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

April 29, 2022 updated by: Gilead Sciences

Multi-center, Israeli, 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)

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).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

143

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Israel
      • Haifa, Israel, 3109601
        • Rambam Medical Center
      • Jerusalem, Israel
        • Hadassah Medical Center
      • Rehovot, Israel, 76100
        • Kaplan Medical Center
      • Tel Aviv, Israel, 6423906
        • Tel Aviv Souraski Medical Center
      • Tel Hashomer, Israel, 52621
        • Sheba Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

N/A

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

The study population will be comprised of antiretroviral therapy (ART)-naïve and ART-experienced HIV-1 infected adults aged ≥ 18 years initiating treatment with B/F/TAF in routine clinical care in Israel.

Description

Inclusion Criteria:

  • HIV-1 infection
  • Signed informed consent
  • Initiating treatment with B/F/TAF

Exclusion Criteria:

  • Participation in any interventional clinical trial

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
B/F/TAF
HIV-1 infected adults who initiate B/F/TAF therapy
Other: B/F/TAF
B/F/TAF administered in accordance with the approved product monograph
Other Names:
  • Biktarvy®

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Percentage of Participants with HIV-1 RNA Suppression (HIV RNA < 50 copies/mL) at 12 Months after Initiating or Switching to B/F/TAF
Time Frame: 12 Months
12 Months

Secondary Outcome Measures

Outcome Measure
Time Frame
Percentage of Participants with HIV-1 RNA Suppression (HIV RNA < 50 copies/mL) at 3 Months After Initiating or Switching to B/F/TAF
Time Frame: 3 Months
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
Time Frame: 6 Months
6 Months
Percentage of Participants with HIV-1 RNA Suppression (HIV RNA < 50 copies/mL) at 24 Months After Initiating or Switching to B/F/TAF
Time Frame: 24 Months
24 Months
Change in CD4 Cell Count at 3 Months After Initiating or Switching to B/F/TAF
Time Frame: 3 Months
3 Months
Change in CD4 Cell Count at 6 Months After Initiating or Switching to B/F/TAF
Time Frame: 6 Months
6 Months
Change in CD4 Cell Count at 12 Months After Initiating or Switching to B/F/TAF
Time Frame: 12 Months
12 Months
Change in CD4 Cell Count at 24 Months After Initiating or Switching to B/F/TAF
Time Frame: 24 Months
24 Months
CD4/CD8 Ratio at 3 Months After Initiating or Switching to B/F/TAF
Time Frame: 3 Months
3 Months
CD4/CD8 Ratio at 6 Months After Initiating or Switching to B/F/TAF
Time Frame: 6 Months
6 Months
CD4/CD8 Ratio at 12 Months After Initiating or Switching to B/F/TAF
Time Frame: 12 Months
12 Months
CD4/CD8 Ratio at 24 Months After Initiating or Switching to B/F/TAF
Time Frame: 24 Months
24 Months
Percentage of Participants Experiencing Adverse Events and Serious Adverse Events
Time Frame: 24 Months
24 Months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Gilead Sciences

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

July 9, 2019

Primary Completion (ACTUAL)

March 21, 2022

Study Completion (ACTUAL)

March 21, 2022

Study Registration Dates

First Submitted

July 2, 2019

First Submitted That Met QC Criteria

July 2, 2019

First Posted (ACTUAL)

July 5, 2019

Study Record Updates

Last Update Posted (ACTUAL)

May 3, 2022

Last Update Submitted That Met QC Criteria

April 29, 2022

Last Verified

April 1, 2022

More Information

Terms related to this study

Other Study ID Numbers

  • GS-IL-380-5335

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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