NCT00002045已完成不适用
A Prospective Double-Blind Study of Retrovir in Early HIV Infection
Glaxo Wellcome2 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
To evaluate the safety and tolerance of chronic administration of Retrovir (AZT) to adult patients with early manifestations of HIV disease. To assess the efficacy of AZT therapy in the treatment of HIV disease in these patients.
(12/01/89) Information supplied by drug company update. Study discontinued due to positive data from ACTG 016.
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
- •Concurrent Treatment:
- •Electron beam therapy to an area of less than 100 cm
- •Patient must have signs and symptoms of HIV infection confined to those of stages WRII-V or CDC groups III IV-A, IV-C-2 (except recurrent Salmonella bacteremia, nocardiosis, or disseminated/extrapulmonary Mycobacterium tuberculosis), and IV-E (except diffuse interstitial lymphoid pneumonitis).
- •Patient must be able to give informed consent.
排除标准
- •Co-existing Condition:
- •Patients with the following are excluded:
- •Evidence of nervous system dysfunction caused by factors other than HIV infection, including chronic alcohol or drug abuse.
- •Present or prior known AIDS-defining opportunistic infections, lymphomas, or malignancies based on CDC criteria.
- •Present or prior known systemic opportunistic diseases most recently included in the expanded CDC definition of AIDS:
- •extrapulmonary or disseminated Mycobacterium tuberculosis infections, recurrent nontyphoidal Salmonella septicemia, coccidioidomycosis, diffuse interstitial lymphoid pneumonitis.
- •Evidence of compromised bone marrow function defined by specified lab values.
- •Evidence of HIV neurologic disease.
- •Evidence of HIV-associated "wasting syndrome".
- •Hypersensitivity to zidovudine (AZT).
- •Concurrent Medication:
- •Cytotoxic chemotherapeutic agents.
- •Steroids.
- •Interferon or immunomodulating agents.
- •Any antiretroviral drug including, but not limited to zidovudine (AZT), ribavirin, HPA23, AL 721, or phosphonoformate.
- •Patients with the following are excluded:
- •Evidence of nervous system dysfunction caused by factors other than HIV infection, including chronic alcohol or drug abuse. Present or prior known AIDS-defining opportunistic infections, lymphomas, or malignancies based on CDC criteria. Present or prior known systemic opportunistic diseases most recently included in the expanded CDC definition of AIDS:
- •extrapulmonary or disseminated Mycobacterium tuberculosis infections, recurrent nontyphoidal Salmonella septicemia, coccidioidomycosis, diffuse interstitial lymphoid pneumonitis.
- •Evidence of compromised bone marrow function defined by specified lab values. Evidence of HIV neurologic disease.
- •Evidence of HIV-associated wasting syndrome.
- •Hypersensitivity to retrovir.
- •Prior Medication:
- •Excluded within 4 weeks of study entry:
- •Interferon.
- •Immunomodulating agents.
- •Myelosuppressive drugs.
- •Nephrotoxic agents.
- •Other experimental chemotherapy.
- •Prior Treatment:
- •Treatment with radiation therapy (with the exception of electron beam therapy to an area of less than 100 cm2).
- •Chronic alcohol or drug abuse.
研究者
研究点 (2)
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