A Phase 4 interventional study of Biktarvy and Symtuza in HIV Infections and Obesity, sponsored by East Carolina University. Recruiting at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-11-14.
Sponsored by East Carolina University · Phase 4, Interventional, and Basic science
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.
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.
4,258 studies on the registry are indexed under HIV Infections; 240 are open to participants now.
This study's planned enrollment of 30 is below the median of 83 across 3,251 interventional studies indexed under HIV Infections.
Browse HIV Infections studies →East Carolina University is the lead sponsor of 83 studies on the registry; 13 are open to participants now.
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Exclusion Criteria:
15 subjects will get Biktarvy (single-tablet regimen of bictegravir/emtricitabine/tenofovir alafenamide) once daily.
Drug: Biktarvy
15 subjects will get Symtuza (single-tablet regimen of darunavir/cobicistat/emtricitabine/tenofovir alafenamide) once daily.
Drug: Symtuza
microRNA profiles of subjects on Biktarvy, will be compared with those who are on Symtuza, at various time points.
Also known as: bictegravir/emtricitabine/tenofovir alafenamide
microRNA profiles of subjects on Symtuza, will be compared with those who are on Biktarvy, at various time points.
Also known as: darunavir/cobicistat/emtricitabine/tenofovir alafenamide
miRNA(microRNA) profiles of the two groups
we will monitor microRNAs of the two groups
Time frame: 48 weeks
Change from baseline in Body mass index-BMI(kg/m^2) of the participants
Weight(in kilograms or kg) and height(in meters or m) will be combined to report BMI in kg/m\^2
Time frame: 48 weeks
Change from baseline in body weight(in kilograms or kg) of the participants
we will monitor change in body weight \& BMI
Time frame: 48 weeks
Calorie intake of subjects in the two groups.
we will monitor calorie intake of subjects in two grouos
Time frame: 48 weeks
Plan to share: No
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