← Back to Clinical Trials
Recruiting Phase 2 NCT07336797

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

Trial Parameters

Condition Metabolic Syndrome
Sponsor Abdelrahman Mahmoud
Study Type INTERVENTIONAL
Phase Phase 2
Enrollment 66
Sex ALL
Min Age 18 Years
Max Age 65 Years
Start Date 2025-09-01
Completion 2026-12-30
Interventions
Empagliflozin (oral)Placebo

Brief Summary

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

Eligibility Criteria

Inclusion Criteria: * 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 Criteria: * 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

Related Trials