BIC-STaR: Effectiveness, Safety, Adherence, and Health-related Quality of Life in HIV-1 Infected Adults Receiving Bictegravir/ Emtricitabine/Tenofovir Alafenamide (B/F/TAF)
Sponsor
Gilead Sciences (Industry)
Overall Status
Completed
CT.gov ID
NCT04009057
Collaborator
(none)
143
5
32.4
28.6
0.9
Study Details
Study Description
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).
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Study Design
Study Type:
Observational
Actual Enrollment
:
143 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
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)
Actual Study Start Date
:
Jul 9, 2019
Actual Primary Completion Date
:
Mar 21, 2022
Actual Study Completion Date
:
Mar 21, 2022
Arms and Interventions
| Arm | 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:
|
Outcome Measures
Primary Outcome Measures
- Percentage 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 Outcome Measures
- Percentage 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]
- Percentage 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]
- Change in CD4 Cell Count at 3 Months After Initiating or Switching to B/F/TAF [3 Months]
- Change in CD4 Cell Count at 6 Months After Initiating or Switching to B/F/TAF [6 Months]
- Change in CD4 Cell Count at 12 Months After Initiating or Switching to B/F/TAF [12 Months]
- Change in CD4 Cell Count at 24 Months After Initiating or Switching to B/F/TAF [24 Months]
- CD4/CD8 Ratio at 3 Months After Initiating or Switching to B/F/TAF [3 Months]
- CD4/CD8 Ratio at 6 Months After Initiating or Switching to B/F/TAF [6 Months]
- CD4/CD8 Ratio at 12 Months After Initiating or Switching to B/F/TAF [12 Months]
- CD4/CD8 Ratio at 24 Months After Initiating or Switching to B/F/TAF [24 Months]
- Percentage of Participants Experiencing Adverse Events and Serious Adverse Events [24 Months]
Eligibility Criteria
Criteria
Ages Eligible for Study:
18 Years
and Older
Sexes Eligible for Study:
All
Inclusion Criteria:
-
HIV-1 infection
-
Signed informed consent
-
Initiating treatment with B/F/TAF
Exclusion Criteria:
- Participation in any interventional clinical trial
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Rambam Medical Center | Haifa | Israel | 3109601 | |
| 2 | Hadassah Medical Center | Jerusalem | Israel | ||
| 3 | Kaplan Medical Center | Rehovot | Israel | 76100 | |
| 4 | Tel Aviv Souraski Medical Center | Tel Aviv | Israel | 6423906 | |
| 5 | Sheba Medical Center | Tel Hashomer | Israel | 52621 |
Sponsors and Collaborators
- Gilead Sciences
Investigators
- Study Director: Gilead Study Director, Gilead Sciences
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.Responsible Party:
Gilead Sciences
ClinicalTrials.gov Identifier:
NCT04009057
Other Study ID Numbers:
- GS-IL-380-5335
First Posted:
Jul 5, 2019
Last Update Posted:
May 3, 2022
Last Verified:
Apr 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Device Product:
No