Skip to main content
OpenTrials
Completed

NCT Number: NCT03580668

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

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).

Completed

Looking for future studies?

Notify Me

Key information

Conditions

HIV-1-infection

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Clinique Medicale du Quartier Latin, Montreal, Canada

Loading trial locations.

Who can participate

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

B/F/TAF

Drug

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

Other names: Biktarvy®

Primary outcomes

  1. 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 outcomes

  1. 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

  2. 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

  3. 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

  4. Proportion of Participants with HIV-1 RNA Suppression (HIV RNA < 50 copies/mL) at 36 Months after initiating or switching to B/F/TAF

    Time frame: 36 months

  5. Proportion of Participants with HIV-1 RNA Suppression (HIV RNA < 50 copies/mL) at 48 Months after initiating or switching to B/F/TAF

    Time frame: 48 months

  6. Proportion of Participants with HIV-1 RNA Suppression (HIV RNA < 50 copies/mL) at 60 Months after initiating or switching to B/F/TAF

    Time frame: 60 months

  7. Change in CD4 Cell Count at 3 Months

    Time frame: 3 months

  8. Change in CD4 Cell Count at 6 Months

    Time frame: 6 months

  9. Change in CD4 Cell Count at 12 Months

    Time frame: 12 months

  10. Change in CD4 Cell Count at 24 Months

    Time frame: 24 months

  11. Change in CD4 Cell Count at 36 Months

    Time frame: 36 months

  12. Change in CD4 Cell Count at 48 Months

    Time frame: 48 months

  13. Change in CD4 Cell Count at 60 Months

    Time frame: 60 months

  14. CD4/CD8 Ratio at 3 Months

    Time frame: 3 months

  15. CD4/CD8 Ratio at 6 Months

    Time frame: 6 months

  16. CD4/CD8 Ratio at 12 Months

    Time frame: 12 months

  17. CD4/CD8 Ratio at 24 Months

    Time frame: 24 months

  18. CD4/CD8 Ratio at 36 Months

    Time frame: 36 months

  19. CD4/CD8 Ratio at 48 Months

    Time frame: 48 months

  20. CD4/CD8 Ratio at 60 Months

    Time frame: 60 months

  21. Proportion of Participants Experiencing Adverse Events (AEs)

    Time frame: 60 months

  22. Proportion of Participants Experiencing and Serious Adverse Events (SAEs)

    Time frame: 60 months

Sponsors and collaborators

Lead sponsor

Gilead Sciences

Industry

Registry information

Official study 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)

Acronym: BIC-STaR

Important dates

Study start
2018
Primary completion
2024
Study completion
2024
First posted
Jul 9, 2018
Registry last updated
Jun 18, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.