HIV InfectionsPhase 2BI-LIGHTNCT06338826
Study Evaluating the Safety, in Terms of HBV Virological Control At 96 Weeks, of 2 Antiviral Treatment Relief Strategies, in Patients Co-infected with the HIV-1 and HBV Viruses
A Phase 2 study testing TDF - 245mg or TAF -25mg associated to 3TC - 300mg or FTC - 200mg and a NNRTI or PI/r or INSTI and Dual therapy with 3TC in combination with DTG or ritonavir-boosted Darunavir (rDVR) in people with HIV Infections and HBV Coinfection, run by ANRS, Emerging Infectious Diseases.
Trial summary
The main objective of this study is to evaluate at 96 weeks the safety with respect to hepatitis B control of 2 treatment reduction strategies for patients with previously controlled HIV-HBV co-infection on continuous triple therapy Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- HIV Infections, HBV Coinfection
- What is being tested?
- TDF - 245mg or TAF -25mg associated to 3TC - 300mg or FTC - 200mg and a NNRTI or PI/r or INSTI and Dual therapy with 3TC in combination with DTG or ritonavir-boosted Darunavir (rDVR)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 140 participants
- Where
- No sites listed yet
- Study dates
- 1 Feb 2025to 30 Sep 2027
- Phase
- Phase 2
- 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
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- HIV-1-HBV co-infection (positive HIV-1 serology associated with 2 positive HBsAg serologies within more than 6 months);
- Age ≥ 18 years
- Fibroscan less than 6 months < 9kPa
- Current daily antiretroviral tritherapy not modified for ≥ 12 months must including tenofovir disoproxil fumarate (TDF) 245mg or tenofovir alafenamide fumarate (TAF -25mg) associated to lamivudine (3TC - 300mg) or emtricitabine (FTC - 200mg) and a NNRTI or PI/r or INSTI to choose from
- NNRTI = efavirenz, rilpivirine, etravirine, doravirine
- PI/r = atazanavir/r ou darunavir/r
Show all 16Show fewer
- INSTI = bictegravir, dolutegravir, elvitegravir/cobicistat, raltegravir;
- Absence of documented HBV and HIV genotypic resistance compromising virologic control of any of the maintenance strategies. Patients with no genotypic history may be included);
- HIV CV < 50cp/ml for ≥ 2 years (only 1 annual blip allowed if HIV CV < 200cp/ml and previous and subsequent viral loads are undetectable);
- HBV CV < 10 IU/ml for ≥ 2 years (only 1 annual blip allowed if HBV CV < 200IU/ml and if previous and subsequent viral loads are undetectable);
- Have ≥ 3 available measurements of HIV CV < 50cp/ml and HBV CV < 10 IU/mL over the past 24 months (including that of pre-inclusion);
- CD4 lymphocytes > 250/mm3 at pre-inclusion;
- ALT < 3N at pre-inclusion;
- For women of childbearing potential, negative pregnancy test and commitment to use effective contraception throughout the trial;
- Person affiliated with or benefiting from a social security system;
- Free, informed, written consent, signed by the person and the investigator at the latest on the day of inclusion and before any examination carried out as part of the study (article L1122-1-1 of the Public Health Code)
Who cannot join
- HIV-2 infection;
- HIV and/or HBV genotype not compatible with dual therapy DTG-3TC or DRVr-3TC;
- HBeAg+;
- Fibrosis history at stage F3-F4 in pre-therapy evaluated by PBH, fibrotest and/or fibroscan with a value of Elastometry ≥ 9kPa;
- Chronic active viral hepatitis C (HCV RNA positive);
- Delta co-infection;
Show all 12Show fewer
- Alcohol consumption > 14 units/week for women and 21 units/week for men;
- Current treatment with chemo- or immunotherapy (including interferon or interleukins);
- Active opportunistic infection or acute treatment for opportunistic infection;
- Any condition (drug use, neurological, neuropsychiatric, etc.) that, in the judgment of the investigator, may compromise patient compliance and adherence to the protocol;
- Pregnant or breastfeeding woman or refusal of contraception;
- Major incapacity, legal protection, guardianship or curatorship
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
Karine Amat contact
About this study
Official title: Interventional, Multicenter, Open-label, Randomized, Non-comparative Trial Evaluating the Safety, in Terms of HBV Virological Control At 96 Weeks, of 2 Antiviral Treatment Relief Strategies, in Patients Co-infected with the HIV-1 and HBV Viruses
The main objective of this study is to evaluate at 96 weeks the safety with respect to hepatitis B control of 2 treatment reduction strategies for patients with previously controlled HIV-HBV co-infection on continuous triple therapy
- Conditions
- HIV Infections, HBV Coinfection
- Being tested
- TDF - 245mg or TAF -25mg associated to 3TC - 300mg or FTC - 200mg and a NNRTI or PI/r or INSTI, Dual therapy with 3TC in combination with DTG or ritonavir-boosted Darunavir (rDVR)
- Medical subject headings
- HIV Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TDF - 245mg or TAF -25mg associated to 3TC - 300mg or FTC - 200mg and a NNRTI or PI/r or INSTIDrug
The study will include patients under current daily antiretroviral tritherapy not modified for ≥ 12 months must including tenofovir disoproxil fumarate (TDF) 245mg or tenofovir alafenamide fumarate (TAF -25mg) associated to lamivudine (3TC - 300mg) or emtricitabine (FTC - 200mg) and a NNRTI or PI/r or INSTI to choose from
- NNRTI = efavirenz, rilpivirine, etravirine, doravirine
- PI/r = atazanavir/r ou darunavir/r
- INSTI = bictegravir, dolutegravir, elvitegravir/cobicistat, raltegravir
Dual therapy with 3TC in combination with DTG or ritonavir-boosted Darunavir (rDVR)Drug
dual therapy without TDF or TAF but including 3TC in combination with Dolutegravir (DTG) or ritonavir-boosted Darunavir (rDVR
| Study group | Role | What they receive |
|---|---|---|
| Arm 1 | No intervention | - Arm 1 (reference arm): Continuation of continuous (7 days/week) triple antiviral therapy including TDF or TAF |
| Arm 2 (T4): | Experimental | - Arm 2 (T4): Relief from previous triple antiviral therapy (containing TDF or TAF) on 4 out of 7 consecutive days Receives: Drug: TDF - 245mg or TAF -25mg associated to 3TC - 300mg or FTC - 200mg and a NNRTI or PI/r or INSTI |
| Arm 3 (B7) | Experimental | Switch from prior triple antiviral therapy (containing TDF or TAF) to continuous dual therapy without TDF or TAF but including 3TC in combination with Dolutegravir (DTG) or ritonavir-boosted Darunavir (rDVR Receives: Drug: Dual therapy with 3TC in combination with DTG or ritonavir-boosted Darunavir (rDVR) |
What is being measured
The primary outcome is the main question the study is designed to answer.
The proportion of participants with HBV virological failure at 96 weeks.
HBV virologoical failure is defined by 2 successive varial load ≥ 10UI/ml
Measured: 96 weeks
Secondary outcomes (17)
• HBV virological success rate at 48 weeks
HBV virological success is defined by a viral load ≤10 UI/ml
Measured: at Week 48
• HIV virological success rate at 48 and 96 weeks
HIV virological success is defined by a viral load ≤ 50 cp/ml
Measured: At week 48 and week 96
• Time to virological failure (rebound HBV and/or HIV viral load)
Measured: between Week 0 and Week96
• The rate of participants with at least one HBV viral load blip until W48 and until W96
a blip is defined by a HBV viral load >10UI/mL followed by a control value ≤ 10UIml
Measured: At week 48 and week 96
• Selection of HBV resistance mutations at the time of virological failure
Measured: between Week 0 and Week 96
• Incidence of grade 3 or higher adverse events of grade 3 or higher, incidence of adverse events and incidence of strategy discontinuation of the strategy at W48 and W96
Measured: At week 48 and week 96
• Evolution of CD4 from W0 to W48 and W96
Measured: Week 0 to Week 48 and week 96
• Evolution of total cholesterol from W0 to W48 and W96
Measured: from Week 0 to Week 48 and Week 96
• Evaluation of the adherence by self-reported questionnaire
without analysis scale
Measured: at Week 0, Week 12, Week 24, Week 48, Week 72 and Week 96
• Evaluation of quality of life using the Pro-Qol self-questionnaire
without analysis scale
Measured: at Week 0, Week 12, Week 24, Week 48, Week 72 and Week 96
Evolution of CD8 T lymphocytes from W0 to W48 and W96
Measured: Week 0 to Week 48 and week 96
Evolution of the CD4/CD8 ratio from W0 to W48 and W96
Measured: Week 0 to Week 48 and week 96
Evolution of LDL-c from W0 to W48 and W96
Measured: from Week 0 to Week 48 and Week 96
Evolution of HDL-c from W0 to W48 and W96
Measured: from Week 0 to Week 48 and Week 96
Evolution of triglycerides from W0 to W48 and W96
Measured: from Week 0 to Week 48 and Week 96
Evolution of fasting blood sugar from W0 to W48 and W96
Measured: from Week 0 to Week 48 and Week 96
HBV virological success rate at 96 weeks between arms
HBV virological success is defined by a viral load ≤10 UI/ml
Measured: at Week 96
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Apr 2024
- Study start1 Feb 2025 (estimated)
- Primary completion30 Sep 2027 (estimated)
- Study completion30 Sep 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HIV InfectionsStudies 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Model description
- Interventional, sequential, Phase IIA equivalent, multicenter, open-label, randomized, non-comparative study evaluating, for 96 weeks, the safety in terms of HBV virological control of 2 antiviral therapy relief strategies, in HIV-1 and HBV co-infected patients with prolonged virological success (undetectable HIV-1 and HBV viral loads for ≥ 2 years) and on unmodified antiviral therapy for ≥ 1 year. Participants will be randomized 1:2:2 into 3 parallel arms: * Arm 1 (reference arm): Continuation of continuous (7 days/week) triple antiviral therapy including TDF or TAF * Arm 2 (T4): Relief from previous triple antiviral therapy (containing TDF or TAF) on 4 out of 7 consecutive days * Arm 3 (B7): Switch from prior triple antiviral therapy (containing TDF or TAF) to continuous dual therapy without TDF or TAF but including 3TC in combination with Dolutegravir (DTG) or ritonavir-boosted Darunavir (rDVR). The choice of dual therapy is left to the discretion of the investigator.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 140 participants (estimated)
Sponsor and investigators
- Lead sponsor
- ANRS, Emerging Infectious Diseases
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- Julie Bottero, Principal investigator, Bicetre Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06338826
- Sponsor's protocol ID
- ANRS0250s-BI-LIGHT
- Acronym
- BI-LIGHT
- Status last verified
- Jan 2025
- First submitted
- 27 Nov 2023
- Last updated
- 5 Feb 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
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
- Interventional, Multicenter, Open-label, Randomized, Non-comparative Trial Evaluating the Safety, in Terms of HBV Virological Control At 96 Weeks, of 2 Antiviral Treatment Relief Strategies, in Patients Co-infected with the HIV-1 and HBV Viruses
- ClinicalTrials.gov ID
- NCT06338826
- Acronym / sponsor ID
- BI-LIGHT / ANRS0250s-BI-LIGHT
- Conditions
- HIV Infections, HBV Coinfection
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 140 participants (estimated)
- Lead sponsor
- ANRS, Emerging Infectious DiseasesOther government
- Study start
- 1 Feb 2025 (estimated)
- Primary completion
- 30 Sep 2027 (estimated)
- Study completion
- 30 Sep 2027 (estimated)
- First posted
- 1 Apr 2024 (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 this study is to evaluate at 96 weeks the safety with respect to hepatitis B control of 2 treatment reduction strategies for patients with previously controlled HIV-HBV co-infection on continuous triple therapy
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Single blind (participant)
- Number of arms
- 3
- Model description
- Interventional, sequential, Phase IIA equivalent, multicenter, open-label, randomized, non-comparative study evaluating, for 96 weeks, the safety in terms of HBV virological control of 2 antiviral therapy relief strategies, in HIV-1 and HBV co-infected patients with prolonged virological success (undetectable HIV-1 and HBV viral loads for ≥ 2 years) and on unmodified antiviral therapy for ≥ 1 year. Participants will be randomized 1:2:2 into 3 parallel arms: * Arm 1 (reference arm): Continuation of continuous (7 days/week) triple antiviral therapy including TDF or TAF * Arm 2 (T4): Relief from previous triple antiviral therapy (containing TDF or TAF) on 4 out of 7 consecutive days * Arm 3 (B7): Switch from prior triple antiviral therapy (containing TDF or TAF) to continuous dual therapy without TDF or TAF but including 3TC in combination with Dolutegravir (DTG) or ritonavir-boosted Darunavir (rDVR). The choice of dual therapy is left to the discretion of the investigator.
| Arm | Type | Receives |
|---|---|---|
| Arm 1 | No intervention | –- Arm 1 (reference arm): Continuation of continuous (7 days/week) triple antiviral therapy including TDF or TAF |
| Arm 2 (T4): | Experimental | Drug: TDF - 245mg or TAF -25mg associated to 3TC - 300mg or FTC - 200mg and a NNRTI or PI/r or INSTI- Arm 2 (T4): Relief from previous triple antiviral therapy (containing TDF or TAF) on 4 out of 7 consecutive days |
| Arm 3 (B7) | Experimental | Drug: Dual therapy with 3TC in combination with DTG or ritonavir-boosted Darunavir (rDVR)Switch from prior triple antiviral therapy (containing TDF or TAF) to continuous dual therapy without TDF or TAF but including 3TC in combination with Dolutegravir (DTG) or ritonavir-boosted Darunavir (rDVR |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (16 listed)
- HIV-1-HBV co-infection (positive HIV-1 serology associated with 2 positive HBsAg serologies within more than 6 months);
- Age ≥ 18 years
- Fibroscan less than 6 months < 9kPa
- Current daily antiretroviral tritherapy not modified for ≥ 12 months must including tenofovir disoproxil fumarate (TDF) 245mg or tenofovir alafenamide fumarate (TAF -25mg) associated to lamivudine (3TC - 300mg) or emtricitabine (FTC - 200mg) and a NNRTI or PI/r or INSTI to choose from
- Absence of documented HBV and HIV genotypic resistance compromising virologic control of any of the maintenance strategies. Patients with no genotypic history may be included);
Key exclusion criteria (12 listed)
- HIV-2 infection;
- HIV and/or HBV genotype not compatible with dual therapy DTG-3TC or DRVr-3TC;
- HBeAg+;
- Fibrosis history at stage F3-F4 in pre-therapy evaluated by PBH, fibrotest and/or fibroscan with a value of Elastometry ≥ 9kPa;
- Chronic active viral hepatitis C (HCV RNA positive);
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 |
|---|---|---|
| TDF - 245mg or TAF -25mg associated to 3TC - 300mg or FTC - 200mg and a NNRTI or PI/r or INSTIThe study will include patients under current daily antiretroviral tritherapy not modified for ≥ 12 months must including tenofovir disoproxil fumarate (TDF) 245mg or tenofovir alafenamide fumarate (TAF -25mg) associated to lamivudine (3TC - 300mg) or emtricitabine (FTC - 200mg) and a NNRTI or PI/r or INSTI to choose from * NNRTI = efavirenz, rilpivirine, etravirine, doravirine * PI/r = atazanavir/r ou darunavir/r * INSTI = bictegravir, dolutegravir, elvitegravir/cobicistat, raltegravir | Drug | Arm 2 (T4): |
| Dual therapy with 3TC in combination with DTG or ritonavir-boosted Darunavir (rDVR)dual therapy without TDF or TAF but including 3TC in combination with Dolutegravir (DTG) or ritonavir-boosted Darunavir (rDVR | Drug | Arm 3 (B7) |
Primary outcome
The proportion of participants with HBV virological failure at 96 weeks.
Time frame: 96 weeks
HBV virologoical failure is defined by 2 successive varial load ≥ 10UI/ml
17 secondary outcomes
• HBV virological success rate at 48 weeks
Time frame: at Week 48
• HIV virological success rate at 48 and 96 weeks
Time frame: At week 48 and week 96
• Time to virological failure (rebound HBV and/or HIV viral load)
Time frame: between Week 0 and Week96
• The rate of participants with at least one HBV viral load blip until W48 and until W96
Time frame: At week 48 and week 96
• Selection of HBV resistance mutations at the time of virological failure
Time frame: between Week 0 and Week 96
• Incidence of grade 3 or higher adverse events of grade 3 or higher, incidence of adverse events and incidence of strategy discontinuation of the strategy at W48 and W96
Time frame: At week 48 and week 96
• Evolution of CD4 from W0 to W48 and W96
Time frame: Week 0 to Week 48 and week 96
• Evolution of total cholesterol from W0 to W48 and W96
Time frame: from Week 0 to Week 48 and Week 96
• Evaluation of the adherence by self-reported questionnaire
Time frame: at Week 0, Week 12, Week 24, Week 48, Week 72 and Week 96
• Evaluation of quality of life using the Pro-Qol self-questionnaire
Time frame: at Week 0, Week 12, Week 24, Week 48, Week 72 and Week 96
Evolution of CD8 T lymphocytes from W0 to W48 and W96
Time frame: Week 0 to Week 48 and week 96
Evolution of the CD4/CD8 ratio from W0 to W48 and W96
Time frame: Week 0 to Week 48 and week 96
Evolution of LDL-c from W0 to W48 and W96
Time frame: from Week 0 to Week 48 and Week 96
Evolution of HDL-c from W0 to W48 and W96
Time frame: from Week 0 to Week 48 and Week 96
Evolution of triglycerides from W0 to W48 and W96
Time frame: from Week 0 to Week 48 and Week 96
Evolution of fasting blood sugar from W0 to W48 and W96
Time frame: from Week 0 to Week 48 and Week 96
HBV virological success rate at 96 weeks between arms
Time frame: at Week 96
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.
- Individual participant dataSharing planned: Undecided
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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.
Karine Amat contact
Julie Bottero principal investigator
Bicetre Hospital
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing TDF - 245mg or TAF -25mg associated to 3TC - 300mg or FTC - 200mg and a NNRTI or PI/r or INSTI and Dual therapy with 3TC in combination with DTG or ritonavir-boosted Darunavir (rDVR) in people with HIV Infections and HBV Coinfection, run by ANRS, Emerging Infectious Diseases.
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 16 inclusion and 12 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.
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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 (0144236110 ext. +33, fatoumata.coulibaly@anrs.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The proportion of participants with HBV virological failure at 96 weeks. (time frame: 96 weeks). 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.