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NCT Number: NCT06338826

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

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

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Key information

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • 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
  • 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)

Exclusion criteria

  • 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;
  • 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

Treatment and study plan

TDF - 245mg or TAF -25mg associated to 3TC - 300mg or FTC - 200mg and a NNRTI or PI/r or INSTI

Drug

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

Primary outcomes

  1. 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

Secondary outcomes

  1. • HBV virological success rate at 48 weeks

    Time frame: at Week 48

    HBV virological success is defined by a viral load ≤10 UI/ml

  2. • HIV virological success rate at 48 and 96 weeks

    Time frame: At week 48 and week 96

    HIV virological success is defined by a viral load ≤ 50 cp/ml

  3. • Time to virological failure (rebound HBV and/or HIV viral load)

    Time frame: between Week 0 and Week96

  4. • 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

    a blip is defined by a HBV viral load >10UI/mL followed by a control value ≤ 10UIml

  5. • Selection of HBV resistance mutations at the time of virological failure

    Time frame: between Week 0 and Week 96

  6. • 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

  7. • Evolution of CD4 from W0 to W48 and W96

    Time frame: Week 0 to Week 48 and week 96

  8. • Evolution of total cholesterol from W0 to W48 and W96

    Time frame: from Week 0 to Week 48 and Week 96

  9. • Evaluation of the adherence by self-reported questionnaire

    Time frame: at Week 0, Week 12, Week 24, Week 48, Week 72 and Week 96

    without analysis scale

  10. • 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

    without analysis scale

  11. Evolution of CD8 T lymphocytes from W0 to W48 and W96

    Time frame: Week 0 to Week 48 and week 96

  12. Evolution of the CD4/CD8 ratio from W0 to W48 and W96

    Time frame: Week 0 to Week 48 and week 96

  13. Evolution of LDL-c from W0 to W48 and W96

    Time frame: from Week 0 to Week 48 and Week 96

  14. Evolution of HDL-c from W0 to W48 and W96

    Time frame: from Week 0 to Week 48 and Week 96

  15. Evolution of triglycerides from W0 to W48 and W96

    Time frame: from Week 0 to Week 48 and Week 96

  16. Evolution of fasting blood sugar from W0 to W48 and W96

    Time frame: from Week 0 to Week 48 and Week 96

  17. HBV virological success rate at 96 weeks between arms

    Time frame: at Week 96

    HBV virological success is defined by a viral load ≤10 UI/ml

Study contacts

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

Fatoumata COULIBALY

CONTACT

[email protected]

0144236110 ext. +33

Karine Amat

CONTACT

[email protected]

Sponsors and collaborators

Lead sponsor

ANRS, Emerging Infectious Diseases

Other Gov

Registry information

Official study 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

Acronym: BI-LIGHT

Important dates

Study start
2025
Primary completion
2027
Study completion
2027
First posted
Apr 1, 2024
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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