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

Sponsor
Institut de Médecine et d'Epidémiologie Appliquée - Fondation Internationale Léon M'Ba (Other)
Overall Status
Unknown status
CT.gov ID
NCT03858478
Collaborator
(none)
110
Enrollment
17
Locations
1
Arm
25.4
Anticipated Duration (Months)
6.5
Patients Per Site
0.3
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease Intervention/Treatment Phase
  • Drug: Biktarvy arm
 Phase 4

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 Design

Study Type:
Interventional
Anticipated Enrollment :
110 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Intervention Model Description:
Pilot study, single arm, multicentric, nationalPilot 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
Actual Study Start Date :
Nov 18, 2019
Anticipated Primary Completion Date :
Mar 31, 2021
Anticipated Study Completion Date :
Dec 31, 2021

Arms and Interventions

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)

Outcome Measures

Primary Outcome Measures

  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) [virological suppression at Month 6 (M6)]

Secondary Outcome Measures

  1. proportion of participants with a false positive HIV screening test (i.e. a first positive test that has not been confirmed) [DAY 0 (D0)]

  2. proportion of participants with plasma HIV-RNA < 50 copies/ml [Month 1 (M1), Month 3 (M3), Month 6 (M6), Month 9 (M9), Month 12 (M12)]

  3. change in CD4 T cell count [between DAY 0 (D0) and Month 3 (M3), Month 6 (M6) and Month 12 (M12)]

  4. change in CD4/CD8 ratio [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 [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) [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) [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 [Between Month 6 (M6) and Month 12 (M12)]

  9. number of comedications used during the 12-months study period [Between DAY 0 (D0) and Month 12 (M12)]

  10. adherence to study treatment evaluated by drug concentrations measurement in hair [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) [Between DAY 0 (D0) and Month 12 (M12)]

  12. participants' acceptability of immediate antiretroviral initiation treatment (self-assessed auto-questionnaires [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), [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 [Month 1 (M1), Month 3 (M3), Month 6 (M6) and Month 12 (M12)]

  15. type of comedications used during the 12-months study period [Between DAY 0 (D0) and Month 12 (M12)]

Eligibility Criteria

Criteria

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

Locations

Site City State Country Postal Code
1 Hopital Zobda Quitman Fort-de-france Martinique France 97261
2 Hôpital Pellegrin - Service de Médecine Interne et Maladies Infectieuses Bordeaux France 33000
3 Hôpital Côte de Nacre - Service des Maladies Infectieuses Caen France 14033
4 Centre hospitalier Sud Francilien Corbeil-Essonnes France 91106
5 Hôpital Henri Mondor - Service d'Immunologie Clinique Créteil France 94010
6 Hopital Francois Mitterrand Dijon France 21034
7 Hopital Raymond Poincare Garches France 92380
8 Hopital Sainte-Marguerite Marseille France 13274
9 Hôpital Gui de Chauliac - Service de Maladies Infectieuses et Tropicales Montpellier France 34000
10 L'ARCHET Nice France 06200
11 Hopital Saint Antoine Paris France 75012
12 Hopital Necker Paris France 75015
13 Hopital Bichat Paris France 75018
14 Hopital Tenon Paris France 75020
15 Hopital Foch Suresnes France 92150
16 Hopital Gustave Dron Tourcoing France 59208
17 Hopital Bretonneau Tours France 37044

Sponsors and Collaborators

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

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Institut de Médecine et d'Epidémiologie Appliquée - Fondation Internationale Léon M'Ba
ClinicalTrials.gov Identifier:
NCT03858478
Other Study ID Numbers:
  • IMEA 055- FAST
First Posted:
Feb 28, 2019
Last Update Posted:
Jan 9, 2020
Last Verified:
Nov 1, 2019
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

Study Results

No Results Posted as of Jan 9, 2020