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

23. April 2018 aktualisiert von: Janssen-Cilag S.p.A.

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.

Studienübersicht

Status

Abgeschlossen

Bedingungen

Studientyp

Beobachtungs

Einschreibung (Tatsächlich)

337

Teilnahmekriterien

Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.

Zulassungskriterien

Studienberechtigtes Alter

18 Jahre und älter (Erwachsene, Älterer Erwachsener)

Akzeptiert gesunde Freiwillige

Nein

Studienberechtigte Geschlechter

Alle

Probenahmeverfahren

Nicht-Wahrscheinlichkeitsprobe

Studienpopulation

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.

Beschreibung

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

Studienplan

Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.

Wie ist die Studie aufgebaut?

Designdetails

Kohorten und Interventionen

Gruppe / Kohorte
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.

Was misst die Studie?

Primäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Percentage of Patients With Human Immunodeficiency Virus - RiboNucleic Acid (HIV-RNA) Less Than (<)50 Copies/Milliliters (copies/mL) Measured at Week 48
Zeitfenster: At Visit 4 (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)

Sekundäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Change From Baseline in HIV-Symptoms Distress Module (HIV-SDM) Score
Zeitfenster: Baseline, Up to Visit 4 (Week 48)
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
Zeitfenster: Baseline, Up to Visit 4 (Week 48)
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
Zeitfenster: At Visit 3 (Week 24)
At Visit 3 (Week 24)
Change From Baseline in CD4 Cell Count
Zeitfenster: Baseline, Up to Visit 4 (Week 48)
CD4 cell count will be assessed as immunological parameter.
Baseline, Up to Visit 4 (Week 48)
Change From Baseline in CD4/CD8 Ratio
Zeitfenster: Baseline, Up to Visit 4 (Week 48)
CD4/CD8 ratio will be assessed as immunological parameter.
Baseline, Up to Visit 4 (Week 48)
Change From Baseline in CD4 Percentage
Zeitfenster: Baseline, Up to Visit 4 (Week 48)
CD4 percentage will be assessed as immunological parameter.
Baseline, Up to Visit 4 (Week 48)
Change From Baseline in Creatinine Levels
Zeitfenster: Baseline, Up to Visit 4 (Week 48)
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)
Zeitfenster: Baseline, Up to Visit 4 (Week 48)
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)
Zeitfenster: Baseline, Up to Visit 4 (Week 48)
Baseline, Up to Visit 4 (Week 48)
Change From Baseline in Alanine-Amino Transferase (ALT)
Zeitfenster: Baseline, Up to Visit 4 (Week 48)
Baseline, Up to Visit 4 (Week 48)
Change From Baseline in Gamma-Glutamyl Transferase (GGT)
Zeitfenster: Baseline, Up to Visit 4 (Week 48)
Baseline, Up to Visit 4 (Week 48)
Change From Baseline in Alkaline Phosphatase (ALP)
Zeitfenster: Baseline, Up to Visit 4 (Week 48)
Baseline, Up to Visit 4 (Week 48)
Change From Baseline in Total Cholesterol
Zeitfenster: Baseline, Up to Visit 4 (Week 48)
Baseline, Up to Visit 4 (Week 48)
Change From Baseline in Low Density Lypoprotein (LDL)
Zeitfenster: Baseline, Up to Visit 4 (Week 48)
Baseline, Up to Visit 4 (Week 48)
Change From Baseline in High Density Lypoprotein (HDL)
Zeitfenster: Baseline, Up to Visit 4 (Week 48)
Baseline, Up to Visit 4 (Week 48)
Change From Baseline in Triglycerides
Zeitfenster: Baseline, Up to Visit 4 (Week 48)
Baseline, Up to Visit 4 (Week 48)
Change From Baseline in Glucose
Zeitfenster: Baseline, Up to Visit 4 (Week 48)
Baseline, Up to Visit 4 (Week 48)

Mitarbeiter und Ermittler

Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.

Sponsor

Janssen-Cilag S.p.A.

Studienaufzeichnungsdaten

Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.

Haupttermine studieren

Studienbeginn (Tatsächlich)

22. Juli 2016

Primärer Abschluss (Tatsächlich)

14. Februar 2018

Studienabschluss (Tatsächlich)

14. Februar 2018

Studienanmeldedaten

Zuerst eingereicht

21. September 2016

Zuerst eingereicht, das die QC-Kriterien erfüllt hat

5. Oktober 2016

Zuerst gepostet (Schätzen)

6. Oktober 2016

Studienaufzeichnungsaktualisierungen

Letztes Update gepostet (Tatsächlich)

24. April 2018

Letztes eingereichtes Update, das die QC-Kriterien erfüllt

23. April 2018

Zuletzt verifiziert

1. April 2018

Mehr Informationen

Begriffe im Zusammenhang mit dieser Studie

Zusätzliche relevante MeSH-Bedingungen

Andere Studien-ID-Nummern

  • CR108148
  • TMC114FD1HTX4003 (Andere Kennung: Janssen-Cilag S.p.A., Italy)

Arzneimittel- und Geräteinformationen, Studienunterlagen

Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt

Nein

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