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

University of North Carolina System

Status and phase: Enrolling; Phase 4

Conditions: Obesity; HIV Infections

Treatments: Drug: Biktarvy; Drug: Symtuza

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT05463783

UMCIRB 22-000833

Details and patient eligibility

About

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.

Full description

With advances in HIV treatment, the life expectancy of persons with HIV (PWH) has improved and complications associated with antiretroviral (ARV) medications have become more apparent. Among them, weight gain and obesity, because of their associated complications, is one of the more concerning ones. Certain drug regimens are more adipogenic than others, but not a lot is known about molecular mechanisms responsible for these differences. Micro RNAs (miRNAs) are small non-coding RNAs that control gene expression and regulate a wide array of biological processes. In recent years miRNAs have been studied in a number of diseases for diagnostic and even therapeutic purposes. There are studies showing differences in miRNA profiles in obese vs non-obese non-HIV population, as well as certain miRNAs as biomarkers of response to weight-loss diets. In PWH, there are studies that looked at the effect of HIV infection on the miRNA profile and how a particular miRNA profile is predictive of ARV resistance. But there are no studies that specifically looked at how ARV medications alter the miRNA profile and how (in terms of miRNA profiles) one combination is more adipogenic than the other.

Enrollment: 30 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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30 participants in 2 patient groups

Biktarvy

Experimental group

Description:

15 subjects will get Biktarvy (single-tablet regimen of bictegravir/emtricitabine/tenofovir alafenamide) once daily.

Treatment:

Drug: Biktarvy

Symtuza

Experimental group

Description:

15 subjects will get Symtuza (single-tablet regimen of darunavir/cobicistat/emtricitabine/tenofovir alafenamide) once daily.

Treatment:

Drug: Symtuza