Clinical Trials

MainTitle

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

This study is currently recruiting participants. (see Contacts and Locations)

Verified November 2019 by Institut de Médecine et d'Epidémiologie Appliquée - Fondation Internationale Léon M'Ba

Sponsor
Institut de Médecine et d'Epidémiologie Appliquée - Fondation Internationale Léon M'Ba


Information provided by (Responsible Party)
Institut de Médecine et d'Epidémiologie Appliquée - Fondation Internationale Léon M'Ba
ClinicalTrials.gov Identifier
NCT03858478

First received: February 25, 2019
Last updated: January 6, 2020
Last Verified: November 2019
History of Changes
Purpose

Purpose

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

Condition Intervention Phase
HIV Seropositivity

Drug : Biktarvy arm
Phase 4

Study Type: Interventional
Study Design: Allocation: N/A
Intervention Model: Single Group Assignment
Intervention Model Description: Pilot study, single arm, multicentric, national
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Initiation of First-line Antiretroviral Treatment With TENOFOVIR ALAFENAMIDE - EMTRICITABINE - BICTEGRAVIR at the First Clinical Contact in France

Further study details as provided by Institut de Médecine et d'Epidémiologie Appliquée - Fondation Internationale Léon M'Ba:

Primary Outcome Measures

  • 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) ]
Secondary Outcome Measures:
  • proportion of participants with a false positive HIV screening test (i.e. a first positive test that has not been confirmed) [ Time Frame: DAY 0 (D0) ]
  • proportion of participants with plasma HIV-RNA < 50 copies/ml [ Time Frame: Month 1 (M1), Month 3 (M3), Month 6 (M6), Month 9 (M9), Month 12 (M12) ]
  • change in CD4 T cell count [ Time Frame: between DAY 0 (D0) and Month 3 (M3), Month 6 (M6) and Month 12 (M12) ]
  • change in CD4/CD8 ratio [ Time Frame: between DAY 0 (D0) and Month 6 (M6) and Month 12 (M12) ]
  • 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 [ Time Frame: Between DAY 0 (D0) and Month 12 (M12) ]
  • proportion of participants experiencing a grade 3-4 adverse event (related or not related to study treatment) [ Time Frame: Between DAY 0 (D0) and Month 12 (M12) ]
  • 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) [ Time Frame: Between Month 6 (M6) and Month 12 (M12) ]
  • proportion of participants harboring a virus developing resistance-associated mutations at the time of protocol-defined virological failure [ Time Frame: Between Month 6 (M6) and Month 12 (M12) ]
  • number of comedications used during the 12-months study period [ Time Frame: Between DAY 0 (D0) and Month 12 (M12) ]
  • adherence to study treatment evaluated by drug concentrations measurement in hair [ Time Frame: Month 1 (M1), Month 3 (M3), Month 6 (M6) and Month 12 (M12) ]
  • 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) [ Time Frame: Between DAY 0 (D0) and Month 12 (M12) ]
  • participants' acceptability of immediate antiretroviral initiation treatment (self-assessed auto-questionnaires [ Time Frame: At Day 0 (D0), Month 3 (M3), Month 6 (M6) and Month 12 (M12) ]
  • adherence to study treatment evaluated by (i) self-assessed auto-questionnaires (4-day recall), [ Time Frame: Month 1 (M1), Month 3 (M3), Month 6 (M6) and Month 12 (M12) ]
  • adherence to study treatment evaluated by drug concentrations measurement in plasma [ Time Frame: Month 1 (M1), Month 3 (M3), Month 6 (M6) and Month 12 (M12) ]
  • type of comedications used during the 12-months study period [ Time Frame: Between DAY 0 (D0) and Month 12 (M12) ]

Estimated Enrollment: 110
Study Start Date: November 18, 2019
Estimated Study Completion Date: December 31, 2021
Estimated Primary Completion Date: March 31, 2021 (Final data collection date for primary outcome measure)

Arms Assigned Interventions
Experimental: Biktarvy arm
one tablet of BIKTARVY including [TAF (25mg) / FTC (200mg) / BICTEGRAVIR (50mg) ] one tablet once a day for 48 weeks
Drug: Biktarvy arm

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

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

Eligibility

Eligibility

Ages Eligible for Study: 18 Years and older  
Sexes Eligible for Study: All  
Accepts Healthy Volunteers: No  

Criteria

Inclusion Criteria:

  • 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


Exclusion Criteria:
  • 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)

contacts and locations

Contacts and Locations

Choosing to participate in a study is an important personal decision.Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT03858478

Contacts

Contact:   AIDA AB BENALYCHERIF +33.1.40.25.63.65 aida.beanlycherif@imea.fr
Contact:   KARINE KA AMAT +33.1.40.25.63.52 karine.amat@imea.fr

Locations

France
Hopital Zobda Quitman Not yet recruiting
Fort-de-france, Martinique, France, 97261
Contact: André AC CABIE, PhD    +33.5.96.55.23.01    andre.cabie@chu-fort-de-france.fr
Principal Investigator: André AC CABIE, PhD
Hôpital Pellegrin - Service de Médecine Interne et Maladies Infectieuses Recruiting
Bordeaux, France, 33000
Contact: SEVERINE SL LE PUIL    33.5.56.79.55.36    severine.lepuil@chu-bordeaux.fr
Contact: I
Principal Investigator: Didier NEAU, MD
Hôpital Côte de Nacre - Service des Maladies Infectieuses Recruiting
Caen, France, 14033
Contact: Renaud RV VERDON, MD, PhD    33.2.31.06.47.09    verdon-r@chu-caen.fr
Contact: Pascale PG GOUBIN    33.2.31.06.47.09    goubin-p@chu-caen.fr
Principal Investigator: Renaud VERDON, MD, PhD
Sub-Investigator: Jean-Jacques PARIENTI, MD
Sub-Investigator: Sylvie DARGERE, MD
Centre hospitalier Sud Francilien Not yet recruiting
Corbeil-Essonnes, France, 91106
Contact: Nouara NA AGHER    +33.1.61.69.77.04    nouara.agher@chsf.fr
Principal Investigator: Amélie AC CHABROL, MD
Hôpital Henri Mondor - Service d'Immunologie Clinique Recruiting
Créteil, France, 94010
Contact: Jean-Daniel JDL LELIEVRE, MD    33.1.49.81.24.05    jean-daniel.lelievre@aphp.fr
Principal Investigator: Jean-Daniel LELIEVRE, MD
Hopital Francois Mitterrand Recruiting
Dijon, France, 21034
Contact: Sandrine SG GOHIER    +33.3.80.29.36.31    sandrine.gohier@chu-dijon.fr
Principal Investigator: Lionel LP PIROTH, PhD
Hopital Raymond Poincare Recruiting
Garches, France, 92380
Contact: Morgane HB MARCOU    +33.1.47.10.46.65    morgane.marcou@aphp.fr
Principal Investigator: Pierre PT DE TRUCHIS, PhD
Hopital Sainte-Marguerite Not yet recruiting
Marseille, France, 13274
Contact: Caroline CD DEBREUX    +33.4.91.74.61.63    caroline.debreux@ap-hm.fr
Principal Investigator: Isabelle IM POIZOT-MARTIN, MD, PhD
Hôpital Gui de Chauliac - Service de Maladies Infectieuses et Tropicales Not yet recruiting
Montpellier, France, 34000
Contact: Jacques REYNES, MD, PhD    33.4.67.33.77.25    j-reynes@chu-montpellier.fr
Contact: Christine TRAMONI    33.4.67.33.77.26    c-tramoni@chu-montpellier.fr
Principal Investigator: Jacques REYNES, MD, PhD
L'ARCHET Not yet recruiting
Nice, France, 06200
Contact: Ghaleb GZ ZOUZOU    +33 4 92 03 58 24    zouzou.g@chu-nice.fr
Principal Investigator: ALISSA AN NAQVI, MD
Hopital Saint Antoine Recruiting
Paris, France, 75012
Contact: Christian CT TRAN    +33.1.49.28.24.86    christian.tran@aphp.fr
Principal Investigator: Karine KL LACOMBE, MD, PhD
Hopital Necker Recruiting
Paris, France, 75015
Contact: Fatima FT TOUAM    +33.1.44.49.40.28    fatima.touam@nck.aphp.fr
Principal Investigator: Claudine CD DUVIVIER, PhD
Hopital Bichat Recruiting
Paris, France, 75018
Contact: Zélie ZJ JULIA    +33.1.40.25.70.57    zelie.julia@aphp.fr
Principal Investigator: Yazdan YY YAZDANPANAH, MD, PhD
Hopital Tenon Recruiting
Paris, France, 75020
Contact: Anne AA ADDA    +33.1.56.01.74.36    anne.adda@aphp.fr
Principal Investigator: Gilles GP PIALOUX, MD, PhD
Hopital Foch Recruiting
Suresnes, France, 92150
Contact: Amina AF FADLI    +33.1.46.25.11.73    a.fadli@hopital.foch.org
Principal Investigator: David DZ ZUCMAN, MD
Hopital Gustave Dron Recruiting
Tourcoing, France, 59208
Contact: Sylvie SV VANDAMME    svandamme@ch-tourcoing.fr
Principal Investigator: Faiza FA AJANA, MD
Hopital Bretonneau Not yet recruiting
Tours, France, 37044
Contact: Olivier OB BOURGAULT    +33.2.47.47.37.14    o.bourgault@chu-tours.fr
Principal Investigator: Louis LB BERNARD, MD, PhD

Sponsors and Collaborators

Institut de Médecine et d'Epidémiologie Appliquée - Fondation Internationale Léon M'Ba
More Information

More Information


Responsible Party: Institut de Médecine et d'Epidémiologie Appliquée - Fondation Internationale Léon M'Ba  
ClinicalTrials.gov Identifier: NCT03858478   History of Changes  
Other Study ID Numbers: IMEA 055- FAST  
Study First Received: February 25, 2019  
Last Updated: January 6, 2020  

Studies a U.S. FDA-regulated Drug Product: No  
Studies a U.S. FDA-regulated Device Product: No  

Keywords provided by Institut de Médecine et d'Epidémiologie Appliquée - Fondation Internationale Léon M'Ba:

HIV, new diagnosis, Biktarvy

Additional relevant MeSH terms:
HIV Seropositivity

ClinicalTrials.gov processed this data on May 24, 2020
This information is provided by ClinicalTrials.gov.