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.
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)
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
BASIC_SCIENCE
Masking
NONE
Enrollment
34
blood samples, rectal biopsies, nodes biopsies, cutaneous fat tissues biopsies, semen sample
Antoine-Beclere Hospita
Clamart, France
Bicetre Hospital
Le Kremlin-Bicêtre, France
Hotel Dieu Hospital
Paris, France
Necker Hospital
Paris, France
Pitie Salpetriere Hospital
Characterization of the diffusion of bictegravir and associated backbone (tenofovir alafenamide and emtricitabine) in sperm
Dosage of the different antiretroviral drugs molecules in sperm
Time frame: At Day 0, At time T0 (before taking treatments)
Characterization of the diffusion of bictegravir and associated backbone (tenofovir alafenamide and emtricitabine) in lymph nodes
Dosage of the different antiretroviral drugs molecules in lymph nodes
Time frame: At Day 0, between T1 (maximum 3 hours after tacking treatments) and T3 (8 hours after taking treatments)
Characterization of the diffusion of bictegravir and associated backbone (tenofovir alafenamide and emtricitabine) in fat tissues
Dosage of the different antiretroviral drugs molecules in fat tissues
Time frame: At Day 0, between T1 (maximum 3 hours after tacking treatments) and T3 (8 hours after taking treatments)
Characterization of the diffusion of bictegravir and associated backbone (tenofovir alafenamide and emtricitabine) in rectal tissues
Dosage of the different antiretroviral drugs molecules in rectal tissues
Time frame: At Day 0, T1 (maximum 3 hours after taking treatment)
Characterization of the level of the replication (RNA-HIV) in the reservoirs
Analyze and comparison of the level of viral transcription by measuring the cell-associated HIV- RNA in the different tissues and fluids: lymphoid, rectal, genital secretion, blood and fat biopsies as well as cerebrospinal fluid.
Time frame: At Day 0
Characterization of the level of infection (DNA-HIV) in the reservoirs
Analyze and comparison of the reservoir level by measuring the cell-associated total HIV- DNA in the different tissues and fluids
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Paris, France
Saint Antoine Hospital
Paris, France
Time frame: At Day 0
Study of the spatial dynamics of viral quasi-species In the different reservoirs
Analyze of the spatial dynamics of HIV-DNA and HIV-RNA from Lymphoid, rectal, genital secretion, blood, fat cells by phylogenetic analyses after sequencing Env HIV-DNA and HIV-RNA
Time frame: At Day 0
Study of the mutations of resistance in the integrase gene
Description of resistance mutations in Integrase gene which could be linked to suboptimal concentrations of bictegravir
Time frame: At Day 0
Description for each compartment of the relationship between exposure to therapeutic combinations and the level of infection / viral replication
Characterization of the relationship between the concentration of bictegravir and backbone drugs with the level of wild type viral replication in the different compartments. Analyze of the impact of backbone drugs associated to bictegravir on viral level production. Correlation between the level of resistant virus replication and the exposure to bictegravir and the backbone drugs. Evaluation by simulation the effect of different dosing regimen of bictegravir (including higher doses) on the level of viral replication and on resistance
Time frame: At Day 0