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NCT Number: NCT05222945

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

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.

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Key information

Conditions

HIV-1-infection

Age range

18 year and older

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

Antoine-Beclere Hospita, Clamart, France

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About this study

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)

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Biopsies and bloood samplings

Other

blood samples, rectal biopsies, nodes biopsies, cutaneous fat tissues biopsies, semen sample

Primary outcomes

  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 outcomes

  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

Study contacts

Contact information is provided by the study sponsor or research team.

Fatoumata Coulibaly

CONTACT

[email protected]

+331 44 23 61 10

Sophie LETROU

CONTACT

[email protected]

+331 40 25 65 81

Sponsors and collaborators

Lead sponsor

ANRS, Emerging Infectious Diseases

Other Gov

Collaborators

  • Gilead Sciences

Registry information

Official study 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

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Feb 3, 2022
Registry last updated
Feb 5, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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