Effect of Empagliflozin on Metabolic Outcomes in Adults Living With HIV Receiving Dolutegravir-Based Therapy
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-65
SponsorAbdelrahman Mahmoud
About this trial
We investigate the role of empagliflozin in the treatment of obesity in PLWH.
Eligibility criteria
Qualifiers
Age >18 years up to 65 years old.
Body Mass Index (BMI) > 30 kg/m².
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.
Disqualifiers
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/1.73m²).
Active viral hepatitis B or C.
Hypersensitivity to empagliflozin or any of its excipients.
Trial design
Treatments tested in this trial
- Empagliflozin (oral)
- Placebo
Treatment groups
66 Participants
are divided into 2 treatment groupsSponsors and collaborators
Abdelrahman Mahmoud
Lead sponsor
Cairo University
Sponsor institution
Source ClinicalTrials.gov