Effectiveness and Persistence of Same-day Re-start with B/F/TAF Among Patients with HIV Who Experienced Discontinuation from Previous NNRTI Based Regimens in China
试验速览
- 阶段
- 4 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 250
- 试验地点
- 1
- 主要终点
- The efficacy of re-initiation of B/F/TAF
研究概览
简要总结
In China, free first-line ART regimens typically consist of two nucleoside reverse transcriptase inhibitors (NRTIs) and a non-nucleoside reverse transcriptase inhibitor (NNRTI). As of the end of 2022, approximately 1.135 million individuals were receiving ART, achieving a coverage rate of 92.8%, largely due to participation in free treatment programs. However, around 36,000 patients have discontinued treatment, primarily due to side effects associated with Efavirenz (EFV), a common NNRTI. The challenges posed by side effects and resistance profiles of existing NNRTIs highlight the need for effective re-initiation of ART to improve overall treatment coverage. INSTIs, particularly B/F/TAF (Bictegravir/emtricitabine/tenofovir alafenamide), demonstrates effective viral suppression and a higher barrier to resistance than NNRTIs. B/F/TAF has shown efficacy in patients with resistance mutations, making it a strong candidate for same-day ART re-initiation, especially in resource-limited areas where genotypic resistance testing may be unavailable. This study aims to evaluate the feasibility and effectiveness of rapidly restarting B/F/TAF in patients with treatment interruptions from previous NNRTI regimens.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 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
- •Patients with 18 years old or above.
- •Discontinuation of previous NNRTI based regimen for more than 90 days.
- •No known CrCl< 30mL/min or severe hepatic impairment.
- •No known or suspected resistance to BIC.
- •No known pregnancy
排除标准
- ••Patients who are pregnant.
- •Patients who have abnormal liver and kidney function indicators(Child-pugh class C, CrCl< 30).Hepatitis virus co-infection does not serve as an exclusion criterion.
- •Patients who have historic resistance test indicating drug resistant to BIC or baseline resistance test indicating resistance to BIC.
- •Patients who are psychiatric illness or active tuberculosis co-infection.
研究组 & 干预措施
AIDS patients who discontinued NNRTI for more than 90 days
HIV patients of any gender, older than 18 years of age, who have been off their prior NNRTI regimen for more than 90 days and who have an HIV-1 viral load greater than 50 copies/uL.In this study, eligible patients will restart treatment on the same day and receive B/F/TAF for one year.We will conduct follow-ups on the patients and carry out routine clinical tests.
干预措施: Regimen：BIC+FTC+TAF (Drug)
结局指标
主要结局
The efficacy of re-initiation of B/F/TAF
时间窗: From enrollment to the end of treatment at 24 weeks
Evaluate the efficacy following the re-initiation of B/F/TAF as determined by the achievement of HIV-RNA undetectable (\< 50 copies/ml).
次要结局
- Drug resistance status(From enrollment to the end of treatment at 48 weeks)
- The reasons for discontinuation of prior therapy(From enrollment to the end of treatment at 1 week)
- The efficacy of B/F/TAF(From enrollment to the end of treatment at Week 12, Week24 and Week 48)
- The persistence on B/F/TAF .(From enrollment to the end of treatment at 48 weeks)
- The changes in parameters of quality of life and treatment satisfaction(From enrollment to the end of treatment at Week24 and Week 48)
- The safety and tolerability on B/F/TAF(From enrollment to the end of treatment at 48 weeks)
- The emergence of drug resistance(From enrollment to the end of treatment at 48 weeks)