Substitution current ARV therapy by BIKTARVY in hiv infected patients over 65 years old

Phase 1

• Conditions: HIV-1-infected patientAge > 65 years oldPlasma HIV RNA = 50 copies/mL for = 6 months: one blip between 50 et 200 cp/ml is allowed in the last 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. Patient enrolled in or a beneficiary of a Social Security program Informed consent form signed; Therapeutic area: Diseases [C] - Virus Diseases [C02]

• Registration Number: EUCTR2019-002843-81-FR
• Lead Sponsor: IMEA

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2019-08-06
• Last Update Posted: 9 September 2024

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 50

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 last 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

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) no
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 50

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 in force during the screening phase
•Patients under judicial protection due to temporarily and slightly diminished mental or physical faculties or under legal guardianship.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified