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A 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

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ClinicalTrials.gov Identifier: NCT05222945
Recruitment Status : Not yet recruiting
First Posted : February 3, 2022
Last Update Posted : February 3, 2022
Sponsor:
Collaborator:
Gilead Sciences
Information provided by (Responsible Party):
ANRS, Emerging Infectious Diseases

Study Description
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Brief Summary:
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.

Condition or disease Intervention/treatment Phase
HIV-1-infection Other: Biopsies and bloood samplings Not Applicable

Detailed Description:

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 Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 34 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: 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
Estimated Study Start Date : February 1, 2022
Estimated Primary Completion Date : March 1, 2023
Estimated Study Completion Date : March 1, 2024

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS

Arms and Interventions
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Arm Intervention/treatment
Single arm composed by 34 HIV-1 infected male subjects Other: Biopsies and bloood samplings
blood samples, rectal biopsies, nodes biopsies, cutaneous fat tissues biopsies, semen sample


Outcome Measures
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Primary Outcome Measures :
  1. Characterization of the diffusion of bictegravir and associated backbone (tenofovir alafenamide and emtricitabine) in sperm [ Time Frame: At Day 0, At time T0 (before taking treatments) ]
    Dosage of the different antiretroviral drugs molecules in sperm

  2. Characterization of the diffusion of bictegravir and associated backbone (tenofovir alafenamide and emtricitabine) in lymph nodes [ Time Frame: 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

  3. Characterization of the diffusion of bictegravir and associated backbone (tenofovir alafenamide and emtricitabine) in fat tissues [ Time Frame: 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

  4. Characterization of the diffusion of bictegravir and associated backbone (tenofovir alafenamide and emtricitabine) in rectal tissues [ Time Frame: At Day 0, T1 (maximum 3 hours after taking treatment) ]
    Dosage of the different antiretroviral drugs molecules in rectal tissues


Secondary Outcome Measures :
  1. Characterization of the level of the replication (RNA-HIV) in the reservoirs [ Time Frame: At Day 0 ]
    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.

  2. Characterization of the level of infection (DNA-HIV) in the reservoirs [ Time Frame: At Day 0 ]
    Analyze and comparison of the reservoir level by measuring the cell-associated total HIV- DNA in the different tissues and fluids

  3. Study of the spatial dynamics of viral quasi-species In the different reservoirs [ Time Frame: At Day 0 ]
    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

  4. Study of the mutations of resistance in the integrase gene [ Time Frame: At Day 0 ]
    Description of resistance mutations in Integrase gene which could be linked to suboptimal concentrations of bictegravir

  5. Description for each compartment of the relationship between exposure to therapeutic combinations and the level of infection / viral replication [ Time Frame: At Day 0 ]
    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


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Gender Based Eligibility:   Yes
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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)

Exclusion Criteria:

  • 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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05222945


Contacts
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Contact: Laura NAILLER +33 153 94 80 64 laura.nailler@anrs.fr

Locations
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France
Antoine-Beclere Hospita
Clamart, France
Contact: Sophie ABGRALL         
Principal Investigator: Sophie ABGRALL         
Bicetre Hospital
Le Kremlin-Bicêtre, France
Contact: Antoine CHERET         
Principal Investigator: Antoine CHERET         
Hotel Dieu Hospital
Paris, France
Contact: Dominique SALMON-CERON         
Principal Investigator: Dominique SALMON-CERON         
Necker Hospital
Paris, France
Contact: Claudine Duvivier         
Principal Investigator: Claudine Duvivier         
Pitie Salpetriere Hospital
Paris, France
Contact: Valérie MARTINEZ         
Principal Investigator: Valérie MARTINEZ         
Saint Antoine Hospital
Paris, France
Contact: Karine LACOMBE         
Principal Investigator: Karine LACOMBE         
Sponsors and Collaborators
ANRS, Emerging Infectious Diseases
Gilead Sciences
Investigators
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Principal Investigator: Antoine CHERET Bicetre Hospital
More Information
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Responsible Party: ANRS, Emerging Infectious Diseases
ClinicalTrials.gov Identifier: NCT05222945    
Other Study ID Numbers: ANRS EP69 BICTEVOIR
First Posted: February 3, 2022    Key Record Dates
Last Update Posted: February 3, 2022
Last Verified: January 2022

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by ANRS, Emerging Infectious Diseases:
Viral cartography
Viral reservoir
Antiretroviral treatments diffusion