Back to resultsInitiation of First-line Antiretroviral Treatment With TENOFOVIR ALAFENAMIDE - EMTRICITABINE - BICTEGRAVIR at the First Clinical Contact in France: Trial IMEA 055 - FAST (FAST)
Primary Purpose
HIV Seropositivity
Status
Unknown status
Phase
Phase 4
Locations
France
Study Type
Interventional
Intervention
Biktarvy arm
Sponsored by
About this trial
This is an interventional treatment trial for HIV Seropositivity focused on measuring HIV, new diagnosis, Biktarvy
Eligibility 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)
Sites / Locations
- Hopital Zobda Quitman
- Hôpital Pellegrin - Service de Médecine Interne et Maladies InfectieusesRecruiting
- Hôpital Côte de Nacre - Service des Maladies InfectieusesRecruiting
- Centre hospitalier Sud Francilien
- Hôpital Henri Mondor - Service d'Immunologie CliniqueRecruiting
- Hopital Francois MitterrandRecruiting
- Hopital Raymond PoincareRecruiting
- Hopital Sainte-Marguerite
- Hôpital Gui de Chauliac - Service de Maladies Infectieuses et Tropicales
- L'ARCHET
- Hopital Saint AntoineRecruiting
- Hopital NeckerRecruiting
- Hopital BichatRecruiting
- Hopital TenonRecruiting
- Hopital FochRecruiting
- Hopital Gustave DronRecruiting
- Hopital Bretonneau
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Biktarvy arm
Arm Description
one tablet of BIKTARVY including [TAF (25mg) / FTC (200mg) / BICTEGRAVIR (50mg) ] one tablet once a day for 48 weeks
Outcomes
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)
Secondary Outcome Measures
proportion of participants with a false positive HIV screening test (i.e. a first positive test that has not been confirmed)
proportion of participants with plasma HIV-RNA < 50 copies/ml
change in CD4 T cell count
change in CD4/CD8 ratio
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
proportion of participants experiencing a grade 3-4 adverse event (related or not related to study treatment)
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)
proportion of participants harboring a virus developing resistance-associated mutations at the time of protocol-defined virological failure
number of comedications used during the 12-months study period
adherence to study treatment evaluated by drug concentrations measurement in hair
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)
participants' acceptability of immediate antiretroviral initiation treatment (self-assessed auto-questionnaires
adherence to study treatment evaluated by (i) self-assessed auto-questionnaires (4-day recall),
adherence to study treatment evaluated by drug concentrations measurement in plasma
type of comedications used during the 12-months study period
Full Information
NCT ID
NCT03858478
First Posted
February 25, 2019
Last Updated
January 6, 2020
Sponsor
Institut de Médecine et d'Epidémiologie Appliquée - Fondation Internationale Léon M'Ba
1. Study Identification
Unique Protocol Identification Number
NCT03858478
Brief Title
Initiation of First-line Antiretroviral Treatment With TENOFOVIR ALAFENAMIDE - EMTRICITABINE - BICTEGRAVIR at the First Clinical Contact in France: Trial IMEA 055 - FAST
Acronym
FAST
Official Title
Initiation of First-line Antiretroviral Treatment With TENOFOVIR ALAFENAMIDE - EMTRICITABINE - BICTEGRAVIR at the First Clinical Contact in France
Study Type
Interventional
2. Study Status
Record Verification Date
November 2019
Overall Recruitment Status
Unknown status
Study Start Date
November 18, 2019 (Actual)
Primary Completion Date
March 31, 2021 (Anticipated)
Study Completion Date
December 31, 2021 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Institut de Médecine et d'Epidémiologie Appliquée - Fondation Internationale Léon M'Ba
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
Evaluation of antiretroviral treatment adherence using determination of Bictegravir, Emtricitabine and Tenofovir with new HIV patients in France
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
HIV Seropositivity
Keywords
HIV, new diagnosis, Biktarvy
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Model Description
Pilot study, single arm, multicentric, national
Masking
None (Open Label)
Allocation
N/A
Enrollment
110 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Biktarvy arm
Arm Type
Experimental
Arm Description
one tablet of BIKTARVY including [TAF (25mg) / FTC (200mg) / BICTEGRAVIR (50mg) ] one tablet once a day for 48 weeks
Intervention Type
Drug
Intervention Name(s)
Biktarvy arm
Intervention Description
BIKTARVY : one tablet QD, every day between D0 and M12 includind - TAF (25mg) / FTC (200mg) / BICTEGRAVIR (50mg)
Primary Outcome Measure Information:
Title
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 Measure Information:
Title
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)
Title
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)
Title
change in CD4 T cell count
Time Frame
between DAY 0 (D0) and Month 3 (M3), Month 6 (M6) and Month 12 (M12)
Title
change in CD4/CD8 ratio
Time Frame
between DAY 0 (D0) and Month 6 (M6) and Month 12 (M12)
Title
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)
Title
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)
Title
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)
Title
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)
Title
number of comedications used during the 12-months study period
Time Frame
Between DAY 0 (D0) and Month 12 (M12)
Title
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)
Title
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)
Title
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)
Title
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)
Title
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)
Title
type of comedications used during the 12-months study period
Time Frame
Between DAY 0 (D0) and Month 12 (M12)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
AIDA AB BENALYCHERIF
Phone
+33.1.40.25.63.65
Email
aida.beanlycherif@imea.fr
First Name & Middle Initial & Last Name or Official Title & Degree
KARINE KA AMAT
Phone
+33.1.40.25.63.52
Email
karine.amat@imea.fr
Facility Information:
Facility Name
Hopital Zobda Quitman
City
Fort-de-france
State/Province
Martinique
ZIP/Postal Code
97261
Country
France
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
André AC CABIE, PhD
Phone
+33.5.96.55.23.01
Email
andre.cabie@chu-fort-de-france.fr
First Name & Middle Initial & Last Name & Degree
André AC CABIE, PhD
Facility Name
Hôpital Pellegrin - Service de Médecine Interne et Maladies Infectieuses
City
Bordeaux
ZIP/Postal Code
33000
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
SEVERINE SL LE PUIL
Phone
33.5.56.79.55.36
Email
severine.lepuil@chu-bordeaux.fr
First Name & Middle Initial & Last Name & Degree
I
First Name & Middle Initial & Last Name & Degree
Didier NEAU, MD
Facility Name
Hôpital Côte de Nacre - Service des Maladies Infectieuses
City
Caen
ZIP/Postal Code
14033
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Renaud RV VERDON, MD, PhD
Phone
33.2.31.06.47.09
Email
verdon-r@chu-caen.fr
First Name & Middle Initial & Last Name & Degree
Pascale PG GOUBIN
Phone
33.2.31.06.47.09
Email
goubin-p@chu-caen.fr
First Name & Middle Initial & Last Name & Degree
Renaud VERDON, MD, PhD
First Name & Middle Initial & Last Name & Degree
Jean-Jacques PARIENTI, MD
First Name & Middle Initial & Last Name & Degree
Sylvie DARGERE, MD
Facility Name
Centre hospitalier Sud Francilien
City
Corbeil-Essonnes
ZIP/Postal Code
91106
Country
France
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Nouara NA AGHER
Phone
+33.1.61.69.77.04
Email
nouara.agher@chsf.fr
First Name & Middle Initial & Last Name & Degree
Amélie AC CHABROL, MD
Facility Name
Hôpital Henri Mondor - Service d'Immunologie Clinique
City
Créteil
ZIP/Postal Code
94010
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jean-Daniel JDL LELIEVRE, MD
Phone
33.1.49.81.24.05
Email
jean-daniel.lelievre@aphp.fr
First Name & Middle Initial & Last Name & Degree
Jean-Daniel LELIEVRE, MD
Facility Name
Hopital Francois Mitterrand
City
Dijon
ZIP/Postal Code
21034
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sandrine SG GOHIER
Phone
+33.3.80.29.36.31
Email
sandrine.gohier@chu-dijon.fr
First Name & Middle Initial & Last Name & Degree
Lionel LP PIROTH, PhD
Facility Name
Hopital Raymond Poincare
City
Garches
ZIP/Postal Code
92380
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Morgane HB MARCOU
Phone
+33.1.47.10.46.65
Email
morgane.marcou@aphp.fr
First Name & Middle Initial & Last Name & Degree
Pierre PT DE TRUCHIS, PhD
Facility Name
Hopital Sainte-Marguerite
City
Marseille
ZIP/Postal Code
13274
Country
France
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Caroline CD DEBREUX
Phone
+33.4.91.74.61.63
Email
caroline.debreux@ap-hm.fr
First Name & Middle Initial & Last Name & Degree
Isabelle IM POIZOT-MARTIN, MD, PhD
Facility Name
Hôpital Gui de Chauliac - Service de Maladies Infectieuses et Tropicales
City
Montpellier
ZIP/Postal Code
34000
Country
France
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jacques REYNES, MD, PhD
Phone
33.4.67.33.77.25
Email
j-reynes@chu-montpellier.fr
First Name & Middle Initial & Last Name & Degree
Christine TRAMONI
Phone
33.4.67.33.77.26
Email
c-tramoni@chu-montpellier.fr
First Name & Middle Initial & Last Name & Degree
Jacques REYNES, MD, PhD
Facility Name
L'ARCHET
City
Nice
ZIP/Postal Code
06200
Country
France
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ghaleb GZ ZOUZOU
Phone
+33 4 92 03 58 24
Email
zouzou.g@chu-nice.fr
First Name & Middle Initial & Last Name & Degree
ALISSA AN NAQVI, MD
Facility Name
Hopital Saint Antoine
City
Paris
ZIP/Postal Code
75012
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Christian CT TRAN
Phone
+33.1.49.28.24.86
Email
christian.tran@aphp.fr
First Name & Middle Initial & Last Name & Degree
Karine KL LACOMBE, MD, PhD
Facility Name
Hopital Necker
City
Paris
ZIP/Postal Code
75015
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Fatima FT TOUAM
Phone
+33.1.44.49.40.28
Email
fatima.touam@nck.aphp.fr
First Name & Middle Initial & Last Name & Degree
Claudine CD DUVIVIER, PhD
Facility Name
Hopital Bichat
City
Paris
ZIP/Postal Code
75018
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Zélie ZJ JULIA
Phone
+33.1.40.25.70.57
Email
zelie.julia@aphp.fr
First Name & Middle Initial & Last Name & Degree
Yazdan YY YAZDANPANAH, MD, PhD
Facility Name
Hopital Tenon
City
Paris
ZIP/Postal Code
75020
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Anne AA ADDA
Phone
+33.1.56.01.74.36
Email
anne.adda@aphp.fr
First Name & Middle Initial & Last Name & Degree
Gilles GP PIALOUX, MD, PhD
Facility Name
Hopital Foch
City
Suresnes
ZIP/Postal Code
92150
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Amina AF FADLI
Phone
+33.1.46.25.11.73
Email
a.fadli@hopital.foch.org
First Name & Middle Initial & Last Name & Degree
David DZ ZUCMAN, MD
Facility Name
Hopital Gustave Dron
City
Tourcoing
ZIP/Postal Code
59208
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sylvie SV VANDAMME
Email
svandamme@ch-tourcoing.fr
First Name & Middle Initial & Last Name & Degree
Faiza FA AJANA, MD
Facility Name
Hopital Bretonneau
City
Tours
ZIP/Postal Code
37044
Country
France
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Olivier OB BOURGAULT
Phone
+33.2.47.47.37.14
Email
o.bourgault@chu-tours.fr
First Name & Middle Initial & Last Name & Degree
Louis LB BERNARD, MD, PhD
12. IPD Sharing Statement
Learn more about this trial
Initiation of First-line Antiretroviral Treatment With TENOFOVIR ALAFENAMIDE - EMTRICITABINE - BICTEGRAVIR at the First Clinical Contact in France: Trial IMEA 055 - FAST
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