An Italian Observation of Antiretroviral Treatment in Participants Taking Darunavir/ Cobicistat Plus Emtricitabine and Tenofovir Alafenamide Fumarate
NCT ID: NCT03577470
Last Updated: 2024-10-15
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
246 participants
OBSERVATIONAL
2018-06-13
2020-09-28
Brief Summary
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Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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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.
D/C/F/TAF Fixed-Dose Combination (FDC)
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.
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.
D/C/F/TAF Fixed-Dose Combination (FDC)
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.
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.
D/C/F/TAF Fixed-Dose Combination (FDC)
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.
Interventions
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D/C/F/TAF Fixed-Dose Combination (FDC)
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.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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)
Exclusion Criteria
* Currently enrolled in an interventional study
* Currently enrolled in an observational study sponsored or supported by Janssen
* Chemotherapy scheduled during study observation
18 Years
ALL
No
Sponsors
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Janssen-Cilag S.p.A.
INDUSTRY
Responsible Party
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Principal Investigators
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Janssen-Cilag S.p.A., Italy Clinical Trial
Role: STUDY_DIRECTOR
Janssen-Cilag S.p.A.
Locations
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Azienda Ospedaliera Papa Giovanni XXIII
Bergamo, , Italy
Azienda Ospedaliera Spedali Civili di Brescia
Brescia, , Italy
ASST Valle Olona - P.O. di Busto Arsizio
Busto Arsizio, , Italy
Ente Ospedaliero Ospedeli Galliera
Genova, , Italy
Ospedale San Raffaele
Milan, , Italy
Ospedale San Paolo Clinica Universitaria Malattie Infettive E Tropicali
Milan, , Italy
A.O. Ospedale L. Sacco - Polo Universitario
Milan, , Italy
Div Malattie Infettive - Ospedale L. Sacco
Milan, , Italy
Azienda Ospedaliero Universitaria di Cagliari - Policlinico Duilio Casula di Monserrato
Monserrato, , Italy
Azienda Ospedaliera dei Colli - P.O. 'D. Cotugno'
Napoli, , Italy
Azienda Ospedaliera di Padova
Padua, , Italy
Azienda Ospedaliero Universitaria Policlinico Paolo Giaccone
Palermo, , Italy
Policlinico Tor Vergata
Roma, , Italy
Istituto nazionale malattie infettive 'L. Spallanzani'
Roma, , Italy
Universita Di Roma 'La Sapienza'
Roma, , Italy
Istituto di Ematologia - Clinica Universitaria
Sassari, , Italy
A O Universitaria Senese Ospedale Santa Maria alle Scotte
Siena, , Italy
Ospedale Amedeo di Savoia
Torino, , Italy
Countries
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Other Identifiers
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TMC114FD1HTX4011
Identifier Type: OTHER
Identifier Source: secondary_id
CR108466
Identifier Type: -
Identifier Source: org_study_id
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