NCT05506605进行中（未招募）4 期
Open-label, Single-arm, Unicenter and Pilot Study of a Switch Strategy From Etravirine (ETR) to Doravirine (DOR) in Virologically-Suppressed HIV-1 Infected Adults With ETR-Resistance
Fundacion Clinic per a la Recerca Biomédica1 个研究点 分布在 1 个国家目标入组 12 人开始时间: 2022年12月12日最近更新:
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）
- 发起方
- 入组人数
- 12
- 试验地点
- 1
- 主要终点
- Percentage of participants with confirmed HIV viral load>50 copies/mL
研究概览
简要总结
Phase IV, open-label, single arm, unicenter and pilot study on virologically suppressed HIV infected adults with ETR resistance, to assess the efficacy of a Switch strategy from Etravirine (ETR) to Doravirine (DOR).
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
- •HIV-1-infected subjects with age ≥18 years old.
- •Desire of the patient to simplify their ART-regimen.
- •Having plasma HIV-1 RNA < 50 copies/mL during at least the previous 24 weeks.
- •Currently receiving an ETR-containing regimen (unchanged during the previous 24 weeks).
- •Documented pooled/historical genotype or GRT in pro-viral DNA must show the presence of 103N and/or 181C and/or 190A and/or 100I and/or 138K/A.
排除标准
- •Documented pooled/historical genotype or GRT in pro-viral DNA of any DOR-DRM (Mutations V106A, Y188L, and M230L, and combinations of V106A and L234I; V106A and F227L and L234I; and V106A and 190A and F227L).
- •Pregnant, breastfeeding women, women with a positive pregnancy test at the time of screening, sexually active fertile women wishing to conceive or unwilling to commit to contraceptive methods, for the duration of the study and until 4 weeks after the last dose of study medication. All women are considered fertile unless they have undergone a sterilizing surgery or are over the age of 50 with spontaneous amenorrhea for over 12 months prior to study entry.
- •Active tuberculosis infection.
- •Any clinical condition or therapy that, in the opinion of the Investigator, would make the individual unsuitable for the study or unable to comply with the dosing requirements.
研究组 & 干预措施
Switch from Etravirine to Doravirine
Experimental
Switch from etravirine to Doravirine (Pifeltro) 100 mg each day
干预措施: Doravirine 100Mg Tab (Drug)
结局指标
主要结局
Percentage of participants with confirmed HIV viral load>50 copies/mL
时间窗: at week 24
Measured by blood HIV viral load
次要结局
- Changes in CD4, CD8 cell counts and ratio CD4/CD8(at 48 weeks)
- Maximum concentrations (Cmax) of DRV/r and DRV/c with DOR(at weeks 2 and 4)
- Concentrations at the end of the dosing interval (C24) of DRV/r and DRV/c with DOR(at weeks 2 and 4)
- Percentage of participants with HIV viral load>50 copies/mL(at week 12 and 48)
- Percentage of participants with HIV viral load<50 copies/mL(at week 12, 24 and 48)
- Incidence of Treatment-Emergent adverse events and serious adverse events(at week 48)
- AUC during the dose interval (AUC0-24) of DRV/r and DRV/c with DOR(at weeks 2 and 4)
- Elimination half-life (t1/2) of DRV/r and DRV/c with DOR(at weeks 2 and 4)
研究者
Anna Cruceta
Medical Coordinator
Fundacion Clinic per a la Recerca Biomédica
研究点 (1)
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