ACTRN12609000575235进行中（未招募）3 期
Randomised double-blind placebo controlled study to measure the effect of antiretroviral therapy (ART) intensification with raltegravir and/or hyper-immune bovine colostrum on CD4+ T cell count in ART treated, Human Immunodeficiency Virus-1 (HIV-1) infected individuals with suboptimal CD4+ T cell responses despite prolonged virologic suppression
niversity of New South Wales (UNSW)0 个研究点目标入组 72 人开始时间: 2009年7月14日最近更新:
适应症
试验速览
- 阶段
- 3 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 72
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
- Blinded (masking used)
入排标准
- 年龄范围
- 18 Years 至 o limit（—）
- 性别
- All
入选标准
- •1.Documented HIV-1 infection
- •2. Age >18 years
- •3.Signed informed consent
- •4.Receiving combination ART for at least 12 months with a stable cART regimen for a minimum of 6 months.
- •5.Two consecutive plasma HIV RNA viral load measurements <50 in the 9 months preceding the screening visit.
- •6.CD4+ T cell count <350 cells/µL throughout the 6 months preceding the screening visit with <50 cells/µL increase in the last 12 months
排除标准
- •1.Receiving a cART regimen containing an integrase inhibitor
- •2.Anticipated change of cART in the 24 weeks following randomisation
- •3.Participating in study with an investigational compound or device within 30 days of signing informed consent
- •4.Use of immune modulating therapies or immunosuppressive medications within 60 days prior to study entry. Patients using inhaled or nasal steroids are not excluded
- •5.Pregnant or breastfeeding woman
- •6.Cow’s milk allergy
- •7.Concurrent treatment with phenobarbitol, phenytoin or rifampicin.
- •8.A known cause of impaired CD4+ T cell gain: for example individuals whose current cART regimen contains both tenofovir and didanosine
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