Clinical Trials

MainTitle

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

This study is ongoing, but not recruiting participants.
Sponsor
Gilead Sciences


Information provided by (Responsible Party)
Gilead Sciences
ClinicalTrials.gov Identifier
NCT03580668

First received: June 26, 2018
Last updated: March 2, 2020
Last Verified: March 2020
History of Changes
Purpose

Purpose

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).

Condition Intervention
HIV-1-infection

Drug : B/F/TAF

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: 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)

Further study details as provided by Gilead Sciences:

Primary Outcome Measures

  • Proportion of Participants with HIV-1 RNA Suppression (HIV RNA < 50 copies/mL) at 12 Months after initiating or switching to B/F/TAF [ Time Frame: 12 months ]
Secondary Outcome Measures:
  • Proportion of Participants with HIV-1 RNA Suppression (HIV RNA < 50 copies/mL) at 3 Months after initiating or switching to B/F/TAF [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 24 months ]
    HIV-1 RNA suppression is defined as HIV-1 RNA <50 copies/mL, at 12 months after
  • Change in CD4 Cell Count at 3 Months [ Time Frame: 3 months ]
  • Change in CD4 Cell Count at 6 Months [ Time Frame: 6 months ]
  • Change in CD4 Cell Count at 12 Months [ Time Frame: 12 months ]
  • Change in CD4 Cell Count at 24 Months [ Time Frame: 24 months ]
  • CD4/CD8 Ratio at 3 Months [ Time Frame: 3 months ]
  • CD4/CD8 Ratio at 6 Months [ Time Frame: 6 months ]
  • CD4/CD8 Ratio at 12 Months [ Time Frame: 12 months ]
  • CD4/CD8 Ratio at 24 Months [ Time Frame: 24 months ]
  • Incidence of Adverse Events (AEs) and Serious Adverse Events (SAEs) [ Time Frame: 24 months ]

Enrollment: 200
Study Start Date: November 13, 2018
Estimated Study Completion Date: November 2021
Estimated Primary Completion Date: November 2021 (Final data collection date for primary outcome measure)

Arms Assigned Interventions
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 Name: Biktarvy®
Eligibility

Eligibility

Ages Eligible for Study: 18 Years and older  
Sexes Eligible for Study: All  
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.

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

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: NCT03580668

Locations

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

Sponsors and Collaborators

Gilead Sciences

Investigators

Study Director: Gilead Study Director Gilead Sciences
More Information

More Information


Responsible Party: Gilead Sciences  
ClinicalTrials.gov Identifier: NCT03580668   History of Changes  
Other Study ID Numbers: GS-CA-380-4574  
Study First Received: June 26, 2018  
Last Updated: March 2, 2020  
Individual Participant Data    
Plan to Share IPD: No  

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

Keywords provided by Gilead Sciences:

Observational

ClinicalTrials.gov processed this data on June 02, 2020
This information is provided by ClinicalTrials.gov.