HIV Infections
Conditions
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
Interventions
At BSL all the participants will be switched from a booster containing regimen (ritonavir or cobicistat) to TAF/FTC/BIC (BIKTARVY).
Sponsors
Pierre and Marie Curie University
Institut de Médecine et d'Epidémiologie Appliquée - Fondation Internationale Léon M'Ba
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
65 Years to No maximum
Healthy volunteers
No
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 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
* 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| DAD Score | Day 1,Week 24 and Week 48 | • Assessment of cardio vascular risk |
| polymedication | Baseline, Week 24 and Week 48 | • Assessment of polymedication and potential drug-drug interactions |
| drug interactions | Baseline To Week 48 | • Change of drug-drug interactions |
| • adverses events | Baseline To Week 48 | Rate of participants withdrawn from the study for grade 3 or 4 adverse event |
| therapeutic success | Week 24 and Week 48 | • Rate of therapeutic success |
| 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 |
| Blip detectable | Baseline to Week 48 | • Rate of participants with a blip |
| Charlson and Fried Score | Day 1, Week 24 and Week 48 | • Assessment of co morbidities and frailty |
| immunology parameters | Baseline, to Week 24 and Week 48 | • Change of CD4 and CD8 cell count from BSL, |
| 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) |
| 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 |
| Renal parameters (Urine) | Baseline, Week 24, Week 48 | urine albumin, urine creatinine, urine protein, beta-2-microglobulin and retinol binding protein |
| mutation | Day 1 to Week 48 | • Emergence of resistance mutations at time of virological failure |
Countries
France
Contacts
Primary ContactAïda BENALYCHERIF
Outcome results
None listed