Switch to TAF+FTC+BIC in HIV-1-infected Patients Over 65 Years Old at Risk of Polymedication
- Registration Number
- NCT04222283
- Lead Sponsor
- Institut de Médecine et d'Epidémiologie Appliquée - Fondation Internationale Léon M'Ba
- Brief 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.
- Detailed 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
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 27
- 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 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
- 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 ongoing 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
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description open label, multicentric, non randomized BIKTARVY 50Mg-200Mg-25Mg Tablet 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.
- Primary Outcome Measures
Name Time Method Virological failure is defined by plasma HIV RNA > 50 cps/mL on 2 following samples at 2 to 4 weeks apart Week 24 The primary outcome is the proportion of patients with virological failure at Week 24.
- Secondary Outcome Measures
Name Time Method Renal parameters (Urine) Baseline, Week 24, Week 48 urine albumin, urine creatinine, urine protein, beta-2-microglobulin and retinol binding protein
Charlson and Fried Score Day 1, Week 24 and Week 48 • Assessment of co morbidities and frailty
drug interactions Baseline To Week 48 • Change of drug-drug interactions
polymedication Baseline, Week 24 and Week 48 • Assessment of polymedication and potential drug-drug interactions
DAD Score Day 1,Week 24 and Week 48 • Assessment of cardio vascular risk
therapeutic success Week 24 and Week 48 • Rate of therapeutic success
Blip detectable Baseline to Week 48 • Rate of participants with a blip
immunology parameters Baseline, to Week 24 and Week 48 • Change of CD4 and CD8 cell count from BSL,
Viral load detectable From Baseline to Week 48 • 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
• adverses events Baseline To Week 48 Rate of participants withdrawn from the study for grade 3 or 4 adverse event
lipid parameters Baseline, Week 24, Week 48 • Evolution of lipid parameters
Renal parameters Baseline,Week 4,Week 12,Week 24 and Week 48 ; Renal glomerular filtration, creatinine clearance
pharmacology Baseline, Week 12, Week 24, Week 48 • Plasma levels of antiretroviral drugs (TAF, FTC, BIC)
mutation Day 1 to Week 48 • Emergence of resistance mutations at time of virological failure
Addherence Baseline, Week 24 and Week 48 • Adherence to treatment: self-administered questionnaire
Tolerance Week 4, Week 24 and Week 48 • Tolerance to treatment: questionnaire
Trial Locations
- Locations (8)
Hopital Sainte Marguerite
🇫🇷Marseille, France
Hopital Hotel Dieu
🇫🇷Nantes, France
Hôpital Hotel Dieu
🇫🇷Paris, France
Hopital L'Archet
🇫🇷Nice, France
Bichat Hospital
🇫🇷Paris, France
CH de Saint Nazaire
🇫🇷Saint-Nazaire, France
Hopital Gustave Dron
🇫🇷Tourcoing, France
Hopital Bretonneau
🇫🇷Tours, France