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临床试验/NCT00002066
NCT00002066已完成不适用

Double Blind Study of Thymopentin Effects on Patients With HIV-1 Infection

Immunobiology Research Institute2 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
2

研究概览

简要总结

Examine the ability of thymopentin (Timunox) to:

Reduce the amount and/or frequency of virus isolation. Stimulate the immune system and alter the clinical findings in patients infected with HIV who do not yet have AIDS.

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

入选标准

  • Concurrent Medication:
  • Aerosolized pentamidine.
  • Prior Medication:
  • Aerosolized pentamidine.

排除标准

  • Co-existing Condition:
  • Patients with an abnormal chest x-ray indicative of active disease (opportunistic infection) within 30 days prior to entry are excluded.
  • Concurrent Medication:
  • Excluded within 90 days of study entry:
  • Zidovudine (AZT).
  • Prior Medication:
  • Excluded within 30 days of study entry:
  • Immunomodulatory or experimental therapy.
  • Excluded within 90 days of study entry:
  • Zidovudine (AZT).
  • Patients must not have:
  • Hemophilia A or B or other hematologic disorders requiring current or previous administration of blood products.
  • AIDS as defined by the CDC (except for those with HIV "wasting syndrome").
  • Significant hepatic disease.
  • Thrombocytopenia (< 75000 platelets/mm3).
  • Patient must voluntarily sign consent and be seropositive for HIV-1 (ELISA assay) confirmed by Western blot.
  • HIV-1 p24 antigen must be detected in supernatant fluids from co-cultures of patient's peripheral blood monocytes (PBMC) on two separate occasions.
  • Patients with HIV "wasting syndrome" are included.
  • Intravenous drug abuse.

研究者

发起方
Immunobiology Research Institute
申办方类型
Industry

研究点 (2)

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