An Italian Observation of Antiretroviral Treatment in Participants Taking Darunavir/ Cobicistat Plus Emtricitabine and Tenofovir Alafenamide Fumarate

Human Immunodeficiency Virus (HIV) Clinical Trial

— DIAMANTE  

Official title:

Italian Retrospective and Prospective Observation of Antiretroviral Treatment in Patients Taking DarunavIr/cobicistAt Plus eMtricitabine and Tenofovir AlafeNamide fumaraTE - DIAMANTE

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03577470
• Other study ID #: CR108466
• Secondary ID: TMC114FD1HTX4011
• Status: Completed
• Start date: June 13, 2018
• Est. completion date: September 28, 2020

Study information

• Verified date: November 2020
• Source: Janssen-Cilag S.p.A.
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 246
• Est. completion date: September 28, 2020
• Est. primary completion date: September 28, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Acquired Immunodeficiency Syndrome
• HIV Infections
• Human Immunodeficiency Virus (HIV)

Intervention

Drug:
• 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.

Locations

Country	Name	City	State
Italy	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	A.O. Ospedale L. Sacco - Polo Universitario	Milano
Italy	Ospedale San Paolo Clinica Universitaria Malattie Infettive E Tropicali	Milano
Italy	Ospedale San Raffaele	Milano
Italy	Div Malattie Infettive - Ospedale L. Sacco	Milano N/a
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	Padova
Italy	Azienda Ospedaliero Universitaria Policlinico Paolo Giaccone	Palermo
Italy	Istituto nazionale malattie infettive 'L. Spallanzani'	Roma
Italy	Policlinico Tor Vergata	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

Sponsors (1)

Lead Sponsor	Collaborator
Janssen-Cilag S.p.A.

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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.	At Baseline (Visit 1)
Secondary	Time to Virosuppression	For participants entering with VL greater than (>) 50cp/mL, the time to virosuppression will be recorded.	At Baseline (Visit 1)
Secondary	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.	At Baseline (Visit 1)
Secondary	Cluster Differentiation 4 (CD4) Cells Nadir Count	CD4 cells nadir count will be reported.	At Baseline (Visit 1)
Secondary	CD4 Cell Count	CD4 cells count will be reported.	At Baseline (Visit 1)
Secondary	Cluster Differentiation 4/ Cluster Differentiation 8 (CD4/CD8) Ratio	CD4/CD8 ratio will be reported.	At Baseline (Visit 1)
Secondary	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.	Up to Week 48
Secondary	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.	Up to Week 48
Secondary	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.	Up to Week 48
Secondary	Percentage of Participants Withdrawing From the Study for any Reason	The percentage of participants withdrawing from the study for any reason will be reported.	Up to Week 48
Secondary	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.	Up to Week 48
Secondary	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.	Up to Week 48
Secondary	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.	Baseline and Week 48
Secondary	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.	Baseline and Week 48