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Not yet recruiting 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

No phase Interventional HIV-1-infection

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Biopsies and bloood samplings.
Who it may be relevant to
Registry conditions: HIV-1-infection. Basic parameters: from 18 years · Male.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
France
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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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

Overview

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.

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)

Interventions

  • Other Biopsies and bloood samplings
    blood samples, rectal biopsies, nodes biopsies, cutaneous fat tissues biopsies, semen sample

Primary outcome measures

  • 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)]
  • 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)]
  • 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)]
  • 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)]
Secondary outcome measures (5)
  • Characterization of the level of the replication (RNA-HIV) in the reservoirs [Time frame: At Day 0]
  • Characterization of the level of infection (DNA-HIV) in the reservoirs [Time frame: At Day 0]
  • Study of the spatial dynamics of viral quasi-species In the different reservoirs [Time frame: At Day 0]
  • Study of the mutations of resistance in the integrase gene [Time frame: At Day 0]
  • Description for each compartment of the relationship between exposure to therapeutic combinations and the level of infection / viral replication [Time frame: At Day 0]

Eligibility 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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Basic science

Study locations

France · 6 centers
  • Antoine-Beclere Hospita — Clamart
  • Bicetre Hospital — Le Kremlin-Bicêtre
  • Hotel Dieu Hospital — Paris
  • Necker Hospital — Paris
  • Pitie Salpetriere Hospital — Paris
  • Saint Antoine Hospital — Paris

Identifiers

NCT: NCT05222945 · ANRS EP69 BICTEVOIR

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗