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

NCT04222283 | Unknown Phase 4

• 1 other identifier: IMEA 057
• Study Type: interventional
• Target: 27
• Locations: 1 country
• Sites: 8

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.

Conditions

HIV Infections

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (16)

• Charlson and Fried Score

  Day 1, Week 24 and Week 48

• DAD Score

  Day 1,Week 24 and Week 48

• polymedication

  Baseline, Week 24 and Week 48

• drug interactions

  Baseline To Week 48

• • adverses events

  Baseline To Week 48

Study Arms (1)

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.

Drug: BIKTARVY 50Mg-200Mg-25Mg Tablet

Interventions

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).

open label, multicentric, non randomized

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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 under judicial protection due to temporarily and slightly diminished mental or physical faculties or under legal guardianship.

Sponsors & Collaborators

• Institut de Médecine et d'Epidémiologie Appliquée - Fondation Internationale Léon M'Ba: lead
• Pierre and Marie Curie University: collaborator

Study Sites (8)

Hopital Sainte Marguerite

Marseille, 13009, France

RECRUITING

Hopital Hotel Dieu

Nantes, 44093, France

RECRUITING

Hopital L'Archet

Nice, France

RECRUITING

Hôpital Hotel Dieu

Paris, 75004, France

RECRUITING

Bichat Hospital

Paris, 75018, France

RECRUITING

CH de Saint Nazaire

Saint-Nazaire, France

ACTIVE NOT RECRUITING

Hopital Gustave Dron

Tourcoing, 59208, France

RECRUITING

Hopital Bretonneau

Tours, France

ACTIVE NOT RECRUITING

MeSH Terms

Conditions

HIV Infections

Interventions

bictegravir, emtricitabine, tenofovir alafenamide, drug combination

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases

Central Study Contacts

Aïda BENALYCHERIF

CONTACT

40256365; aida.benalycherif@fondation-imea.org

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 5, 2019
• First Posted: January 9, 2020
• Study Start: August 17, 2020
• Primary Completion: December 20, 2021
• Study Completion: June 30, 2022
• Last Updated: June 10, 2022

Record last verified: 2022-06

Data Sharing

• IPD Sharing: Will not share

Locations

FR (8)