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

NCT05463783 | Unknown Phase 4 FDA Drug

• 1 other identifier: UMCIRB 22-000833
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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

Keywords

microRNA; miRNA; ARV; Antiretroviral medications

Outcome Measures

Primary Outcomes (3)

• miRNA(microRNA) profiles of the two groups

  we will monitor microRNAs of the two groups

  48 weeks

• Change from baseline in Body mass index-BMI(kg/m^2) of the participants

  Weight(in kilograms or kg) and height(in meters or m) will be combined to report BMI in kg/m\^2

  48 weeks

• Change from baseline in body weight(in kilograms or kg) of the participants

  we will monitor change in body weight \& BMI

  48 weeks

Secondary Outcomes (1)

• Calorie intake of subjects in the two groups.

  48 weeks

Study Arms (2)

Biktarvy

EXPERIMENTAL

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

Drug: Biktarvy

Symtuza

EXPERIMENTAL

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

Drug: Symtuza

Interventions

Biktarvy DRUG

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

Also known as: bictegravir/emtricitabine/tenofovir alafenamide

Biktarvy

Symtuza DRUG

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

Also known as: darunavir/cobicistat/emtricitabine/tenofovir alafenamide

Symtuza

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• Morbid obesity (BMI\>/=40) or cachexia (BMI=/\<20)
• Known or suspected active substance abuse that in the opinion of the investigator would impact study participation
• On medications associated with weight loss or gain, including insulin, glucagon-like peptide(GLP)-1 analogs, anti-depressants, antipsychotics, corticosteroids, orlistat
• Bedbound due to other chronic conditions
• Pregnant females
• Prisoners
• Unwilling or unable to comply with protocol requirements.
• On medication known to interact significantly with any of the components of Symtuza or Biktarvy.

Sponsors & Collaborators

• East Carolina University: lead
• Janssen Scientific Affairs, LLC: collaborator

Study Sites (1)

Adult Specialty Care Clinic-East Carolina University

Greenville, North Carolina, 27834, United States

RECRUITING

MeSH Terms

Conditions

HIV Infections; Obesity

Interventions

bictegravir, emtricitabine, tenofovir alafenamide, drug combination; symtuza; Darunavir

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases; Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Sulfonamides; Amides; Organic Chemicals; Carbamates; Acids, Acyclic; Carboxylic Acids; Sulfones; Sulfur Compounds; Furans; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Paul Cook, MD

  East Carolina University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Paul Cook, MD

CONTACT

252-744-4500; cookp@ecu.edu

Smit Rajput, MD

CONTACT

252-744-2574; rajputs20@ecu.edu

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Professor

Model Details: Interventional, open-label, parallel-group, randomized trial

Study Record Dates

• First Submitted: May 25, 2022
• First Posted: July 19, 2022
• Study Start: March 14, 2023
• Primary Completion: March 1, 2025
• Study Completion: March 1, 2025
• Last Updated: November 14, 2023

Record last verified: 2023-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)