Switching to a Fixed Dose Combination of Biktarvy in Treatment Experienced People With HIV Who Are Currently Virologically Suppressed and at Least 65 Years of Age
试验速览
- 阶段
- 4 期
- 发起方
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Improvement in treatment satisfaction by a change in total satisfaction scale as measured by the HIVTSQ survey.
研究概览
简要总结
To assess patient reported treatment satisfaction and medication tolerability in virologically suppressed HIV-1 infected adults who are at least 65 years of age who switch to a bictegravir/emtricitabine/tenofovir alafenamide (B/F/TAF) fixed-dose combination regimen.
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
- 65 Years 至 —（Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Be at least 65 years of age at the time of signing the informed consent form.
- •Be currently receiving an antiretroviral regimen for ≥ 3 months prior to the screening visit.
- •Have documented plasma HIV-1 RNA < 50 copies/mL for a minimum of 3 months on current ART regimen.
- •Have a plasma HIV-1 RNA < 50 copies/mL at screening visit.
排除标准
- •Have resistance to tenofovir (K65R/E/N, ≥3 thymidine analogue mutations or T69-insertions), primary INSTI-resistance, or a history of failure on an INSTI-based regimen.
- •Have been treated with B/F/TAF
- •Participants with CrCl <30 mL/min
- •Known or suspected severe hepatic impairment (Child-Pugh Class C)
研究组 & 干预措施
B/F/TAF
B/F/TAF for 48 weeks
干预措施: B/F/TAF (Drug)
结局指标
主要结局
Improvement in treatment satisfaction by a change in total satisfaction scale as measured by the HIVTSQ survey.
时间窗: 48 weeks
Improvement in treatment satisfaction by a change in total satisfaction scale as measured by the HIVTSQ survey. The range of scores is between -33 and +33. The higher the score, the greater the improvement in satisfaction. Satisfaction may be positive or negative.
Improvement in overall quality of life as characterized by a change in total satisfaction scale as measured by the HIVDQoL survey.
时间窗: 48 weeks
Improvement in overall quality of life as characterized by a change in total satisfaction scale as measured by the HIVDQoL survey. The range of scores is between -9 to +3. The higher the score the greater the impact. Impacts may be positive or negative.
次要结局
- Percentage of all participants who have plasma HIV-1 RNA Viral Load < 50 c/mL at end of study(Week 48)
- Percentage of Participants experiencing Adverse Events (AEs) through End of Study (Week 48)(Week 48)
- Percentage of all participants who have plasma HIV-1 RNA Viral Load < 50 c/mL at W24(Week 24)
- Percentage of patients who reduced their number of total medications from baseline.(Week 48)
研究者
Tulika Singh, MD
Director of Research and Associate Chief Medical Officer
Desert AIDS Project