Effects of Switching From ATRIPLA™ (Efavirenz, Tenofovir, Emtricitabine) to MK-1439A (Doravirine, Tenofovir, Lamivudine) in Virologically-Suppressed Participants (MK-1439A-028)

• Status: Active, not recruiting
• Trial end date: 2024-03-11
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Merck Sharp & Dohme Corp.
• Treatments: Efavirenz; Efavirenz, Emtricitabine, Tenofovir Disoproxil Fumarate Drug Combination; Emtricitabine; Lamivudine; Tenofovir

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).