2023-508634-34-00招募中2 期
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
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- Inserm
- 入组人数
- 140
- 试验地点
- 20
- 主要终点
- The primary endpoint was the proportion of participants with HBV virological failure at 96 weeks. Failure was defined as two successive HBV viral load measurements >10 IU/mL or one HBV viral load measurement above the detection threshold followed by permanent discontinuation of the strategy or follow-up in the trial.
研究概览
简要总结
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
研究设计
- 分配方式
- Randomized
- 主要目的
- Entire title
- 盲法
- None
入排标准
- 年龄范围
- 18 years 至 64 years（18-64 Years）
- 接受健康志愿者
- 否
入选标准
- •HIV-1-HBV co-infection (positive HIV-1 serology associated with 2 positive HBsAg serologies within more than 6 months)
- •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 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
排除标准
- •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
- •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
结局指标
主要结局
The primary endpoint was the proportion of participants with HBV virological failure at 96 weeks. Failure was defined as two successive HBV viral load measurements >10 IU/mL or one HBV viral load measurement above the detection threshold followed by permanent discontinuation of the strategy or follow-up in the trial.
The primary endpoint was the proportion of participants with HBV virological failure at 96 weeks. Failure was defined as two successive HBV viral load measurements >10 IU/mL or one HBV viral load measurement above the detection threshold followed by permanent discontinuation of the strategy or follow-up in the trial.
次要结局
- • Time to virological failure (rebound HBV and/or HIV viral load)
- • The rate of participants with at least one HBV viral load blip until S48 and until S96
- • HBV virological success rate at 48 weeks
- • HIV virological success rate at 48 and 96 weeks
- • Selection of HBV resistance mutations at the time of virological failure
- • 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
- • Evolution of CD4 and CD8 T lymphocytes, and the CD4/CD8 ratio from W0 to W48 and W96
- • Evolution of metabolic parameters (total cholesterol, LDL-c, HDL-c, triglycerides and fasting blood sugar) from W0 to W48 and W96
- • Participants' compliance with treatment (self-questionnaire) at S0, S12, S24, S48, S72 and S96
- • Participants' quality of life using the Pro-Qol self-questionnaire at S0, S12, S24, S48, S72 and S96
- HBV virological success rate at 96 weeks between arms
研究者
fatoumata Coulibaly
Scientific
Inserm
研究点 (20)
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