RECRUITING

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

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

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.

Official Title

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

Quick Facts

Study Start:2023-03-14
Study Completion:2025-03
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05463783

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.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. 1. Subjects age \>/=18 years
  2. 2. HIV infection with HIV RNA \>/= 1000 copies/ml of plasma
  3. 3. Treatment naïve
  4. 4. Have access to a smartphone with internet access
  5. 5. Willing to provide written informed consent.
  1. 1. Morbid obesity (BMI\>/=40) or cachexia (BMI=/\<20)
  2. 2. Known or suspected active substance abuse that in the opinion of the investigator would impact study participation
  3. 3. On medications associated with weight loss or gain, including insulin, glucagon-like peptide(GLP)-1 analogs, anti-depressants, antipsychotics, corticosteroids, orlistat
  4. 4. Bedbound due to other chronic conditions
  5. 5. Pregnant females
  6. 6. Prisoners
  7. 7. Unwilling or unable to comply with protocol requirements.
  8. 8. On medication known to interact significantly with any of the components of Symtuza or Biktarvy.

Contacts and Locations

Study Contact

Paul Cook, MD
CONTACT
252-744-4500
cookp@ecu.edu
Smit Rajput, MD
CONTACT
252-744-2574
rajputs20@ecu.edu

Principal Investigator

Paul Cook, MD
PRINCIPAL_INVESTIGATOR
East Carolina University

Study Locations (Sites)

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

Collaborators and Investigators

Sponsor: East Carolina University

  • Paul Cook, MD, PRINCIPAL_INVESTIGATOR, East Carolina University

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-03-14
Study Completion Date2025-03

Study Record Updates

Study Start Date2023-03-14
Study Completion Date2025-03

Terms related to this study

Keywords Provided by Researchers

  • microRNA
  • miRNA
  • ARV
  • Antiretroviral medications

Additional Relevant MeSH Terms

  • HIV Infections
  • Obesity