HIV-1-infectionNCT05222945
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
A study testing Biopsies and bloood samplings in people with HIV-1-infection, run by ANRS, Emerging Infectious Diseases at 6 sites in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- HIV-1-infection
- What is being tested?
- Biopsies and bloood samplings
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 34 participants
- Where
- 6 sitesFrance
- Study dates
- 1 Apr 2025to 31 Oct 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- 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.
Trial locations and contacts
6 sites in 1 country. Contact the study team or a site near you to ask about taking part.
6 sites in 1 country
France6 sites
Antoine-Beclere Hospita
Clamart
Sophie ABGRALL
Sophie ABGRALL
Bicetre Hospital
Le Kremlin-Bicêtre
Elina TEICHER
Antoine CHERET
Hotel Dieu Hospital
Paris
Dominique SALMON-CERON
Dominique SALMON-CERON
Necker Hospital
Paris
Claudine Duvivier
Claudine Duvivier
Pitie Salpetriere Hospital
Paris
Valérie MARTINEZ
Valérie MARTINEZ
Saint Antoine Hospital
Paris
Karine LACOMBE
Karine LACOMBE
About this study
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
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.
Read the 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)
- Conditions
- HIV-1-infection
- Being tested
- Biopsies and bloood samplings
- Keywords
- Viral cartography, Viral reservoir, Antiretroviral treatments diffusion
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Biopsies and bloood samplingsOther
blood samples, rectal biopsies, nodes biopsies, cutaneous fat tissues biopsies, semen sample
| Study group | Role | What they receive |
|---|---|---|
| Single arm composed by 34 HIV-1 infected male subjects | Other | Not described Receives: Other: Biopsies and bloood samplings |
What is being measured
The primary outcome is the main question the study is designed to answer.
Characterization of the diffusion of bictegravir and associated backbone (tenofovir alafenamide and emtricitabine) in sperm
Dosage of the different antiretroviral drugs molecules in sperm
Measured: 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
Measured: 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
Measured: 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
Measured: At Day 0, T1 (maximum 3 hours after taking treatment)
Secondary outcomes (5)
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.
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: At Day 0
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Feb 2022
- Study start1 Apr 2025 (estimated)
- Primary completion30 Oct 2025 (estimated)
- Study completion31 Oct 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HIV-1-infectionStudies of the same condition, open and under way.
- More trials run by ANRS, Emerging Infectious DiseasesThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 34 participants (estimated)
Sponsor and investigators
- Lead sponsor
- ANRS, Emerging Infectious Diseases
- Sponsor type
- Other government
- Collaborators
- Gilead Sciences
- Responsible party
- Sponsor
- Investigators
- Antoine CHERET, Pr, Principal investigator, Centre de Diagnostic et de Thérapeutique pluridisciplinaire CHU Pointe-à-Pitre/Abymes
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05222945
- Sponsor's protocol ID
- ANRS EP69 BICTEVOIR
- Status last verified
- Feb 2025
- First submitted
- 10 Jan 2022
- Last updated
- 5 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05222945
- Acronym / sponsor ID
- ANRS EP69 BICTEVOIR
- Conditions
- HIV-1-infection
- Keywords
- Viral cartography, Viral reservoir, Antiretroviral treatments diffusion
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 34 participants (estimated)
- Lead sponsor
- ANRS, Emerging Infectious DiseasesOther government
- Collaborators
- Gilead Sciences
- Study start
- 1 Apr 2025 (estimated)
- Primary completion
- 30 Oct 2025 (estimated)
- Study completion
- 31 Oct 2025 (estimated)
- First posted
- 3 Feb 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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)
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Single arm composed by 34 HIV-1 infected male subjects | Other | Other: Biopsies and bloood samplings |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Biopsies and bloood samplingsblood samples, rectal biopsies, nodes biopsies, cutaneous fat tissues biopsies, semen sample | Other | Single arm composed by 34 HIV-1 infected male subjects |
Primary outcome
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
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
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
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
5 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Feb 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Antoine CHERET, Pr principal investigator
Centre de Diagnostic et de Thérapeutique pluridisciplinaire CHU Pointe-à-Pitre/Abymes
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Biopsies and bloood samplings in people with HIV-1-infection, run by ANRS, Emerging Infectious Diseases at 6 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 5 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Fatoumata Coulibaly (+331 44 23 61 10, fatoumata.coulibay@inserm.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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)). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Feb 2025.