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

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)

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT04009057

Acronym

BIC-STaR

Enrollment

143

Registered

2019-07-05

Start date

2019-07-09

Completion date

2022-03-21

Last updated

2022-05-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

HIV-1-infection

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).

Interventions

OTHERB/F/TAF

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

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Inclusion criteria

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

Exclusion criteria

* Participation in any interventional clinical trial

Design outcomes

Primary

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	12 Months

Secondary

Measure	Time frame
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
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
Change in CD4 Cell Count at 6 Months After Initiating or Switching to B/F/TAF	6 Months
Change in CD4 Cell Count 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
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

Countries

Israel

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026