safety and efficacy of doravirine (mk-1439) in participants with human immunodeficiency virus 1 (hiv-1) (mk-1439-018)

Conditions: HIV-1

Summary: 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.

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.

Eligibility criteria:
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.