HIV InfectionsPhase 4NCT05463783
Effect of Biktarvy & Symtuza on microRNAs in HIV and Correlation With Weight Gain
A Phase 4 study testing Biktarvy and Symtuza in people with HIV Infections and Obesity, run by East Carolina University at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- HIV Infections, Obesity
- What is being tested?
- Biktarvy and Symtuza
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- 14 Mar 2023to Mar 2025
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
Adult Specialty Care Clinic-East Carolina University
Greenville, North Carolina, 27834
Jamie Wigent, RN, 252-414-2655, wigentj17@ecu.edu
Allison Geigel, RN, 252-414-2655, geigela20@ecu.edu
About this study
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
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.
Read the detailed 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.
- Conditions
- HIV Infections, Obesity
- Being tested
- Biktarvy, Symtuza
- Keywords
- microRNA, miRNA, ARV, Antiretroviral medications
- Medical subject headings
- HIV Infections, Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BiktarvyDrug
Also called bictegravir/emtricitabine/tenofovir alafenamide
microRNA profiles of subjects on Biktarvy, will be compared with those who are on Symtuza, at various time points.
SymtuzaDrug
Also called darunavir/cobicistat/emtricitabine/tenofovir alafenamide
microRNA profiles of subjects on Symtuza, will be compared with those who are on Biktarvy, at various time points.
| Study group | Role | What they receive |
|---|---|---|
| Biktarvy | Experimental | 15 subjects will get Biktarvy (single-tablet regimen of bictegravir/emtricitabine/tenofovir alafenamide) once daily. Receives: Drug: Biktarvy |
| Symtuza | Experimental | 15 subjects will get Symtuza (single-tablet regimen of darunavir/cobicistat/emtricitabine/tenofovir alafenamide) once daily. Receives: Drug: Symtuza |
What is being measured
The primary outcome is the main question the study is designed to answer.
miRNA(microRNA) profiles of the two groups
we will monitor microRNAs of the two groups
Measured: 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
Measured: 48 weeks
Change from baseline in body weight(in kilograms or kg) of the participants
we will monitor change in body weight \& BMI
Measured: 48 weeks
Secondary outcomes (1)
Calorie intake of subjects in the two groups.
we will monitor calorie intake of subjects in two grouos
Measured: 48 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jul 2022
- Study start14 Mar 2023
- Primary completionMar 2025 (estimated)
- Study completionMar 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for HIV InfectionsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Interventional, open-label, parallel-group, randomized trial
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- East Carolina University
- Sponsor type
- University, hospital or other
- Collaborators
- Janssen Scientific Affairs, LLC
- Responsible party
- Principal investigator, Paul Cook, East Carolina University
- Investigators
- Paul Cook, MD, Principal investigator, East Carolina University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05463783
- Sponsor's protocol ID
- UMCIRB 22-000833
- Status last verified
- Nov 2023
- First submitted
- 25 May 2022
- Last updated
- 14 Nov 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Majumdar N, Pokharel BR, Williams F, Rajput S, Cook PP, Akula SM. A crucial role for novel miR-12137-3p in supporting weight gain in treatment naive HIV-infected patients on antiretroviral therapies. J Transl Med. 2026 Feb 28;24(1):473. doi: 10.1186/s12967-026-07922-8.
PubMed 41764532
Study at a glance
From the registry record, last updated by the sponsor on 14 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05463783
- Acronym / sponsor ID
- UMCIRB 22-000833
- Conditions
- HIV Infections, Obesity
- Keywords
- microRNA, miRNA, ARV, Antiretroviral medications
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- East Carolina UniversityUniversity, hospital or other
- Collaborators
- Janssen Scientific Affairs, LLC
- Study start
- 14 Mar 2023 (actual)
- Primary completion
- Mar 2025 (estimated)
- Study completion
- Mar 2025 (estimated)
- First posted
- 19 Jul 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Interventional, open-label, parallel-group, randomized trial
| Arm | Type | Receives |
|---|---|---|
| Biktarvy | Experimental | Drug: Biktarvy15 subjects will get Biktarvy (single-tablet regimen of bictegravir/emtricitabine/tenofovir alafenamide) once daily. |
| Symtuza | Experimental | Drug: Symtuza15 subjects will get Symtuza (single-tablet regimen of darunavir/cobicistat/emtricitabine/tenofovir alafenamide) once daily. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BiktarvyAlso: bictegravir/emtricitabine/tenofovir alafenamidemicroRNA profiles of subjects on Biktarvy, will be compared with those who are on Symtuza, at various time points. | Drug | Biktarvy |
| SymtuzaAlso: darunavir/cobicistat/emtricitabine/tenofovir alafenamidemicroRNA profiles of subjects on Symtuza, will be compared with those who are on Biktarvy, at various time points. | Drug | Symtuza |
Primary outcome
miRNA(microRNA) profiles of the two groups
Time frame: 48 weeks
we will monitor microRNAs of the two groups
Change from baseline in Body mass index-BMI(kg/m^2) of the participants
Time frame: 48 weeks
Weight(in kilograms or kg) and height(in meters or m) will be combined to report BMI in kg/m^2
Change from baseline in body weight(in kilograms or kg) of the participants
Time frame: 48 weeks
we will monitor change in body weight \& BMI
1 secondary outcome
Calorie intake of subjects in the two groups.
Time frame: 48 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Nov 2023.
- Derived from this study: PubMed 41764532Majumdar N, Pokharel BR, Williams F, Rajput S, Cook PP, Akula SM. A crucial role for novel miR-12137-3p in supporting weight gain in treatment naive HIV-infected patients on antiretroviral therapies. J Transl Med. 2026 Feb 28;24(1):473. doi: 10.1186/s12967-026-07922-8.
- Individual participant dataSharing planned: No
Related trials for HIV Infections
Not yet recruiting
HealthMpowerment Korea: Pilot Testing the Cultural Adaptation of a Digital HIV Intervention for Men Who Have Sex With Men in South Korea
HIV Infections, HIV Prevention and Care
Not yet recruiting
Prescribe to Prevent HIV: A Hybrid Trial Helping Addiction Clinics Prevent HIV & Infections Through Safer Drug Use Support
People Who Use Opioids/People With Opioid Use Disorder (OUD)
Recruiting
Evaluating the Impact of Using the B-OK Bottles for HIV and ART Literacy in South Africa
HIV, HIV Treatment
Recruiting
Trial Phase: Syndemic Adapted Medly Uganda
Mental Health
RecruitingObservational study
Olfactory Function and Model-Based Behavior in People Living With HIV and SUD
HIV, Substance Use Disorder
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Paul Cook, MD principal investigator
East Carolina University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Biktarvy and Symtuza in people with HIV Infections and Obesity, run by East Carolina University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 14 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Paul Cook, MD (252-744-4500, cookp@ecu.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
miRNA(microRNA) profiles of the two groups (time frame: 48 weeks). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05463783, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Nov 2023.