NCT06338826尚未招募2 期
Interventional, 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
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 入组人数
- 140
- 主要终点
- The proportion of participants with HBV virological failure at 96 weeks.
研究概览
简要总结
The main objective of this study is to evaluate at 96 weeks the safety with respect to 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
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Sequential
- 主要目的
- Treatment
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 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);
- •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
- •NNRTI = efavirenz, rilpivirine, etravirine, doravirine
- •PI/r = atazanavir/r ou darunavir/r
- •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;
- •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)
排除标准
- •HIV-2 infection;
- •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;
- •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
研究组 & 干预措施
Arm 2 (T4):
Experimental
- Arm 2 (T4): Relief from previous triple antiviral therapy (containing TDF or TAF) on 4 out of 7 consecutive days
干预措施: TDF - 245mg or TAF -25mg associated to 3TC - 300mg or FTC - 200mg and a NNRTI or PI/r or INSTI (Drug)
Arm 3 (B7)
Experimental
Switch from prior triple antiviral therapy (containing TDF or TAF) to continuous dual therapy without TDF or TAF but including 3TC in combination with Dolutegravir (DTG) or ritonavir-boosted Darunavir (rDVR
干预措施: Dual therapy with 3TC in combination with DTG or ritonavir-boosted Darunavir (rDVR) (Drug)
结局指标
主要结局
The proportion of participants with HBV virological failure at 96 weeks.
时间窗: 96 weeks
HBV virologoical failure is defined by 2 successive varial load ≥ 10UI/ml
次要结局
- • HIV virological success rate at 48 and 96 weeks(At week 48 and week 96)
- Evolution of the CD4/CD8 ratio from W0 to W48 and W96(Week 0 to Week 48 and week 96)
- • Evolution of total cholesterol from W0 to W48 and W96(from Week 0 to Week 48 and Week 96)
- • 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(At week 48 and week 96)
- Evolution of LDL-c from W0 to W48 and W96(from Week 0 to Week 48 and Week 96)
- • The rate of participants with at least one HBV viral load blip until W48 and until W96(At week 48 and week 96)
- Evolution of triglycerides from W0 to W48 and W96(from Week 0 to Week 48 and Week 96)
- Evolution of fasting blood sugar from W0 to W48 and W96(from Week 0 to Week 48 and Week 96)
- • HBV virological success rate at 48 weeks(at Week 48)
- • Time to virological failure (rebound HBV and/or HIV viral load)(between Week 0 and Week96)
- • Selection of HBV resistance mutations at the time of virological failure(between Week 0 and Week 96)
- • Evaluation of the adherence by self-reported questionnaire(at Week 0, Week 12, Week 24, Week 48, Week 72 and Week 96)
- • Evolution of CD4 from W0 to W48 and W96(Week 0 to Week 48 and week 96)
- Evolution of CD8 T lymphocytes from W0 to W48 and W96(Week 0 to Week 48 and week 96)
- • Evaluation of quality of life using the Pro-Qol self-questionnaire(at Week 0, Week 12, Week 24, Week 48, Week 72 and Week 96)
- Evolution of HDL-c from W0 to W48 and W96(from Week 0 to Week 48 and Week 96)
- HBV virological success rate at 96 weeks between arms(at Week 96)
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