Study of Renal Adverse Effects of Tenofovir Containing Regimen in HIV Infected Children
试验速览
- 阶段
- Phase 3 4
- 状态
- 尚未招募
- 入组人数
- 70
- 试验地点
- 1
- 主要终点
- 2.Changes of serum creatinine from base line
研究概览
简要总结
This study enrolled HIV infected children aged from 10 to 21 years or weighing more than 30kg, receiving tenofovir containing regimens for at least 6 months at ART Centre, It is a single Centre observational analytical cross sectional study based on renal function parameters by serum and urine analysis. This study will improve the overall management of HIV infected children and help in improving the quality of life in these children.
Inclusion criteria-
-
All HIV infected children from age 10 years or weight more than 30 kg to 21 years of age receiving tenofovir containing ART for at least 6 months
-
eGFR more than 60 ml/min/m2 at enrolment
-
Individuals whose base line parameters available before starting treatment
Exclusion criteria-
-
History of hypertension, diabetes mellitus, congenital heart disease, chronic liver failure, cardiovascular disease, nephrotic syndrome
-
Hepatitis B and C infection
-
Transfer of care to the other medical care facilities
Laboratory parameters-
CD4 count, serum creatinine, serum protein, serum phosphate, serum uric acid, serum potassium, RBS, urinary protein, urinary glucose will be measured and eGFR, creatinine clearance will be calculated
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 10.00 Year(s) 至 21.00 Year(s)（—）
- 性别
- All
入选标准
- •1.All HIV infected children from age 10 years or weight more than 30 kg to 21 years of age receiving Tenofovir containing ART for at least 6 months 2.eGFR more than 60 ml/min/m2 3.Individuals whose base line parameters available before starting ART treatment.
排除标准
- •1.History of Hypertension, Diabetes Mellitus, Congenital Heart disease, Chronic liver failure, Cardio Vascular Disease, Nephrotic syndrome.
- •2.Hepatitis B and C infection.
- •3.Transfer of care to other medical care facilities.
结局指标
主要结局
2.Changes of serum creatinine from base line
时间窗: 3 months
1.Changes of eGFR from base line
时间窗: 3 months
3.Changes in creatinine clearance from base line
时间窗: 3 months
次要结局
- 1.Changes of CD4 count from base line(2.Changes of Serum phosphate during treatment)