Human Immunodeficiency VirusSTORENCT02926456
Study in HIV1-Positive, Virosuppressed Patients Currently inTreatment With Ritonavir-Boosted Protease Inhibitors (PI/r) Starting Cobicistat-Boosted Darunavir (DRV/c - Rezolsta)
An observational study of Human Immunodeficiency Virus, run by Janssen-Cilag S.p.A..
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Human Immunodeficiency Virus
- How many people
- 337 participants
- Where
- No sites listed yet
- Study dates
- 22 Jul 2016to 14 Feb 2018
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- 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)
Show all 9Show fewer
- 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
About this study
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
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.
- Conditions
- Human Immunodeficiency Virus
- Medical subject headings
- Acquired Immunodeficiency Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: At Visit 4 (Week 48)
Secondary outcomes (17)
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".
Measured: 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.
Measured: Baseline, Up to Visit 4 (Week 48)
Percentage of Patients with HIV-RNA <50 copies/mL Measured at Week 24
Measured: At Visit 3 (Week 24)
Change From Baseline in CD4 Cell Count
CD4 cell count will be assessed as immunological parameter.
Measured: Baseline, Up to Visit 4 (Week 48)
Change From Baseline in CD4/CD8 Ratio
CD4/CD8 ratio will be assessed as immunological parameter.
Measured: Baseline, Up to Visit 4 (Week 48)
Change From Baseline in CD4 Percentage
CD4 percentage will be assessed as immunological parameter.
Measured: 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.
Measured: 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.
Measured: Baseline, Up to Visit 4 (Week 48)
Change From Baseline in Aspartate Transferase (AST)
Measured: Baseline, Up to Visit 4 (Week 48)
Change From Baseline in Alanine-Amino Transferase (ALT)
Measured: Baseline, Up to Visit 4 (Week 48)
Change From Baseline in Gamma-Glutamyl Transferase (GGT)
Measured: Baseline, Up to Visit 4 (Week 48)
Change From Baseline in Alkaline Phosphatase (ALP)
Measured: Baseline, Up to Visit 4 (Week 48)
Change From Baseline in Total Cholesterol
Measured: Baseline, Up to Visit 4 (Week 48)
Change From Baseline in Low Density Lypoprotein (LDL)
Measured: Baseline, Up to Visit 4 (Week 48)
Change From Baseline in High Density Lypoprotein (HDL)
Measured: Baseline, Up to Visit 4 (Week 48)
Change From Baseline in Triglycerides
Measured: Baseline, Up to Visit 4 (Week 48)
Change From Baseline in Glucose
Measured: Baseline, Up to Visit 4 (Week 48)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Oct 2016 (estimated)
- Study start22 Jul 2016
- Primary completion14 Feb 2018
- Study completion14 Feb 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Human Immunodeficiency VirusStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 337 participants (actual)
Sponsor and investigators
- Lead sponsor
- Janssen-Cilag S.p.A.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Janssen-Cilag S.p.A., Italy Clinical Trial, Study director, Janssen-Cilag S.p.A.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02926456
- Sponsor's protocol ID
- CR108148
- Other IDs
- TMC114FD1HTX4003
- Acronym
- STORE
- Status last verified
- Apr 2018
- First submitted
- 21 Sep 2016
- Last updated
- 24 Apr 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Apr 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02926456
- Acronym / sponsor ID
- STORE / CR108148
- Conditions
- Human Immunodeficiency Virus
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 337 participants (actual)
- Lead sponsor
- Janssen-Cilag S.p.A.Industry (pharma, biotech, devices)
- Study start
- 22 Jul 2016 (actual)
- Primary completion
- 14 Feb 2018 (actual)
- Study completion
- 14 Feb 2018 (actual)
- First posted
- 6 Oct 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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).
17 secondary outcomes
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)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Apr 2018.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Janssen-Cilag S.p.A., Italy Clinical Trial study director
Janssen-Cilag S.p.A.
Questions about this trial
What is this clinical trial studying?
An observational study of Human Immunodeficiency Virus, run by Janssen-Cilag S.p.A..
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Apr 2018. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome 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)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Apr 2018.