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

HIV Infections Clinical Trial

— BICOLDER  

Official title:

Switch to Tenofovir Alafenamide (TAF), Emtricitabine (FTC), Bictegravir (BIC)(Biktarvy®) in HIV-1-infected Patients Over 65 Years Old at Risk of Polymedication

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04222283
• Other study ID #: IMEA 057
• Status: Recruiting
• Phase: Phase 4
• Start date: August 17, 2020
• Est. completion date: June 30, 2022

Study information

• Verified date: June 2022
• Source: Institut de Médecine et d'Epidémiologie Appliquée - Fondation Internationale Léon M'Ba
• Contact: Aïda BENALYCHERIF
• Phone: 40256365
• Email: aida.benalycherif[@]fondation-imea.org
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Recruiting
• Enrollment: 27
• Est. completion date: June 30, 2022
• Est. primary completion date: December 20, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 65 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• HIV Infections

Intervention

Drug:
• BIKTARVY 50Mg-200Mg-25Mg Tablet
At BSL all the participants will be switched from a booster containing regimen (ritonavir or cobicistat) to TAF/FTC/BIC (BIKTARVY).

Locations

Country	Name	City	State
France	Hopital Sainte Marguerite	Marseille
France	Hopital Hotel Dieu	Nantes
France	Hopital L'Archet	Nice
France	Bichat Hospital	Paris
France	Hôpital Hotel Dieu	Paris
France	CH de Saint Nazaire	Saint-Nazaire
France	Hopital Gustave Dron	Tourcoing
France	Hopital Bretonneau	Tours

Sponsors (2)

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

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Secondary	Charlson and Fried Score	• Assessment of co morbidities and frailty	Day 1, Week 24 and Week 48
Secondary	DAD Score	• Assessment of cardio vascular risk	Day 1,Week 24 and Week 48
Secondary	polymedication	• Assessment of polymedication and potential drug-drug interactions	Baseline, Week 24 and Week 48
Secondary	drug interactions	• Change of drug-drug interactions	Baseline To Week 48
Secondary	• adverses events	Rate of participants withdrawn from the study for grade 3 or 4 adverse event	Baseline To Week 48
Secondary	therapeutic success	• Rate of therapeutic success	Week 24 and Week 48
Secondary	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
Secondary	Blip detectable	• Rate of participants with a blip	Baseline to Week 48
Secondary	mutation	• Emergence of resistance mutations at time of virological failure	Day 1 to Week 48
Secondary	immunology parameters	• Change of CD4 and CD8 cell count from BSL,	Baseline, to Week 24 and Week 48
Secondary	lipid parameters	• Evolution of lipid parameters	Baseline, Week 24, Week 48
Secondary	Renal parameters	Renal glomerular filtration, creatinine clearance	Baseline,Week 4,Week 12,Week 24 and Week 48 ;
Secondary	pharmacology	• Plasma levels of antiretroviral drugs (TAF, FTC, BIC)	Baseline, Week 12, Week 24, Week 48
Secondary	Addherence	• Adherence to treatment: self-administered questionnaire	Baseline, Week 24 and Week 48
Secondary	Tolerance	• Tolerance to treatment: questionnaire	Week 4, Week 24 and Week 48
Secondary	Renal parameters (Urine)	urine albumin, urine creatinine, urine protein, beta-2-microglobulin and retinol binding protein	Baseline, Week 24, Week 48