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)
BIC-NOW
1 other identifier
interventional
208
1 country
15
Brief Summary
The goal of this study is to analyze in treatment-naïve HIV patients the antiviral activity, using a test and treat strategy, in real life of BIC/FTC/TAF. Secondary, this study aims to evaluate outcomes for implementation of the evidence based test and treat strategy.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_4 hiv-infections
Started Oct 2020
Typical duration for phase_4 hiv-infections
15 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 27, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 30, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
October 30, 2023
CompletedFirst Submitted
Initial submission to the registry
December 7, 2023
CompletedFirst Posted
Study publicly available on registry
December 20, 2023
CompletedDecember 20, 2023
December 1, 2023
3 years
December 7, 2023
December 18, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
HIV-1 RNA in plasma (week 24)
copies of HIV RNA -1 in plasma at week 24
24 week
HIV-1 RNA in plasma week 48
copies of HIV RNA -1 in plasma at week 48
48 week
Secondary Outcomes (9)
Medicaction adherence
48 week
Retention in care
48 week
Quality of Life patient reported outcomes EQ-5D
48 week
Quality of Life patient reported outcomes dichotomized HIV-Symptoms Index
48 week
Feasibility of test and treat strategy
48 week
- +4 more secondary outcomes
Study Arms (1)
study group
EXPERIMENTALHIV-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.
Interventions
TEST and TREAT strategy: Study group will start the intervention at the first visit with their healthcare provider.
Eligibility Criteria
You may qualify if:
- HIV-1 infected adults (\>17 y.o.)
- Antiretroviral-naïve.
- Be able to comply with protocol requirements and instructions.
- Subject or the subject's representative capable of giving signed informed consent
You may not qualify if:
- Women who are breastfeeding or plan to become pregnant during the study.
- Patients who in the investigator's judgment, poses a significant drop out risk or life expectancy inferior to study ending.
- Patients with anticipated need to change the ART before study ending.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Carmen Hidalgo Tenoriolead
- Gilead Sciencescollaborator
Study Sites (15)
Hospital Universitario Virgen de Las Nieves
Granada, Andalusia, 18008, 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, 18014, 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
Related Publications (2)
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.
PMID: 40982450DERIVEDHidalgo-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.
PMID: 38574873DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- Principal Investigator, Medical Director of the Early Stage Clinical Trial Unit-IBS.Granada
Study Record Dates
First Submitted
December 7, 2023
First Posted
December 20, 2023
Study Start
October 27, 2020
Primary Completion
October 30, 2023
Study Completion
October 30, 2023
Last Updated
December 20, 2023
Record last verified: 2023-12
Data Sharing
- IPD Sharing
- Will not share