EUCTR2010-020442-10-IT进行中（未招募）不适用
Efficacy of atazanavir/ritonavir monotherapy as maintenance in patients with viral suppression. Randomized, open label non inferiority trial. (MODAt STUDY) - ND
FONDAZIONE CENTRO S. RAFFAELE DEL MONTE TABOR0 个研究点开始时间: 2010年5月13日最近更新:
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •age > 18 years
- •- HIV infected patients
- •- First line ATV/r based HAART with ATV/r plus 2 NRTIs for at least 48 weeks
- •- Virological suppression (HIV-RNA<50 c/ml) by at least 24 weeks with ATV/r plus 2 NRTIs
- •- CD4 cells nadir >100 cells/ml
- •- PPI and H2-receptor antagonists as follows: the proton-pump inhibitors should not be used; if H2-receptor antagonists are co-administered, a dose equivalent to famotidine 20 mg BID should not be exceeded.
- •- No detected genotypic resistance mutations to ATV at baseline (as specified in the IAS classification: 10I/F/V/C, 16E, 20R/M/I/T/V, 24I, 32I, 33F/I/V, 34Q, 36I/L/V, 46I/L, 48V, 50L, 53L/Y, 54A/L/M/T/V, 60E, 62V, 64L/M/V, 71V/I/T/L, 73C/S/T/A, 82A/F/I/T, 84V, 85V, 88S, 90M, 93L/M)
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range
排除标准
- •-Pregnancy and breast feeding women
- •-AIDS defining events
- •-active HBV infection (HBsAg positive)
- •-Previous virological failure
- •-Use of contraindicated drugs
研究者
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