The Efficacy, Safety, and Tolerability of Switching to a Bictegravir (BIC)/Emtricitabine(FTC)/Tenofovir Alafenamide (TAF) Regimen in Virally Suppressed Human Immunodeficiency Viruses (HIV)-Positive Patients Post-Renal Transplant
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Number of Subjects With Plasma HIV-1 Ribonucleic Acid (RNA) <50 Copies/ml
研究概览
简要总结
This is an open-label study, where participants will be switched from their current HIV medication to the study drug, BIC/F/TAF. Open-label means both the investigator and the participant will know what drug will be given. Participants will be followed for 48 weeks in order to monitor the efficacy, safety and tolerability of BIC/F/TAF. The investigator hypothesizes that BIC/F/TAF will be an important addition to the management of HIV-positive post renal transplant patients, especially since it is a one pill daily dosing regimen, thereby decreasing the pill burden in this population.
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
- •At least 18 years old on day of signing informed consent
- •Positive for human immunodeficiency virus (HIV)
- •Received a previous renal transplant
- •Must have controlled HIV infection for at least 3 months prior to enrollment
排除标准
- •Received a kidney from a donor who was HIV positive (unless a false positive)
- •Currently taking BIC/F/TAF for treatment of HIV
- •Has allergies to any of the HIV medications in BIC/F/TAF (bictegravir, emtricitabine, or tenofovir alafenamide)
- •Currently taking dofetilide or rifampin
- •Is pregnant or breastfeeding
研究组 & 干预措施
Bictegravir/Emtricitabine/Tenofovir Alafenamide (BIC/F/TAF)
Participants receive a BIC/F/TAF tablet orally once daily with or without food.
干预措施: BIC/F/TAF 50Mg-200Mg-25Mg Tablet (Drug)
结局指标
主要结局
Number of Subjects With Plasma HIV-1 Ribonucleic Acid (RNA) <50 Copies/ml
时间窗: Up to week 48 (End of Study)
HIV viral loads will be obtained from lab reports.
Renal Function as Measured by Blood Urea Nitrogen (BUN)
时间窗: 24 weeks, 48 weeks (End of study)
Renal Function as Measured by Creatinine
时间窗: 24 weeks, 48 weeks (End of study)
Safety (Tolerability) as Measured by the Number of Subjects Who Had a Serious Adverse Event (SAE)
时间窗: Up to week 48 (End of study)
Intracellular TAF Levels as Measured by Dried Blood Spot
时间窗: 12 weeks
Fmol/punch refers to the concentration of a substance, measured in femtomoles per a specific size of a dried blood spot (DBS) punch.
Intracellular TAF Levels as Measured by Peripheral Blood Mononuclear Cells (PBMCs)
时间窗: 12 weeks
pmol/10\^6 cells refers to the amount of a particular substance (in picomoles) per one million cells
Renal Function as Measured by Creatinine Clearance
时间窗: 24 weeks, 48 weeks (End of study)
Renal Function as Measured by Estimated Glomerular Filtration Rate (eGFR)
时间窗: 24 weeks, 48 weeks (End of study)
Tacrolimus Levels
时间窗: 12 weeks, 24 weeks, 48 weeks (End of study)
次要结局
- Participant Satisfaction With Reduced Pill Burden and Adverse Events (Tolerability) Measured by the Health-related Quality of Life Questionnaire(Week 24, Week 48 (End of study))
- Change From Baseline CD4+ T Lymphocyte Numbers Post Renal Transplant(Day 1 (Baseline), Week 4, Week 12, Week 24, Week 36, Week 48 (End of study))
- Change From Baseline CD4+ T Lymphocyte Percentages Post Renal Transplant(Day 1 (Baseline), Week 4, Week 12, Week 24, Week 36, Week 48 (End of study))
- Number of Subjects With Rejection of the Kidney Transplant, Post Renal Transplant(up to 48 weeks (End of study))