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

Status

Indicates the current recruitment status or the expanded access status.
Unknown

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
110

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

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
        • Hopital 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
        • Hôpital 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
        • Hôpital 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

14 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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
November 18, 2019

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
March 31, 2021

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 31, 2021

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 25, 2019

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 27, 2019

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
February 28, 2019

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
January 9, 2020

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 6, 2020

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
November 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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