Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 2:17 AM
Ignite Modification Date:
2025-12-25 @ 2:17 AM
NCT ID:
NCT02652260
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).
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT02652260
Study Brief:
Protocol Section:
NCT02652260