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

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What is this study about?

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.

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 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 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 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 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 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 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 Study?

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 Study?

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.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name	City	Country
Hopital Necker Enfants Malades	Paris	France
Centre Hospitalier Intercommunal Creteil	Creteil	France
Centre Hospitalier Universitaire De Bordeaux	Bordeaux	France
Oncopole Claudius Regaud	Toulouse	France

Other Sites

Site Name	City	Country
Hopital Saint Antoine	Paris	France
Hopitaux Universitaires Pitie Salpetriere	Paris	France
Hopital Tenon	Paris	France
Centre Hospitalier De Tourcoing	Tourcoing	France
Centre Hospitalier Universitaire De La Reunion	St Denis	France
Hôpital Avicenne	Bobigny	France
Centre Hospitalier Universitaire De Montpellier	Montpellier	France
Centre Hospitalier Universitaire De Nantes	Nantes	France
Hopital Beaujon	Clichy	France
Henoelm lmibprmrkjapao 1	Nice	France
Htranrd Bgpiyo Cwhhrrfwrbwsts Abbsy	Paris	France
Rbktrpthjscrrvyk Hhcitmmd	Garches	France
Cil Dwbyf Bhineznbw Hvqdhor Fhrccmqp Mizsoaqgp	Dijon	France
Apcptmyczx Pxlbgxxa Hmxduvcb Dx Pojwu	Paris	France
Aidtzgolxk Phzenmww Hkjwirex Dn Msejfjaaa	Marseille	France

Trial status

Country	Status	Recruitment Start
France	Recruiting	01.03.2024

Trial locations

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.

Investigated diseases:

HIV infection

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 ID:

2023-508634-34-00

Protocol code:

ANRS0250s-BI-LIGHT

Trial Phase:

Therapeutic exploratory (Phase II)

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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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