uses or has had a recent history of using recreational or illicit drugs.

- Has been treated for a viral infection other than HIV-1, such as hepatitis B, with an
agent that is active against HIV-1.

- Has documented or known resistance to study drugs including MK-1439, darunavir,
ritonavir, emtricitabine, tenofovir, abacavir and/or lamivudine.

- Has participated in a study with an investigational compound/device within the prior
month, or anticipates doing so during this study.

- Has used systemic immunosuppressive therapy or immune modulators within the prior 30
days, or anticipates doing so during this study.

- Has significant hypersensitivity or other contraindication to any of the components
of the study drugs.

- Has a current (active) diagnosis of acute hepatitis due to any cause.

- Is pregnant, breastfeeding or expecting to conceive at any time during the study.

- Female who expects to donate eggs, or male who expects to donate sperm at any time
during the study.
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