Study of Bictegravir/Emtricitavine/Tenofovir Alafenamide in HIV-1 Infected naïve Patients Using Test and Treat Stategy Rapid-initiation Model of Care: BIC-NOW Clinical Trial (BIC-NOW)
NCT ID: NCT06177574
Last Updated: 2023-12-20
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
PHASE4
208 participants
INTERVENTIONAL
2020-10-27
2023-10-30
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Keywords
Explore important study keywords that can help with search, categorization, and topic discovery.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
study group
HIV-1 infected adults, ART-naive subjects, who start BIC/FTC/TAF using test and treat strategy recruited at infectious diseases units from various Spanish public healthcare centers.
BIC/FTC/TAF
TEST and TREAT strategy: Study group will start the intervention at the first visit with their healthcare provider.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
BIC/FTC/TAF
TEST and TREAT strategy: Study group will start the intervention at the first visit with their healthcare provider.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
2. Antiretroviral-naïve.
3. Be able to comply with protocol requirements and instructions.
4. Subject or the subject's representative capable of giving signed informed consent
Exclusion Criteria
2. Patients who in the investigator's judgment, poses a significant drop out risk or life expectancy inferior to study ending.
3. Patients with anticipated need to change the ART before study ending.
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Gilead Sciences
INDUSTRY
Carmen Hidalgo Tenorio
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Carmen Hidalgo Tenorio
Principal Investigator, Medical Director of the Early Stage Clinical Trial Unit-IBS.Granada
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Hospital Universitario Virgen de Las Nieves
Granada, Andalusia, Spain
H JEREZ
Jerez de la Frontera, Cádiz, Spain
Hospital Universitario Torrecárdenas
Almería, , Spain
Hospital Universitario Puerto Real, INIBICA,
Cadiz, , Spain
Hospital Campus de la Salud
Granada, , Spain
Complejo Hospitalario de Jaén,
Jaén, , Spain
Hospital Clínico San Carlos, Complutense University, CIBERINFEC ISCIII, Madrid, Spain
Madrid, , Spain
Hu Infanta Leonor
Madrid, , Spain
Hu La Princesa
Madrid, , Spain
Ramon Y Cajal
Madrid, , Spain
Hospital General Universitario Santa Lucía
Murcia, , Spain
Hospital Universitario Virgen de la Arrixaca, IMIB,
Murcia, , Spain
Hospital de Son Llàtzer
Palma de Mallorca, , Spain
Hospital Clínico Universitario de Valencia
Valencia, , Spain
HU la Fé
Valencia, , Spain
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
Sequera-Arquelladas S, Vivancos MJ, Vinuesa D, Collado A, Santos IL, Sorni P, Cabello-Clotet N, Montero M, Font CR, Terron A, Galindo MJ, Martinez O, Ryan P, Omar-Mohamed M, Albendin-Iglesias H, Javier R, Romero A, Vallecillos CG, Calleja MA, Hidalgo-Tenorio C. Impact of bictegravir/emtricitabine/tenofovir alafenamide on health-related quality of life and economic outcomes in HIV care: Substudy of the BIC-NOW clinical trial. PLoS One. 2025 Sep 22;20(9):e0323167. doi: 10.1371/journal.pone.0323167. eCollection 2025.
Hidalgo-Tenorio C, Sequera S, Vivancos MJ, Vinuesa D, Collado A, Santos IL, Sorni P, Cabello-Clotet N, Montero M, Font CR, Terron A, Galindo MJ, Martinez O, Ryan P, Omar-Mohamed M, Albendin-Iglesias H, Javier R, Ruz MAL, Romero A, Garcia-Vallecillos C. Bictegravir/emtricitabine/tenofovir alafenamide as first-line treatment in naive HIV patients in a rapid-initiation model of care: BIC-NOW clinical trial. Int J Antimicrob Agents. 2024 Jun;63(6):107164. doi: 10.1016/j.ijantimicag.2024.107164. Epub 2024 Apr 2.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
BIC-NOW
Identifier Type: -
Identifier Source: org_study_id