ISRCTN78584791已完成不适用
Simplification with fosamprenavir/ritonavir (FPV/r) monotherapy: a pilot, prospective one-arm non-comparative multicentre study
Institute of Biomedical Investigations of Bellvitge (Institut d'Investigació Biomèdica de Bellvitge) (IDIBELL) (Spain)0 个研究点目标入组 30 人开始时间: 2008年12月23日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 30
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. Adult human immunodeficiency virus (HIV) infected patients (greater than 18 years, either gender)
- •2. Receiving a highly active anti-retroviral therapy (HAART) regimen including FPV/r (for at least four weeks) and two nucleoside/nucleotide analogues
- •3. Without previous failure with protease inhibitor regimens
- •4. Viral load less than 40 copies/mL for at least six months
- •5. CD4 counts greater than 100 cells/uL at inclusion
排除标准
- •1. Previous virologic failure (confirmed or suspected) while receiving a PI-based regimen
- •2. Alanine aminotransferase (ALT) greater than 5 x upper limit of normal
- •3. Clinical suspicion of cirrosis
- •4. Renal insufficiency with glomerular filtrate less than 50 ml/min
- •5. Haemoglobin less than 9 g/dl
- •6. Neutrophils less than 1000/mm^3
- •7. Platelets less than 30,000 /mm^3
- •8. Pregnant women or no contraceptive measures
- •9. Active infection in the two weeks prior to inclusion in the study
- •10. Systemic therapy for neoplasms
- •11. Patients with positive hepatitis B surface antigens (HBsAg) receiving tenofovir and/or lamiduvine
研究者
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