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

NCT ID: NCT03580668

Last Updated: 2024-06-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

201 participants

Study Classification

OBSERVATIONAL

Study Start Date

2018-11-13

Study Completion Date

2024-06-03

Brief Summary

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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).

Detailed Description

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Conditions

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HIV-1-infection

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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B/F/TAF

Bictegravir/Emtricitabine/Tenofovir alafenamide (B/F/TAF) therapy in HIV-1 infected adults who initiate B/F/TAF therapy

B/F/TAF

Intervention Type DRUG

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

Interventions

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B/F/TAF

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

Intervention Type DRUG

Other Intervention Names

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Biktarvy®

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Gilead Sciences

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Gilead Study Director

Role: STUDY_DIRECTOR

Gilead Sciences

Locations

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Clinique Medicale du Quartier Latin

Montreal, , Canada

Site Status

University of Ottawa

Ottawa, , Canada

Site Status

Regina General Hospital

Regina, , Canada

Site Status

St. Clair Medical Association/Balmoral Clinic

Toronto, , Canada

Site Status

Maple Leaf Research

Toronto, , Canada

Site Status

Spectrum Health

Vancouver, , Canada

Site Status

Countries

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Canada

Related Links

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Other Identifiers

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GS-CA-380-4574

Identifier Type: -

Identifier Source: org_study_id

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