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

1439-018

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.

2014-12-01

2016-09-29

2023-03-06

Completed

Early phase I

769

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.

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2024-03-21