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

Launched by EAST CAROLINA UNIVERSITY · Jul 14, 2022

Keywords

ClinConnect Summary

This clinical trial is studying how two different HIV medications, Biktarvy and Symtuza, affect weight gain in people with HIV. The researchers want to understand why some HIV treatments lead to more weight gain than others by looking at tiny molecules in the body called micro-RNAs, which help control how genes work. By comparing the micro-RNA levels in people taking either Biktarvy or Symtuza over 48 weeks, the team hopes to find out how these medications influence changes in body weight and body mass index (BMI). They will also track participants' calorie intake to see how it relates to weight changes during treatment.

To participate in this study, you need to be at least 18 years old, have a confirmed HIV infection, and not have started treatment yet. You’ll also need access to a smartphone and be willing to give your consent to join. Participants can expect to have their weight and other health information monitored throughout the trial. This research could help improve our understanding of HIV treatments and their impact on weight gain, which is important for the health of people living with HIV.

Gender

ALL

Eligibility criteria

• 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.