Switching to a Fixed Dose Combination of Bictegravir/Emtricitabine/Tenofovir Alafenamide (B/F/TAF) in HIV-1 Infected Marginalized Populations Who Are Virologically Suppressed
试验速览
- 阶段
- 4 期
- 发起方
- 入组人数
- 40
- 试验地点
- 2
- 主要终点
- The proportion of subjects that remain virally suppressed at week 48
研究概览
简要总结
In an effort to engage more HIV-infected PWUD into care, and ensure treatment adherence and efficacy, simplification of older, multi-tablet regimens is required. Newer, more potent molecules can also overcome resistant that has persisted with previous regimens, while simultaneously providing a high barrier to resistance. The co-formulation of B/F/TAF is a viable switch-option for patients who have experienced lower adherence with previous regimens due to high pill burden, or for those requiring a more potent regimen due to emergent resistances. The formal evaluation of B/F/TAF in this context will allow us to optimize care for HIV-infected PWUD.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 19 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Participant is ≥19 years of age infected with HIV-1
- •Participant has an undetectable viral load <40 copies/mL at screening with any CD4 count and has exhibited any, or all of the following:
- •Transient HIV viremia (episodes of HIV viral load between 40-1000 copies/mL) in the past 12 months, OR Virologic breakthrough (HIV viral load > 1000 copies/mL) in the past 12 months, OR Documented instances of non-adherence for a period of more than 7 days or...
- •Participant is currently on multi-tablet HIV antiretroviral therapy, including multi-tablet regimens and/or two drug combinations (dual therapy)
- •Participant has a history or current indication of illicit drug use.
- •Patients infected with HCV and or HBV can be included in this study.
- •If female, participant must have a negative pregnancy test and agree to use, for the duration of the study, a method of birth control that has a history of proven reliability as judged by the investigator.
排除标准
- •They have any documented history of integrase inhibitor resistance
- •They exhibit any of the following:
- •Creatinine Clearance Rate < 30 ml/min
- •Hemoglobin < 10.0 g/dL
- •Absolute neutrophil count <750 cells/mL
- •Platelet count < 50,000 /mL
- •ALT or AST >5x upper limit of normal (ULN)
- •Creatinine > 1.5x ULN
- •They are taking medication that is contraindicated with any component of B/F/TAF.
- •They are pregnant or breastfeeding.
- •They do not/have not ever used any form of illicit drug use.
研究组 & 干预措施
B/F/TAF
Switching participants who are currently on multi-tablet HIV antiretroviral therapy, including multi-tablet regimens and/or two drug combinations (dual therapy) to one oral tablet of B/F/TAF once-daily for 72 weeks
干预措施: Bictegravir/emtricitabine/tenofovir alafenamide (Drug)
结局指标
主要结局
The proportion of subjects that remain virally suppressed at week 48
时间窗: Interim analysis of efficacy will be done at 24 weeks
The proportion of subjects with HIV RNA \<40 copies/mL
次要结局
- Changes to baseline quality of life at week 4, 12, 36, 60, and 72 using the HIV Symptoms Distress Module(Analysis will be done at 72 weeks)
- The proportion of viral blips on regimens pre-switch compared to the blips on B/F/TAF(Analysis will be done at 72 weeks)
- The proportion of participants that discontinued B/F/TAF due to side-effects at weeks 36 and72(Analysis will be done at 72 weeks)
- The proportion of subjects with viral blips(Analysis will be done at 72 weeks)
- Changes of adherence(Analysis will be done at 72 weeks)
- Proportion of patients that achieved >90% adherence(Analysis will be done at 72 weeks)