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Report for Clinical Trial NCT04222283

Developed by Shray Alag, 2020.
SNP Clinical Trial Gene

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

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.

NCT04222283 HIV Infections
MeSH:HIV Infections

1 Interventions

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

Description: At BSL all the participants will be switched from a booster containing regimen (ritonavir or cobicistat) to TAF/FTC/BIC (BIKTARVY).
Type: Drug
Group Labels: 1

open label, multicentric, non randomized


Primary Outcomes

Description: The primary outcome is the proportion of patients with virological failure at Week 24.

Measure: Virological failure is defined by plasma HIV RNA > 50 cps/mL on 2 following samples at 2 to 4 weeks apart

Time: Week 24

Secondary Outcomes

Description: • Assessment of co morbidities and frailty

Measure: Charlson and Fried Score

Time: Day 1, Week 24 and Week 48

Description: • Assessment of cardio vascular risk

Measure: DAD Score

Time: Day 1,Week 24 and Week 48

Description: • Assessment of polymedication and potential drug-drug interactions

Measure: polymedication

Time: Baseline, Week 24 and Week 48

Description: • Change of drug-drug interactions

Measure: drug interactions

Time: Baseline To Week 48

Description: Rate of participants withdrawn from the study for grade 3 or 4 adverse event

Measure: • adverses events

Time: Baseline To Week 48

Description: • Rate of therapeutic success

Measure: therapeutic success

Time: Week 24 and Week 48

Description: • 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

Measure: Viral load detectable

Time: From Baseline to Week 48

Description: • Rate of participants with a blip

Measure: Blip detectable

Time: Baseline to Week 48

Description: • Emergence of resistance mutations at time of virological failure

Measure: mutation

Time: Day 1 to Week 48

Description: • Change of CD4 and CD8 cell count from BSL,

Measure: immunology parameters

Time: Baseline, to Week 24 and Week 48

Description: • Evolution of lipid parameters

Measure: lipid parameters

Time: Baseline, Week 24, Week 48

Description: Renal glomerular filtration, creatinine clearance

Measure: Renal parameters

Time: Baseline,Week 4,Week 12,Week 24 and Week 48 ;

Description: • Plasma levels of antiretroviral drugs (TAF, FTC, BIC)

Measure: pharmacology

Time: Baseline, Week 12, Week 24, Week 48

Description: • Adherence to treatment: self-administered questionnaire

Measure: Addherence

Time: Baseline, Week 24 and Week 48

Description: • Tolerance to treatment: questionnaire

Measure: Tolerance

Time: Week 4, Week 24 and Week 48

Description: urine albumin, urine creatinine, urine protein, beta-2-microglobulin and retinol binding protein

Measure: Renal parameters (Urine)

Time: Baseline, Week 24, Week 48

Purpose: Treatment

Allocation: N/A

Single Group Assignment


There is one SNP

SNPs


1 M184V

The reverse transcriptase resistant mutations M184V plus one TAM are allowed. --- M184V ---

- 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. --- M184V ---



HPO Nodes