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

NCT ID: NCT04009057

Last Updated: 2022-05-03

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

143 participants

Study Classification

OBSERVATIONAL

Study Start Date

2019-07-09

Study Completion Date

2022-03-21

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

HIV-1 infected adults who initiate B/F/TAF therapy

B/F/TAF

Intervention Type OTHER

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 OTHER

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

Exclusion Criteria

* Participation in any interventional clinical trial
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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Rambam Medical Center

Haifa, , Israel

Site Status

Hadassah Medical Center

Jerusalem, , Israel

Site Status

Kaplan Medical Center

Rehovot, , Israel

Site Status

Tel Aviv Souraski Medical Center

Tel Aviv, , Israel

Site Status

Sheba Medical Center

Tel Litwinsky, , Israel

Site Status

Countries

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Israel

Other Identifiers

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GS-IL-380-5335

Identifier Type: -

Identifier Source: org_study_id

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