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

Last updated: June 8, 2022
Sponsor: Institut de Médecine et d'Epidémiologie Appliquée - Fondation Internationale Léon M'Ba
Overall Status: Active - Recruiting

Phase

4

Condition

Hiv Infections

Treatment

N/A

Clinical Study ID

NCT04222283
IMEA 057
  • Ages > 65
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

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 isallowed in the past 6 months before screening.
  • Currently receiving an antiretroviral regimen containing a booster, ritonavir orcobicistat
  • No resistance mutation to integrase inhibitors on cumulative HIV RNA genotype. Thereverse transcriptase resistant mutations M184V plus one TAM are allowed.
  • If no genotype is available, DNA genotype will be performed at screening visit: noresistance mutation to integrase inhibitors, the reverse transcriptase resistantmutations M184V plus one TAM are allowed.
  • Patient enrolled in or a beneficiary of a Social Security program (State Medical Aidor AME is not a Social Security program)
  • Informed consent form signed by patient and investigator

Exclusion

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 isstill ongoing during the screening phase
  • Patients under judicial protection due to temporarily and slightly diminished mentalor physical faculties or under legal guardianship.

Study Design

Total Participants: 27
Study Start date:
August 17, 2020
Estimated Completion Date:
June 30, 2022

Study 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

Connect with a study center

  • Hopital Sainte Marguerite

    Marseille, 13009
    France

    Active - Recruiting

  • Hopital Hotel Dieu

    Nantes, 44093
    France

    Active - Recruiting

  • Hopital L'Archet

    Nice,
    France

    Active - Recruiting

  • Bichat Hospital

    Paris, 75018
    France

    Active - Recruiting

  • Hôpital Hotel Dieu

    Paris, 75004
    France

    Active - Recruiting

  • CH de Saint Nazaire

    Saint-Nazaire,
    France

    Site Not Available

  • Hopital Gustave Dron

    Tourcoing, 59208
    France

    Active - Recruiting

  • Hopital Bretonneau

    Tours,
    France

    Site Not Available

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