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

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

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.

Study Overview

• Status: Completed
• Conditions: Human Immunodeficiency Virus

• Study Type: Observational
• Enrollment (Actual): 337

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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.

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
Cohort 1; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of Patients With Human Immunodeficiency Virus - RiboNucleic Acid (HIV-RNA) Less Than (<)50 Copies/Milliliters (copies/mL) Measured at Week 48	The percentage of patients with plasma HIV-RNA<50 copies/mL will be analyzed by FDA snapshot analysis (FDA Snapshot Approach is based on the last observed viral load data within the Week 48 window: virologic response is defined as HIV-1 RNA <50 copies/mL (observed case); If there are no data in the defined time window, the proportion of missing data and relative reason will be provided") and Time to loss of virologic response (TLOVR) method algorithm requires sustained HIV-1 RNA < 50 copies/mL; confirmed HIV-1 RNA more than or equal to (>=) 50 copies/mL is considered as non-response (rebound); patients considered non-responder after permanent discontinuation).	At Visit 4 (Week 48)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change From Baseline in HIV-Symptoms Distress Module (HIV-SDM) Score	HIV-SDM is a questionnaire consisting of 20 questions related to all the symptoms which the patient might have had during the past four weeks. For each question patient has to select appropriate answer related to the symptoms: "0 = I do not have this symptom; 1 = I have this symptom and it doesn't bother me; 2 = it bothers me a little; 3 = it bothers me; 4 = it bothers me a lot".	Baseline, Up to Visit 4 (Week 48)
Change From Baseline in HIV-Treatment Satisfaction Questionnaire (HIV-TSQ) Score	The HIV Treatment Satisfaction Questionnaire (HIV-TSQ) is a 10-item instrument that is supported by evidence of good internal consistency reliability. The total score ranges from 0 to 60, with higher scores indicating greater treatment satisfaction. Score change ranges from -30 to +30, with scores<0 and >0 indicating a decrease and increase in treatment satisfaction, respectively.	Baseline, Up to Visit 4 (Week 48)
Percentage of Patients with HIV-RNA <50 copies/mL Measured at Week 24		At Visit 3 (Week 24)
Change From Baseline in CD4 Cell Count	CD4 cell count will be assessed as immunological parameter.	Baseline, Up to Visit 4 (Week 48)
Change From Baseline in CD4/CD8 Ratio	CD4/CD8 ratio will be assessed as immunological parameter.	Baseline, Up to Visit 4 (Week 48)
Change From Baseline in CD4 Percentage	CD4 percentage will be assessed as immunological parameter.	Baseline, Up to Visit 4 (Week 48)
Change From Baseline in Creatinine Levels	The change from baseline in serum creatinine up to 48 weeks will be assessed.	Baseline, Up to Visit 4 (Week 48)
Change From Baseline in estimated Glomerular Filtration Rate (eGFR)	The change from baseline in eGFR will be assessed by Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) formula.	Baseline, Up to Visit 4 (Week 48)
Change From Baseline in Aspartate Transferase (AST)		Baseline, Up to Visit 4 (Week 48)
Change From Baseline in Alanine-Amino Transferase (ALT)		Baseline, Up to Visit 4 (Week 48)
Change From Baseline in Gamma-Glutamyl Transferase (GGT)		Baseline, Up to Visit 4 (Week 48)
Change From Baseline in Alkaline Phosphatase (ALP)		Baseline, Up to Visit 4 (Week 48)
Change From Baseline in Total Cholesterol		Baseline, Up to Visit 4 (Week 48)
Change From Baseline in Low Density Lypoprotein (LDL)		Baseline, Up to Visit 4 (Week 48)
Change From Baseline in High Density Lypoprotein (HDL)		Baseline, Up to Visit 4 (Week 48)
Change From Baseline in Triglycerides		Baseline, Up to Visit 4 (Week 48)
Change From Baseline in Glucose		Baseline, Up to Visit 4 (Week 48)

Collaborators and Investigators

• Sponsor: Janssen-Cilag S.p.A.

Study record dates

Study Major Dates

• Study Start (Actual): July 22, 2016
• Primary Completion (Actual): February 14, 2018
• Study Completion (Actual): February 14, 2018

Study Registration Dates

• First Submitted: September 21, 2016
• First Submitted That Met QC Criteria: October 5, 2016
• First Posted (Estimate): October 6, 2016

Study Record Updates

• Last Update Posted (Actual): April 24, 2018
• Last Update Submitted That Met QC Criteria: April 23, 2018
• Last Verified: April 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: RNA Virus Infections; Virus Diseases; Infections; Blood-Borne Infections; Communicable Diseases; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; Immunologic Deficiency Syndromes; Immune System Diseases; Slow Virus Diseases; HIV Infections; Acquired Immunodeficiency Syndrome
• Other Study ID Numbers: CR108148; TMC114FD1HTX4003 (Other Identifier: Janssen-Cilag S.p.A., Italy)

Drug and device information, study documents

• Studies a U.S. FDA-regulated device product: No