NCT00002005已完成不适用
A Phase I Study of Recombinant CD4(rCD4) in Patients With AIDS and AIDS-Related Complex
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 试验地点
- 1
研究概览
简要总结
To determine the safety profile and maximum tolerated dose (MTD) of recombinant soluble human CD4 (rCD4) therapy in patients with AIDS or AIDS related complex (ARC). To obtain a preliminary indication of the antiviral effects of rCD4 in patients with AIDS and ARC. To measure steady state serum levels of rCD4 following continuous infusion therapy.
研究设计
- 研究类型
- Interventional
- 主要目的
- Treatment
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:
- •HIV-1 seropositivity.
- •Diagnosis of AIDS or AIDS related complex (ARC).
- •Failure to tolerate or respond to zidovudine (AZT) or decided to decline AZT therapy.
- •The ability to sign a written informed consent form prior to treatment.
- •A willingness to abstain from all other experimental therapy for HIV infection during the entire study period.
- •A life expectancy of at least 3 months.
排除标准
- •Co-existing Condition:
- •Patients with the following conditions or symptoms are excluded:
- •Serious active opportunistic infections.
- •Malignancies other than Kaposi's sarcoma.
- •Concurrent Medication:
- •Zidovudine (AZT).
- •Corticosteroids.
- •Nonsteroidal anti-inflammatory agents (NSAI).
- •Other experimental therapy.
- •Patients with the following are excluded:
- •Serious active opportunistic infections.
- •Malignancies other than Kaposi's sarcoma.
- •Prior Medication:
- •Excluded within 3 weeks of study entry:
- •Zidovudine (AZT).
- •Chemotherapy.
- •Immunomodulators.
- •Other experimental therapy.
研究者
研究点 (1)
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