Incidence and Predictor of TDF Associated Nephrotoxicity and Pharmacokinetic of TDF in HIV-1 Infected Thai Patients: A Sub-study of HIV-NAT 006 Long Term Cohort
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 700
- 试验地点
- 1
- 主要终点
- to validate eGFR Thai equation in HIV-infected adults
研究概览
简要总结
To assess and validate equation eGFR in HIV-infected subjects and -uninfected Thai patients
详细描述
With significant reductions in mortality and risk of progression to AIDS with antiretroviral therapy (ART), complications of long-standing HIV infection and treatment, including renal disease, have become increasingly important. Aging, concomitant metabolic diseases, and use of potentially nephrotoxic ART lead to higher risk for renal disease in HIV-infected persons.WHO encourage TDF as first line ARV regimen. The data on TDF related renal toxicity in Asian population is limited.
For this cohort, we plan to look at these topics:
- proximal tubular dysfunction between TDF and non-TDF user
- incidence and predictor of TDF related renal toxicity
- TDF plasma concentrations
- Pharmacokinetic of TDF when used with boosted DRV, boosted ATV, and boosted LPV in Thai population
- Bone density and vitamin D in patients with and without hypophosphatemia.
- Pharmacogenomic of TDF in Thai population
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Cross Sectional
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •> 18 years old.
- •HIV RNA < 50 copies/ml (For ART-experienced group only).
排除标准
- •a history of Tc-99m DTPA allergy,
- •malnutrition (BMI <18m2),
- •amputation,
- •bed-ridden,
- •currently taking cotrimoxazole or cimetidine,
- •acute deterioration of renal function within the last 3 months,
- •serum creatinine > 1.5 mg/dl, or
- •pregnant/lactating.
结局指标
主要结局
to validate eGFR Thai equation in HIV-infected adults
时间窗: Blood specimens were drawn to assess plasma radioactivity at 5, 10, 20, 30, 60, 90, 120, 180, and 240 minutes post 99mTc-DTPA injection
Test of diagnostic accuracy
次要结局
未报告次要终点