Early Clinico Pharmacological Effects of Tenofovir Lamivudine Dolutegravir regimen on Renal Parameters, CD4 Count, and Lipid Profile in Patients with Human Immunodeficiency Virus Infection.
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- To assess changes in renal parameters serum creatinine estimated glomerular filtration rate [eGFR]), CD4 count, and lipid profile (total cholesterol [TC], low- density lipoprotein [LDL], high-density lipoprotein [HDL], triglycerides) in HIV patients on TLD from baseline to 3rd and 6th month.
研究概览
简要总结
Evaluating the early clinico pharmacological effects of the TLD regimen is important because it helps identify how quickly and safely patients respond to this first-line antiretroviral therapy. Early monitoring of renal parameters, CD4 count, and lipid profile provides insight into the drug’s tolerability, efficacy, and safety. Since tenofovir can affect kidney function and dolutegravir may influence lipid metabolism, early detection of any adverse changes allows timely intervention to prevent long-term complications. Moreover, tracking CD4 count improvements helps assessimmune recovery and overall treatment effectiveness, ensuring optimal patient outcomes and adherence.
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 1.00 Month(s) 至 70.00 Year(s)（—）
- 性别
- All
入选标准
- •Patients with confirmed HIV infection.
- •Initiated on TLD regimen (treatment naïve or switched from other ART) for less than 1 month at enrollment.
- •Willing to provide written informed consent.
排除标准
- •Severe renal impairment at baseline.
- •Pregnant or breastfeeding women.
- •Known hypersensitivity to TLD components.
- •Incomplete baseline data for primary outcomes.
结局指标
主要结局
To assess changes in renal parameters serum creatinine estimated glomerular filtration rate [eGFR]), CD4 count, and lipid profile (total cholesterol [TC], low- density lipoprotein [LDL], high-density lipoprotein [HDL], triglycerides) in HIV patients on TLD from baseline to 3rd and 6th month.
时间窗: baseline which is at 0 months | 3rd month | 6th month
次要结局
- To assess changes in renal parameters serum creatinine estimated glomerular filtration rate eGFR, CD4 count & lipid profile total cholesterol , low- density lipoprotein high-density lipoprotein triglycerides in HIV patients on TLD from baseline to 3rd & 6th month.(at 6 months)
研究者
Dr Abhishek Dass
Gajra Raja Medical College, Gwalior