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

Recruiting · NCT07336797 · Interventional (participants receive a specific treatment) · Lead sponsor: Abdelrahman Mahmoud

Interventions studied

Empagliflozin (oral)Placebo

We investigate the role of empagliflozin in the treatment of obesity in PLWH.

Age range

18 Years to 65 Years

Sex

All (male and female)

Healthy volunteers

No - a diagnosis or condition is required

Phase

Phase 2

Study type

Interventional (participants receive a specific treatment)

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.

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

1 location listed.