An Italian Observation of Antiretroviral Treatment in Participants Taking Darunavir/ Cobicistat Plus Emtricitabine and Tenofovir Alafenamide Fumarate
DIAMANTE
Italian Retrospective and Prospective Observation of Antiretroviral Treatment in Patients Taking DarunavIr/cobicistAt Plus eMtricitabine and Tenofovir AlafeNamide fumaraTE - DIAMANTE
2 other identifiers
observational
246
1 country
18
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Jun 2018
Typical duration for all trials
18 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 7, 2018
CompletedStudy Start
First participant enrolled
June 13, 2018
CompletedFirst Posted
Study publicly available on registry
July 5, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 28, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
September 28, 2020
CompletedOctober 15, 2024
October 1, 2024
2.3 years
June 7, 2018
October 11, 2024
Conditions
Outcome Measures
Primary Outcomes (1)
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.
At Week 48
Secondary Outcomes (14)
Participant's Previous Antiretroviral (ARV) Treatment History Determined Using the Web-Based Electronic Case Report Form (eCRF)
At Baseline (Visit 1)
Time to Virosuppression
At Baseline (Visit 1)
Number of Participants with Detectability Below Level of Quantification <50 copies/mL
At Baseline (Visit 1)
Cluster Differentiation 4 (CD4) Cells Nadir Count
At Baseline (Visit 1)
CD4 Cell Count
At Baseline (Visit 1)
- +9 more secondary outcomes
Study Arms (3)
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.
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.
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.
Interventions
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.
Eligibility Criteria
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.
You may qualify if:
- 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:
- i) 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)
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (18)
Azienda Ospedaliera Papa Giovanni XXIII
Bergamo, 24127, Italy
Azienda Ospedaliera Spedali Civili di Brescia
Brescia, 25123, Italy
ASST Valle Olona - P.O. di Busto Arsizio
Busto Arsizio, 21052, Italy
Ente Ospedaliero Ospedeli Galliera
Genova, 16128, Italy
Ospedale San Raffaele
Milan, 20127, Italy
Ospedale San Paolo Clinica Universitaria Malattie Infettive E Tropicali
Milan, 20142, Italy
A.O. Ospedale L. Sacco - Polo Universitario
Milan, 20157, Italy
Div Malattie Infettive - Ospedale L. Sacco
Milan, 20157, Italy
Azienda Ospedaliero Universitaria di Cagliari - Policlinico Duilio Casula di Monserrato
Monserrato, 09042, Italy
Azienda Ospedaliera dei Colli - P.O. 'D. Cotugno'
Napoli, 80131, Italy
Azienda Ospedaliera di Padova
Padua, 35128, Italy
Azienda Ospedaliero Universitaria Policlinico Paolo Giaccone
Palermo, 90127, Italy
Policlinico Tor Vergata
Roma, 00133, Italy
Istituto nazionale malattie infettive 'L. Spallanzani'
Roma, 00149, Italy
Universita Di Roma 'La Sapienza'
Roma, 00161, Italy
Istituto di Ematologia - Clinica Universitaria
Sassari, 07100, Italy
A O Universitaria Senese Ospedale Santa Maria alle Scotte
Siena, 53100, Italy
Ospedale Amedeo di Savoia
Torino, Italy
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Janssen-Cilag S.p.A., Italy Clinical Trial
Janssen-Cilag S.p.A.
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 7, 2018
First Posted
July 5, 2018
Study Start
June 13, 2018
Primary Completion
September 28, 2020
Study Completion
September 28, 2020
Last Updated
October 15, 2024
Record last verified: 2024-10