Overview

This trial is active, not recruiting.

Condition human immunodeficiency virus
Phase phase 4
Sponsor Janssen-Cilag S.p.A.
Start date July 2016
End date March 2018
Trial size 300 participants
Trial identifier NCT02926456, CR108148, TMC114FD1HTX4003

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Observational model cohort
Time perspective prospective
Arm
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.

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
time frame: At Visit 4 (Week 48)

Secondary Outcomes

Measure
Change From Baseline in HIV-Symptoms Distress Module (HIV-SDM) Score
time frame: Baseline, Up to Visit 4 (Week 48)
Change From Baseline in HIV-Treatment Satisfaction Questionnaire (HIV-TSQ) Score
time frame: Baseline, Up to Visit 4 (Week 48)
Percentage of Patients with HIV-RNA <50 copies/mL Measured at Week 24
time frame: At Visit 3 (Week 24)
Change From Baseline in CD4 Cell Count
time frame: Baseline, Up to Visit 4 (Week 48)
Change From Baseline in CD4/CD8 Ratio
time frame: Baseline, Up to Visit 4 (Week 48)
Change From Baseline in CD4 Percentage
time frame: Baseline, Up to Visit 4 (Week 48)
Change From Baseline in Creatinine Levels
time frame: Baseline, Up to Visit 4 (Week 48)
Change From Baseline in estimated Glomerular Filtration Rate (eGFR)
time frame: Baseline, Up to Visit 4 (Week 48)
Change From Baseline in Aspartate Transferase (AST)
time frame: Baseline, Up to Visit 4 (Week 48)
Change From Baseline in Alanine-Amino Transferase (ALT)
time frame: Baseline, Up to Visit 4 (Week 48)
Change From Baseline in Gamma-Glutamyl Transferase (GGT)
time frame: Baseline, Up to Visit 4 (Week 48)
Change From Baseline in Alkaline Phosphatase (ALP)
time frame: Baseline, Up to Visit 4 (Week 48)
Change From Baseline in Total Cholesterol
time frame: Baseline, Up to Visit 4 (Week 48)
Change From Baseline in Low Density Lypoprotein (LDL)
time frame: Baseline, Up to Visit 4 (Week 48)
Change From Baseline in High Density Lypoprotein (HDL)
time frame: Baseline, Up to Visit 4 (Week 48)
Change From Baseline in Triglycerides
time frame: Baseline, Up to Visit 4 (Week 48)
Change From Baseline in Glucose
time frame: Baseline, Up to Visit 4 (Week 48)

Eligibility Criteria

Male or female participants at least 18 years old.

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

Additional Information

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
Trial information was received from ClinicalTrials.gov and was last updated in October 2016.
Information provided to ClinicalTrials.gov by Janssen-Cilag S.p.A..