Effectiveness, Safety, Adherence, and Health-related Quality of Life in HIV-1 Infected Adults Receiving Bictegravir/ Emtricitabine/Tenofovir Alafenamide (BIC-STaR)

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)

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).

Study Overview

• Status: Completed
• Conditions: HIV-1-infection
• Intervention / Treatment: Drug: B/F/TAF

• Study Type: Observational
• Enrollment (Actual): 201

Contacts and Locations

Study Locations

• Canada
  • Montréal, Canada, H2L 4E9
    • Clinique Medicale du Quartier Latin
  • Ottawa, Canada, K1N 6N5
    • University of Ottawa
  • Regina, Canada, S4P 0W5
    • Regina General Hospital
  • Toronto, Canada, M4T3A7
    • St. Clair Medical Association/Balmoral Clinic
  • Toronto, Canada, M5G 1K2
    • Maple Leaf Research
  • Vancouver, Canada, V6Z 2T1
    • Spectrum Health

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: N/A

• Sampling Method: Non-Probability Sample

Study Population

The study population will be comprised of ART-naïve and ART-experienced HIV-1 infected adults aged ≥18 years initiating treatment with B/F/TAF in routine clinical care in Canada.

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
B/F/TAF; Bictegravir/Emtricitabine/Tenofovir alafenamide (B/F/TAF) therapy in HIV-1 infected adults who initiate B/F/TAF therapy	Drug: B/F/TAF; B/F/TAF administered in accordance with the approved product monograph; Other Names: Biktarvy®

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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

Secondary Outcome Measures

Outcome Measure	Time Frame
Proportion of Participants with HIV-1 RNA Suppression (HIV RNA < 50 copies/mL) at 3 Months after initiating or switching to B/F/TAF	3 months
Proportion of Participants with HIV-1 RNA Suppression (HIV RNA < 50 copies/mL) at 6 Months after initiating or switching to B/F/TAF	6 months
Proportion of Participants with HIV-1 RNA Suppression (HIV RNA < 50 copies/mL) at 24 Months after initiating or switching to B/F/TAF	24 months
Proportion of Participants with HIV-1 RNA Suppression (HIV RNA < 50 copies/mL) at 36 Months after initiating or switching to B/F/TAF	36 months
Proportion of Participants with HIV-1 RNA Suppression (HIV RNA < 50 copies/mL) at 48 Months after initiating or switching to B/F/TAF	48 months
Proportion of Participants with HIV-1 RNA Suppression (HIV RNA < 50 copies/mL) at 60 Months after initiating or switching to B/F/TAF	60 months
Change in CD4 Cell Count at 3 Months	3 months
Change in CD4 Cell Count at 6 Months	6 months
Change in CD4 Cell Count at 12 Months	12 months
Change in CD4 Cell Count at 24 Months	24 months
Change in CD4 Cell Count at 36 Months	36 months
Change in CD4 Cell Count at 48 Months	48 months
Change in CD4 Cell Count at 60 Months	60 months
CD4/CD8 Ratio at 3 Months	3 months
CD4/CD8 Ratio at 6 Months	6 months
CD4/CD8 Ratio at 12 Months	12 months
CD4/CD8 Ratio at 24 Months	24 months
CD4/CD8 Ratio at 36 Months	36 months
CD4/CD8 Ratio at 48 Months	48 months
CD4/CD8 Ratio at 60 Months	60 months
Proportion of Participants Experiencing Adverse Events (AEs)	60 months
Proportion of Participants Experiencing and Serious Adverse Events (SAEs)	60 months

Collaborators and Investigators

• Sponsor: Gilead Sciences
• Investigators: Study Director: Gilead Study Director, Gilead Sciences

Publications and helpful links

Helpful Links

• Gilead Clinical Trials Website

Study record dates

Study Major Dates

• Study Start (Actual): November 13, 2018
• Primary Completion (Actual): June 3, 2024
• Study Completion (Actual): June 3, 2024

Study Registration Dates

• First Submitted: June 26, 2018
• First Submitted That Met QC Criteria: June 26, 2018
• First Posted (Actual): July 9, 2018

Study Record Updates

• Last Update Posted (Actual): June 18, 2024
• Last Update Submitted That Met QC Criteria: June 14, 2024
• Last Verified: June 1, 2024

More Information

Terms related to this study

• Keywords: Observational
• Other Study ID Numbers: GS-CA-380-4574

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated device product: No