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

NCT07336797

RecruitingPhase 2

Sponsor: Abdelrahman Mahmoud

Conditions: Metabolic Syndrome, Obesity & Overweight, HIV (Human Immunodeficiency Virus)

Interventions: Empagliflozin (oral), Placebo

Countries: Egypt

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

Eligibility overview

Sex: ALL

Age: 18 Years to 65 Years

Healthy volunteers: No

Study type: INTERVENTIONAL

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 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

Locations (1)

Cairo, Egypt