Study in HIV1-Positive, Virosuppressed Patients Currently inTreatment With Ritonavir-Boosted Protease Inhibitors (PI/r) Starting Cobicistat-Boosted Darunavir (DRV/c - Rezolsta) (STORE)

Janssen (J&J Innovative Medicine)

Status: Completed

Conditions: Human Immunodeficiency Virus

Study type: Observational

Funder types: Industry

Identifiers

NCT02926456

TMC114FD1HTX4003 (Other Identifier)

CR108148

Details and patient eligibility

About

The purpose of this study is to describe the effectiveness of darunavir/cobicistat (DRV/c)-based regimens, measured as maintenance of virological suppression 48 weeks after baseline, defined as the day when the treatment with DRV/c-based regimen is started, through collection of daily practice data in the Italian setting.

Enrollment: 337 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

337 participants in 1 patient group

Cohort 1

Description:

HIV-1-infected patients being in stable ritonavir-boosted Antiretroviral (ARV) treatment with Protease Inhibitors (PIs) (either darunavir 800 milligram \[mg\] each day -based or not) since at least twelve months and virologically suppressed (HIV-RNA less than \[\<\]50 copies/milliliters) since at least six months.