Switch to TAF+FTC+BIC in HIV-1-infected Patients Over 65 Years Old at Risk of Polymedication
NCT ID: NCT04222283
Last Updated: 2022-06-10
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE4
27 participants
INTERVENTIONAL
2020-08-17
2022-06-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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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.
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).
Interventions
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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).
Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
65 Years
ALL
No
Sponsors
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Pierre and Marie Curie University
OTHER
Institut de Médecine et d'Epidémiologie Appliquée - Fondation Internationale Léon M'Ba
OTHER
Responsible Party
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Locations
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Hopital Sainte Marguerite
Marseille, , France
Hopital Hotel Dieu
Nantes, , France
Hopital L'Archet
Nice, , France
Hôpital Hotel Dieu
Paris, , France
Bichat Hospital
Paris, , France
CH de Saint Nazaire
Saint-Nazaire, , France
Hopital Gustave Dron
Tourcoing, , France
Hopital Bretonneau
Tours, , France
Countries
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Central Contacts
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Facility Contacts
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Alissa NAQVI
Role: primary
Role: backup
Laurence WEISS
Role: primary
Role: backup
Other Identifiers
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IMEA 057
Identifier Type: -
Identifier Source: org_study_id
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