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HIV SeropositivityPhase 4FASTNCT03858478

Initiation of First-line Antiretroviral Treatment With TENOFOVIR ALAFENAMIDE - EMTRICITABINE - BICTEGRAVIR at the First Clinical Contact in France: Trial IMEA 055 - FAST

A Phase 4 study testing Biktarvy arm in people with HIV Seropositivity, run by Institut de Médecine et d'Epidémiologie Appliquée - Fondation Internationale Léon M'Ba at 17 sites in France.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

Evaluation of antiretroviral treatment adherence using determination of Bictegravir, Emtricitabine and Tenofovir with new HIV patients in France Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
HIV Seropositivity
What is being tested?
Biktarvy arm
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
110 participants
Where
17 sitesFrance
Study dates
18 Nov 2019to 31 Dec 2021
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

  • age > 18 years
  • newly diagnosed HIV-infected individual evidenced by any of the following tests: (i) positive self-test, (ii) positive HIV Rapid antibody test, (iii) positive HIV immunoassay (ELISA 4th generation) test
  • antiretroviral-treatment naive
  • negative urine pregnancy test for women of childbearing potential and willing to use effective contraception (mechanical or medicamental)
  • willing to sign an informed written consent-
  • regular health insurance
  • willing to provide two distinct contact information (telephone number and/or email) in order to be easily reached if needed between Day 0 and Day 7

Who cannot join

  • clinical symptoms suggestive of opportunistic infections
  • participant not willing to provide two distinct contact information
  • a woman who is pregnant or breast-feeding or planning to become pregnant during the expected study period.
  • Co-medication with deleterious interaction with study treatment (eg enzyme inducer)

Trial locations and contacts

17 sites in 1 country.

AIDA AB BENALYCHERIF contact

+33.1.40.25.63.65

aida.beanlycherif@imea.fr

KARINE KA AMAT contact

+33.1.40.25.63.52

karine.amat@imea.fr

17 sites in 1 country

France17 sites, 17 recruiting

  • Hôpital Pellegrin - Service de Médecine Interne et Maladies Infectieuses

    Bordeaux, 33000

    SEVERINE SL LE PUIL, 33.5.56.79.55.36, severine.lepuil@chu-bordeaux.fr

    I

    Recruiting

  • Hôpital Côte de Nacre - Service des Maladies Infectieuses

    Caen, 14033

    Renaud RV VERDON, MD, PhD, 33.2.31.06.47.09, verdon-r@chu-caen.fr

    Pascale PG GOUBIN, 33.2.31.06.47.09, goubin-p@chu-caen.fr

    Recruiting

  • Centre hospitalier Sud Francilien

    Corbeil-Essonnes, 91106

    Nouara NA AGHER, +33.1.61.69.77.04, nouara.agher@chsf.fr

    Amélie AC CHABROL, MD

    Not yet recruiting

  • Hôpital Henri Mondor - Service d'Immunologie Clinique

    Créteil, 94010

    Jean-Daniel JDL LELIEVRE, MD, 33.1.49.81.24.05, jean-daniel.lelievre@aphp.fr

    Jean-Daniel LELIEVRE, MD

    Recruiting

  • Hopital Francois Mitterrand

    Dijon, 21034

    Sandrine SG GOHIER, +33.3.80.29.36.31, sandrine.gohier@chu-dijon.fr

    Lionel LP PIROTH, PhD

    Recruiting

  • Hopital Zobda Quitman

    Fort-de-france, Martinique, 97261

    André AC CABIE, PhD, +33.5.96.55.23.01, andre.cabie@chu-fort-de-france.fr

    André AC CABIE, PhD

    Not yet recruiting

  • Hopital Raymond Poincare

    Garches, 92380

    Morgane HB MARCOU, +33.1.47.10.46.65, morgane.marcou@aphp.fr

    Pierre PT DE TRUCHIS, PhD

    Recruiting

  • Hopital Sainte-Marguerite

    Marseille, 13274

    Caroline CD DEBREUX, +33.4.91.74.61.63, caroline.debreux@ap-hm.fr

    Isabelle IM POIZOT-MARTIN, MD, PhD

    Not yet recruiting

  • Hôpital Gui de Chauliac - Service de Maladies Infectieuses et Tropicales

    Montpellier, 34000

    Jacques REYNES, MD, PhD, 33.4.67.33.77.25, j-reynes@chu-montpellier.fr

    Christine TRAMONI, 33.4.67.33.77.26, c-tramoni@chu-montpellier.fr

    Not yet recruiting

  • L'ARCHET

    Nice, 06200

    Ghaleb GZ ZOUZOU, +33 4 92 03 58 24, zouzou.g@chu-nice.fr

    ALISSA AN NAQVI, MD

    Not yet recruiting

  • Hopital Saint Antoine

    Paris, 75012

    Christian CT TRAN, +33.1.49.28.24.86, christian.tran@aphp.fr

    Karine KL LACOMBE, MD, PhD

    Recruiting

  • Hopital Necker

    Paris, 75015

    Fatima FT TOUAM, +33.1.44.49.40.28, fatima.touam@nck.aphp.fr

    Claudine CD DUVIVIER, PhD

    Recruiting

  • Hopital Bichat

    Paris, 75018

    Zélie ZJ JULIA, +33.1.40.25.70.57, zelie.julia@aphp.fr

    Yazdan YY YAZDANPANAH, MD, PhD

    Recruiting

  • Hopital Tenon

    Paris, 75020

    Anne AA ADDA, +33.1.56.01.74.36, anne.adda@aphp.fr

    Gilles GP PIALOUX, MD, PhD

    Recruiting

  • Hopital Foch

    Suresnes, 92150

    Amina AF FADLI, +33.1.46.25.11.73, a.fadli@hopital.foch.org

    David DZ ZUCMAN, MD

    Recruiting

  • Hopital Gustave Dron

    Tourcoing, 59208

    Sylvie SV VANDAMME, svandamme@ch-tourcoing.fr

    Faiza FA AJANA, MD

    Recruiting

  • Hopital Bretonneau

    Tours, 37044

    Olivier OB BOURGAULT, +33.2.47.47.37.14, o.bourgault@chu-tours.fr

    Louis LB BERNARD, MD, PhD

    Not yet recruiting

Other trials in France

About this study

Official title: Initiation of First-line Antiretroviral Treatment With TENOFOVIR ALAFENAMIDE - EMTRICITABINE - BICTEGRAVIR at the First Clinical Contact in France

Evaluation of antiretroviral treatment adherence using determination of Bictegravir, Emtricitabine and Tenofovir with new HIV patients in France

Read the detailed description
  • Patient treated at the first clinical contact
  • 18 sites (hospitals) in France
  • Treatment during 48 weeks with principal objective at W24 (plasma HIV-RNA < 50 copies/ml)
  • Evaluation of antiretroviral treatment adherence using determination of Bictegravir, Emtricitabine and Tenofovir in hair sample
Being tested
Biktarvy arm
Keywords
HIV, new diagnosis, Biktarvy
Medical subject headings
HIV Seropositivity

What participants receive

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

  • Biktarvy armDrug

    BIKTARVY : one tablet QD, every day between D0 and M12 includind - TAF (25mg) / FTC (200mg) / BICTEGRAVIR (50mg)

Study groups in NCT03858478
Study groupRoleWhat they receive
Biktarvy armExperimentalone tablet of BIKTARVY including [TAF (25mg) / FTC (200mg) / BICTEGRAVIR (50mg) ] one tablet once a day for 48 weeks
Receives: Drug: Biktarvy arm

What is being measured

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

  1. To achieve virological suppression (plasma HIV-RNA < 50 copies/ml) at Month 6 (M6)on study treatment with a first-line treatment with TAF / FTC/ BIC initiated at the first clinical contact (Snapshot method)

    Measured: virological suppression at Month 6 (M6)

Secondary outcomes (15)

  1. proportion of participants with a false positive HIV screening test (i.e. a first positive test that has not been confirmed)

    Measured: DAY 0 (D0)

  2. proportion of participants with plasma HIV-RNA < 50 copies/ml

    Measured: Month 1 (M1), Month 3 (M3), Month 6 (M6), Month 9 (M9), Month 12 (M12)

  3. change in CD4 T cell count

    Measured: between DAY 0 (D0) and Month 3 (M3), Month 6 (M6) and Month 12 (M12)

  4. change in CD4/CD8 ratio

    Measured: between DAY 0 (D0) and Month 6 (M6) and Month 12 (M12)

  5. proportion of participants requiring discontinuation/modification of TAF/FTC/Bictegravir due to (i) Baseline resistance to one of the study drugs, (ii) adverse events leading to study treatment discontinuation/Modification

    Measured: Between DAY 0 (D0) and Month 12 (M12)

  6. proportion of participants experiencing a grade 3-4 adverse event (related or not related to study treatment)

    Measured: Between DAY 0 (D0) and Month 12 (M12)

  7. proportion of participants with protocol defined virological failure (plasma HIV-RNA > 400 copies/ml at Week 12 confirmed on a second sample drawn 15-21 days later, or two consecutive plasma HIV-RNA > 50 copies/ml within 15-21 days as of Week 24)

    Measured: Between Month 6 (M6) and Month 12 (M12)

  8. proportion of participants harboring a virus developing resistance-associated mutations at the time of protocol-defined virological failure

    Measured: Between Month 6 (M6) and Month 12 (M12)

  9. number of comedications used during the 12-months study period

    Measured: Between DAY 0 (D0) and Month 12 (M12)

  10. adherence to study treatment evaluated by drug concentrations measurement in hair

    Measured: Month 1 (M1), Month 3 (M3), Month 6 (M6) and Month 12 (M12)

  11. proportion of participants lost to follow-up throughout the 12-months study period (LFU = having missed more than two consecutive visits except for W24 and W48 visit)

    Measured: Between DAY 0 (D0) and Month 12 (M12)

  12. participants' acceptability of immediate antiretroviral initiation treatment (self-assessed auto-questionnaires

    Measured: At Day 0 (D0), Month 3 (M3), Month 6 (M6) and Month 12 (M12)

  13. adherence to study treatment evaluated by (i) self-assessed auto-questionnaires (4-day recall),

    Measured: Month 1 (M1), Month 3 (M3), Month 6 (M6) and Month 12 (M12)

  14. adherence to study treatment evaluated by drug concentrations measurement in plasma

    Measured: Month 1 (M1), Month 3 (M3), Month 6 (M6) and Month 12 (M12)

  15. type of comedications used during the 12-months study period

    Measured: Between DAY 0 (D0) and Month 12 (M12)

Timeline

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

  1. First posted28 Feb 2019
  2. Study start18 Nov 2019
  3. Primary completion31 Mar 2021 (estimated)
  4. Study completion31 Dec 2021 (estimated)

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
Model description
Pilot study, single arm, multicentric, national
Masking
None (open label)
Enrolment
110 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03858478
Sponsor's protocol ID
IMEA 055- FAST
Acronym
FAST
Status last verified
Nov 2019
First submitted
25 Feb 2019
Last updated
9 Jan 2020
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Biktarvy arm in people with HIV Seropositivity, run by Institut de Médecine et d'Epidémiologie Appliquée - Fondation Internationale Léon M'Ba at 17 sites in France.

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 7 inclusion and 4 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: status not confirmed, as of the sponsor's last update on 9 Jan 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 17 sites in France. 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?

Results are not available in the source record.

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

Contact AIDA AB BENALYCHERIF (+33.1.40.25.63.65, aida.beanlycherif@imea.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

To achieve virological suppression (plasma HIV-RNA < 50 copies/ml) at Month 6 (M6)on study treatment with a first-line treatment with TAF / FTC/ BIC initiated at the first clinical contact (Snapshot method) (time frame: virological suppression at Month 6 (M6)). 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 NCT03858478.

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 9 Jan 2020.

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