Effect of Darunavir/Cobicistat/Emtricitabine/Tenofovir Alafenamide and Bictegravir/Emtricitabine/Tenofovir Alafenamide on the Circulatory microRNA Profile in Treatment naïve HIV Patients, and Its Correlation With Change in Body Weight
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- miRNA(microRNA) profiles of the two groups
研究概览
简要总结
The purpose of this research study is to understand why certain HIV medication regimens (called anti-retroviral or ARV medications) cause more weight gain than others. In this research, the investigators will compare micro-RNA profiles of people who take Symtuza(darunavir(D)/cobicistat(C)/emtricitabine(F)/tenofovir alafenamide (TAF))[D/C/F/TAF] with those who take Biktarvy(bictegravir(B)/emtricitabine(F)/tenofovir alafenamide (TAF))[B/F/TAF] and try to correlate this with the change in body weight and BMI over a course of 48 weeks. The investigators will also attempt to monitor the calorie intake of the participants in the two groups and correlate it with treatment-induced weight gain. Micro-RNAs are small molecules that are produced naturally in the human body, and which are responsible for modifying the expressions of genes. They have the potential to be used in diagnostic and therapeutic medicine and their putative role has been explored in many diseases across many clinical trials. By doing this research, the investigators hope to learn more about their role in HIV disease and its correlation with treatment-induced weight gain.
详细描述
With advances in HIV treatment, the life expectancy of persons with HIV (PWH) has improved and complications associated with antiretroviral (ARV) medications have become more apparent. Among them, weight gain and obesity, because of their associated complications, is one of the more concerning ones. Certain drug regimens are more adipogenic than others, but not a lot is known about molecular mechanisms responsible for these differences. Micro RNAs (miRNAs) are small non-coding RNAs that control gene expression and regulate a wide array of biological processes. In recent years miRNAs have been studied in a number of diseases for diagnostic and even therapeutic purposes. There are studies showing differences in miRNA profiles in obese vs non-obese non-HIV population, as well as certain miRNAs as biomarkers of response to weight-loss diets. In PWH, there are studies that looked at the effect of HIV infection on the miRNA profile and how a particular miRNA profile is predictive of ARV resistance. But there are no studies that specifically looked at how ARV medications alter the miRNA profile and how (in terms of miRNA profiles) one combination is more adipogenic than the other.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 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
- •Subjects age >/=18 years
- •HIV infection with HIV RNA >/= 1000 copies/ml of plasma
- •Treatment naïve
- •Have access to a smartphone with internet access
- •Willing to provide written informed consent.
排除标准
- •Morbid obesity (BMI>/=40) or cachexia (BMI=/<20)
- •Known or suspected active substance abuse that in the opinion of the investigator would impact study participation
- •On medications associated with weight loss or gain, including insulin, glucagon-like peptide(GLP)-1 analogs, anti-depressants, antipsychotics, corticosteroids, orlistat
- •Bedbound due to other chronic conditions
- •Pregnant females
- •Unwilling or unable to comply with protocol requirements.
- •On medication known to interact significantly with any of the components of Symtuza or Biktarvy.
研究组 & 干预措施
Biktarvy
15 subjects will get Biktarvy (single-tablet regimen of bictegravir/emtricitabine/tenofovir alafenamide) once daily.
干预措施: Biktarvy (Drug)
Symtuza
15 subjects will get Symtuza (single-tablet regimen of darunavir/cobicistat/emtricitabine/tenofovir alafenamide) once daily.
干预措施: Symtuza (Drug)
结局指标
主要结局
miRNA(microRNA) profiles of the two groups
时间窗: 48 weeks
we will monitor microRNAs of the two groups
Change from baseline in Body mass index-BMI(kg/m^2) of the participants
时间窗: 48 weeks
Weight(in kilograms or kg) and height(in meters or m) will be combined to report BMI in kg/m\^2
Change from baseline in body weight(in kilograms or kg) of the participants
时间窗: 48 weeks
we will monitor change in body weight \& BMI
次要结局
- Calorie intake of subjects in the two groups.(48 weeks)
研究者
Paul Cook
Clinical Professor
East Carolina University