E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
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 |
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E.1.1.1 | Medical condition in easily understood language |
Older up, 65HIV infection patient cuurently receving active ARV beneficiary of a Social Security and consent form signed |
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E.1.1.2 | Therapeutic area | Diseases [C] - Virus Diseases [C02] |
MedDRA Classification |
E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
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 copies/mL) on a regimen containing a pharmacokinetic enhancer as ritonavir or cobicistat |
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E.2.2 | Secondary objectives of the trial |
Assessment of co morbidities and frailty Assessment of cardio vascular risk Assessment of polymedication and potential drug-drug interactions Change of drug-drug interactions Rate of participants withdrawn from the study for grade 3 or 4 adverse event Rate of therapeutic success Rate of participants with detectable signal in case viral load is less than 20 c/ml threshold • Rate of participants with a blip • Emergence of resistance mutations at time of virological failure • Change of CD4 and CD8 cell count • Evolution of lipid parameters • Renal glomerular filtration, creatinine clearance ; urine albumin, urine creatinine, urine protein, beta-2-microglobulin and retinol binding protein • Plasma levels of antiretroviral drugs (TFV, FTC, BIC) • Adherence to treatment: self-administered questionnaire • Tolerance to treatment: questionnaire
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal 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
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E.4 | Principal 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.
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E.5 End points |
E.5.1 | Primary end point(s) |
The primary outcome is the proportion of patients with virological failure at W24. Virological failure is defined by plasma HIV RNA > 50 cps/mL on 2 following samples at 2 to 4 weeks apart
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
The primary outcome is the proportion of patients with virological failure at W24 |
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E.5.2 | 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
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
BSL, Week 4, Week 12, Week 24, and Week48 |
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | No |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | Yes |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | No |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | No |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | Yes |
E.8 Design of the trial |
E.8.1 | Controlled | No |
E.8.1.1 | Randomised | No |
E.8.1.2 | Open | Yes |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | No |
E.8.1.5 | Parallel group | No |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | Yes |
E.8.1.7.1 | Other trial design description |
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E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | No |
E.8.2.3 | Other | No |
E.8.3 |
The trial involves single site in the Member State concerned
| Yes |
E.8.4 | The trial involves multiple sites in the Member State concerned | Yes |
E.8.4.1 | Number of sites anticipated in Member State concerned | 4 |
E.8.5 | The trial involves multiple Member States | No |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | No |
E.8.6.2 | Trial being conducted completely outside of the EEA | No |
E.8.7 | Trial has a data monitoring committee | Yes |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
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Last visit of the last subject |
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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 1 |
E.8.9.1 | In the Member State concerned months | 6 |
E.8.9.1 | In the Member State concerned days | 0 |