Randomized, Double-Blind Study to Evaluate the Safety and Efficacy of Switching From Efavirenz/Emtricitabine/Tenofovir Disoproxil Fumarate to Bictegravir/ Emtricitabine/Tenofovir Alafenamide in HIV-1 Infected Virologically Suppressed Adults
试验速览
- 阶段
- 4 期
- 状态
- 终止
- 入组人数
- 28
- 试验地点
- 1
- 主要终点
- Urine Albumin/Creatinine Ratio (UACR)
研究概览
简要总结
Atripla (ATP: FTC/TDF/EFV) was the first single pill treatment for HIV and was the most prescribed first-line treatment from approximately 2008 to 2013 for people infected with HIV. However, ATP has not been recommended as a "preferred" treatment for HIV since 2015, due to there now being single pill treatments that work better. There are a lot of people who are still taking ATP and it is working for them. However, it has the potential to cause serious side effects (chronic kidney disease and fractures and serious neurological effects). These side effects are caused by components in ATP (namely the TDF and EFV parts). Also, the efavirenz (EFV) component is not compatible for treatment of Hepatitis C (HCV) - which is often also seen in people who have HIV. For these reasons, there is a need to find a better alternative treatment for these people currently being treated with ATP.
详细描述
B/F/TAF (bictegravir/FTC/TAF) is an investigational single pill drug treatment drug that contains neither TDF nor EFV. This study is looking at whether changing people to this new drug treatment will continue to suppress their HIV and have fewer side effects.
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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 21 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •HIV-1 seropositive
- •Age > 21 years
- •Receiving ATP > 2 years as their only ART, with HIV-1 RNA < 50 copies/mL at screening and all HIV-1 RNA tests < 100 copies/mL in the past 18 months
- •No documented resistance mutations to the components of ATP
- •Any CD4 count, but no active AIDS-defining opportunistic infections or cancers
- •HBsAg+ permitted if plasma HBV DNA is unquantifiable and the patient does not have decompensated liver disease
排除标准
- •Pregnancy, breastfeeding or planned pregnancy in the next 2 years
- •Documented resistance to the components of ATP
- •Active AIDS-defining opportunistic infection or cancer
- •Cancer in past 3 years, except non melanoma skin cancer
- •Active psychotic disease or active depression that may interfere with study participation according investigator discretion
- •Any illness with a life expectancy less than 2 years
- •eGFR < 50 mL/min
- •Urine protein/creatinine > 40 mg/mmoL
- •Patients who the investigator feels are unlikely to commit to the study requirements for any reason
- •Prescription drug therapy for osteoporosis (calcium and/or vitamin D is allowed)
研究组 & 干预措施
B/F/TAF
B/F/TAF + Atripla Placebo
Each pill is taken once daily, (total of 2 tablets) The blinded treatment phase of this study will last for 52 weeks
干预措施: B/F/TAF (Drug)
B/F/TAF
B/F/TAF + Atripla Placebo
Each pill is taken once daily, (total of 2 tablets) The blinded treatment phase of this study will last for 52 weeks
干预措施: Atripla Placebo (Drug)
Atripla
Atripla + B/F/TAF Placebo
Each pill is taken once daily, (total of 2 tablets) The blinded treatment phase of this study will last for 52 weeks
干预措施: Atripla (Drug)
Atripla
Atripla + B/F/TAF Placebo
Each pill is taken once daily, (total of 2 tablets) The blinded treatment phase of this study will last for 52 weeks
干预措施: B/F/TAF Placebo (Drug)
结局指标
主要结局
Urine Albumin/Creatinine Ratio (UACR)
时间窗: Baseline and week 48
change in urine albumin/creatinine ratio (UACR)
次要结局
- Serum Lipids(Baseline and week 48)
- Adverse Events(Baseline, week 4, week 12, week 24, week 36, and week 48)
- Efavirenz (EFV) Symptom Scores(Baseline and week 4)
- Urine Protein/Creatinine Ratio (UPCR)(Baseline and week 48)
- Estimated Glomerular Filtration Rate (eGFR)(Baseline and week 48)
- Bone Mineral Density (BMD) at the Hip(Baseline and week 48)
- CD4 Lymphocyte Counts(Baseline and week 48)
- HIV-1 RNA(Week 48)
- Bone Mineral Density (BMD) at the Spine(Baseline and week 48)