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:
2025-12-24 @ 11:30 PM
Ignite Modification Date:
2025-12-24 @ 11:30 PM
NCT ID:
NCT02926456
Eligibility Criteria:
Inclusion Criteria:
* Adult greater than or equal to (\>=18 years), male and female patients
* Documented Human Immunodeficiency Virus-1 (HIV-1) infection
* Eligible to darunavir/cobicistat (DRV/c) treatment according to Summary of Product Characteristics
* Patients who are able to understand the nature of the study and to provide their consent voluntarily having signed an Informed Consent Form (ICF) allowing data collection and source data verification in accordance with local requirements
* Patients in stable (\>= 12 months) treatment with an Antiretroviral (ARV) therapy PI/ritonavir (PI/r)-based, being prescribed Rezolsta (DRV/c) by treating physician
* Patients virosuppressed (HIV-RNA less than \[\<\] 50 copies/milliliters) since at least 6 months, within their HIV treatment at the moment of enrollment; single values of HIV-RNA more than \[\>\] 50 copies/ml not confirmed (blips) will be considered acceptable; last value collected being \< 50 copies/ml
Exclusion Criteria:
* Patient currently enrolled in an interventional study
* Patient currently enrolled in an observational study sponsored or supported by Janssen
* Estimated Glomerular Filtration Rate (eGFR) \< 70 milliliters per minute (ml/min) if any co-administered agent (example emtricitabine, lamivudine, tenofovir disoproxil fumarate, or adefovir dipivoxil) requires dose adjustment based on creatinine clearance
* Pregnancy or breast feeding at enrollment
* Allergy or intolerance to sulphonamides
* Switch from darunavir/ritonavir (DRV/r) 600/100 bis in die (bid)
* Patient currently in mono PI/r therapy
* Patients to be treated within one year with Direct Acting Antivirals (DAAs) for Hepatitis C Virus (HCV) infection
* Chemotherapy scheduled
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT02926456
Study Brief:
Protocol Section:
NCT02926456