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

Study Results

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

769 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-12-01

Study Completion Date

2023-03-06

Brief Summary

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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). Participants will receive double-blind treatment during the 96-week Base Study. Eligible participants in either of the Base Study groups will continue to receive the doravirine-containing regimen open label for an additional 96 weeks in the Study Extension 1. Eligible participants who are deriving benefit will continue in Study Extension 2 to receive the doravirine-containing regimen open label until doravirine becomes locally available or for an additional 96 weeks, whichever comes first. 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.

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Detailed Description

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Participants in Australia, Russia, and South Africa who are deriving benefit from MK-1439A are also eligible to continue receiving study drug during Study Extension 3, which will last for 2 years or until drug is available locally, whichever comes first.

Conditions

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HIV-1

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Doravirine 100 mg

Double-blind Doravirine 100 mg administered orally (p.o.) once daily (q.d.) + investigator selected TRUVADA™ or EPZICOM™/KIVEXA™ administered p.o. q.d. for 96 weeks in the Base Study. Eligible participants may continue in Study Extension 1 with open-label Doravirine 100 mg administered p.o. q.d. + investigator selected TRUVADA™ or EPZICOM™/KIVEXA™ administered p.o., q.d. for an additional 96 weeks. Eligible participants may continue to receive the Doravirine regimen in Study Extension 2 until Doravirine becomes locally available, or for an additional 96 weeks, whichever comes first. Eligible participants may continue to receive the Doravirine regimen in Study Extension 3 until Doravirine becomes locally available, or for an additional 96 weeks, whichever comes first.

Group Type EXPERIMENTAL

Doravirine

Intervention Type DRUG

Doravirine 100 mg tablet administered p.o. q.d.

TRUVADA™ or EPZICOM™/KIVEXA™

Intervention Type DRUG

The investigator selects either TRUVADA™, a tablet containing 200 mg emtricitabine and 300 mg tenofovir disoproxil fumarate p.o. q.d. or EPZICOM™/KIVEXA™, a tablet containing 600 mg abacavir sulfate and 300 mg lamivudine, p.o. q.d.

Darunavir 800 mg and Ritonavir 100 mg

Double-blind Darunavir 800 mg and Ritonavir 100 mg administered p.o. q.d. + investigator selected TRUVADA™ or EPZICOM™/KIVEXA™ administered p.o. q.d. for 96 weeks. Eligible participants may continue in Study Extension 1 with open-label Doravirine 100 mg administered p.o. q.d. + investigator selected TRUVADA™ or EPZICOM™/KIVEXA™ administered p.o. q.d. for an additional 96 weeks. Eligible participants may continue to receive the Doravirine regimen in Study Extension 2 until Doravirine becomes locally available, or for an additional 96 weeks, whichever comes first. Eligible participants may continue to receive the Doravirine regimen in Study Extension 3 until Doravirine becomes locally available, or for an additional 96 weeks, whichever comes first.

Group Type ACTIVE_COMPARATOR

Doravirine

Intervention Type DRUG

Doravirine 100 mg tablet administered p.o. q.d.

Darunavir

Intervention Type DRUG

Darunavir 800 mg tablet administered p.o. q.d.

Ritonavir

Intervention Type DRUG

Ritonavir 100 mg tablet administered p.o. q.d.

TRUVADA™ or EPZICOM™/KIVEXA™

Intervention Type DRUG

The investigator selects either TRUVADA™, a tablet containing 200 mg emtricitabine and 300 mg tenofovir disoproxil fumarate p.o. q.d. or EPZICOM™/KIVEXA™, a tablet containing 600 mg abacavir sulfate and 300 mg lamivudine, p.o. q.d.

Interventions

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Doravirine

Doravirine 100 mg tablet administered p.o. q.d.

Intervention Type DRUG

Darunavir

Darunavir 800 mg tablet administered p.o. q.d.

Intervention Type DRUG

Ritonavir

Ritonavir 100 mg tablet administered p.o. q.d.

Intervention Type DRUG

TRUVADA™ or EPZICOM™/KIVEXA™

The investigator selects either TRUVADA™, a tablet containing 200 mg emtricitabine and 300 mg tenofovir disoproxil fumarate p.o. q.d. or EPZICOM™/KIVEXA™, a tablet containing 600 mg abacavir sulfate and 300 mg lamivudine, p.o. q.d.

Intervention Type DRUG

Eligibility Criteria

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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.
* Eligibility for the Study Extension 1 at the Week 96 visit: 1) completed the Week 96 visit, 2) derived benefit from participation through Week 96 in the opinion of the investigator, 3) is a clinically-appropriate candidate for an additional 96 weeks of treatment with the Study Extension regimen.
* Eligibility for the Study Extension 2 at the Week 192 visit: 1) completed the Week 192 visit, 2) derived benefit from participation through Week 192 in the opinion of the investigator, 3) is a clinically-appropriate candidate for 96 weeks of treatment with the Study Extension regimen.

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 doravirine, 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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No