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

Study at a glance

From the registry record, last updated by the sponsor on 3 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.

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)

ClinicalTrials.gov ID

NCT04009057

Acronym / sponsor ID

BIC-STaR / GS-IL-380-5335

Conditions

HIV-1-infection

Study type

Observational

Recruitment status

Completed

Enrolment

143 participants (actual)

Lead sponsor

Gilead SciencesIndustry (pharma, biotech, devices)

Study start

9 Jul 2019 (actual)

Primary completion

21 Mar 2022 (actual)

Study completion

21 Mar 2022 (actual)

First posted

5 Jul 2019 (actual)

Results

Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Observational model

Cohort

Time perspective

Prospective

Number of arms

1

Who may qualify

Ages

18 years and older

Sex

All

Age groups

Adult, Older adult

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.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Primary outcome

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

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

• Official record on ClinicalTrials.govLast updated by the sponsor 3 May 2022.
• Derived from this study: PubMed 41284214Antinori A, Yokomaku Y, Elinav H, Pullukcu H, de Wet J, Antela A, Lu PL, Sabranski M, Kim YS, Bonnet F, den Hollander J, Jackson A, Choy CY, Cai W, Zhang F, Thorpe D, Marongiu A, Harrison R, Jarrett J, Boffito M. Quality of Life and Treatment Satisfaction in People with HIV Switching to Bictegravir/Emtricitabine/Tenofovir Alafenamide: Pooled Analysis from Observational Cohort Studies. Infect Dis Ther. 2026 Jan;15(1):217-244. doi: 10.1007/s40121-025-01252-w. Epub 2025 Nov 24.
• Individual participant dataSharing planned: No

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

5 sites in 1 country: see every site and its status.