Safety and Efficacy of Doravirine, Tenofovir, Lamivudine (MK-1439A) in Participants Infected With Treatment-Naïve Human Immunodeficiency Virus (HIV) -1 With Transmitted Resistance (MK-1439A-030)
Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Merck Sharp & Dohme LLC
This study had a Base Study (Day 1 to Week 96) and an optional Study Extension (Week 96 to Week 192).
Age
18–any
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
Is HIV-1 positive within 45 days prior to the treatment phase of this study, and have HIV treatment indicated based on physician assessment.
Is naïve to antiretroviral therapy (ART) including investigational antiretroviral agents.
Prior to screening, have had a genotype performed confirming the presence of only one of the following NNRTI mutations: K103N, Y181C, or G190A.
Is considered clinically stable with no signs or symptoms of active infection at time of entry into the study (i.e. clinical status and all chronic medications should be unchanged for at least 2 weeks prior to the start of treatment in this study).
Is highly unlikely to become pregnant or to impregnate a partner
You may not be if
Is a user of recreational or illicit drugs or has had a recent history of drug or alcohol abuse or dependence.
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, tenofovir, entecavir, emtricitabine, or lamivudine.
Has documented or known resistance to study drugs (doravirine, lamivudine, and/or tenofovir)
Has participated or anticipates participating in a study with an investigational compound/device within 30 days prior to signing informed consent
Has any medical condition requiring, or likely to require, chronic systemic administration of corticosteroids, tumor necrosis factor (TNF) antagonists, or other immunosuppressant drugs during the course of the trial.
Requires or anticipates requiring any of the prohibited medications
Has significant hypersensitivity or other contraindication to any of the components of the study drug
Has a current (active) diagnosis of acute hepatitis due to any cause
Has evidence of decompensated liver disease or has liver cirrhosis and a Child-Pugh Class C score or Pugh-Turcotte (CPT) score \> 9
Is pregnant, breastfeeding, or expecting to conceive
Is female and expecting to donate eggs, or is male and is expecting to donate sperm at any time during the study
Clareo Health | Safety and Efficacy of Doravirine, Tenofovir, Lamivudine (MK-1439A) in Participants Infected With Treatment-Naïve Human Immunodeficiency Virus (HIV) -1 With Transmitted Resistance (MK-1439A-030)
