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

UMCIRB 22-000833

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.

2023-03-14

2025-03-01

2025-03-01

Recruiting

Early phase I

30

Inclusion Criteria: 1. Subjects age \>/=18 years 2. HIV infection with HIV RNA \>/= 1000 copies/ml of plasma 3. Treatment naïve 4. Have access to a smartphone with internet access 5. Willing to provide written informed consent. Exclusion Criteria: 1. Morbid obesity (BMI\>/=40) or cachexia (BMI=/\<20) 2. Known or suspected active substance abuse that in the opinion of the investigator would impact study participation 3. On medications associated with weight loss or gain, including insulin, glucagon-like peptide(GLP)-1 analogs, anti-depressants, antipsychotics, corticosteroids, orlistat 4. Bedbound due to other chronic conditions 5. Pregnant females 6. Prisoners 7. Unwilling or unable to comply with protocol requirements. 8. On medication known to interact significantly with any of the components of Symtuza or Biktarvy.

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2023-11-14