NL-OMON46033已完成3 期
Switching to Tenofovir Alafenamide Fumarate or ABACavir in patients with Tenofovir Disoproxil Fumarate associated eGFR decline. A randomized clinical trial. - BACTAF
适应症
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 80
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 99（—）
入选标准
- •* 18 years or older.
- •* Stable on TDF/FTC or TDF/3TC for ><=12 months (365 days) in combination with a third antiretroviral agent (NNRTI, INI, or PI) and with an unchanged 3th agent for at least 1 month .
- •* HIV-1 RNA <50 copies/mL for * 6 months.
- •* Confirmed/probable TDF-related accelerated eGFR decline
- •* Concomittantly used medication does not interfere with trial procedures (on investigators* discretion).
- •* Patient is negative for the HLA B5701 allele.
排除标准
- •* Likely other cause of non-TDF-related accelerated GFR decline:
- •* Diabetic patients
- •* Hypertensive patients (defined as the use of more than 2 antihypertensives or untreated systolic (>=160mmHg) or diastolic (>=95mmHg) hypertension) or hypertension with use of antihypertensives and with proteinuria at the screening visit..
- •* Nephrotic syndromes/nephrotic range proteinuria (uACR >300mg/mmol and uAPR * 0.4, or total 24hrs proteinuria >3.5g/24hr, or biopsy proven)
- •* Nephrotic syndromes including rapid progressive glomerulonephritis and tubular interstitial nephritis (defined as active urine sediment with erythrocyturia and leucocyturia and proteinuria with eGFR decline, with or without the presence of systemic disease, or biopsy proven).
- •* Obvious other renal toxic effects related to lifestyle or medication (e.g. creatin use) suspected by the investigators or biopsy proven.;* HLA-B5701 positivity.
- •* Active hepatitis C or B.
- •- Intermediate or high level resistance to ABC
- •- eGFR <30 ml/min
- •Symptomatic arterial disease e.g. a history of coronary artery disease, ischemic cerebrovascular accident or claudication intermittens in medical history.
- •* Any other disease or medical condition that, in the opinion of the investigators, would interfere with the safety of the participant or the conduct of the trial.
研究者
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