TO STUDY THE EFFICACY AND SAFETY OF THE TENOFOVIR, LAMIVUDINE & DOLUTEGRAVIR (TLD) REGIMEN BY ASSESSING HEMATOLOGICAL AND BIOCHEMICAL PARAMETERS IN NEWLY DIAGNOSED HIV PATIENTS: A PROSPECTIVE OBSERVATIONAL STUDY
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 190
- 试验地点
- 1
- 主要终点
- Change in hematological and biochemical parameters over time in newly diagnosed HIV patients receiving TLD regimen.
研究概览
简要总结
This study aims to evaluate the efficacy and safety of the Tenofovir, Lamivudine, and Dolutegravir (TLD) regimen in newly diagnosed HIV patients. It is a prospective observational study conducted at the ART centre of Bowring and Lady Curzon Hospital, Bangalore. The study will assess changes in hematological and biochemical parameters such as hemoglobin, liver enzymes, renal markers, and lipid profile at baseline, 3 months, and 6 months of TLD therapy. A total of 190 participants will be enrolled and monitored for drug adherence and adverse drug reactions. The goal is to generate region-specific data on the safety and treatment outcomes of the TLD regimen in the Indian population.
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 18.00 Year(s) 至 99.00 Year(s)（—）
- 性别
- All
入选标准
- •1.Newly diagnosed HIV patients aged more than 18 years initiated on TLD therapy 2.Patients providing informed consent for participation.
排除标准
- •Patients with abnormal Liver function tests, Renal function tests, Lipid profiles and all types of Anaemia (IDA, Megaloblastic anaemia etc.) which may have confounding factors that affect the interpretation of Hematological and Biochemical parameters
- •Pregnant or lactating women.
- •Patients diagnosed with any co-morbid conditions such as diabetes mellitus, hypertension, tuberculosis, hepatitis B or C, chronic kidney disease, or any other condition.
结局指标
主要结局
Change in hematological and biochemical parameters over time in newly diagnosed HIV patients receiving TLD regimen.
时间窗: 1. At Baseline | 2. At 3 months | 3. At 6 months
次要结局
未报告次要终点
研究者
Dr GAJENDRA G
Shri Atal Bihari Vajpayee Medical College and Research Institute