Role of Empagliflozin in Metabolic Changes Associated With Antiretroviral Therapy in Human Immunodeficiency Virus
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 66
- 试验地点
- 2
- 主要终点
- Weight change
研究概览
简要总结
We investigate the role of empagliflozin in the treatment of obesity in PLWH.
详细描述
HIV remains a major global public health concern. In 2024, approximately 40.8 million people were living with HIV worldwide. Around 630,000 deaths occurred due to AIDS-related illnesses. The preferred first-line ART regimen includes: Tenofovir disoproxil fumarate (TDF)+Emtricitabine (FTC) or Lamivudine (3TC)+Dolutegravir (DTG).
The introduction of highly active antiretroviral therapy transformed HIV from a fatal disease into a manageable chronic condition, significantly reducing morbidity and mortality.
Integrase strand transfer inhibitors (INSTIs), particularly dolutegravir (DTG), have been associated with greater weight gain compared with non-INSTI antiretroviral regimens.
The observed weight gain is strongly linked to adverse metabolic outcomes, including increased incidence of metabolic syndrome, higher rates of insulin resistance, and dyslipidemia.
Individuals living with HIV receiving antiretroviral therapy (ART) have been shown to have approximately 1.5-fold higher odds of developing metabolic syndrome (MetS).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age >18 years up to 65 years old.
- •Body Mass Index (BMI) > 30 kg/m^
- •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.
排除标准
- •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
研究组 & 干预措施
Control Group
Patients in the control group will receive an identical placebo and Standard Antiretroviral Therapy (ART)
干预措施: Placebo (Drug)
EMPA Group + SOC
Patients in the intervention arm will receive Empagliflozin 10 mg once daily for 6 months in addition to the standard DTG-based antiretroviral therapy.
干预措施: Empagliflozin (oral) (Drug)
结局指标
主要结局
Weight change
时间窗: 6 months
Weight will be measured in kilograms using a calibrated scale from baseline to 6 months in PLWH on dolutegravir-based antiretroviral therapy.
次要结局
- Change in Fasting Blood Glucose(6 months)
- Change in Glycated Hemoglobin (HbA1c)(6 months)
- Change in Serum Creatinine(6 months)
- Change in Total Cholesterol(6 months)
- Change in Systolic and Diastolic Blood Pressure(6 months)
- Change in Waist Circumference(Baseline, 3 and 6 months)
- Change in Absolute CD4+ T-cell Count(baseline and 6 months)
- Change in Body Mass Index (BMI)(Baseline and 6 months)
- Change in Plasma HIV-1 RNA Viral Load(baseline and 6 months)
研究者
Abdelrahman Mahmoud
Teaching and Research Assistant
Cairo University