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STATUS Recruitment Complete

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

LAST UPDATED

April 8, 2024

Clinicaltrials.gov ID

NCT03580668

OVERVIEW

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) (BIC-STaR)

PROTOCOL SUMMARY

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).

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Participation Requirements

Calendar

Age

18 Years +

Condition

Sex

All

Healthy Icon

Healthy Volunteers

No

Study Details

Medical Condition

HIV-1-infection

Gender

N/A

Date

November 2018 - May 2024

Study Type

Observational

Study Phase

Product

B/F/TAF

Eligibility Information

Inclusion

Inclusion Criteria

  • HIV-1 infection
  • Signed informed consent
  • Initiating treatment with B/F/TAF in accordance with the product monograph
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Exclusion

Exclusion Criteria

  • Participation in any other observational or interventional clinical trial without prior approval from the Medical Monitor
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Locations

Locations (6)
Other

Clinique Medicale du Quartier Latin

Montréal, Canada, H2L 4E9

Other

University of Ottawa

Ottawa, Canada, K1N 6N5

Other

Regina General Hospital

Regina, Canada, S4P 0W5

Other

St. Clair Medical Association/Balmoral Clinic

Toronto, Canada, M4T3A7

Other

Maple Leaf Research

Toronto, Canada, M5G 1K2

Other

Spectrum Health

Vancouver, Canada, V6Z 2T1