Switch to Tenofovir Alafenamide (TAF), Emtricitabine (FTC), Bictegravir (BIC)(Biktarvy®) in HIV-1-infected Patients Over 65 Years Old at Risk of Polymedication
试验速览
- 阶段
- 4 期
- 发起方
- 入组人数
- 27
- 试验地点
- 8
- 主要终点
- Virological failure is defined by plasma HIV RNA > 50 cps/mL on 2 following samples at 2 to 4 weeks apart
研究概览
简要总结
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.
详细描述
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
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 65 Years 至 —（Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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.
研究组 & 干预措施
open label, multicentric, non randomized
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.
干预措施: BIKTARVY 50Mg-200Mg-25Mg Tablet (Drug)
结局指标
主要结局
Virological failure is defined by plasma HIV RNA > 50 cps/mL on 2 following samples at 2 to 4 weeks apart
时间窗: Week 24
The primary outcome is the proportion of patients with virological failure at Week 24.
次要结局
- Renal parameters (Urine)(Baseline, Week 24, Week 48)
- Charlson and Fried Score(Day 1, Week 24 and Week 48)
- drug interactions(Baseline To Week 48)
- DAD Score(Day 1,Week 24 and Week 48)
- polymedication(Baseline, Week 24 and Week 48)
- therapeutic success(Week 24 and Week 48)
- Blip detectable(Baseline to Week 48)
- immunology parameters(Baseline, to Week 24 and Week 48)
- • adverses events(Baseline To Week 48)
- Viral load detectable(From Baseline to Week 48)
- lipid parameters(Baseline, Week 24, Week 48)
- Renal parameters(Baseline,Week 4,Week 12,Week 24 and Week 48 ;)
- pharmacology(Baseline, Week 12, Week 24, Week 48)
- mutation(Day 1 to Week 48)
- Addherence(Baseline, Week 24 and Week 48)
- Tolerance(Week 4, Week 24 and Week 48)