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Study on Reducing HIV-HBV Treatment with Darunavir, Ritonavir, and Lamivudine for Patients with Controlled Co-Infection

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What is this trial about?

A plain-language summary of the goals, design and what participants do

This clinical trial is focused on studying patients who are co-infected with both the HIV-1 and Hepatitis B viruses. The study aims to evaluate the safety of two different strategies for reducing antiviral treatment in these patients. The medications involved in this study include PREZISTA (darunavir), Norvir (ritonavir), Tivicay (dolutegravir sodium), and Epivir (lamivudine). These medications are used to manage the viral infections and are administered in various forms such as film-coated tablets and oral suspension.

The purpose of the study is to assess the safety of reducing treatment while maintaining control over the Hepatitis B virus in patients who have previously been on continuous triple therapy for their co-infection. The study will last for 96 weeks, during which participants will be monitored to ensure that the viral infections remain under control. Participants will receive either a combination of darunavir boosted with ritonavir and lamivudine, or a combination of dolutegravir sodium and lamivudine. The study will also include a group receiving a placebo for comparison.

Throughout the study, participants will have regular check-ups to monitor their health and the effectiveness of the treatment strategies. The main focus will be on ensuring that the Hepatitis B virus remains controlled, while also observing the impact on the HIV-1 virus. The study will also look at the participants' quality of life and any side effects they may experience. This research is important for understanding how to safely reduce medication in patients with these co-infections while maintaining their health.

The research process

The trial runs in 7 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Joining the trial

    Upon joining the trial, eligibility is confirmed based on specific criteria, including co-infection with HIV-1 and HBV, stable health conditions, and previous treatment history.

    A signed consent form is required before participation.

  2. Step 2

    Initial assessment

    An initial assessment is conducted to establish baseline health metrics, including viral load measurements and CD4 lymphocyte counts.

    This assessment helps in monitoring progress throughout the trial.

  3. Step 3

    Medication regimen

    Participants receive a combination of medications: PREZISTA (darunavir) 800 mg, Norvir (ritonavir) 100 mg, Tivicay (dolutegravir sodium) 50 mg, and Epivir (lamivudine) 300 mg.

    All medications are taken orally as film-coated tablets or oral suspension, as prescribed by the trial protocol.

  4. Step 4

    Ongoing monitoring

    Regular monitoring occurs at specified intervals: weeks 0, 12, 24, 48, 72, and 96.

    This includes viral load tests, CD4 and CD8 T lymphocyte counts, and metabolic parameter evaluations.

  5. Step 5

    Self-assessment

    Participants complete self-questionnaires to assess treatment compliance and quality of life at specified intervals.

    These assessments help in understanding the personal impact of the treatment.

  6. Step 6

    Evaluation of outcomes

    The primary outcome is evaluated at 96 weeks, focusing on the control of HBV viral load.

    Secondary outcomes include success rates at 48 weeks, time to virological failure, and incidence of adverse events.

  7. Step 7

    Completion of trial

    The trial concludes with a final assessment to determine the overall effectiveness and safety of the treatment strategies.

    Participants receive feedback on their health status and any necessary follow-up care.

Who can join the trial?

13 criteria

  • Must be co-infected with the HIV-1 and HBV viruses. This means having positive test results for both HIV-1 and HBV for more than 6 months.
  • ALT levels must be less than 3 times the normal value at the start of the study. ALT is a liver enzyme that is measured in blood tests.
  • Women who can have children must have a negative pregnancy test and agree to use effective birth control during the study.
  • Must be affiliated with or benefiting from a social security system.
  • Must provide free, informed, written consent, signed by both the participant and the investigator before any study-related procedures.
  • Must be 18 years of age or older.
  • A Fibroscan test done in the last 6 months must show a result of less than 9 kPa. A Fibroscan is a test that checks liver stiffness.
  • Must be on a stable daily antiretroviral therapy for at least 12 months, including specific medications like tenofovir, lamivudine, or emtricitabine, and one of the following types of drugs: NNRTI, PI/r, or INSTI.
  • No documented resistance to HBV and HIV treatments that would affect the study's treatment strategies. Patients without a genotypic history can be included.
  • HIV viral load must be less than 50 copies per milliliter for at least 2 years, with only one annual increase allowed if it stays below 200 copies per milliliter and previous and next tests are undetectable.
  • HBV viral load must be less than 10 IU per milliliter for at least 2 years, with only one annual increase allowed if it stays below 200 IU per milliliter and previous and next tests are undetectable.
  • Must have at least 3 available measurements of HIV viral load less than 50 copies per milliliter and HBV viral load less than 10 IU per milliliter over the past 24 months, including the pre-inclusion measurement.
  • CD4 lymphocytes must be greater than 250 per cubic millimeter at the start of the study. CD4 lymphocytes are a type of white blood cell important for the immune system.

Who cannot join the trial?

1 criterion

  • Patients who are not co-infected with both the HIV-1 and HBV viruses cannot participate. Co-infected means having both infections at the same time. HIV-1 is a virus that affects the immune system, and HBV is a virus that affects the liver.
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Investigated drugs

  • Antiviral Treatment Strategy 1

    is a therapy being tested in the trial to see how well it controls hepatitis B virus (HBV) in patients who are also infected with the human immunodeficiency virus (HIV-1). This strategy involves reducing the number of antiviral medications that patients take, while still keeping the virus under control. The goal is to maintain the health of the liver and prevent the HBV from becoming active again.

  • Antiviral Treatment Strategy 2

    is another approach being evaluated in the trial. Like the first strategy, it aims to reduce the number of antiviral drugs used by patients who have both HIV-1 and HBV. The focus is on ensuring that the HBV remains controlled, even with fewer medications, to protect the liver and overall health of the patients.

What is already known about the treatment

Tenofovir – This medication is administered orally in tablet form and is used to treat patients co-infected with HIV-1 and HBV viruses. It is currently well-established in medical literature as an effective antiviral agent for managing these infections. The main therapeutic indication is to control viral replication in patients with HIV-1 and HBV co-infection. At the molecular level, Tenofovir works by inhibiting the reverse transcriptase enzyme, which is crucial for viral replication. It is classified pharmacologically as a nucleotide reverse transcriptase inhibitor.

Investigated diseases

  • HIV-1 Infection

    HIV-1 is a virus that attacks the immune system, specifically targeting CD4 cells, which are crucial for fighting infections. Over time, if untreated, the virus can significantly reduce the number of these cells, weakening the immune system and making the body more susceptible to other infections and diseases. The progression of HIV-1 infection can vary, but it typically involves an initial acute phase with flu-like symptoms, followed by a chronic phase where the virus continues to replicate at lower levels. Without intervention, this can eventually lead to acquired immunodeficiency syndrome (AIDS), where the immune system is severely compromised.

  • Hepatitis B Virus (HBV) Infection

    Hepatitis B is a viral infection that primarily affects the liver, causing inflammation and potential damage. The virus can be transmitted through contact with infectious body fluids, such as blood. In many cases, the infection is acute and resolves on its own, but it can become chronic, leading to long-term liver issues such as cirrhosis or liver cancer. Chronic HBV infection may not show symptoms for years, but the virus continues to damage the liver over time. The progression of the disease can vary, with some individuals remaining asymptomatic while others experience significant liver damage.

Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase IITrial ID2023-508634-34-00Protocol codeANRS0250s-BI-LIGHTEstimated enrolment140 patientsSponsorInserm

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On this site, “treatment” means an investigational medicine being studied in a clinical trial. Its safety and efficacy for the use being studied have not yet been confirmed, some participants may receive a placebo or a comparator medicine, and taking part does not guarantee any health benefit. The decision to take part is made by the doctor at the research site. This site is for information only and does not replace medical advice.

This service is not affiliated with the European Commission, the EMA, or the official CTIS system. Most information comes from publicly available international clinical-trial registries, supplemented by data from academic sites, national regulators and commercial sponsors. On this site, “treatment” and “therapy” mean a medicine being tested in a clinical trial. Its safety and effectiveness in the use being studied are not yet confirmed, some participants may receive a placebo or a comparator, and taking part does not guarantee a health benefit. The doctor at the research site decides who can take part. This site provides information, not medical advice. Certain content and visual elements on this website have been generated or enhanced using artificial intelligence (AI).