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Effect of Biktarvy & Symtuza on microRNAs in HIV and Correlation With Weight Gain

Description

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.

Study Overview

Study Details

Study overview

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.

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

Effect of Biktarvy & Symtuza on microRNAs in HIV and Correlation With Weight Gain

Condition
HIV Infections
Intervention / Treatment

-

Contacts and Locations

Greenville

Adult Specialty Care Clinic-East Carolina University, Greenville, North Carolina, United States, 27834

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility 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.
  • 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.

Ages Eligible for Study

18 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

East Carolina University,

Paul Cook, MD, PRINCIPAL_INVESTIGATOR, East Carolina University

Study Record Dates

2025-03