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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 de abril de 2018 actualizado por: 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.

Descripción general del estudio

Estado

Terminado

Condiciones

Tipo de estudio

De observación

Inscripción (Actual)

337

Criterios de participación

Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.

Criterio de elegibilidad

Edades elegibles para estudiar

18 años y mayores (Adulto, Adulto Mayor)

Acepta Voluntarios Saludables

No

Géneros elegibles para el estudio

Todos

Método de muestreo

Muestra no probabilística

Población de estudio

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.

Descripción

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

Plan de estudios

Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.

¿Cómo está diseñado el estudio?

Detalles de diseño

Cohortes e Intervenciones

Grupo / Cohorte
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.

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Percentage of Patients With Human Immunodeficiency Virus - RiboNucleic Acid (HIV-RNA) Less Than (<)50 Copies/Milliliters (copies/mL) Measured at Week 48
Periodo de tiempo: 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)

Medidas de resultado secundarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Change From Baseline in HIV-Symptoms Distress Module (HIV-SDM) Score
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: At Visit 3 (Week 24)
At Visit 3 (Week 24)
Change From Baseline in CD4 Cell Count
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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)
Periodo de tiempo: 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)
Periodo de tiempo: Baseline, Up to Visit 4 (Week 48)
Baseline, Up to Visit 4 (Week 48)
Change From Baseline in Alanine-Amino Transferase (ALT)
Periodo de tiempo: Baseline, Up to Visit 4 (Week 48)
Baseline, Up to Visit 4 (Week 48)
Change From Baseline in Gamma-Glutamyl Transferase (GGT)
Periodo de tiempo: Baseline, Up to Visit 4 (Week 48)
Baseline, Up to Visit 4 (Week 48)
Change From Baseline in Alkaline Phosphatase (ALP)
Periodo de tiempo: Baseline, Up to Visit 4 (Week 48)
Baseline, Up to Visit 4 (Week 48)
Change From Baseline in Total Cholesterol
Periodo de tiempo: Baseline, Up to Visit 4 (Week 48)
Baseline, Up to Visit 4 (Week 48)
Change From Baseline in Low Density Lypoprotein (LDL)
Periodo de tiempo: Baseline, Up to Visit 4 (Week 48)
Baseline, Up to Visit 4 (Week 48)
Change From Baseline in High Density Lypoprotein (HDL)
Periodo de tiempo: Baseline, Up to Visit 4 (Week 48)
Baseline, Up to Visit 4 (Week 48)
Change From Baseline in Triglycerides
Periodo de tiempo: Baseline, Up to Visit 4 (Week 48)
Baseline, Up to Visit 4 (Week 48)
Change From Baseline in Glucose
Periodo de tiempo: Baseline, Up to Visit 4 (Week 48)
Baseline, Up to Visit 4 (Week 48)

Colaboradores e Investigadores

Aquí es donde encontrará personas y organizaciones involucradas en este estudio.

Patrocinador

Janssen-Cilag S.p.A.

Fechas de registro del estudio

Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados ​​por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.

Fechas importantes del estudio

Inicio del estudio (Actual)

22 de julio de 2016

Finalización primaria (Actual)

14 de febrero de 2018

Finalización del estudio (Actual)

14 de febrero de 2018

Fechas de registro del estudio

Enviado por primera vez

21 de septiembre de 2016

Primero enviado que cumplió con los criterios de control de calidad

5 de octubre de 2016

Publicado por primera vez (Estimar)

6 de octubre de 2016

Actualizaciones de registros de estudio

Última actualización publicada (Actual)

24 de abril de 2018

Última actualización enviada que cumplió con los criterios de control de calidad

23 de abril de 2018

Última verificación

1 de abril de 2018

Más información

Términos relacionados con este estudio

Términos MeSH relevantes adicionales

Otros números de identificación del estudio

  • CR108148
  • TMC114FD1HTX4003 (Otro identificador: Janssen-Cilag S.p.A., Italy)

Información sobre medicamentos y dispositivos, documentos del estudio

Estudia un producto de dispositivo regulado por la FDA de EE. UU.

No

Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .

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