Switch to TAF+FTC+BIC in HIV-1-infected Patients Over 65 Years Old at Risk of Polymedication

• Status: Unknown status
• Trial end date: 2021-06-30
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Institut de Médecine et d'Epidémiologie Appliquée - Fondation Internationale Léon M'Ba
• Collaborator: Pierre and Marie Curie University
• Treatments: Emtricitabine

Criteria

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.