Clinical trial NCT04222283: Switch to TAF+FTC+BIC in HIV-1-infected Patients Over 65 Years Old at Risk of Polymedication
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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: HIV Infections
Lead sponsor: Institut de Médecine et d'Epidémiologie Appliquée - Fondation Internationale Léon M'Ba
Sponsor class: OTHER
Collaborators: name: Pierre and Marie Curie University
First posted: 2020-01-09
Enrollment: 27
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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

Eligibility 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.

Primary outcomes:
measure: Virological failure is defined by plasma HIV RNA > 50 cps/mL on 2 following samples at 2 to 4 weeks apart
timeFrame: Week 24
Secondary outcomes:
measure: Charlson and Fried Score
timeFrame: Day 1, Week 24 and Week 48
measure: DAD Score
timeFrame: Day 1,Week 24 and Week 48
measure: polymedication
timeFrame: Baseline, Week 24 and Week 48
measure: drug interactions
timeFrame: Baseline To Week 48
measure: • adverses events
timeFrame: Baseline To Week 48
measure: therapeutic success
timeFrame: Week 24 and Week 48
measure: Viral load detectable
timeFrame: From Baseline to Week 48
measure: Blip detectable
timeFrame: Baseline to Week 48
measure: mutation
timeFrame: Day 1 to Week 48
measure: immunology parameters
timeFrame: Baseline, to Week 24 and Week 48
measure: lipid parameters
timeFrame: Baseline, Week 24, Week 48
measure: Renal parameters
timeFrame: Baseline,Week 4,Week 12,Week 24 and Week 48 ;
measure: pharmacology
timeFrame: Baseline, Week 12, Week 24, Week 48
measure: Addherence
timeFrame: Baseline, Week 24 and Week 48
measure: Tolerance
timeFrame: Week 4, Week 24 and Week 48
measure: Renal parameters (Urine)
timeFrame: Baseline, Week 24, Week 48
Other outcomes:
Locations:
city: Marseille
country: France
facility: Hopital Sainte Marguerite
city: Nantes
country: France
facility: Hopital Hotel Dieu
city: Nice
country: France
facility: Hopital L'Archet
city: Paris
country: France
facility: Hôpital Hotel Dieu
city: Paris
country: France
facility: Bichat Hospital
city: Saint-Nazaire
country: France
facility: CH de Saint Nazaire
city: Tourcoing
country: France
facility: Hopital Gustave Dron
city: Tours
country: France
facility: Hopital Bretonneau
Study officials:
References: