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

Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 4
SUMMARY

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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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.

Locations
United States
North Carolina
Adult Specialty Care Clinic-East Carolina University
RECRUITING
Greenville
Contact Information
Primary
Paul Cook, MD
cookp@ecu.edu
252-744-4500
Backup
Smit Rajput, MD
rajputs20@ecu.edu
252-744-2574
Time Frame
Start Date: 2023-03-14
Estimated Completion Date: 2025-03
Participants
Target number of participants: 30
Treatments
Experimental: Biktarvy
15 subjects will get Biktarvy (single-tablet regimen of bictegravir/emtricitabine/tenofovir alafenamide) once daily.
Experimental: Symtuza
15 subjects will get Symtuza (single-tablet regimen of darunavir/cobicistat/emtricitabine/tenofovir alafenamide) once daily.
Related Therapeutic Areas
Sponsors
Collaborators: Janssen Scientific Affairs, LLC
Leads: East Carolina University

This content was sourced from clinicaltrials.gov