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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT02926456
Recruitment Status : Completed
First Posted : October 6, 2016
Last Update Posted : April 24, 2018
Information provided by (Responsible Party):
Janssen-Cilag S.p.A.

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.

Condition or disease
Human Immunodeficiency Virus

Study Type : Observational
Actual Enrollment : 337 participants
Observational Model: Cohort
Time Perspective: Prospective
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
Actual Study Start Date : July 22, 2016
Actual Primary Completion Date : February 14, 2018
Actual Study Completion Date : February 14, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS

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.

Primary Outcome Measures :
  1. 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) ]
    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).

Secondary Outcome Measures :
  1. Change From Baseline in HIV-Symptoms Distress Module (HIV-SDM) Score [ Time Frame: 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".

  2. Change From Baseline in HIV-Treatment Satisfaction Questionnaire (HIV-TSQ) Score [ Time Frame: 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.

  3. Percentage of Patients with HIV-RNA <50 copies/mL Measured at Week 24 [ Time Frame: At Visit 3 (Week 24) ]
  4. Change From Baseline in CD4 Cell Count [ Time Frame: Baseline, Up to Visit 4 (Week 48) ]
    CD4 cell count will be assessed as immunological parameter.

  5. Change From Baseline in CD4/CD8 Ratio [ Time Frame: Baseline, Up to Visit 4 (Week 48) ]
    CD4/CD8 ratio will be assessed as immunological parameter.

  6. Change From Baseline in CD4 Percentage [ Time Frame: Baseline, Up to Visit 4 (Week 48) ]
    CD4 percentage will be assessed as immunological parameter.

  7. Change From Baseline in Creatinine Levels [ Time Frame: Baseline, Up to Visit 4 (Week 48) ]
    The change from baseline in serum creatinine up to 48 weeks will be assessed.

  8. Change From Baseline in estimated Glomerular Filtration Rate (eGFR) [ Time Frame: 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.

  9. Change From Baseline in Aspartate Transferase (AST) [ Time Frame: Baseline, Up to Visit 4 (Week 48) ]
  10. Change From Baseline in Alanine-Amino Transferase (ALT) [ Time Frame: Baseline, Up to Visit 4 (Week 48) ]
  11. Change From Baseline in Gamma-Glutamyl Transferase (GGT) [ Time Frame: Baseline, Up to Visit 4 (Week 48) ]
  12. Change From Baseline in Alkaline Phosphatase (ALP) [ Time Frame: Baseline, Up to Visit 4 (Week 48) ]
  13. Change From Baseline in Total Cholesterol [ Time Frame: Baseline, Up to Visit 4 (Week 48) ]
  14. Change From Baseline in Low Density Lypoprotein (LDL) [ Time Frame: Baseline, Up to Visit 4 (Week 48) ]
  15. Change From Baseline in High Density Lypoprotein (HDL) [ Time Frame: Baseline, Up to Visit 4 (Week 48) ]
  16. Change From Baseline in Triglycerides [ Time Frame: Baseline, Up to Visit 4 (Week 48) ]
  17. Change From Baseline in Glucose [ Time Frame: Baseline, Up to Visit 4 (Week 48) ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT02926456

Sponsors and Collaborators
Janssen-Cilag S.p.A.
Study Director: Janssen-Cilag S.p.A., Italy Clinical Trial Janssen-Cilag S.p.A.

Responsible Party: Janssen-Cilag S.p.A. Identifier: NCT02926456     History of Changes
Other Study ID Numbers: CR108148
TMC114FD1HTX4003 ( Other Identifier: Janssen-Cilag S.p.A., Italy )
First Posted: October 6, 2016    Key Record Dates
Last Update Posted: April 24, 2018
Last Verified: April 2018

Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Immunologic Deficiency Syndromes
Acquired Immunodeficiency Syndrome
HIV Infections
Immune System Diseases
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Slow Virus Diseases
HIV Protease Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anti-HIV Agents
Anti-Retroviral Agents
Antiviral Agents
Anti-Infective Agents
Cytochrome P-450 CYP3A Inhibitors
Cytochrome P-450 Enzyme Inhibitors