BI-LIGHTInterventional, 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
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)
Blood-Borne Infections+11
+ Urogenital Diseases
+ Genital Diseases
Treatment Study
Summary
Study start date: February 1, 2025
Actual date on which the first participant was enrolled.The study focuses on patients who have both HIV-1 and hepatitis B virus (HBV) infections and have been successfully managing these conditions with a continuous triple therapy. The main goal is to understand if it is safe to reduce their treatment while still keeping the hepatitis B virus under control over a period of 96 weeks. This is important because managing treatment can be challenging, and finding safe ways to reduce medication could make it easier for patients to maintain their health and potentially reduce side effects from long-term medication use. Participants in this study will follow one of two different strategies to decrease their current antiviral treatment. Researchers will closely monitor these patients to ensure that the hepatitis B virus remains under control during the study period. While the study does not detail the specific risks or benefits, it aims to provide valuable insights into the safety of reducing treatment for those living with both HIV and HBV, potentially leading to improved strategies for managing these co-infections.
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.140 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Treatment Study
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Any sex
Biological sex of participants that are eligible to enroll.Over 18 Years
Range of ages for which participants are eligible to join.Healthy volunteers not allowed
If individuals who are healthy and do not have the condition being studied can participate.Conditions
Pathology
Criteria
Inclusion Criteria: 1. HIV-1-HBV co-infection (positive HIV-1 serology associated with 2 positive HBsAg serologies within more than 6 months); 2. Age ≥ 18 years 3. Fibroscan less than 6 months \< 9kPa 4. 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; 5. 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); 6. 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); 7. 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); 8. 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); 9. CD4 lymphocytes \> 250/mm3 at pre-inclusion; 10. ALT \< 3N at pre-inclusion; 11. For women of childbearing potential, negative pregnancy test and commitment to use effective contraception throughout the trial; 12. Person affiliated with or benefiting from a social security system; 13. 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: 1. HIV-2 infection; 2. HIV and/or HBV genotype not compatible with dual therapy DTG-3TC or DRVr-3TC; 3. HBeAg+; 4. Fibrosis history at stage F3-F4 in pre-therapy evaluated by PBH, fibrotest and/or fibroscan with a value of Elastometry ≥ 9kPa; 5. Chronic active viral hepatitis C (HCV RNA positive); 6. Delta co-infection; 7. Alcohol consumption \> 14 units/week for women and 21 units/week for men; 8. Current treatment with chemo- or immunotherapy (including interferon or interleukins); 9. Active opportunistic infection or acute treatment for opportunistic infection; 10. Any condition (drug use, neurological, neuropsychiatric, etc.) that, in the judgment of the investigator, may compromise patient compliance and adherence to the protocol; 11. Pregnant or breastfeeding woman or refusal of contraception; 12. Major incapacity, legal protection, guardianship or curatorship
Study Plan
Find out more about all the medication administered in this study, their detailed description and what they involve.2 intervention groups are designated in this study
This study does not include a placebo group
Treatment Groups
Group I
ExperimentalGroup II
ExperimentalStudy Objectives
Primary Objectives
Secondary Objectives