Effect of Empagliflozin on Metabolic Outcomes in Adults Living With HIV Receiving Dolutegravir-Based Therapy
Role of Empagliflozin in Metabolic Changes Associated With Antiretroviral Therapy in Human Immunodeficiency Virus
Abdelrahman Mahmoud
66 participants
Sep 1, 2025
INTERVENTIONAL
Conditions
Summary
We investigate the role of empagliflozin in the treatment of obesity in PLWH.
Eligibility
Inclusion Criteria6
- Age \>18 years up to 65 years old.
- Body Mass Index (BMI) \> 30 kg/m\^2.
- Currently receiving an integrase strand transfer inhibitor (INSTI)-based regimen (dolutegravir-based ART).
- Sustained virologic suppression, defined as HIV-1 RNA \< 200 copies/mL for at least 6 months.
- Current CD4 count \> 250 cells/mL.
- Ability and willingness to provide written informed consent.
Exclusion Criteria9
- Diagnosis of Diabetes Mellitus, defined as a fasting blood glucose level \> 126 mg/dL or glycated hemoglobin (HbA1c) \> 6.5% (or per ADA definition).
- Renal impairment (e.g., eGFR \< 60 ml/min/1.73m\^2).
- Active viral hepatitis B or C.
- Hypersensitivity to empagliflozin or any of its excipients.
- Pregnancy or breastfeeding.
- Current use of other SGLT-2 inhibitors.
- Drugs that may interact with empagliflozin (e.g., rifampin or phenytoin) or dolutegravir (e.g., antacids, carbamazepine, or phenytoin).
- Current or recent use of medications known to be associated with significant weight gain (e.g., systemic corticosteroids, antipsychotics, mood stabilizers, or other agents with established weight-promoting effects).
- Known thyroid disease, defined as TSH \> 6.0 mIU/L or \< 0.35 mIU/L
Interventions
Empagliflozin is an oral medication used primarily to treat type 2 diabetes. It belongs to a class of drugs called SGLT2 inhibitors (sodium-glucose co-transporter 2 inhibitors). Empagliflozin blocks SGLT2 proteins in the kidneys. This prevents glucose reabsorption, causing excess sugar to be excreted in urine. It helps lower blood sugar levels and can also reduce body weight and blood pressure.
TDF/FTC+DLG
Locations(1)
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NCT07336797