- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04009057
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
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
-
-
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Haifa, Israel, 3109601
- Rambam Medical Center
-
Jerusalem, Israel
- Hadassah Medical Center
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Rehovot, Israel, 76100
- Kaplan Medical Center
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Tel Aviv, Israel, 6423906
- Tel Aviv Souraski Medical Center
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Tel Hashomer, Israel, 52621
- Sheba Medical Center
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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
|
B/F/TAF administered in accordance with the approved product monograph
Other Names:
|
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
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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
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3 Months
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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
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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