Clinical trial

Multi-center, Canadian, Non-interventional, Cohort Study of the Effectiveness, Safety, Adherence, and Health-related Quality of Life in HIV-1 Infected Adult Patients Receiving Bictegravir/ Emtricitabine/Tenofovir Alafenamide (B/F/TAF)

Name

GS-CA-380-4574

Description

The primary objective of this study is to evaluate HIV-1 RNA suppression, defined as HIV-1 RNA \<50 copies/mL, at 12 months after initiating or switching to Bictegravir/ Emtricitabine/Tenofovir alafenamide (B/F/TAF).

Trial arms

Trial start

2018-11-13

Estimated PCD

2024-05-01

Trial end

2024-05-01

Status

Active (not recruiting)

Treatment

B/F/TAF

B/F/TAF administered in accordance with the approved product monograph

Arms:

B/F/TAF

Other names:

Biktarvy®

Size

201

Primary endpoint

Proportion of Participants with HIV-1 RNA Suppression (HIV RNA < 50 copies/mL) at 12 Months after initiating or switching to B/F/TAF

12 months

Eligibility criteria

Inclusion Criteria: * HIV-1 infection * Signed informed consent * Initiating treatment with B/F/TAF in accordance with the product monograph Exclusion Criteria: Participation in any other observational or interventional clinical trial without prior approval from the Medical Monitor

Protocol

{'studyType': 'OBSERVATIONAL', 'patientRegistry': False, 'designInfo': {'observationalModel': 'COHORT', 'timePerspective': 'PROSPECTIVE'}, 'enrollmentInfo': {'count': 201, 'type': 'ACTUAL'}}

Updated at

2024-05-06

1 organization

1 product

1 indication

Organization

Gilead Sciences

Product

B/F/TAF

Indication

HIV-1 infection