BridgeMD
Interventional, multicenter, open-label, randomized, non-comparative trial evaluating the safety, in terms of HBV virological control, of 2 antiviral treatment relief strategies, in patients co-infected with the HIV-1 and HBV viruses
EU CTIS ID: 2023-508634-34-00
What this study is testing
The main objective of this trial is to evaluate at 96 weeks the safety with respect to chronic viral hepatitis B control of 2 treatment reduction strategies for patients with previously controlled HIV-HBV co-infection on continuous triple therapy
- Therapeutic exploratory (Phase II)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- HIV-1-HBV co-infection (positive HIV-1 serology associated with 2 positive HBsAg serologies within more than 6 months)
- 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 30 months (including that of pre-inclusion
- CD4 lymphocytes > 250/mm3 at pre-inclusion
- Positive Ag HBs HBV serology at pre-inclusion
You likely can't join if
- HIV-2 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.
- HIV and/or HBV genotype not compatible with dual therapy DTG-3TC or DRVr-3TC
- HBeAg+.
See the full eligibility criteria
- HIV-1-HBV co-infection (positive HIV-1 serology associated with 2 positive HBsAg serologies within more than 6 months)
- 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 30 months (including that of pre-inclusion
- CD4 lymphocytes > 250/mm3 at pre-inclusion
- Positive Ag HBs HBV serology 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)
- 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 o NNRTI = efavirenz, rilpivirine, etravirine, doravirine o PI/r = atazanavir/r ou darunavir/r o 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-2 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.
- 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
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18-64 years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.