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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 (FAST)

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ClinicalTrials.gov Identifier: NCT03858478
Recruitment Status : Recruiting
First Posted : February 28, 2019
Last Update Posted : January 9, 2020
Sponsor:
Information provided by (Responsible Party):
Institut de Médecine et d'Epidémiologie Appliquée - Fondation Internationale Léon M'Ba

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
HIV Seropositivity 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

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 110 participants
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
Actual Study Start Date : November 18, 2019
Estimated Primary Completion Date : March 31, 2021
Estimated Study Completion Date : December 31, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS

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)




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) [ Time Frame: 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) [ Time Frame: DAY 0 (D0) ]
  2. 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) ]
  3. change in CD4 T cell count [ Time Frame: between DAY 0 (D0) and Month 3 (M3), Month 6 (M6) and Month 12 (M12) ]
  4. change in CD4/CD8 ratio [ Time Frame: 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 [ Time Frame: 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) [ Time Frame: 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) [ Time Frame: 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 [ Time Frame: Between Month 6 (M6) and Month 12 (M12) ]
  9. number of comedications used during the 12-months study period [ Time Frame: Between DAY 0 (D0) and Month 12 (M12) ]
  10. 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) ]
  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) [ Time Frame: Between DAY 0 (D0) and Month 12 (M12) ]
  12. 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) ]
  13. 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) ]
  14. 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) ]
  15. type of comedications used during the 12-months study period [ Time Frame: Between DAY 0 (D0) and Month 12 (M12) ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03858478


Contacts
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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
Show Show 17 study locations
Sponsors and Collaborators
Institut de Médecine et d'Epidémiologie Appliquée - Fondation Internationale Léon M'Ba
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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: February 28, 2019    Key Record Dates
Last Update Posted: January 9, 2020
Last Verified: November 2019

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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:
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HIV Seropositivity
HIV Infections
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases