NCT00002280已完成不适用
An Open Label Study Regimen of Videx (2',3'-Dideoxyinosine, ddI) in Children With Acquired Immunodeficiency Syndrome (AIDS) Who Have Demonstrated Significant Deterioration or Intolerance to Zidovudine (Retrovir)
Bristol-Myers Squibb1 个研究点 分布在 1 个国家开始时间: 2001年8月31日最近更新:
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 试验地点
- 1
研究概览
简要总结
The purpose of this study is to make didanosine (ddI) available to children with AIDS who are clinically deteriorating on zidovudine (AZT) or intolerant to AZT and cannot enter the Phase II ddI programs due to protocol exclusion or geographic location.
研究设计
- 研究类型
- Interventional
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 3 Months 至 12 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Concurrent Medication:
- •Concomitant medications for the treatment of complications of AIDS.
- •Concomitant use of ddI with the following drugs must be done with extreme caution:
- •Other nucleosides (e.g., ganciclovir).
- •Drugs with toxicities similar to those observed with ddI (e.g., phenytoin).
- •Drugs with significant pancreatic toxicities, including many drugs used for treatment of major opportunistic infections.
- •Use of Sulfonamides or intravenous pentamidine for treatment of acute Pneumocystis carinii pneumonia (PCP) requires discontinuation of ddI for a week following treatment of PCP.
- •Caution should also be exercised with patients having intractable diarrhea or patients following a low sodium diet.
- •Patients must have the following:
- •- Diagnosis of AIDS. Demonstrated either significant deterioration despite parenteral dosing with zidovudine (AZT) or significant intolerance to AZT.
- •Signed informed consent by parent or legal guardian. Evaluations every 7-14 days while taking ddI for the first 4 months. Monthly follow-up is required thereafter.
排除标准
- •Co-existing Condition:
- •Patients with the following conditions or symptoms are excluded:
- •Acute pancreatitis or any history of pancreatitis.
- •Seizures or a history of seizure disorder.
- •Grade I or greater peripheral neuropathy.
- •Preexisting cardiomyopathy.
- •Concurrent Medication:
- •Zidovudine (AZT).
- •Chemotherapy with cytotoxic agents.
- •Those agents that may cause pancreatitis such as:
- •Pentamidine.
- •Sulfonamides.
- •Antituberculosis drugs.
- •Cimetidine.
- •Ranitidine.
- •Corticosteroids.
- •NOTE the cautionary statement in Patient Inclusion Concurrent Medication.
- •Patients with the following are excluded:
- •Acute pancreatitis or any history of pancreatitis.
- •Seizures or a history of seizure disorder.
- •Grade I or greater peripheral neuropathy.
- •Preexisting cardiomyopathy.
- •Prior Medication:
- •Excluded within 15 days of study entry:
- •Any anti-retroviral except zidovudine (AZT).
- •Zidovudine (AZT).
研究者
研究点 (1)
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