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

January 6, 2020 updated by: Institut de Médecine et d'Epidémiologie Appliquée - Fondation Internationale Léon M'Ba

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

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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

Study Type

Interventional

Enrollment (Anticipated)

110

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • France
      • Bordeaux, France, 33000
        • Recruiting
        • Hôpital Pellegrin - Service de Médecine Interne et Maladies Infectieuses
        • Contact:
          • I
        • Contact:
        • Principal Investigator:
          • Didier NEAU, MD
      • Caen, France, 14033
        • Recruiting
        • Hôpital Côte de Nacre - Service des Maladies Infectieuses
        • Contact:
        • Contact:
        • Principal Investigator:
          • Renaud VERDON, MD, PhD
        • Sub-Investigator:
          • Jean-Jacques PARIENTI, MD
        • Sub-Investigator:
          • Sylvie DARGERE, MD
      • Corbeil-Essonnes, France, 91106
        • Not yet recruiting
        • Centre Hospitalier Sud Francilien
        • Contact:
        • Principal Investigator:
          • Amélie AC CHABROL, MD
      • Créteil, France, 94010
        • Recruiting
        • Hôpital Henri Mondor - Service d'Immunologie Clinique
        • Contact:
        • Principal Investigator:
          • Jean-Daniel LELIEVRE, MD
      • Dijon, France, 21034
        • Recruiting
        • Hôpital François Mitterrand
        • Contact:
        • Principal Investigator:
          • Lionel LP PIROTH, PhD
      • Garches, France, 92380
        • Recruiting
        • Hôpital Raymond Poincaré
        • Contact:
        • Principal Investigator:
          • Pierre PT DE TRUCHIS, PhD
      • Marseille, France, 13274
        • Not yet recruiting
        • Hôpital Sainte-Marguerite
        • Contact:
        • Principal Investigator:
          • Isabelle IM POIZOT-MARTIN, MD, PhD
      • Montpellier, France, 34000
        • Not yet recruiting
        • Hôpital Gui de Chauliac - Service de Maladies Infectieuses et Tropicales
        • Contact:
        • Contact:
        • Principal Investigator:
          • Jacques REYNES, MD, PhD
      • Nice, France, 06200
        • Not yet recruiting
        • L'ARCHET
        • Contact:
        • Principal Investigator:
          • ALISSA AN NAQVI, MD
      • Paris, France, 75015
        • Recruiting
        • Hôpital Necker
        • Contact:
        • Principal Investigator:
          • Claudine CD DUVIVIER, PhD
      • Paris, France, 75012
        • Recruiting
        • Hopital Saint Antoine
        • Contact:
        • Principal Investigator:
          • Karine KL LACOMBE, MD, PhD
      • Paris, France, 75020
        • Recruiting
        • Hopital Tenon
        • Contact:
        • Principal Investigator:
          • Gilles GP PIALOUX, MD, PhD
      • Paris, France, 75018
        • Recruiting
        • Hôpital Bichat
        • Contact:
        • Principal Investigator:
          • Yazdan YY YAZDANPANAH, MD, PhD
      • Suresnes, France, 92150
        • Recruiting
        • Hopital Foch
        • Contact:
        • Principal Investigator:
          • David DZ ZUCMAN, MD
      • Tourcoing, France, 59208
        • Recruiting
        • Hôpital Gustave Dron
        • Contact:
        • Principal Investigator:
          • Faiza FA AJANA, MD
      • Tours, France, 37044
        • Not yet recruiting
        • Hôpital Bretonneau
        • Contact:
        • Principal Investigator:
          • Louis LB BERNARD, MD, PhD
    • Martinique
      • Fort-de-france, Martinique, France, 97261
        • Not yet recruiting
        • Hopital Zobda Quitman
        • Contact:
        • Principal Investigator:
          • André AC CABIE, PhD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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)
virological suppression at Month 6 (M6)

Secondary Outcome Measures

Outcome Measure
Time Frame
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
Between DAY 0 (D0) and Month 12 (M12)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 18, 2019

Primary Completion (Anticipated)

March 31, 2021

Study Completion (Anticipated)

December 31, 2021

Study Registration Dates

First Submitted

February 25, 2019

First Submitted That Met QC Criteria

February 27, 2019

First Posted (Actual)

February 28, 2019

Study Record Updates

Last Update Posted (Actual)

January 9, 2020

Last Update Submitted That Met QC Criteria

January 6, 2020

Last Verified

November 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IMEA 055- FAST

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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