Recruiting

Symtuza & Biktarvy

Sponsor:

East Carolina University

Code:

NCT05463783

Conditions

HIV Infections

Obesity

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Biktarvy

Symtuza

Study Details

Brief 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.

Conditions

HIV Infections

Obesity

Study ID

NCT05463783

Start date

Mar 14, 2023

Status verified date

Nov, 2023

Completion date

Mar, 2025

Anticipated

Primary completion date

Mar, 2025

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

30 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Basic Science

Interventions and Outcome Measures

Arms

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.

Interventions

Biktarvy

microRNA profiles of subjects on Biktarvy, will be compared with those who are on Symtuza, at various time points.

Symtuza

microRNA profiles of subjects on Symtuza, will be compared with those who are on Biktarvy, at various time points.

Primary outcome measure

  • miRNA(microRNA) profiles of the two groups [ Time Frame: 48 weeks ]
  • Change from baseline in Body mass index-BMI(kg/m^2) of the participants [ Time Frame: 48 weeks ]
  • Change from baseline in body weight(in kilograms or kg) of the participants [ Time Frame: 48 weeks ]

Central Contacts and Locations

Central contacts

Locations

Adult Specialty Care Clinic-East Carolina University

Recruiting

Greenville, North Carolina, United States, 27834

Contacts

More Information

Sponsor

East Carolina University

Last update posted

Nov 14, 2023

Last verified

Nov, 2023

Keywords

  • microRNA
  • miRNA
  • ARV
  • Antiretroviral medications

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by East Carolina University on 2023-11-14.