ACTRN12609000179235已完成3 期
A randomised, open-label, cross-over study to examine the pharmacokinetics, and short-term safety and efficacy of two dosing strategies of raltegravir plus atazanavir in human immunodeficiency virus (HIV)-infected patients
ational Centre in HIV Epidemiology/The University of New South Wales0 个研究点目标入组 24 人开始时间: 2009年4月17日最近更新:
适应症
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 24
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomised controlled trial
- 主要目的
- Treatment
- 盲法
- Open (masking not used)
入排标准
- 年龄范围
- 18 Years 至 o limit（—）
- 性别
- All
入选标准
- •aged 18 years or more with laboratory evidence of HIV-1 infection;
- •currently receiving 3 or more unchanged antiretroviral agents including atazanavir (with or without ritonavir boosting) for at least 24 weeks prior to study entry;
- •plasma HIV RNA less than 50 copies/mL for at least 24 weeks prior to study entry;
- •provide written, informed consent.
排除标准
- •prior clinical/virological failure on a protease inhibitor-containing regimen
- •no clinical history of primary HIV-1 protease mutations identified in local baseline genotypic analysis of HIV with interpretation using current International AIDS Society United States of America (IAS-USA) Drug Resistance Mutations in HIV-1;
- •women: pregnant, breastfeeding, or not willing to use adequate contraception (including barrier contraception) if of child-bearing potential;
- •laboratory abnormalities at screening:
- •o absolute neutrophil count (ANC) less than 750 x 106/L
- •o haemoglobin less than 8.5 g/dL
- •o platelet count less than 50 x 109/L
- •o asparate aminotransferase (AST), alanine aminotransferase (ALT) greater than 5 times the upper limit of normal (ULN)
- •o serum bilirubin greater than 5 times ULN;
- •chronic active hepatitis B virus (HBV) infection defined by presence of serum viral hepatitis B surface antigen (HBsAg) or hepatitis B deoxyribonucelic acid (HBV DNA)-positive;
- •any malabsorption syndrome likely to affect drug absorption (eg Crohn’s disease, chronic pancreatitis);
- •concurrent therapy with human growth hormone or other immunomodulatory agents;
- •concomitant medication contraindicated for use with either atazanavir or raltegravir therapy;
- •subjects who have discontinued any prohibited concomitant agent/s must have ceased this therapy at least 30 days prior to screening;
- •any inter-current illness requiring hospitalisation;
- •current excessive alcohol or illicit substance use;
- •unlikely to be able to remain in follow-up for the protocol-defined period.
研究者
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