ACTRN12605000407695尚未招募3 期
An open-label, randomised study comparing the uptake of rIL-2 in HIV-1 infected individuals receiving different combinations of antiemetics and analgesic agents during rIL-2 dosing in ESPRIT: Toxicity substudy of ESPRIT: TOXIL-2 substudy
niversity of New South Wales, Sydney, Australia.0 个研究点目标入组 168 人开始时间: 2005年9月14日最近更新:
适应症
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 168
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
- ot stated 至 ot stated（—）
- 性别
- All
入选标准
- •Patients participating in ESPRIT and randomised to the rIL-2 arm, who: 1. are not at CD4+ T-cell target for the protocol;2. have not received rIL-2 for >2 months;3. have reported both GI upset and constitutional side-effects as one of the reasons for either dose modifying in prior cycles or unwillingness to receive further rIL-2;4. are considered by the Investigator as medically safe to receive further dosing with rIL-2; 5. are willing to receive further dosing with rIL-2 at the dose specified by the Investigator; 6. are willing to sign informed consent to participate in the substudy.
排除标准
- •1. All exclusions for the receipt of rIL-2 on ESPRIT, 2. Known allergy to non-steroidal anti-inflammatory drugs (NSAIDS), opiates, 5HT-3 (serotonin-3) inhibitors, anti-dopaminergic antiemetics, or any other components of the proposed adjunct regimens.3. Use of other NSAIDS, cyclooxygenase-2 (COX-2) inhibitors, corticosteroids) or opiates analgesics within two weeks of rIL-2 dosing. Use of low dose aspirin as a cardio-protective agent is allowed.
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