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Completed

NCT Number: NCT04009057

Effectiveness, Safety, Adherence, and Health-related Quality of Life in HIV-1 Infected Adults 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).

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Key information

Conditions

HIV-1-infection

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Rambam Medical Center, Haifa, Israel

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Who can participate

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • Participation in any interventional clinical trial

Treatment and study plan

B/F/TAF

Other

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

Other names: Biktarvy®

Primary outcomes

  1. 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

Secondary outcomes

  1. 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

  2. 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

  3. 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

  4. Change in CD4 Cell Count at 3 Months After Initiating or Switching to B/F/TAF

    Time frame: 3 Months

  5. Change in CD4 Cell Count at 6 Months After Initiating or Switching to B/F/TAF

    Time frame: 6 Months

  6. Change in CD4 Cell Count at 12 Months After Initiating or Switching to B/F/TAF

    Time frame: 12 Months

  7. Change in CD4 Cell Count at 24 Months After Initiating or Switching to B/F/TAF

    Time frame: 24 Months

  8. CD4/CD8 Ratio at 3 Months After Initiating or Switching to B/F/TAF

    Time frame: 3 Months

  9. CD4/CD8 Ratio at 6 Months After Initiating or Switching to B/F/TAF

    Time frame: 6 Months

  10. CD4/CD8 Ratio at 12 Months After Initiating or Switching to B/F/TAF

    Time frame: 12 Months

  11. CD4/CD8 Ratio at 24 Months After Initiating or Switching to B/F/TAF

    Time frame: 24 Months

  12. Percentage of Participants Experiencing Adverse Events and Serious Adverse Events

    Time frame: 24 Months

Sponsors and collaborators

Lead sponsor

Gilead Sciences

Industry

Registry information

Official study 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)

Acronym: BIC-STaR

Important dates

Study start
2019
Primary completion
2022
Study completion
2022
First posted
Jul 5, 2019
Registry last updated
May 3, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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