NCT00002109已完成3 期
Double-Blind Study of Timunox (Thymopentin) in Asymptomatic HIV-Infected Patients Receiving Either Mono (AZT or ddI) or Combination (AZT/ddI or AZT/ddC) Anti-Retroviral Therapy
Immunobiology Research Institute90 个研究点 分布在 2 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
- 3 期
- 状态
- 已完成
- 发起方
- 试验地点
- 90
研究概览
简要总结
To confirm results from a previous study in which the combination of thymopentin plus zidovudine ( AZT ), an antiretroviral agent, slowed disease progression in HIV-infected asymptomatic patients. To evaluate the efficacy and safety of thymopentin in HIV-infected asymptomatic patients receiving either monotherapy with AZT, didanosine ( ddI ), or stavudine ( d4T ), or combination antiretroviral therapy with AZT / ddI or AZT / zalcitabine ( ddC ).
研究设计
- 研究类型
- Interventional
- 主要目的
- Treatment
- 盲法
- Double
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients must have:
- •Asymptomatic HIV infection.
- •CD4 count 100-400 cells/mm
- •No HIV-associated neurologic abnormalities or constitutional symptoms.
- •No oral hairy leukoplakia.
- •At least 6 months of prior AZT.
排除标准
- •Co-existing Condition:
- •Patients with the following symptoms or conditions are excluded:
- •Abnormal chest x-ray, consistent with active opportunistic infection.
- •Hypersensitivity to thymopentin.
- •Significant chronic underlying medical illness.
- •Grade 2 or worse peripheral neuropathy.
- •Concurrent Medication:
- •HIV vaccines.
- •Investigational or non-FDA approved medication.
- •Immunomodulatory therapies.
- •Experimental therapies.
- •Any antiretroviral therapy other than AZT, ddI, ddC, d4T, or 3TC.
- •Patients with the following prior conditions are excluded:
- •Herpes zoster (within the past year).
- •Recurrent (> one episode) oral candidiasis (confirmed).
- •Vulvovaginal candidiasis (persistent, frequent, or poorly responsive to therapy).
- •Bacillary angiomatosis.
- •Listeriosis.
- •Idiopathic thrombocytopenia purpura.
- •Prior Medication:
- •Excluded at any time prior to study entry:
- •More than one dose of thymopentin.
- •Excluded within 30 days prior to study entry:
- •HIV vaccines.
- •Investigational or non-FDA approved medication.
- •Immunomodulatory therapies.
- •Experimental therapies.
- •Any antiretroviral therapy other than AZT, ddI, ddC, d4T, or 3TC.
- •Prior AZT (>= 300 mg/day) for at least 6 months; on current regimen (any combination of approved nucleoside analogues) for at least 4 weeks.
- •Significant active alcohol or drug abuse.
研究者
研究点 (90)
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