AzTrials
AzTrials

HIV InfectionsPhase 4BIC-NOWNCT06177574

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)

A Phase 4 study testing BIC/FTC/TAF in people with HIV Infections, run by Carmen Hidalgo Tenorio at 15 sites in Spain.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
HIV Infections
What is being tested?
BIC/FTC/TAF
Could I receive a placebo?
No, everyone receives an active treatment
How many people
208 participants
Where
15 sitesSpain
Study dates
27 Oct 2020to 30 Oct 2023
Phase
Phase 4
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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.

Trial locations and contacts

15 sites in 1 country.

15 sites in 1 country

Spain15 sites

  • Hospital Universitario Torrecárdenas

    Almería

  • Hospital Universitario Puerto Real, INIBICA,

    Cadiz

  • Hospital Universitario Virgen de Las Nieves

    Granada, Andalusia, 18008

  • Hospital Campus de la Salud

    Granada, 18014

  • Complejo Hospitalario de Jaén,

    Jaén

  • H JEREZ

    Jerez de la Frontera, Cádiz

  • Hospital Clínico San Carlos, Complutense University, CIBERINFEC ISCIII, Madrid, Spain

    Madrid

  • Hu Infanta Leonor

    Madrid

  • Hu La Princesa

    Madrid

  • Ramon Y Cajal

    Madrid

  • Hospital General Universitario Santa Lucía

    Murcia

  • Hospital Universitario Virgen de la Arrixaca, IMIB,

    Murcia

  • Hospital de Son Llàtzer

    Palma de Mallorca

  • Hospital Clínico Universitario de Valencia

    Valencia

  • HU la Fé

    Valencia

Other trials in Spain

About this study

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.

Conditions
HIV Infections
Being tested
BIC/FTC/TAF
Keywords
HIV, TEST and TREAT, IMPLEMENTATION
Medical subject headings
HIV Infections

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • BIC/FTC/TAFDrug

    TEST and TREAT strategy: Study group will start the intervention at the first visit with their healthcare provider.

Study groups in NCT06177574
Study groupRoleWhat they receive
study groupExperimentalHIV-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.
Receives: Drug: BIC/FTC/TAF

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. HIV-1 RNA in plasma (week 24)

    copies of HIV RNA -1 in plasma at week 24

    Measured: 24 week

  2. HIV-1 RNA in plasma week 48

    copies of HIV RNA -1 in plasma at week 48

    Measured: 48 week

Secondary outcomes (9)

  1. Medicaction adherence

    proportion of pills taken, self-reported

    Measured: 48 week

  2. Retention in care

    Subjects completing all study visits

    Measured: 48 week

  3. Quality of Life patient reported outcomes EQ-5D

    effect of test and treat strategy on health related quality of life and HIV-related symptoms to treatment-naïve HIV patients through PROs EQ-5D (Five dimensions descriptive system of quality of live from EuroQoL)

    Measured: 48 week

  4. Quality of Life patient reported outcomes dichotomized HIV-Symptoms Index

    effect of test and treat strategy on health related quality of life and HIV-related symptoms to treatment-naïve HIV patients through PROs dichotomized HIV-SI

    Measured: 48 week

  5. Feasibility of test and treat strategy

    Time to full enrolment of 139 eligible treatment-naïve HIV patients at 22 public healthcare centers in Spain and by physicians using screening data reports

    Measured: 48 week

  6. demographics and baseline characteristics

    Proportion of subjects by patient subgroup (e.g. by gender, age…) with plasma HIV-1 RNA <50 copies/mL at week 48 using FDA Snapshot algorithm

    Measured: 48 week

  7. viral resistance

    Incidence of treatment-emergent genotypic or/and phenotypic resistence to any ART

    Measured: 48 week

  8. antiviral activity

    Time to viral suppression and absolute changes from baseline in lymphocyte count at week 48

    Measured: 48 week

  9. Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]

    Incidence and severity of adverse events and laboratory abnormalities

    Measured: 48 week

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted20 Dec 2023
  2. Study start27 Oct 2020
  3. Primary completion30 Oct 2023
  4. Study completion30 Oct 2023

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 4
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
208 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06177574
Sponsor's protocol ID
BIC-NOW
Acronym
BIC-NOW
Status last verified
Dec 2023
First submitted
7 Dec 2023
Last updated
20 Dec 2023
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 40982450

  • 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.

    PubMed 38574873

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing BIC/FTC/TAF in people with HIV Infections, run by Carmen Hidalgo Tenorio at 15 sites in Spain.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 20 Dec 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 15 sites in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

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

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

HIV-1 RNA in plasma (week 24) (time frame: 24 week). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06177574, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Dec 2023.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in