NCT05122754进行中（未招募）4 期
Switching From Tenofovir Disoproxil Fumarate-based Antiretroviral Therapy Regimens to Bictegravir/Emtricitabine/Tenofovir Alafenamide in Virally Suppressed Adults With HIV-1 Infection
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 进行中（未招募）
- 入组人数
- 150
- 试验地点
- 3
- 主要终点
- Percentage change from baseline in spine and hip bone mineral density (DXA) at 48 weeks
研究概览
简要总结
To evaluate the safety and efficacy of bictegravir/emtricitabine/tenofovir alafenamide versus tenofovir disoproxil fumarate-based antiretroviral regimens in HIV-infected individuals with virological suppression.
详细描述
This study is a multicenter, randomized, controlled, open labeled clinical trial, which aims to evaluate the safety and efficacy of B/F/TAF versus TDF-based antiretroviral therapy in HIV-infected individuals with virological suppression, and to evaluate the changes in quality of life and adherence after switching from a TDF-based regimen to B/F/TAF in HIV-infected individuals with virological suppression.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
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
- •Meet the Diagnostic Criteria for AIDS or HIV Infection (WS 293-2019);
- •Age 18 or above (included 18);
- •Continuous administration of a TDF-based triple ART regimen with a backbone of non-nucleoside reverse transcriptase or protease inhibitors ≥24 weeks and ongoing use;
- •Maintaining virological suppression (viral load < 50 copies/mL) for ≥ 24 weeks, and maintaining virological suppression at present;
- •Glomerular filtration rate (eGFR) ≥ 50 mL/min/1.73 m2 (calculated according to the CKD-EPI formula);
- •ECG is normal;
- •White blood cell count ≥3×109/L, Neutrophil count ≥1.5×109/L, Hemoglobin ≥90 g/L, and Platelet count ≥ 75×109/L;
- •Alanine aminotransferase and aspartate aminotransferase ≤5×ULN, direct bilirubin ≤1.5×ULN, amylase≤2×ULN；
- •Those who volunteered for this study and were able to complete all follow-up visits and sign the informed consent form in accordance with the protocol.
排除标准
- •In the 30 days(inclusive) before the screening period, an AIDS-related opportunistic infection or tumor occurred;
- •History of known past HIV resistance (confirmed HIV viral load > 200 copies /ml) or resistance to any nucleoside (acid) analogues;
- •Decompensated liver cirrhosis;
- •Female subject who has a positive urine pregnancy test;
- •Lactating women;
- •Women who are unable to take a reasonable method of contraception during the trial (including the Screening Period and 30 days after discontinuation of experimental drugs);
- •Subjects had other medical conditions requiring treatment with either of the current ART regimens or other drugs which have drug-drug interaction with B/F/TAF and cannot be discontinued.
- •Being involved in other interventional clinical studies;
- •Those with allergic constitution or known allergy to the components of the drug;
- •Suffering from serious mental or neurological diseases;
- •Suspected or confirmed history of alcohol and drug abuse; Patients who were not considered by the investigator to be suitable for participating in this clinical trial (such as weak constitution, poor compliance, etc.).
研究组 & 干预措施
B/F/TAF group
Experimental
Bictegravir/emtricitabine/tenofovir alafenamide for 48 weeks.
干预措施: B/F/TAF (Drug)
TDF-based triple ART regimen switching to B/F/TAF
Active Comparator
TDF-based triple ART regimen for 24 weeks, and all switch to bictegravir/emtricitabine/tenofovir alafenamide for the later 24 weeks.
干预措施: TDF-based triple ART regimen switching to B/F/TAF (Drug)
结局指标
主要结局
Percentage change from baseline in spine and hip bone mineral density (DXA) at 48 weeks
时间窗: From baseline to Week 48
次要结局
- The percentage of subjects with spine or hip bone mineral density (DXA) that increased or decreased by more than 3% (not included) from baseline at Weeks 24 and 48(From baseline to Week 24, 48)
- Changes from Baseline in eGFR at Weeks 24 and 48 (CKD-EPI Formula)(From baseline to Week 24, 48)
- The percentage of subjects with HIV viral load < 50 copies /ml at Weeks 24 and 48(From baseline to Week 24, 48)
- Adherence (Visual Analog Scale) change from baseline at Weeks 24 and 48(From baseline to Week 24, 48)
- Changes from baseline in blood lipid (TC, TG, LDL, HDL) at Weeks 24 and 48(From baseline to Week 24, 48)
- Quality of life score (WHO QOL-BREF-HIV Scale) change from baseline at Weeks 24 and 48(From baseline to Week 24, 48)
- Changes from baseline in CD4 T cell count at Weeks 24 and 48(From baseline to Week 24, 48)
- Changes from baseline in CD4/CD8 ratio at Weeks 24 and 48(From baseline to Week 24, 48)
- Patients reported outcome using SSC-HIV-SC scale(From baseline to Week 24, 48)
- Percentage change from baseline in spine and hip bone mineral density (DXA) at Week 24(From baseline to Week 24)
- Changes from Baseline in Spine and Hip Bone Mineral Density T-Values (DXA) at Weeks 24 and 48(From baseline to Week 24, 48)
研究者
Jun Chen, MD
Deputy Director of Department of Infectious Diseases and Immunology
Shanghai Public Health Clinical Center
研究点 (3)
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