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

NCT03858478 | Unknown Phase 4 DMC

• 1 other identifier: IMEA 055- FAST
• Study Type: interventional
• Target: 110
• Locations: 1 country
• Sites: 17

Brief Summary

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

Conditions

HIV Seropositivity

Keywords

HIV, new diagnosis, Biktarvy

Outcome Measures

Primary Outcomes (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 Outcomes (15)

• proportion of participants with a false positive HIV screening test (i.e. a first positive test that has not been confirmed)

  DAY 0 (D0)

• 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)

• change in CD4 T cell count

  between DAY 0 (D0) and Month 3 (M3), Month 6 (M6) and Month 12 (M12)

• change in CD4/CD8 ratio

  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

  Between DAY 0 (D0) and Month 12 (M12)

Study Arms (1)

Biktarvy arm

EXPERIMENTAL

one tablet of BIKTARVY including \[TAF (25mg) / FTC (200mg) / BICTEGRAVIR (50mg) \] one tablet once a day for 48 weeks

Drug: Biktarvy arm

Interventions

Biktarvy arm DRUG

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

Biktarvy arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

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

Study Sites (17)

Hopital Zobda Quitman

Fort-de-france, Martinique, 97261, France

NOT YET RECRUITING

Hôpital Pellegrin - Service de Médecine Interne et Maladies Infectieuses

Bordeaux, 33000, France

RECRUITING

Hôpital Côte de Nacre - Service des Maladies Infectieuses

Caen, 14033, France

RECRUITING

Centre hospitalier Sud Francilien

Corbeil-Essonnes, 91106, France

NOT YET RECRUITING

Hôpital Henri Mondor - Service d'Immunologie Clinique

Créteil, 94010, France

RECRUITING

Hopital Francois Mitterrand

Dijon, 21034, France

RECRUITING

Hopital Raymond Poincare

Garches, 92380, France

RECRUITING

Hopital Sainte-Marguerite

Marseille, 13274, France

NOT YET RECRUITING

Hôpital Gui de Chauliac - Service de Maladies Infectieuses et Tropicales

Montpellier, 34000, France

NOT YET RECRUITING

L'ARCHET

Nice, 06200, France

NOT YET RECRUITING

Hopital Saint Antoine

Paris, 75012, France

RECRUITING

Hopital Necker

Paris, 75015, France

RECRUITING

Hopital Bichat

Paris, 75018, France

RECRUITING

Hopital Tenon

Paris, 75020, France

RECRUITING

Hopital Foch

Suresnes, 92150, France

RECRUITING

Hopital Gustave Dron

Tourcoing, 59208, France

RECRUITING

Hopital Bretonneau

Tours, 37044, France

NOT YET RECRUITING

MeSH Terms

Conditions

HIV Seropositivity

Condition Hierarchy (Ancestors)

HIV Infections; Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases

Central Study Contacts

AIDA AB BENALYCHERIF

CONTACT

+33.1.40.25.63.65; aida.beanlycherif@imea.fr

KARINE KA AMAT

CONTACT

+33.1.40.25.63.52; karine.amat@imea.fr

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Pilot study, single arm, multicentric, national

Study Record Dates

• First Submitted: February 25, 2019
• First Posted: February 28, 2019
• Study Start: November 18, 2019
• Primary Completion: March 31, 2021
• Study Completion: December 31, 2021
• Last Updated: January 9, 2020

Record last verified: 2019-11

Locations

FR (17)