Clinical Trials

MainTitle

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

This study is currently recruiting participants. (see Contacts and Locations)

Verified August 2019 by Janssen-Cilag S.p.A.

Sponsor
Janssen-Cilag S.p.A.


Information provided by (Responsible Party)
Janssen-Cilag S.p.A.
ClinicalTrials.gov Identifier
NCT03577470

First received: June 7, 2018
Last updated: August 5, 2019
Last Verified: August 2019
History of Changes
Purpose

Purpose

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.

Condition Intervention
Human Immunodeficiency Virus (HIV)

Drug : D/C/F/TAF Fixed-Dose Combination (FDC)

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Italian Retrospective and Prospective Observation of Antiretroviral Treatment in Patients Taking DarunavIr/cobicistAt Plus eMtricitabine and Tenofovir AlafeNamide fumaraTE - DIAMANTE

Further study details as provided by Janssen-Cilag S.p.A.:

Primary Outcome Measures

  • 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.
Secondary Outcome Measures:
  • Participant's Previous Antiretroviral (ARV) Treatment History Determined Using the Web-Based Electronic Case Report Form (eCRF) [ Time Frame: At Baseline (Visit 1) ]
    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.
  • Time to Virosuppression [ Time Frame: At Baseline (Visit 1) ]
    For participants entering with VL greater than (>) 50cp/mL, the time to virosuppression will be recorded.
  • Number of Participants with Detectability Below Level of Quantification <50 copies/mL [ Time Frame: At Baseline (Visit 1) ]
    Number of participants with detectability below level of quantification <50 copies/mL will be reported.
  • Cluster Differentiation 4 (CD4) Cells Nadir Count [ Time Frame: At Baseline (Visit 1) ]
    CD4 cells nadir count will be reported.
  • CD4 Cell Count [ Time Frame: At Baseline (Visit 1) ]
    CD4 cells count will be reported.
  • Cluster Differentiation 4/ Cluster Differentiation 8 (CD4/CD8) Ratio [ Time Frame: At Baseline (Visit 1) ]
    CD4/CD8 ratio will be reported.
  • Percentage of Participants with VL<50cp/mL Measured by the FDA Snapshot Algorithm and Stratified by Age [ Time Frame: Up to Week 48 ]
    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.
  • 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 ]
    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.
  • 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 ]
    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.
  • Percentage of Participants Withdrawing From the Study for any Reason [ Time Frame: Up to Week 48 ]
    The percentage of participants withdrawing from the study for any reason will be reported.
  • 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 ]
    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.
  • Percentage of Participants with Virological Failure in Virosuppressed Participants [ Time Frame: Up to Week 48 ]
    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.
  • Change from Baseline in Human Immunodeficiency Virus-Treatment Satisfaction Questionnaire Score (HIV-TSQs) at Week 48 [ Time Frame: Baseline and 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.
  • Change from Baseline in Participants Reported Outcome Based on Narrative Plots at Week 48 [ Time Frame: Baseline and Week 48 ]
    Narrative plots will be recorded onto paper forms and will be considered as source data to describe the participants experience during treatment.

Estimated Enrollment: 250
Study Start Date: June 13, 2018
Estimated Study Completion Date: July 31, 2020
Estimated Primary Completion Date: March 30, 2020 (Final data collection date for primary outcome measure)

Arms Assigned Interventions
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.
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.

Other Name: Symtuza
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.
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.

Other Name: Symtuza
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.
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.

Other Name: Symtuza
Eligibility

Eligibility

Ages Eligible for Study: 18 Years and older  
Sexes Eligible for Study: All  
Accepts Healthy Volunteers: No  
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.

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

contacts and locations

Contacts and Locations

Choosing to participate in a study is an important personal decision.Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT03577470

Contacts

Contact:   Study Contact 844-434-4210 JNJ.CT@sylogent.com

Locations

Italy
Azienda Ospedaliera Papa Giovanni XXIII Recruiting
Bergamo, Italy, 24127
Policlinico Sant'Orsola Malpighi Not yet recruiting
Bologna, Italy, 40138
Azienda Ospedaliera Spedali Civili di Brescia Recruiting
Brescia, Italy, 25123
ASST Valle Olona - P.O. di Busto Arsizio Recruiting
Busto Arsizio, Italy, 21052
Ente Ospedaliero Ospedeli Galliera Recruiting
Genova, Italy, 16128
Div Malattie Infettive - Ospedale L. Sacco Recruiting
Milano N/a, Italy, 20157
Ospedale San Raffaele Recruiting
Milano, Italy, 20127
Ospedale San Paolo Clinica Universitaria Malattie Infettive E Tropicali Recruiting
Milano, Italy, 20142
A.O. Ospedale L. Sacco - Polo Universitario Recruiting
Milano, Italy, 20157
Azienda Ospedaliero Universitaria di Cagliari - Policlinico Duilio Casula di Monserrato Recruiting
Monserrato, Italy, 09042
Azienda Ospedaliera dei Colli - P.O. 'D. Cotugno' Recruiting
Napoli, Italy, 80131
Azienda Ospedaliera di Padova Recruiting
Padova, Italy, 35128
Azienda Ospedaliero Universitaria Policlinico Paolo Giaccone Recruiting
Palermo, Italy, 90127
Policlinico Tor Vergata Recruiting
Roma, Italy, 00133
Istituto nazionale malattie infettive 'L. Spallanzani' Recruiting
Roma, Italy, 00149
Universita Di Roma 'La Sapienza' Recruiting
Roma, Italy, 00161
Istituto di Ematologia - Clinica Universitaria Recruiting
Sassari, Italy, 07100
A.O. Universitaria Senese- Ospedale Santa Maria alle Scotte Recruiting
Siena, Italy, 53100
Ospedale Amedeo di Savoia Not yet recruiting
Torino, Italy, 10149
Ospedale Amedeo di Savoia Recruiting
Torino, Italy

Sponsors and Collaborators

Janssen-Cilag S.p.A.

Investigators

Study Director: Janssen-Cilag S.p.A., Italy Clinical Trial Janssen-Cilag S.p.A.
More Information

More Information

Additional Information:

To learn how to participate in this trial please click here.

Responsible Party: Janssen-Cilag S.p.A.  
ClinicalTrials.gov Identifier: NCT03577470   History of Changes  
Other Study ID Numbers: CR108466  
  TMC114FD1HTX4011  
Study First Received: June 7, 2018  
Last Updated: August 5, 2019  

Studies a U.S. FDA-regulated Drug Product: No  
Studies a U.S. FDA-regulated Device Product: No  

Additional relevant MeSH terms:
Acquired Immunodeficiency Syndrome
HIV Infections
Tenofovir
Emtricitabine
Darunavir
Cobicistat
Anti-Retroviral Agents

ClinicalTrials.gov processed this data on October 15, 2019
This information is provided by ClinicalTrials.gov.