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| Name | Class |
|---|---|
| Pierre and Marie Curie University | OTHER |
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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.
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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| open label, multicentric, non randomized | Experimental | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| BIKTARVY 50Mg-200Mg-25Mg Tablet | Drug | At BSL all the participants will be switched from a booster containing regimen (ritonavir or cobicistat) to TAF/FTC/BIC (BIKTARVY). |
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| Measure | Description | Time Frame |
|---|---|---|
| Virological failure is defined by plasma HIV RNA > 50 cps/mL on 2 following samples at 2 to 4 weeks apart | The primary outcome is the proportion of patients with virological failure at Week 24. | Week 24 |
| Measure | Description | Time Frame |
|---|---|---|
| Charlson and Fried Score | • Assessment of co morbidities and frailty | Day 1, Week 24 and Week 48 |
| DAD Score | • Assessment of cardio vascular risk |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Aïda BENALYCHERIF | Contact | 40256365 | 331 | aida.benalycherif@fondation-imea.org |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hopital Sainte Marguerite | Recruiting | Marseille | 13009 | France |
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| Day 1,Week 24 and Week 48 |
| polymedication | • Assessment of polymedication and potential drug-drug interactions | Baseline, Week 24 and Week 48 |
| drug interactions | • Change of drug-drug interactions | Baseline To Week 48 |
| • adverses events | Rate of participants withdrawn from the study for grade 3 or 4 adverse event | Baseline To Week 48 |
| therapeutic success | • Rate of therapeutic success | Week 24 and Week 48 |
| Viral load detectable | • 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 | From Baseline to Week 48 |
| Blip detectable | • Rate of participants with a blip | Baseline to Week 48 |
| mutation | • Emergence of resistance mutations at time of virological failure | Day 1 to Week 48 |
| immunology parameters | • Change of CD4 and CD8 cell count from BSL, | Baseline, to Week 24 and Week 48 |
| lipid parameters | • Evolution of lipid parameters | Baseline, Week 24, Week 48 |
| Renal parameters | Renal glomerular filtration, creatinine clearance | Baseline,Week 4,Week 12,Week 24 and Week 48 ; |
| pharmacology | • Plasma levels of antiretroviral drugs (TAF, FTC, BIC) | Baseline, Week 12, Week 24, Week 48 |
| Addherence | • Adherence to treatment: self-administered questionnaire | Baseline, Week 24 and Week 48 |
| Tolerance | • Tolerance to treatment: questionnaire | Week 4, Week 24 and Week 48 |
| Renal parameters (Urine) | urine albumin, urine creatinine, urine protein, beta-2-microglobulin and retinol binding protein | Baseline, Week 24, Week 48 |
| Hopital Hotel Dieu | Recruiting | Nantes | 44093 | France |
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| Hopital L'Archet | Recruiting | Nice | France |
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| Hôpital Hotel Dieu | Recruiting | Paris | 75004 | France |
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| Bichat Hospital | Recruiting | Paris | 75018 | France |
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| CH de Saint Nazaire | Active, not recruiting | Saint-Nazaire | France |
| Hopital Gustave Dron | Recruiting | Tourcoing | 59208 | France |
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| Hopital Bretonneau | Active, not recruiting | Tours | France |
| ID | Term |
|---|---|
| D015658 | HIV Infections |
| ID | Term |
|---|---|
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D007239 | Infections |
| D015229 | Sexually Transmitted Diseases, Viral |
| D012749 | Sexually Transmitted Diseases |
| D016180 | Lentivirus Infections |
| D012192 | Retroviridae Infections |
| D012327 | RNA Virus Infections |
| D014777 | Virus Diseases |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D007153 | Immunologic Deficiency Syndromes |
| D007154 | Immune System Diseases |
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| ID | Term |
|---|---|
| C000654125 | bictegravir, emtricitabine, tenofovir alafenamide, drug combination |
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