NCT03580668

Brief 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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
201

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Nov 2018

Longer than P75 for all trials

Geographic Reach
1 country

6 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 26, 2018

Completed
13 days until next milestone

First Posted

Study publicly available on registry

July 9, 2018

Completed
4 months until next milestone

Study Start

First participant enrolled

November 13, 2018

Completed
5.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 3, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 3, 2024

Completed
Last Updated

June 18, 2024

Status Verified

June 1, 2024

Enrollment Period

5.6 years

First QC Date

June 26, 2018

Last Update Submit

June 14, 2024

Conditions

HIV-1-infection

Keywords

Observational

Outcome Measures

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

    12 months

Secondary Outcomes (22)

  • 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

  • +17 more secondary outcomes

Study Arms (1)

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

Interventions

B/F/TAFDRUG

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

Also known as: Biktarvy®
B/F/TAF

Eligibility Criteria

Age18 Years+
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (6)

Clinique Medicale du Quartier Latin

Montreal, H2L 4E9, Canada

Location

University of Ottawa

Ottawa, K1N 6N5, Canada

Location

Regina General Hospital

Regina, S4P 0W5, Canada

Location

St. Clair Medical Association/Balmoral Clinic

Toronto, M4T3A7, Canada

Location

Maple Leaf Research

Toronto, M5G 1K2, Canada

Location

Spectrum Health

Vancouver, V6Z 2T1, Canada

Location

Related Publications (1)

  • Antinori A, Yokomaku Y, Elinav H, Pullukcu H, de Wet J, Antela A, Lu PL, Sabranski M, Kim YS, Bonnet F, den Hollander J, Jackson A, Choy CY, Cai W, Zhang F, Thorpe D, Marongiu A, Harrison R, Jarrett J, Boffito M. Quality of Life and Treatment Satisfaction in People with HIV Switching to Bictegravir/Emtricitabine/Tenofovir Alafenamide: Pooled Analysis from Observational Cohort Studies. Infect Dis Ther. 2026 Jan;15(1):217-244. doi: 10.1007/s40121-025-01252-w. Epub 2025 Nov 24.

    PMID: 41284214DERIVED

Related Links

MeSH Terms

Interventions

bictegravir, emtricitabine, tenofovir alafenamide, drug combination

Study Officials

  • Gilead Study Director

    Gilead Sciences

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 26, 2018

First Posted

July 9, 2018

Study Start

November 13, 2018

Primary Completion

June 3, 2024

Study Completion

June 3, 2024

Last Updated

June 18, 2024

Record last verified: 2024-06

Data Sharing

IPD Sharing
Will not share

Locations

CA(6)