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Switch to TAF+FTC+BIC in HIV-1-infected Patients Over 65 Years Old at Risk of Polymedication (BICOLDER)

Primary Purpose

HIV Infections

Status
Recruiting
Phase
Phase 4
Locations
France
Study Type
Interventional
Intervention
BIKTARVY 50Mg-200Mg-25Mg Tablet
Sponsored by
Institut de Médecine et d'Epidémiologie Appliquée - Fondation Internationale Léon M'Ba
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for HIV Infections

Eligibility Criteria

65 Years - undefined (Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • HIV-1-infected patient
  • Age > 65 years old
  • Plasma HIV RNA ≤ 50 copies/mL for ≥ 6 months: one blip between 50 et 200 cp/ml is allowed in the past 6 months before screening.
  • Currently receiving an antiretroviral regimen containing a booster, ritonavir or cobicistat
  • No resistance mutation to integrase inhibitors on cumulative HIV RNA genotype. The reverse transcriptase resistant mutations M184V plus one TAM are allowed.
  • If no genotype is available, DNA genotype will be performed at screening visit: no resistance mutation to integrase inhibitors, the reverse transcriptase resistant mutations M184V plus one TAM are allowed.
  • Patient enrolled in or a beneficiary of a Social Security program (State Medical Aid or AME is not a Social Security program)
  • Informed consent form signed by patient and investigator

Exclusion Criteria:

  • HIV-2 infection
  • Currently receiving one of the following drugs: Hypericum perforatum, rifampicin, rifabutin, carbamazepine, oxcarbazepine, phenobarbital, phenytoin, sucralfate, cyclosporine, primidone, ténofovir et adéfovir.
  • Hemoglobin < 10g/dL
  • Platelets < 100 000/mm3
  • Hepatic transaminases AST and ALT > 3x upper limit of normal (ULN)
  • Severe hepatic insufficiency (Child Pugh Class C)
  • Creatininemia clairance < 30 mL/min (MDRD)
  • History or presence of allergy to the trial drugs or their components
  • Patients participating in another clinical trial including an exclusion period that is still ongoing during the screening phase
  • Patients under judicial protection due to temporarily and slightly diminished mental or physical faculties or under legal guardianship.

Sites / Locations

  • Hopital Sainte MargueriteRecruiting
  • Hopital Hotel DieuRecruiting
  • Hopital L'ArchetRecruiting
  • Hôpital Hotel DieuRecruiting
  • Bichat HospitalRecruiting
  • CH de Saint Nazaire
  • Hopital Gustave DronRecruiting
  • Hopital Bretonneau

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

open label, multicentric, non randomized

Arm Description

one arm study to evaluate the safety and efficacy of switching from ritonavir- or cobicistat- booster containing regimens to a fixed-dose combination (FDC) of tenofovir alafenamide (TAF), emtricitabine (FTC) and bictegravir (BIC) in over 65 years old HIV-1-infected patients with virological suppression. Polymedications and drug-drug interactions will be analysed.

Outcomes

Primary Outcome Measures

Virological failure is defined by plasma HIV RNA > 50 cps/mL on 2 following samples at 2 to 4 weeks apart
The primary outcome is the proportion of patients with virological failure at Week 24.

Secondary Outcome Measures

Charlson and Fried Score
• Assessment of co morbidities and frailty
DAD Score
• Assessment of cardio vascular risk
polymedication
• Assessment of polymedication and potential drug-drug interactions
drug interactions
• Change of drug-drug interactions
• adverses events
Rate of participants withdrawn from the study for grade 3 or 4 adverse event
therapeutic success
• Rate of therapeutic success
Viral load detectable
• Rate of participants with detectable signal in case viral load is less than 20 c/ml threshold (Cobas/TaqmanHIV-1 Roche Diagnostics) at W24 and W48
Blip detectable
• Rate of participants with a blip
mutation
• Emergence of resistance mutations at time of virological failure
immunology parameters
• Change of CD4 and CD8 cell count from BSL,
lipid parameters
• Evolution of lipid parameters
Renal parameters
Renal glomerular filtration, creatinine clearance
pharmacology
• Plasma levels of antiretroviral drugs (TAF, FTC, BIC)
Addherence
• Adherence to treatment: self-administered questionnaire
Tolerance
• Tolerance to treatment: questionnaire
Renal parameters (Urine)
urine albumin, urine creatinine, urine protein, beta-2-microglobulin and retinol binding protein

Full Information

First Posted
December 5, 2019
Last Updated
June 8, 2022
Sponsor
Institut de Médecine et d'Epidémiologie Appliquée - Fondation Internationale Léon M'Ba
Collaborators
Pierre and Marie Curie University
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1. Study Identification

Unique Protocol Identification Number
NCT04222283
Brief Title
Switch to TAF+FTC+BIC in HIV-1-infected Patients Over 65 Years Old at Risk of Polymedication
Acronym
BICOLDER
Official Title
Switch to Tenofovir Alafenamide (TAF), Emtricitabine (FTC), Bictegravir (BIC)(Biktarvy®) in HIV-1-infected Patients Over 65 Years Old at Risk of Polymedication
Study Type
Interventional

2. Study Status

Record Verification Date
June 2022
Overall Recruitment Status
Recruiting
Study Start Date
August 17, 2020 (Actual)
Primary Completion Date
December 20, 2021 (Actual)
Study Completion Date
June 30, 2022 (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
Collaborators
Pierre and Marie Curie University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
Patients infected and living with HIV are getting older and have more and more non-HIV co-morbidities. These expose them to polypharmacy that increases the risk of pharmacological interaction. Bictegravir, co-formulated with emtricitabine (FTC) and tenofovir alafenamide (TAF) (BIKTARVY) a new generation integrase inhibitor with a high genetic barrier and had no drug interaction may be a treatment of choice for participant over 65 years old who are HIV infected . BIKTARVY improve adherence and quality of life; and on the other hand it would limit the risks of pharmacological interaction. In addition, the use of TAF reducing the risk of long-term renal toxicity and adverse effects on bone would be of interest in this aging population and more at risk of osteoporosis.
Detailed Description
HIV-1-infected patients over 65 years old at risk of polymedication HIV-1-infected adults aged ≥ 65 years who are virologically-suppressed (HIV-1 RNA <50 copies/mL) on a regimen containing a pharmacokinetic enhancer as ritonavir or cobicistat Evaluate the antiviral efficacy of 24 weeks treatment with the fixed dose combination(FDC) of TAF/FTC/BIC

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
HIV Infections

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
27 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
open label, multicentric, non randomized
Arm Type
Experimental
Arm Description
one arm study to evaluate the safety and efficacy of switching from ritonavir- or cobicistat- booster containing regimens to a fixed-dose combination (FDC) of tenofovir alafenamide (TAF), emtricitabine (FTC) and bictegravir (BIC) in over 65 years old HIV-1-infected patients with virological suppression. Polymedications and drug-drug interactions will be analysed.
Intervention Type
Drug
Intervention Name(s)
BIKTARVY 50Mg-200Mg-25Mg Tablet
Intervention Description
At BSL all the participants will be switched from a booster containing regimen (ritonavir or cobicistat) to TAF/FTC/BIC (BIKTARVY).
Primary Outcome Measure Information:
Title
Virological failure is defined by plasma HIV RNA > 50 cps/mL on 2 following samples at 2 to 4 weeks apart
Description
The primary outcome is the proportion of patients with virological failure at Week 24.
Time Frame
Week 24
Secondary Outcome Measure Information:
Title
Charlson and Fried Score
Description
• Assessment of co morbidities and frailty
Time Frame
Day 1, Week 24 and Week 48
Title
DAD Score
Description
• Assessment of cardio vascular risk
Time Frame
Day 1,Week 24 and Week 48
Title
polymedication
Description
• Assessment of polymedication and potential drug-drug interactions
Time Frame
Baseline, Week 24 and Week 48
Title
drug interactions
Description
• Change of drug-drug interactions
Time Frame
Baseline To Week 48
Title
• adverses events
Description
Rate of participants withdrawn from the study for grade 3 or 4 adverse event
Time Frame
Baseline To Week 48
Title
therapeutic success
Description
• Rate of therapeutic success
Time Frame
Week 24 and Week 48
Title
Viral load detectable
Description
• Rate of participants with detectable signal in case viral load is less than 20 c/ml threshold (Cobas/TaqmanHIV-1 Roche Diagnostics) at W24 and W48
Time Frame
From Baseline to Week 48
Title
Blip detectable
Description
• Rate of participants with a blip
Time Frame
Baseline to Week 48
Title
mutation
Description
• Emergence of resistance mutations at time of virological failure
Time Frame
Day 1 to Week 48
Title
immunology parameters
Description
• Change of CD4 and CD8 cell count from BSL,
Time Frame
Baseline, to Week 24 and Week 48
Title
lipid parameters
Description
• Evolution of lipid parameters
Time Frame
Baseline, Week 24, Week 48
Title
Renal parameters
Description
Renal glomerular filtration, creatinine clearance
Time Frame
Baseline,Week 4,Week 12,Week 24 and Week 48 ;
Title
pharmacology
Description
• Plasma levels of antiretroviral drugs (TAF, FTC, BIC)
Time Frame
Baseline, Week 12, Week 24, Week 48
Title
Addherence
Description
• Adherence to treatment: self-administered questionnaire
Time Frame
Baseline, Week 24 and Week 48
Title
Tolerance
Description
• Tolerance to treatment: questionnaire
Time Frame
Week 4, Week 24 and Week 48
Title
Renal parameters (Urine)
Description
urine albumin, urine creatinine, urine protein, beta-2-microglobulin and retinol binding protein
Time Frame
Baseline, Week 24, Week 48

10. Eligibility

Sex
All
Minimum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: HIV-1-infected patient Age > 65 years old Plasma HIV RNA ≤ 50 copies/mL for ≥ 6 months: one blip between 50 et 200 cp/ml is allowed in the past 6 months before screening. Currently receiving an antiretroviral regimen containing a booster, ritonavir or cobicistat No resistance mutation to integrase inhibitors on cumulative HIV RNA genotype. The reverse transcriptase resistant mutations M184V plus one TAM are allowed. If no genotype is available, DNA genotype will be performed at screening visit: no resistance mutation to integrase inhibitors, the reverse transcriptase resistant mutations M184V plus one TAM are allowed. Patient enrolled in or a beneficiary of a Social Security program (State Medical Aid or AME is not a Social Security program) Informed consent form signed by patient and investigator Exclusion Criteria: HIV-2 infection Currently receiving one of the following drugs: Hypericum perforatum, rifampicin, rifabutin, carbamazepine, oxcarbazepine, phenobarbital, phenytoin, sucralfate, cyclosporine, primidone, ténofovir et adéfovir. Hemoglobin < 10g/dL Platelets < 100 000/mm3 Hepatic transaminases AST and ALT > 3x upper limit of normal (ULN) Severe hepatic insufficiency (Child Pugh Class C) Creatininemia clairance < 30 mL/min (MDRD) History or presence of allergy to the trial drugs or their components Patients participating in another clinical trial including an exclusion period that is still ongoing during the screening phase Patients under judicial protection due to temporarily and slightly diminished mental or physical faculties or under legal guardianship.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Aïda BENALYCHERIF
Phone
40256365
Ext
331
Email
aida.benalycherif@fondation-imea.org
Facility Information:
Facility Name
Hopital Sainte Marguerite
City
Marseille
ZIP/Postal Code
13009
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
ISABELLE POZOT MARTIN
Phone
0491746163
Ext
334
Email
isabelle.poizot@mail.ap-hm.fr
First Name & Middle Initial & Last Name & Degree
Isabelle POIZOT-MARTIN, MD,PHD
Facility Name
Hopital Hotel Dieu
City
Nantes
ZIP/Postal Code
44093
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
CLOTILDE ALLAVENA
Phone
40083110
Ext
332
Email
clotilde.allavena@chu-nantes.fr
First Name & Middle Initial & Last Name & Degree
CLOTILDE ALLAVENA
Facility Name
Hopital L'Archet
City
Nice
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Alissa NAQVI
Email
naqvi.a@chu-nice.fr
Facility Name
Hôpital Hotel Dieu
City
Paris
ZIP/Postal Code
75004
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Laurence WEISS
Email
laurence.weiss@aphp.fr
Facility Name
Bichat Hospital
City
Paris
ZIP/Postal Code
75018
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Valentina ISERNIA, MD
Phone
40257057
Ext
331
Email
valentina.isernia@aphp.fr
First Name & Middle Initial & Last Name & Degree
BAO PHUNG, MD
Phone
40257057
Ext
331
Email
bao.phung@aphp.fr
First Name & Middle Initial & Last Name & Degree
YAZDAN YAZDANPANAH, MD,PHD
Facility Name
CH de Saint Nazaire
City
Saint-Nazaire
Country
France
Individual Site Status
Active, not recruiting
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
FAIZA AJANA
Phone
0320694617
Ext
333
Email
fajana@ch-tourcoing.fr
First Name & Middle Initial & Last Name & Degree
FAIZA AJANA
Facility Name
Hopital Bretonneau
City
Tours
Country
France
Individual Site Status
Active, not recruiting

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Switch to TAF+FTC+BIC in HIV-1-infected Patients Over 65 Years Old at Risk of Polymedication

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