effects of switching from atripla™ (efavirenz, tenofovir, emtricitabine) to mk-1439a (doravirine, tenofovir, lamivudine) in virologically-suppressed participants (mk-1439a-028)

Conditions: HIV-1; Central Nervous System

Summary: this study aims to evaluate a switch from fixed dose combination (fdc) treatment with atripla\^tm for 12 weeks prior to screening to fdc treatment with doravirine, tenofovir, lamivudine (mk-1439a) in virologically-suppressed, human immunodeficiency virus type 1 (hiv-1)-infected participants. the primary hypothesis is that switching from atripla\^tm to doravirine, tenofovir, lamivudine results in a lower proportion of participants with at least one cns toxicity of at least grade 2 intensity at week 12 than continuation of atripla\^tm treatment.


Eligibility criteria:
inclusion criteria: * is taking atripla™, generic versions of atripla™, or the components of atripla™ (efv,tdf plus emtricitabine), * has documentation of hiv-1 ribonucleic acid (rna) \< 50 copies/ml during the 12 weeks prior to screening while on atripla™. * has plasma hiv-1 rna levels below the limits of quantification (bloq) at the screening visit. * if genotyped prior to starting initial antiretroviral regimen, must have no known resistance to any of the study agents * has at least one efv-associated cns toxicities of grade 2 or worse intensity both at the time of screening and at study day 1 * is highly unlikely to become pregnant or to impregnate a partner * to be eligible for study extension 1, participants from immediate switch group (isg) must have completed study week 24, and benefited from study participation; participants from deferred switch group (dsg) must have completed study week 36, and benefited from study participation as determined by the investigator * to be eligible for study extension 2, participants from isg must have completed study week 120, and benefited from study participation; participants from dsg must have completed study week 132, and benefited from study participation as determined by the investigator exclusion criteria: * is a user of recreational or illicit drugs or has had a recent history of drug or alcohol abuse or dependence. * has ongoing grade 4 cns toxicity during screening period that requires a prompt change in art * has been treated for a viral infection other than hiv-1, such as hepatitis b, with an agent that is active against hiv-1 including, but not limited to, adefovir, emtricitabine, entecavir, lamivudine or tenofovir. * has documented or known resistance to study drugs including doravirine, lamivudine, and/or tenofovir * has participated in, or anticipates participating in a study with an investigational compound/device within 30 days prior to signing informed consent * has used systemic immunosuppressive therapy or immune modulators or anticipates using them within 30 days prior to this study * requires or anticipates requiring any of the prohibited medications * 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. * 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. * is pregnant, breastfeeding, or expecting to conceive. * female is expecting to donate eggs (at any time during the study) or male is expecting to donate sperm (at any time during the study).