ANRS EP69 BICTEVOIR : a Prospective Study to Determine the Cartography of Virologic Reservoir Related to Antiretroviral Concentrations in HIV-1 Chronic Patients Treated by a First Line Treatment Containing Bictégravir, Emtricitabine and Ténofovir Alafénamide
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 34
- 试验地点
- 6
- 主要终点
- Characterization of the diffusion of bictegravir and associated backbone (tenofovir alafenamide and emtricitabine) in sperm
研究概览
简要总结
The main objective of the study is to evaluate the diffusion of bictegravir and associated backbone (tenofovir alafenamide and emtricitabine) in HIV-1 chronic patients in the main putative reservoirs, namely inguinal lymph nodes, rectal, fat tissues and sperm.
详细描述
ANRS EP69 BICTEVOIR is an interventional pilot study, multicenter, involving the use of human biological samples.
34 HIV-1 infected male subjects, from Bicetre, La Pitié Salpêtriere, Antoine-Béclère, Necker, Hôtel-Dieu and Saint-Antoine Hospitals will be recruited.
Different samples will be performed during one single day:
- blood samples
- rectal biopsies
- nodes biopsies
- cutaneous fat tissues biopsies
- semen sample (at home)
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Male HIV-1 infected subjects
- •Age > or = 18 years old
- •Currently receiving as first line a stable ARV regimen containing bictegravir (at 50 mg once a day) and two nucleoside reverse transcriptase inhibitors, tenofovir alafenamide/emtricitabine (Biktarvy)
- •HIV RNA <50 Cp/mL, undetectable 6 months after treatment initiation and confirmed and 12 months after treatment initiation.
- •Normal laboratory value of TP and TCA and platelets numbers at screening
- •Written and informed consent signed by the person and the investigator (no later than the day of pre-inclusion and prior to any examination realized in the frame of the research / study / trial) (article L1122-1-1 of the Public Health Code)
- •Person affiliated or beneficiary of a social security scheme (article L1121-11 of the Public Health Code) (State Medical Aid or AME is not a social security scheme)
排除标准
- •Single HIV-2 infection
- •Biopsies contraindication, taking anticoagulant and antiplatelet drugs are not allowed
- •Haemophilia
- •Symptomatic sexually transmitted infection
- •Being under guardianship or trusteeship mandate for future protection
- •Participate to another research involving human person, categories 1 or 2,
- •Associated treatments : carbamazepine, oxcarbazepine, phenytoin, phenobarbital, rifampicin, St. John's Wort.
结局指标
主要结局
Characterization of the diffusion of bictegravir and associated backbone (tenofovir alafenamide and emtricitabine) in sperm
时间窗: At Day 0, At time T0 (before taking treatments)
Dosage of the different antiretroviral drugs molecules in sperm
Characterization of the diffusion of bictegravir and associated backbone (tenofovir alafenamide and emtricitabine) in fat tissues
时间窗: At Day 0, between T1 (maximum 3 hours after tacking treatments) and T3 (8 hours after taking treatments)
Dosage of the different antiretroviral drugs molecules in fat tissues
Characterization of the diffusion of bictegravir and associated backbone (tenofovir alafenamide and emtricitabine) in lymph nodes
时间窗: At Day 0, between T1 (maximum 3 hours after tacking treatments) and T3 (8 hours after taking treatments)
Dosage of the different antiretroviral drugs molecules in lymph nodes
Characterization of the diffusion of bictegravir and associated backbone (tenofovir alafenamide and emtricitabine) in rectal tissues
时间窗: At Day 0, T1 (maximum 3 hours after taking treatment)
Dosage of the different antiretroviral drugs molecules in rectal tissues
次要结局
- Description for each compartment of the relationship between exposure to therapeutic combinations and the level of infection / viral replication(At Day 0)
- Characterization of the level of infection (DNA-HIV) in the reservoirs(At Day 0)
- Characterization of the level of the replication (RNA-HIV) in the reservoirs(At Day 0)
- Study of the spatial dynamics of viral quasi-species In the different reservoirs(At Day 0)
- Study of the mutations of resistance in the integrase gene(At Day 0)