ISRCTN81305260已完成不适用
Highly active anti-retroviral therapy including nevirapine once daily versus twice daily after at least 12 weeks of nevirapine twice daily. A randomized, open, multicentre trial.
Institute of Biomedical Investigations of Bellvitge (Institut d'Investigació Biomèdica de Bellvitge) (IDIBELL) (Spain)0 个研究点目标入组 308 人开始时间: 2006年7月28日最近更新:
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 308
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
- 性别
- All
入选标准
- •1. Human immunodeficiency virus (HIV)-positive confirmed by Western blot
- •2. Adult 18 years or over
- •3. Under treatment with a highly active anti-retroviral therapy (HAART) regimen including nevirapine 200 mg bid for at least 12 weeks. Females with cluster of differentiation subset four molecules (CD4) >250 cells/ul need to have been receiving the nevirapine bid regimen for at least 18 weeks.
- •4. Alanine aminotransferase (ALT) <2.5 times the upper limit normal
- •5. Undetectable viral load (with the test used in each center)
- •6. Written informed consent
排除标准
- •1. Concomitant participation in another clinical trial
- •2. Clinical suspicion of hepatic cirrhosis
- •3. Renal failure with creatinine clearance <50 ml/min
- •4. Any of the following laboratory parameter alterations: amylases more than three times above normal values, haemoglobin <8 mg/dl, neutrophils <500 cells/ul, platelets <30,000/ul
- •5. Pregnancy
- •6. Active infection within the last four weeks
- •7. Treatment for neoplasms
- •8. Treatment with methadone
研究者
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