Informations générales (source: ClinicalTrials.gov)
Switch to Tenofovir Alafenamide (TAF), Emtricitabine (FTC), Bictegravir (BIC)(Biktarvy®) in HIV-1-infected Patients Over 65 Years Old at Risk of Polymedication (BICOLDER)
Interventional
Phase 4
Institut de Médecine et d'Epidémiologie Appliquée - Fondation Internationale Léon M'Ba (Voir sur ClinicalTrials)
août 2020
juin 2022
29 juin 2024
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.
Etablissements
| Les établissements d'Île-de-France dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données | |||||
|---|---|---|---|---|---|
| AP-HP - Hôpital Bichat | Valentina ISERNIA, MD | Contact (sur clinicalTrials) | |||
| AP-HP - Hôpital Hôtel-Dieu | Laurence WEISS | Contact (sur clinicalTrials) | |||
| Les établissements hors Île-de-France dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données | |||||
| CH de Saint Nazaire - Saint-Nazaire - France | Contact (sur clinicalTrials) | ||||
| Hopital Gustave Dron - 59208 - Tourcoing - France | FAIZA AJANA | Contact (sur clinicalTrials) | |||
| Hopital Hotel Dieu - 44093 - Nantes - France | CLOTILDE ALLAVENA | Contact (sur clinicalTrials) | |||
| Les établissements sans correspondance certaine dans le répertoire FINESS dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données | |||||
| Hopital Bretonneau - Tours - France | Contact (sur clinicalTrials) | ||||
| Hopital L'Archet - Nice - France | Alissa NAQVI | Contact (sur clinicalTrials) | |||
| Hopital Sainte Marguerite - 13009 - Marseille - France | ISABELLE POZOT MARTIN | Contact (sur clinicalTrials) | |||
Critères
Tous
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
- 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.