Clinical Trials

MainTitle

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

This study is not yet open for participant recruitment. (see Contacts and Locations)

Verified November 2019 by Institut de Médecine et d'Epidémiologie Appliquée - Fondation Internationale Léon M'Ba

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

Collaborator
Pierre and Marie Curie University

Information provided by (Responsible Party)
Institut de Médecine et d'Epidémiologie Appliquée - Fondation Internationale Léon M'Ba
ClinicalTrials.gov Identifier
NCT04222283

First received: December 5, 2019
Last updated: January 7, 2020
Last Verified: November 2019
History of Changes
Purpose

Purpose

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.

Condition Intervention Phase
HIV Infections

Drug : BIKTARVY 50Mg-200Mg-25Mg Tablet
Phase 4

Study Type: Interventional
Study Design: Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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

Further study details as provided by Institut de Médecine et d'Epidémiologie Appliquée - Fondation Internationale Léon M'Ba:

Primary Outcome Measures

  • Virological failure is defined by plasma HIV RNA > 50 cps/mL on 2 following samples at 2 to 4 weeks apart [ Time Frame: Week 24 ]
    The primary outcome is the proportion of patients with virological failure at Week 24.
Secondary Outcome Measures:
  • Charlson and Fried Score [ Time Frame: Day 1, Week 24 and Week 48 ]
    • Assessment of co morbidities and frailty
  • DAD Score [ Time Frame: Day 1,Week 24 and Week 48 ]
    • Assessment of cardio vascular risk
  • polymedication [ Time Frame: Baseline, Week 24 and Week 48 ]
    • Assessment of polymedication and potential drug-drug interactions
  • drug interactions [ Time Frame: Baseline To Week 48 ]
    • Change of drug-drug interactions
  • • adverses events [ Time Frame: Baseline To Week 48 ]
    Rate of participants withdrawn from the study for grade 3 or 4 adverse event
  • therapeutic success [ Time Frame: Week 24 and Week 48 ]
    • Rate of therapeutic success
  • Viral load detectable [ Time Frame: From Baseline to Week 48 ]
    • 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 [ Time Frame: Baseline to Week 48 ]
    • Rate of participants with a blip
  • mutation [ Time Frame: Day 1 to Week 48 ]
    • Emergence of resistance mutations at time of virological failure
  • immunology parameters [ Time Frame: Baseline, to Week 24 and Week 48 ]
    • Change of CD4 and CD8 cell count from BSL,
  • lipid parameters [ Time Frame: Baseline, Week 24, Week 48 ]
    • Evolution of lipid parameters
  • Renal parameters [ Time Frame: Baseline,Week 4,Week 12,Week 24 and Week 48 ; ]
    Renal glomerular filtration, creatinine clearance
  • pharmacology [ Time Frame: Baseline, Week 12, Week 24, Week 48 ]
    • Plasma levels of antiretroviral drugs (TAF, FTC, BIC)
  • Addherence [ Time Frame: Baseline, Week 24 and Week 48 ]
    • Adherence to treatment: self-administered questionnaire
  • Tolerance [ Time Frame: Week 4, Week 24 and Week 48 ]
    • Tolerance to treatment: questionnaire
  • Renal parameters (Urine) [ Time Frame: Baseline, Week 24, Week 48 ]
    urine albumin, urine creatinine, urine protein, beta-2-microglobulin and retinol binding protein

Estimated Enrollment: 50
Study Start Date: January 15, 2020
Estimated Study Completion Date: June 30, 2021
Estimated Primary Completion Date: January 30, 2021 (Final data collection date for primary outcome measure)

Arms Assigned Interventions
Experimental: open label, multicentric, non randomized
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.
Drug: BIKTARVY 50Mg-200Mg-25Mg Tablet

At BSL all the participants will be switched from a booster containing regimen (ritonavir or cobicistat) to TAF/FTC/BIC (BIKTARVY).

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

Eligibility

Eligibility

Ages Eligible for Study: 65 Years and older  
Sexes Eligible for Study: All  
Accepts Healthy Volunteers: No  

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.

contacts and locations

Contacts and Locations

Choosing to participate in a study is an important personal decision.Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT04222283

Contacts

Contact:   Aïda BENALYCHERIF 40256365 ext 331 aida.benalycherif@imea.fr

Locations

France
Hopital Sainte Marguerite
Marseille, France, 13009
Contact: ISABELLE POZOT MARTIN    0491746163 ext 334    isabelle.poizot@mail.ap-hm.fr
Principal Investigator: Isabelle POIZOT-MARTIN, MD,PHD
Hopital Hotel Dieu
Nantes, France, 44093
Contact: CLOTILDE ALLAVENA    40083110 ext 332    clotilde.allavena@chu-nantes.fr
Principal Investigator: CLOTILDE ALLAVENA
Bichat Hospital
Paris, France, 75018
Contact: Valentina ISERNIA, MD    40257057 ext 331    valentina.isernia@aphp.fr
Contact: BAO PHUNG, MD    40257057 ext 331    bao.phung@aphp.fr
Principal Investigator: YAZDAN YAZDANPANAH, MD,PHD
Hopital Gustave Dron
Tourcoing, France, 59208
Contact: FAIZA AJANA    0320694617 ext 333    fajana@ch-tourcoing.fr
Principal Investigator: FAIZA AJANA

Sponsors and Collaborators

Institut de Médecine et d'Epidémiologie Appliquée - Fondation Internationale Léon M'Ba
Pierre and Marie Curie University
More Information

More Information


Responsible Party: Institut de Médecine et d'Epidémiologie Appliquée - Fondation Internationale Léon M'Ba  
ClinicalTrials.gov Identifier: NCT04222283   History of Changes  
Other Study ID Numbers: IMEA 057  
Study First Received: December 5, 2019  
Last Updated: January 7, 2020  
Individual Participant Data    
Plan to Share IPD: No  

Studies a U.S. FDA-regulated Drug Product: No  
Studies a U.S. FDA-regulated Device Product: No  

Additional relevant MeSH terms:
HIV Infections
Emtricitabine

ClinicalTrials.gov processed this data on May 24, 2020
This information is provided by ClinicalTrials.gov.