Clinical trial NCT02926456: Study in HIV1-Positive, Virosuppressed Patients Currently inTreatment With Ritonavir-Boosted Protease Inhibitors (PI/r) Starting Cobicistat-Boosted Darunavir (DRV/c - Rezolsta)
Official title: Italian Observational, Multicenter Study in HIV1 -Positive, Virosuppressed Patients Currently in Treatment With Ritonavir-boosted Protease Inhibitors (PI/r) Starting Cobicistat-boosted Darunavir (DRV/c - Rezolsta®): the STart Of REzolsta (ST.O.RE.) Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Human Immunodeficiency Virus
Lead sponsor: Janssen-Cilag S.p.A.
Sponsor class: INDUSTRY
First posted: 2016-10-06
Enrollment: 337
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adult out-patients with a confirmed diagnosis of Human Immunodeficiency Virus-1 (HIV-1), belonging to Italian Infectious Disease Hospital departments of Italian specialty hospitals.

Brief summary: 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.


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

Primary outcomes:
measure: Percentage of Patients With Human Immunodeficiency Virus - RiboNucleic Acid (HIV-RNA) Less Than (<)50 Copies/Milliliters (copies/mL) Measured at Week 48
timeFrame: At Visit 4 (Week 48)
Secondary outcomes:
measure: Change From Baseline in HIV-Symptoms Distress Module (HIV-SDM) Score
timeFrame: Baseline, Up to Visit 4 (Week 48)
measure: Change From Baseline in HIV-Treatment Satisfaction Questionnaire (HIV-TSQ) Score
timeFrame: Baseline, Up to Visit 4 (Week 48)
measure: Percentage of Patients with HIV-RNA <50 copies/mL Measured at Week 24
timeFrame: At Visit 3 (Week 24)
measure: Change From Baseline in CD4 Cell Count
timeFrame: Baseline, Up to Visit 4 (Week 48)
measure: Change From Baseline in CD4/CD8 Ratio
timeFrame: Baseline, Up to Visit 4 (Week 48)
measure: Change From Baseline in CD4 Percentage
timeFrame: Baseline, Up to Visit 4 (Week 48)
measure: Change From Baseline in Creatinine Levels
timeFrame: Baseline, Up to Visit 4 (Week 48)
measure: Change From Baseline in estimated Glomerular Filtration Rate (eGFR)
timeFrame: Baseline, Up to Visit 4 (Week 48)
measure: Change From Baseline in Aspartate Transferase (AST)
timeFrame: Baseline, Up to Visit 4 (Week 48)
measure: Change From Baseline in Alanine-Amino Transferase (ALT)
timeFrame: Baseline, Up to Visit 4 (Week 48)
measure: Change From Baseline in Gamma-Glutamyl Transferase (GGT)
timeFrame: Baseline, Up to Visit 4 (Week 48)
measure: Change From Baseline in Alkaline Phosphatase (ALP)
timeFrame: Baseline, Up to Visit 4 (Week 48)
measure: Change From Baseline in Total Cholesterol
timeFrame: Baseline, Up to Visit 4 (Week 48)
measure: Change From Baseline in Low Density Lypoprotein (LDL)
timeFrame: Baseline, Up to Visit 4 (Week 48)
measure: Change From Baseline in High Density Lypoprotein (HDL)
timeFrame: Baseline, Up to Visit 4 (Week 48)
measure: Change From Baseline in Triglycerides
timeFrame: Baseline, Up to Visit 4 (Week 48)
measure: Change From Baseline in Glucose
timeFrame: Baseline, Up to Visit 4 (Week 48)
Other outcomes:
Locations:
Study officials:
affiliation: Janssen-Cilag S.p.A.
name: Janssen-Cilag S.p.A., Italy Clinical Trial
role: STUDY_DIRECTOR
References: