Human Immunodeficiency Virus (HIV)DIAMANTENCT03577470
An Italian Observation of Antiretroviral Treatment in Participants Taking Darunavir/ Cobicistat Plus Emtricitabine and Tenofovir Alafenamide Fumarate
An observational study of Human Immunodeficiency Virus (HIV), run by Janssen-Cilag S.p.A. at 18 sites in Italy.
Trial summary
The purpose of this study is to describe the effectiveness of Darunavir/ Cobicistat/ Emtricitabine/ Tenofovir Alafenamide (D/C/F/TAF), measured as virological response at Week 48 as per Food and Drug Administration (FDA) snapshot algorithm through collection of daily practice data in the Italian setting. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Human Immunodeficiency Virus (HIV)
- What is being tested?
- D/C/F/TAF Fixed-Dose Combination (FDC)
- How many people
- 246 participants
- Where
- 18 sitesItaly
- Study dates
- 13 Jun 2018to 28 Sep 2020
- 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: Any participant with confirmed diagnosis of Human immunodeficiency virus (HIV) infection will be enrolled and around 20 Infectious Diseases Centers in Italy will be involved.
Who may be able to join
- Having a confirmed diagnosis of Human Immunodeficiency Virus-1 (HIV-1)
- Must sign a participation agreement/Informed Consent Form (ICF) allowing data collection and source data verification in accordance with local requirements
- Taking Darunavir/ Cobicistat/ Emtricitabine/ Tenofovir Alafenamide (D/C/F/TAF) as per Summary of Product Characteristics (SmPCs) since at least one month before enrollment:
- Experienced participants [Group 1 and 2]: a) started their antiretroviral (ARV) treatment not before 1/1/2015, b) having at least 1 year of ARV treatment history at study enrollment, c) Group 1, having always been treated with Darunavir (DRV) since the start of ARV treatment as naïve, d) Group 2, not having been treated with DRV before starting of D/C/F/TAF, ii.) Naive (any Viral Load (VL) participants (Group 3)
Who cannot join
- Participants unable to read, to write, to understand and sign the ICF
- Currently enrolled in an interventional study
- Currently enrolled in an observational study sponsored or supported by Janssen
- Chemotherapy scheduled during study observation
Trial locations and contacts
18 sites in 1 country.
18 sites in 1 country
Italy18 sites
Azienda Ospedaliera Papa Giovanni XXIII
Bergamo, 24127
Azienda Ospedaliera Spedali Civili di Brescia
Brescia, 25123
ASST Valle Olona - P.O. di Busto Arsizio
Busto Arsizio, 21052
Ente Ospedaliero Ospedeli Galliera
Genova, 16128
Ospedale San Raffaele
Milan, 20127
Ospedale San Paolo Clinica Universitaria Malattie Infettive E Tropicali
Milan, 20142
A.O. Ospedale L. Sacco - Polo Universitario
Milan, 20157
Div Malattie Infettive - Ospedale L. Sacco
Milan, 20157
Azienda Ospedaliero Universitaria di Cagliari - Policlinico Duilio Casula di Monserrato
Monserrato, 09042
Azienda Ospedaliera dei Colli - P.O. 'D. Cotugno'
Naples, 80131
Azienda Ospedaliera di Padova
Padova, 35128
Azienda Ospedaliero Universitaria Policlinico Paolo Giaccone
Palermo, 90127
Policlinico Tor Vergata
Roma, 00133
Istituto nazionale malattie infettive 'L. Spallanzani'
Roma, 00149
Universita Di Roma 'La Sapienza'
Roma, 00161
Istituto di Ematologia - Clinica Universitaria
Sassari, 07100
A O Universitaria Senese Ospedale Santa Maria alle Scotte
Siena, 53100
Ospedale Amedeo di Savoia
Torino
About this study
Official title: Italian Retrospective and Prospective Observation of Antiretroviral Treatment in Patients Taking DarunavIr/cobicistAt Plus eMtricitabine and Tenofovir AlafeNamide fumaraTE - DIAMANTE
The purpose of this study is to describe the effectiveness of Darunavir/ Cobicistat/ Emtricitabine/ Tenofovir Alafenamide (D/C/F/TAF), measured as virological response at Week 48 as per Food and Drug Administration (FDA) snapshot algorithm through collection of daily practice data in the Italian setting.
- Conditions
- Human Immunodeficiency Virus (HIV)
- Being tested
- D/C/F/TAF Fixed-Dose Combination (FDC)
- 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.
D/C/F/TAF Fixed-Dose Combination (FDC)Drug
Also called Symtuza
Participants in treatment with D/C/F/TAF FDC, coming from different treatment histories will be observed in this study. No interventions will be administered as a part of this study.
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | Participants will not receive any intervention as a part of this study. This group will include participants in treatment with Darunavir/ Cobicistat/ Emtricitabine/ Tenofovir Alafenamide (D/C/F/TAF), who were always being treated with boosted-darunavir (DRV)-based regimen. The primary data source will be the medical records of each participant participating in this study. Receives: Drug: D/C/F/TAF Fixed-Dose Combination (FDC) | |
| Group 2 | Participants will not receive any intervention as a part of this study. This group will include participants who started their antiretroviral (ARV) treatment with any combination excluding DRV before starting D/C/F/TAF treatments, who were always being treated with ARV treatment with any combination excluding DRV before starting D/C/F/TAF treatments. The primary data source will be the medical records of each participant participating in this study. Receives: Drug: D/C/F/TAF Fixed-Dose Combination (FDC) | |
| Group 3 | Participants will not receive any intervention as a part of this study. This group will include participants started with D/C/F/TAF as naive. The primary data source will be the medical records of each participant participating in this study. Receives: Drug: D/C/F/TAF Fixed-Dose Combination (FDC) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Participants with Virological Response at Week 48
Percentage of participants with virologic response defined as plasma Human Immunodeficiency Virus-Ribonucleic Acid (HIV-RNA) Viral Load (VL) less than (<) 50 copies per milliliter (cp/mL) measured according to Food and Drug Administration (FDA) snapshot algorithm will be reported.
Measured: At Week 48
Secondary outcomes (14)
Participant's Previous Antiretroviral (ARV) Treatment History Determined Using the Web-Based Electronic Case Report Form (eCRF)
Participants previous antiretroviral (ARV) treatment history will be determined using the web-based electronic case report form (eCRF) which will be prepared based on the study flow chart.
Measured: At Baseline (Visit 1)
Time to Virosuppression
For participants entering with VL greater than (>) 50cp/mL, the time to virosuppression will be recorded.
Measured: At Baseline (Visit 1)
Number of Participants with Detectability Below Level of Quantification <50 copies/mL
Number of participants with detectability below level of quantification <50 copies/mL will be reported.
Measured: At Baseline (Visit 1)
Cluster Differentiation 4 (CD4) Cells Nadir Count
CD4 cells nadir count will be reported.
Measured: At Baseline (Visit 1)
CD4 Cell Count
CD4 cells count will be reported.
Measured: At Baseline (Visit 1)
Cluster Differentiation 4/ Cluster Differentiation 8 (CD4/CD8) Ratio
CD4/CD8 ratio will be reported.
Measured: At Baseline (Visit 1)
Percentage of Participants with VL<50cp/mL Measured by the FDA Snapshot Algorithm and Stratified by Age
The percentage of participants having virological response defined as plasma HIV-RNA VL< 50 cp/mL measured by the FDA snapshot algorithm, stratified by age [<50, greater than (>) 50 and < 65, > 65 years according to participants' number] will be reported.
Measured: Up to Week 48
Percentage of Participants with VL < 50 cp/mL Measured by the FDA Snapshot Algorithm and Stratified by Gender at Birth
The percentage of participants having virological response defined as plasma HIV-RNA VL< 50 cp/mL measured by the FDA snapshot algorithm, stratified by gender at birth will be reported.
Measured: Up to Week 48
Percentage of Participants with VL < 50 cp/mL Measured by the FDA Snapshot Algorithm and Stratified by Original Group
The percentage of participants having virological response defined as plasma HIV-RNA VL< 50 cp/mL measured by the FDA snapshot algorithm, stratified by original group will be reported.
Measured: Up to Week 48
Percentage of Participants Withdrawing From the Study for any Reason
The percentage of participants withdrawing from the study for any reason will be reported.
Measured: Up to Week 48
Percentage of Participants who are Virologic Responders (VL<50 cp/mL) Measured by the Time to Loss of Virological Response (TLOVR) Algorithm
The percentage of participants having virological response defined as VL< 50 cp/mL, measured by the TLOVR algorithm dataset will be reported. In the TLOVR dataset, participant responses at a specified threshold of HIV-1 RNA (<50 copies/mL) are determined by using the Food and Drug Administration's TLOVR algorithm. Using the TLOVR algorithm, participants are considered to have failed on therapy if they never achieved confirmed RNA levels below the threshold, if they had confirmed rebound of RNA above the threshold, if they made a non-permitted change in background regimen, or if they permanently discontinued investigational product for any reason.
Measured: Up to Week 48
Percentage of Participants with Virological Failure in Virosuppressed Participants
Percentage of participants with virological failure (two consecutive measures of VL greater than or equal to (>=) 50cp/mL) in virosuppressed participants with virological rebound will be calculated and reported.
Measured: Up to Week 48
Change from Baseline in Human Immunodeficiency Virus-Treatment Satisfaction Questionnaire Score (HIV-TSQs) at Week 48
The HIV-TSQ is a 10-item self-reported scale that measures overall satisfaction with treatment by specific items that includes current treatment, control, side effects, demands, convenience, flexibility, understanding, lifestyle, recommend to others, continue. The HIV-TSQ items are summed up to produce a treatment satisfaction total score (0 to 60) and an individual satisfaction rating for each item (0 to 6). The higher the score, the greater the improvement in treatment satisfaction as compared to the past few weeks. A smaller score represents a decline in treatment satisfaction compared to the past few weeks. HIV-TSQs will be recorded onto paper forms and will be considered as source data.
Measured: Baseline and Week 48
Change from Baseline in Participants Reported Outcome Based on Narrative Plots at Week 48
Narrative plots will be recorded onto paper forms and will be considered as source data to describe the participants experience during treatment.
Measured: Baseline and Week 48
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jul 2018
- Study start13 Jun 2018
- Primary completion28 Sep 2020
- Study completion28 Sep 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Human Immunodeficiency Virus (HIV)Studies 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
- 246 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
- NCT03577470
- Sponsor's protocol ID
- CR108466
- Other IDs
- TMC114FD1HTX4011
- Acronym
- DIAMANTE
- Status last verified
- Oct 2024
- First submitted
- 7 Jun 2018
- Last updated
- 15 Oct 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Italian Retrospective and Prospective Observation of Antiretroviral Treatment in Patients Taking DarunavIr/cobicistAt Plus eMtricitabine and Tenofovir AlafeNamide fumaraTE - DIAMANTE
- ClinicalTrials.gov ID
- NCT03577470
- Acronym / sponsor ID
- DIAMANTE / CR108466
- Conditions
- Human Immunodeficiency Virus (HIV)
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 246 participants (actual)
- Lead sponsor
- Janssen-Cilag S.p.A.Industry (pharma, biotech, devices)
- Study start
- 13 Jun 2018 (actual)
- Primary completion
- 28 Sep 2020 (actual)
- Study completion
- 28 Sep 2020 (actual)
- First posted
- 5 Jul 2018 (actual)
- 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/ Emtricitabine/ Tenofovir Alafenamide (D/C/F/TAF), measured as virological response at Week 48 as per Food and Drug Administration (FDA) snapshot algorithm through collection of daily practice data in the Italian setting.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Group 1 | – | Drug: D/C/F/TAF Fixed-Dose Combination (FDC)Participants will not receive any intervention as a part of this study. This group will include participants in treatment with Darunavir/ Cobicistat/ Emtricitabine/ Tenofovir Alafenamide (D/C/F/TAF), who were always being treated with boosted-darunavir (DRV)-based regimen. The primary data source will be the medical records of each participant participating in this study. |
| Group 2 | – | Drug: D/C/F/TAF Fixed-Dose Combination (FDC)Participants will not receive any intervention as a part of this study. This group will include participants who started their antiretroviral (ARV) treatment with any combination excluding DRV before starting D/C/F/TAF treatments, who were always being treated with ARV treatment with any combination excluding DRV before starting D/C/F/TAF treatments. The primary data source will be the medical records of each participant participating in this study. |
| Group 3 | – | Drug: D/C/F/TAF Fixed-Dose Combination (FDC)Participants will not receive any intervention as a part of this study. This group will include participants started with D/C/F/TAF as naive. The primary data source will be the medical records of each participant participating in this study. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Any participant with confirmed diagnosis of Human immunodeficiency virus (HIV) infection will be enrolled and around 20 Infectious Diseases Centers in Italy will be involved.
Key inclusion criteria (4 listed)
- Having a confirmed diagnosis of Human Immunodeficiency Virus-1 (HIV-1)
- Must sign a participation agreement/Informed Consent Form (ICF) allowing data collection and source data verification in accordance with local requirements
- Taking Darunavir/ Cobicistat/ Emtricitabine/ Tenofovir Alafenamide (D/C/F/TAF) as per Summary of Product Characteristics (SmPCs) since at least one month before enrollment:
Key exclusion criteria (4 listed)
- Participants unable to read, to write, to understand and sign the ICF
- Currently enrolled in an interventional study
- Currently enrolled in an observational study sponsored or supported by Janssen
- Chemotherapy scheduled during study observation
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| D/C/F/TAF Fixed-Dose Combination (FDC)Also: SymtuzaParticipants in treatment with D/C/F/TAF FDC, coming from different treatment histories will be observed in this study. No interventions will be administered as a part of this study. | Drug | Group 1, Group 2, Group 3 |
Primary outcome
Percentage of Participants with Virological Response at Week 48
Time frame: At Week 48
Percentage of participants with virologic response defined as plasma Human Immunodeficiency Virus-Ribonucleic Acid (HIV-RNA) Viral Load (VL) less than (<) 50 copies per milliliter (cp/mL) measured according to Food and Drug Administration (FDA) snapshot algorithm will be reported.
14 secondary outcomes
Participant's Previous Antiretroviral (ARV) Treatment History Determined Using the Web-Based Electronic Case Report Form (eCRF)
Time frame: At Baseline (Visit 1)
Time to Virosuppression
Time frame: At Baseline (Visit 1)
Number of Participants with Detectability Below Level of Quantification <50 copies/mL
Time frame: At Baseline (Visit 1)
Cluster Differentiation 4 (CD4) Cells Nadir Count
Time frame: At Baseline (Visit 1)
CD4 Cell Count
Time frame: At Baseline (Visit 1)
Cluster Differentiation 4/ Cluster Differentiation 8 (CD4/CD8) Ratio
Time frame: At Baseline (Visit 1)
Percentage of Participants with VL<50cp/mL Measured by the FDA Snapshot Algorithm and Stratified by Age
Time frame: Up to Week 48
Percentage of Participants with VL < 50 cp/mL Measured by the FDA Snapshot Algorithm and Stratified by Gender at Birth
Time frame: Up to Week 48
Percentage of Participants with VL < 50 cp/mL Measured by the FDA Snapshot Algorithm and Stratified by Original Group
Time frame: Up to Week 48
Percentage of Participants Withdrawing From the Study for any Reason
Time frame: Up to Week 48
Percentage of Participants who are Virologic Responders (VL<50 cp/mL) Measured by the Time to Loss of Virological Response (TLOVR) Algorithm
Time frame: Up to Week 48
Percentage of Participants with Virological Failure in Virosuppressed Participants
Time frame: Up to Week 48
Change from Baseline in Human Immunodeficiency Virus-Treatment Satisfaction Questionnaire Score (HIV-TSQs) at Week 48
Time frame: Baseline and Week 48
Change from Baseline in Participants Reported Outcome Based on Narrative Plots at Week 48
Time frame: Baseline and 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 15 Oct 2024.
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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.
18 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Human Immunodeficiency Virus (HIV), run by Janssen-Cilag S.p.A. at 18 sites in Italy.
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 4 inclusion and 4 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 15 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 18 sites in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
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 Participants with Virological Response at Week 48 (time frame: At 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 15 Oct 2024.