Empagliflozin for metabolic health in adults with HIV on dolutegravir

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This phase 2 interventional trial compares empagliflozin versus placebo in adults with obesity (BMI >30 kg/m2) who are living with HIV and receiving dolutegravir-based ART. Eligible participants are aged 18–65, virologically suppressed (HIV-1 RNA <200 copies/mL) for at least 6 months with CD4 >250, and do not have diabetes, significant renal impairment, or active hepatitis. Participants will receive empagliflozin or placebo and undergo repeated metabolic assessments such as weight, measures of insulin resistance, lipid profiles, and liver-related markers over the treatment period. The trial aims to determine whether SGLT2 inhibition can mitigate dolutegravir-associated weight gain and related cardiometabolic disturbances.

Why it matters

Who can join: the full rules

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

Where it's running

• Faculty of Pharmacy, Cairo University | Kasr El-Aini, Cairo
  Cairo, Egypt Recruiting

Study contacts

• Principal investigator: Abedalrahman Dosoky — Cairo University
• Study coordinator: Abdelrahman Dosoky, Bachelor's degree
• Email: abdelrahman.ibrahim@pharma.cu.edu.eg
• Phone: +201148534951

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.