NCT04009057 (BIC-STaR) is a clinical trial of B/F/TAF in HIV-1-infection, sponsored by Gilead Sciences.

Who is sponsoring NCT04009057?

NCT04009057 is sponsored by Gilead Sciences.

What drugs are being tested in NCT04009057?

Interventions in NCT04009057: B/F/TAF.

What condition does NCT04009057 study?

NCT04009057 studies HIV-1-infection.

Is NCT04009057 still recruiting?

NCT04009057 is currently completed. Last updated 3 May 2022.

Last reviewed 2022-05-03 · How we verify

NCT04009057: BIC-STaR

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

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

Completed Last updated 3 May 2022

What this trial tests

trial testing B/F/TAF in HIV-1-infection in 143 participants. Completed in 21 March 2022.

Timeline

9 July 2019

Primary endpoint
21 March 2022

21 March 2022

Quick facts

Lead sponsor	Gilead Sciences
Status	Completed
Study type	OBSERVATIONAL
Enrollment	143
Start date	9 July 2019
Primary completion	21 March 2022
Estimated completion	21 March 2022
Sites	5 locations across Israel

Drugs / interventions tested

B/F/TAF — full drug profile →

Conditions studied

HIV-1-infection — all drugs for HIV-1-infection →

Sponsor

Gilead Sciences — full company profile →

Who can join

18 and older, any sex, with HIV-1-infection. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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).

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

Accuracy of measures for antiretroviral adherence in people living with HIV.
Smith R, Villanueva G, Probyn K, Sguassero Y, et al · · 2022 · cited 34× · PMID 35871531 · DOI 10.1002/14651858.cd013080.pub2
Quality of Life and Treatment Satisfaction in People with HIV Switching to Bictegravir/Emtricitabine/Tenofovir Alafenamide: Pooled Analysis from Observational Cohort Studies.
Antinori A, Yokomaku Y, Elinav H, Pullukçu H, et al · · 2026 · PMID 41284214 · DOI 10.1007/s40121-025-01252-w

Verify or expand the search:

Other trials of B/F/TAF

Trials testing the same drug.

NCT06619288 — Good-first: B/F/TAF As First-line ART · recruiting
NCT06375304 — The Antiretroviral Speed Access Program Switch (ASAP-Switch) Study · Phase 4 · not yet recruiting
NCT06104306 — Study of B/F/TAF in Participants Switching From CAB + RPV to B/F/TAF for HIV-1 Infection (EMPOWER) · Phase 4 · completed
NCT05585307 — Study of Novel Antiretrovirals in Participants With HIV-1 · Phase 1 · completed
NCT05122754 — Switching From TDF-based Antiretroviral Therapy Regimens to B/F/TAF in Virally Suppressed Adults With HIV-1 Infection · Phase 4 · unknown

Other recruiting trials for HIV-1-infection

Currently open trials in the same condition.

NCT07293559 — Understanding Practices of Lactation and Infant Feeding Together With Women With HIV in the United States · recruiting
NCT06919016 — A Study to Evaluate the Safety and Immunogenicity of the V3-region Directed Immunogens DV700P-RNA Followed by DV701B1.1- · Phase 1 · active not recruiting
NCT06554717 — Tesamorelin as an Adjunct to Exercise for Improving Physical Function in HIV · Phase 2 · recruiting
NCT06774872 — Doravirine/Lamivudine (DOR/3TC) as a Maintenance ART in Comparison With Dolutegravir/Lamivudine (DTG/3TC) in PLWH Succes · Phase 2 · recruiting
NCT06890988 — Ending the Epidemic Interventions in the Dental Setting - UH3 · NA · recruiting

Other Gilead Sciences trials

Trials by the same sponsor.

NCT07115368 — Study of GS-1219 in Participants With HIV-1 · Phase 1 · terminated
NCT06784973 — Study of Obeldesivir to Treat Children With Respiratory Syncytial Virus (RSV) Infection · Phase 2 · terminated
NCT06683482 — A Qualitative Study on Advanced Breast Cancer Patients and Their Caregivers in Spain · completed
NCT06613685 — Study of Oral Weekly GS-1720 and GS-4182 Compared With Biktarvy in People With HIV-1 Who Have Not Been Treated · Phase 2, PHASE3 · terminated
NCT06585150 — Study of Obeldesivir to Treat Nonhospitalized Adults With Acute Respiratory Syncytial Virus (RSV) Infection · Phase 2 · terminated

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT04009057 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Gilead Sciences
Last refreshed: 3 May 2022

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04009057.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing