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. Patient enrolled in or a beneficiary of a Social Security program Informed consent form signed
Conditions
Interventions
Trade Name: BIKTARVY
Pharmaceutical Form: Tablet
Sponsors
IMEA
Eligibility
Sex/Gender
All
Inclusion 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 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
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 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Evaluate the antiviral efficacy of 24 weeks treatment with the fixed dose combination(FDC) of TAF/FTC/BIC in HIV-1-infected adults aged = 65 years who are virologically-suppressed (HIV-1 RNA 50 cps/mL on 2 following samples at 2 to 4 weeks apart ;Timepoint(s) of evaluation of this end point: The primary outcome is the proportion of patients with virological failure at W24 | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): • Assessment of co morbidities and frailty at D0 , W24 and W48: Charlson and Fried Score • Assessment of cardio vascular risk at D0, W24 and W 48: DAD score • Assessment of polymedication and potential drug-drug interactions at BSL, W24 and W48 • Change of drug-drug interactions from BL to W48 • Rate of participants withdrawn from the study for grade 3 or 4 adverse event • Rate of therapeutic success at W24 and W48 • 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 • Rate of participants with a blip from BL to W48 • Emergence of resistance mutations at time of virological failure • Change of CD4 and CD8 cell count from BSL, to W24 and W48 • Evolution of lipid parameters at BSL, W24, W48 • Renal glomerular filtration, creatinine clearance at BSL,W4,W12,W24 and W48 ; urine albumin, urine creatinine, urine protein, beta-2-microglobulin and retinol binding protein BSL, W24, W48 • Plasma levels of antiretroviral drugs (TFV, FTC, BIC) at BSL, W12, W24, W48 • Adherence to treatment: self-administered questionnaire at BSL, W24 and W48 • Tolerance to treatment: questionnaire at W4, W24 and W48 ;Timepoint(s) of evaluation of this end point: BSL, Week 4, Week 12, Week 24, and Week48 | — |
Countries
France
Contacts
Public ContactBENALYCHERIF
IMEA
Outcome results
None listed