Effect of Empagliflozin on Metabolic Outcomes in Adults Living With HIV Receiving Dolutegravir-Based Therapy

Korábbi kezelés

• 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).

Más betegség

• Active viral hepatitis B or C.
• Hypersensitivity to empagliflozin or any of its excipients.
• Known thyroid disease, defined as TSH > 6.0 mIU/L or < 0.35 mIU/L

Laborértékek

• 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).

Egyéb

• Pregnancy or breastfeeding.

• 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.