Clinical trial NCT03577470: An Italian Observation of Antiretroviral Treatment in Participants Taking Darunavir/ Cobicistat Plus Emtricitabine and Tenofovir Alafenamide Fumarate
Official title: Italian Retrospective and Prospective Observation of Antiretroviral Treatment in Patients Taking DarunavIr/cobicistAt Plus eMtricitabine and Tenofovir AlafeNamide fumaraTE - DIAMANTE
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Human Immunodeficiency Virus (HIV)
Lead sponsor: Janssen-Cilag S.p.A.
Sponsor class: INDUSTRY
First posted: 2018-07-05
Enrollment: 246
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
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.

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.


Eligibility criteria: Inclusion Criteria:

* 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)

Exclusion Criteria:

* 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

Primary outcomes:
measure: Percentage of Participants with Virological Response at Week 48
timeFrame: At Week 48
Secondary outcomes:
measure: Participant's Previous Antiretroviral (ARV) Treatment History Determined Using the Web-Based Electronic Case Report Form (eCRF)
timeFrame: At Baseline (Visit 1)
measure: Time to Virosuppression
timeFrame: At Baseline (Visit 1)
measure: Number of Participants with Detectability Below Level of Quantification <50 copies/mL
timeFrame: At Baseline (Visit 1)
measure: Cluster Differentiation 4 (CD4) Cells Nadir Count
timeFrame: At Baseline (Visit 1)
measure: CD4 Cell Count
timeFrame: At Baseline (Visit 1)
measure: Cluster Differentiation 4/ Cluster Differentiation 8 (CD4/CD8) Ratio
timeFrame: At Baseline (Visit 1)
measure: Percentage of Participants with VL<50cp/mL Measured by the FDA Snapshot Algorithm and Stratified by Age
timeFrame: Up to Week 48
measure: Percentage of Participants with VL < 50 cp/mL Measured by the FDA Snapshot Algorithm and Stratified by Gender at Birth
timeFrame: Up to Week 48
measure: Percentage of Participants with VL < 50 cp/mL Measured by the FDA Snapshot Algorithm and Stratified by Original Group
timeFrame: Up to Week 48
measure: Percentage of Participants Withdrawing From the Study for any Reason
timeFrame: Up to Week 48
measure: Percentage of Participants who are Virologic Responders (VL<50 cp/mL) Measured by the Time to Loss of Virological Response (TLOVR) Algorithm
timeFrame: Up to Week 48
measure: Percentage of Participants with Virological Failure in Virosuppressed Participants
timeFrame: Up to Week 48
measure: Change from Baseline in Human Immunodeficiency Virus-Treatment Satisfaction Questionnaire Score (HIV-TSQs) at Week 48
timeFrame: Baseline and Week 48
measure: Change from Baseline in Participants Reported Outcome Based on Narrative Plots at Week 48
timeFrame: Baseline and Week 48
Other outcomes:
Locations:
city: Bergamo
country: Italy
facility: Azienda Ospedaliera Papa Giovanni XXIII
city: Brescia
country: Italy
facility: Azienda Ospedaliera Spedali Civili di Brescia
city: Busto Arsizio
country: Italy
facility: ASST Valle Olona - P.O. di Busto Arsizio
city: Genova
country: Italy
facility: Ente Ospedaliero Ospedeli Galliera
city: Milano N/a
country: Italy
facility: Div Malattie Infettive - Ospedale L. Sacco
city: Milano
country: Italy
facility: Ospedale San Raffaele
city: Milano
country: Italy
facility: Ospedale San Paolo Clinica Universitaria Malattie Infettive E Tropicali
city: Milano
country: Italy
facility: A.O. Ospedale L. Sacco - Polo Universitario
city: Monserrato
country: Italy
facility: Azienda Ospedaliero Universitaria di Cagliari - Policlinico Duilio Casula di Monserrato
city: Napoli
country: Italy
facility: Azienda Ospedaliera dei Colli - P.O. 'D. Cotugno'
city: Padova
country: Italy
facility: Azienda Ospedaliera di Padova
city: Palermo
country: Italy
facility: Azienda Ospedaliero Universitaria Policlinico Paolo Giaccone
city: Roma
country: Italy
facility: Policlinico Tor Vergata
city: Roma
country: Italy
facility: Istituto nazionale malattie infettive 'L. Spallanzani'
city: Roma
country: Italy
facility: Universita Di Roma 'La Sapienza'
city: Sassari
country: Italy
facility: Istituto di Ematologia - Clinica Universitaria
city: Siena
country: Italy
facility: A O Universitaria Senese Ospedale Santa Maria alle Scotte
city: Torino
country: Italy
facility: Ospedale Amedeo di Savoia
Study officials:
affiliation: Janssen-Cilag S.p.A.
name: Janssen-Cilag S.p.A., Italy Clinical Trial
role: STUDY_DIRECTOR
References: