Study in HIV1-Positive, Virosuppressed Patients Currently inTreatment With Ritonavir-Boosted Protease Inhibitors (PI/r) Starting Cobicistat-Boosted Darunavir (DRV/c - Rezolsta)
Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Janssen-Cilag S.p.A.
Age
18–any
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
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
You may not be if
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
Clareo Health | Study in HIV1-Positive, Virosuppressed Patients Currently inTreatment With Ritonavir-Boosted Protease Inhibitors (PI/r) Starting Cobicistat-Boosted Darunavir (DRV/c - Rezolsta)
