Comparing the effects of two HIV medications on weight gain and microRNAs
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
This study is testing how two different HIV medications, Biktarvy and Symtuza, affect weight gain and the body's microRNAs in people living with HIV over 48 weeks.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Enrollment | 30 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | East Carolina University Academic / other |
| Locations | 1 site (Greenville, North Carolina) |
| Trial ID | NCT05463783 on ClinicalTrials.gov |
What this trial studies
This research aims to investigate the differences in weight gain associated with two HIV medication regimens: Biktarvy and Symtuza. The study will analyze the microRNA profiles of participants taking each medication over a 48-week period, correlating these profiles with changes in body weight and BMI. Additionally, calorie intake will be monitored to understand its relationship with treatment-induced weight gain. The goal is to uncover the molecular mechanisms behind the varying effects of these antiretroviral medications on weight gain in individuals with HIV.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older who are treatment-naïve and have an HIV RNA level of 1000 copies/ml or higher.
Not a fit: Patients with morbid obesity, cachexia, or those on medications that significantly affect weight may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to more personalized HIV treatment options that minimize weight gain for patients.
How similar studies have performed: While there have been studies on microRNA profiles in obesity and HIV, this specific approach comparing the adipogenic effects of these two ARV regimens is novel.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Greenville, North Carolina
- Adult Specialty Care Clinic-East Carolina University — Greenville, North Carolina, United States (Recruiting)
Study contacts
- Principal investigator: Paul Cook, MD — East Carolina University
- Study coordinator: Paul Cook, MD
- Email: cookp@ecu.edu
- Phone: 252-744-4500
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.