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HIV InfectionsNCT06518213

Efficacy and Safety of First-line ART With BIC/FTC/TAF Introduced at the First Clinical Visit

An observational study of HIV Infections, run by University Hospital for Infectious Diseases, Croatia at 1 site in Croatia.

Completed

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

Official record
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Trial summary

Bictegravir/emtricitabine/tenofovir alafenamide (BIC/FTC/TAF) is a recommended first-line antiretroviral regimen. Croatia has a centralized care for people living with HIV (PLWH) and all persons are seen and treated in a single center, preferably in a same-day initiation model whenever suitable. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
HIV Infections
Type of treatment
Pill or oral medicine
How many people
112 participants
Where
1 siteCroatia
Study dates
1 May 2019to 31 Mar 2024
Phase
Observational
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

Study population: In Croatia, all people living with HIV are treated at the University Hospital for Infectious Diseases (UHID) in Zagreb in the HIV Outpatient Department. Included in the study were all patients who entered HIV care in the period from May 2019 to December 2022 and met the eligibility criteria.

Who may be able to join

  • HIV seropositivity confirmed by a fourth generation test
  • the subject had not previously taken ART
  • ART was started within 24 hours of the first examination

Who cannot join

  • persons under 18 years of age
  • people who are pregnant, breastfeeding or planning to become pregnant
  • unacceptable interaction with a drug that the subject is already taking

Trial locations and contacts

1 site in 1 country.

Croatia1 site

  • University Hospital for Infectious Diseases ''Dr. Fran Mihaljevic''

    Zagreb, City of Zagreb, 10000

Other trials in Croatia

About this study

Official title: Efficacy and Safety of First-line Antiretroviral Therapy (ART) With Bictegravir/Emtricitabine/Tenofovir Alafenamide (BIC/FTC/TAF) Introduced at the First Clinical Visit: a Real-life Retrospective Single Arm Single Center Study

Bictegravir/emtricitabine/tenofovir alafenamide (BIC/FTC/TAF) is a recommended first-line antiretroviral regimen. Croatia has a centralized care for people living with HIV (PLWH) and all persons are seen and treated in a single center, preferably in a same-day initiation model whenever suitable. This retrospective cohort study evaluated antiretroviral therapy (ART) naïve PLWH who initiated BIC/FTC/TAF, in a same-day model. The goal of the study is to assess safety and efficacy of this model by collecting information from the electronic database of the Croatian HIV Reference Centre.

Conditions
HIV Infections
Keywords
HIV, bictegravir, rapid start, same-day initiation
Medical subject headings
HIV Infections

What participants receive

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

Study groups in NCT06518213
Study groupRoleWhat they receive
Cohort receiving BIC/FTC/TAF as a rapid start, same-day initiation ARTAll included subjects (one group, no control group) were started therapy with BIC/FTC/TAF (co-formulated in one tablet of Biktarvy® consisting of 50 mg of bictegravir, 200 mg of emtricitabine and 25 mg of tenofovir alafenamide) within 24 hours of inclusion in care and continued for 12 months.

What is being measured

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

  1. Virological suppression (HIV-1 RNA below 50 copies/mL plasma)

    Virological suppression (HIV-1 RNA below 50 copies/mL plasma) after 12±3 months of antiretroviral treatment with first-line ART (BIC/FTC/TAF) initiated at first clinical contact

    Measured: 12±3 months of ART (BIC/FTC/TAF)

Secondary outcomes (10)

  1. HIV-1 RNA 50-200 copies/mL

    HIV-1 RNA 50-200 copies/mL of plasma after 6 and 12 months of treatment

    Measured: 6 and 12 months of treatment

  2. HIV-1 RNA above 200 copies/mL

    HIV-1 RNA above 200 copies/mL of plasma after 6 and 12 months of treatment

    Measured: 6 and 12 months of treatment

  3. Virological failure

    Virological failure (HIV-1 RNA above 50 copies/mL) after 6 and 12 months of treatment with BIC/FTC/TAF

    Measured: 6 and 12 months of treatment

  4. Number of CD4+ T-lymphocytes

    Change in the number of CD4+ T-lymphocytes per microL of blood compared to the initial value after 6 and 12 months of treatment

    Measured: 6 and 12 months of treatment

  5. Change in CD4+/CD8+ T-lymphocytes ratio

    Change in ratio of CD4+ and CD8+ T-lymphocytes measured after 6 and 12 months of treatment

    Measured: 6 and 12 months of treatment

  6. Side effect to the drug BIC/FTC/TAF

    Side effect to the administered medication which required discontinuation of treatment

    Measured: through study completion, an average of 1 year

  7. Change in weight

    Change in patient's weight in kilograms measured after 6 and 12 months of treatment

    Measured: 6 and 12 months of treatment

  8. Change in eGFR

    Change in estimated glomerular filtration rate (mL/min/1.73 m2) measured after 6 and 12 months of treatment

    Measured: 6 and 12 months of treatment

  9. Change in liver enzymes

    Change in liver enzymes aspartate aminotransferase (AST), alanine aminotransferase (ALT) and gamma-glutamyl transpeptidase (GGT) concentration (U/L) measured after 6 and 12 months of treatment

    Measured: 6 and 12 months of treatment

  10. Lipids concentration

    Change in lipids (total cholesterol, LDL, HDL and triglycerides) concentration (mmol/L) measured after 6 and 12 months of treatment

    Measured: 6 and 12 months of treatment

Timeline

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

  1. First posted24 Jul 2024
  2. Study start1 May 2019
  3. Primary completion31 Dec 2022
  4. Study completion31 Mar 2024

Resources

More details

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

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Retrospective
Enrolment
112 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06518213
Sponsor's protocol ID
UHID-09
Status last verified
Jul 2024
First submitted
12 Jul 2024
Last updated
24 Jul 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Bogdanic N, Bendig L, Lukas D, Zekan S, Begovac J. Timeliness of antiretroviral therapy initiation in the era before universal treatment. Sci Rep. 2021 May 18;11(1):10508. doi: 10.1038/s41598-021-90043-7.

    PubMed 34006927

  • Mounzer K, Brunet L, Fusco JS, Mcnicholl IR, Diaz Cuervo H, Sension M, Mccurdy L, Fusco GP. Advanced HIV Infection in Treatment-Naive Individuals: Effectiveness and Persistence of Recommended 3-Drug Regimens. Open Forum Infect Dis. 2022 Jan 13;9(3):ofac018. doi: 10.1093/ofid/ofac018. eCollection 2022 Mar.

    PubMed 35169590

  • Camici M, Gagliardini R, Lanini S, Del Duca G, Mondi A, Ottou S, Plazzi MM, De Zottis F, Pinnetti C, Vergori A, Grilli E, Mastrorosa I, Mazzotta V, Paulicelli J, Bellagamba R, Cimini E, Tartaglia E, Notari S, Tempestilli M, Cicalini S, Amendola A, Abbate I, Forbici F, Fabeni L, Girardi E, Vaia F, Maggi F, Antinori A. Rapid ART initiation with bictegravir/emtricitabine/tenofovir alafenamide in individuals presenting with advanced HIV disease (Rainbow study). Int J Antimicrob Agents. 2024 Jan;63(1):107049. doi: 10.1016/j.ijantimicag.2023.107049. Epub 2023 Dec 5.

    PubMed 38056572

  • Bachelard A, Isernia V, Charpentier C, Benalycherif A, Mora M, Donadille C, Duvivier C, Lacombe K, El Mouhebb M, Spire B, Landman R, Descamps D, Peytavin G, Assoumou L, Ghosn J; FAST study group. Same-day initiation of bictegravir/emtricitabine/tenofovir alafenamide: Week 48 results of the FAST study-IMEA 055. J Antimicrob Chemother. 2023 Mar 2;78(3):769-778. doi: 10.1093/jac/dkad008.

    PubMed 36659824

  • 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

  • Ambrosioni J, Rojas Lievano J, Berrocal L, Inciarte A, de la Mora L, Gonzalez-Cordon A, Martinez-Rebollar M, Laguno M, Torres B, Ugarte A, Chivite I, Leal L, de Lazzari E, Miro JM, Blanco JL, Martinez E, Mallolas J. Real-life experience with bictegravir/emtricitabine/tenofovir alafenamide in a large reference clinical centre. J Antimicrob Chemother. 2022 Mar 31;77(4):1133-1139. doi: 10.1093/jac/dkab481.

    PubMed 35040990

Questions about this trial

What is this clinical trial studying?

An observational study of HIV Infections, run by University Hospital for Infectious Diseases, Croatia at 1 site in Croatia.

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 3 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 24 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Croatia. 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.

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?

Virological suppression (HIV-1 RNA below 50 copies/mL plasma) (time frame: 12±3 months of ART (BIC/FTC/TAF)). 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 NCT06518213, which also lists 6 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 24 Jul 2024.

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