Status:
RECRUITING
Antiretroviral Speed Access Program
Lead Sponsor:
Dr. Bertrand Lebouche
Conditions:
HIV Infection
Eligibility:
All Genders
18+ years
Brief Summary
Migrant populations represent an increasing proportion of newly referred people living with HIV in Canada, particularly in Quebec. Timely HIV care of newly referred patients has important individual-l...
Eligibility Criteria
Inclusion
- 18 years or older
- Newly referred at the study site
- HIV-1 infected (fourth generation HIV Ag/Ab combination assay)
- Treatment-naïve to all anti-HIV therapy, except for the use for pre-exposure prophylaxis (PrEP) or post-exposure prophylaxis (PEP), up to one month prior to screening
- Estimated GFR \>30 mL/min/1.73m2 according to the Cockcroft-Gault formula for creatinine clearance
- Must be willing and able to understand the requirements of study participation and provide signed and dated written informed consent prior to screening
- Female participants who are willing to use acceptable methods of birth control as defined in the protocol
Exclusion
- Have received anti-HIV therapy previously, except for PrEP or PEP taken up to one month prior to screening
- Viral load \<100 copies/mL, high suspicion of non-reported ART use or being a long-term nonprogressor or elite controller
- Concomitant use of drugs with contraindication or drug-drug interactions with B/F/TAF
- Documented historic or baseline allergy to any of the components of B/F/TAF
- Estimated eGFR (by Cockcroft-Gault formula) \< 30 mL/min
- Pregnant, breast-feeding or planning or suspected to get pregnant
- Involvement in any other interventional HIV studies during the study period
- Has any reason, in the opinion of the investigator, which would make the candidate inappropriate for participation in an investigative study involving oral medications
Key Trial Info
Start Date :
August 1 2019
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
December 1 2024
Estimated Enrollment :
75 Patients enrolled
Trial Details
Trial ID
NCT04897243
Start Date
August 1 2019
End Date
December 1 2024
Last Update
February 21 2024
Active Locations (1)
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1
Research Institute of the McGill University Health Centre
Montreal, Quebec, Canada, H4A3T2