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| Name | Class |
|---|---|
| Janssen Scientific Affairs, LLC | INDUSTRY |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Biktarvy | Experimental | 15 subjects will get Biktarvy (single-tablet regimen of bictegravir/emtricitabine/tenofovir alafenamide) once daily. |
|
| Symtuza | Experimental | 15 subjects will get Symtuza (single-tablet regimen of darunavir/cobicistat/emtricitabine/tenofovir alafenamide) once daily. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Biktarvy | Drug | microRNA profiles of subjects on Biktarvy, will be compared with those who are on Symtuza, at various time points. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Calorie intake of subjects in the two groups. | we will monitor calorie intake of subjects in two grouos | 48 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Paul Cook, MD | Contact | 252-744-4500 | cookp@ecu.edu | |
| Smit Rajput, MD | Contact | 252-744-2574 | rajputs20@ecu.edu |
| Name | Affiliation | Role |
|---|---|---|
| Paul Cook, MD | East Carolina University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Adult Specialty Care Clinic-East Carolina University | Recruiting | Greenville | North Carolina | 27834 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41764532 | Derived | 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. |
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| Type | Date | Date Unknown |
|---|---|---|
| Release | Oct 13, 2025 | |
| Unrelease | Nov 4, 2025 |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Oct 13, 2025 | Nov 4, 2025 |
| ID | Term |
|---|---|
| D015658 | HIV Infections |
| D009765 | Obesity |
| ID | Term |
|---|---|
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D007239 | Infections |
| D015229 | Sexually Transmitted Diseases, Viral |
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| ID | Term |
|---|---|
| C000654125 | bictegravir, emtricitabine, tenofovir alafenamide, drug combination |
| C000632565 | symtuza |
| D000069454 | Darunavir |
| ID | Term |
|---|---|
| D013449 | Sulfonamides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D002219 | Carbamates |
| D000144 |
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Interventional, open-label, parallel-group, randomized trial
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| Symtuza | Drug | microRNA profiles of subjects on Symtuza, will be compared with those who are on Biktarvy, at various time points. |
|
|
| D012749 | Sexually Transmitted Diseases |
| D016180 | Lentivirus Infections |
| D012192 | Retroviridae Infections |
| D012327 | RNA Virus Infections |
| D014777 | Virus Diseases |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D007153 | Immunologic Deficiency Syndromes |
| D007154 | Immune System Diseases |
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
| D001835 | Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| Acids, Acyclic |
| D002264 | Carboxylic Acids |
| D013450 | Sulfones |
| D013457 | Sulfur Compounds |
| D005663 | Furans |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |