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

Janssen (J&J Innovative Medicine)

Status: Completed

Conditions: Human Immunodeficiency Virus (HIV)

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

Study type: Observational

Funder types: Industry

Identifiers

NCT03577470

CR108466

TMC114FD1HTX4011 (Other Identifier)

Details and patient eligibility

About

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.

Enrollment: 246 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

246 participants in 3 patient groups

Group 1

Description:

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.

Treatment:

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

Group 2

Description:

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.

Treatment:

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

Group 3

Description:

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.

Treatment:

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