NCT00001040已完成2 期
Double-Blind, Randomized, Phase II Study of Ro 31-8959 Plus Zidovudine (AZT) Versus AZT Plus Zalcitabine (Dideoxycytidine; ddC) Versus Ro 31-8959 Plus AZT Plus ddC
适应症
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 300
- 试验地点
- 19
研究概览
简要总结
PRIMARY: To determine the efficacy and toxicity of three treatment regimens: saquinavir mesylate (Ro 31-8959) plus zidovudine (AZT) vs. AZT plus zalcitabine (dideoxycytidine; ddC) vs. Ro 31-8959 plus AZT plus ddC.
SECONDARY: To investigate the pharmacokinetics and effects on various clinical parameters of the three regimens.
研究设计
- 研究类型
- Interventional
- 主要目的
- Treatment
入排标准
- 年龄范围
- 13 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Prior Medication: Required:
- •At least 4 months total of AZT at some point in the past, alone or in combination with other antiretroviral therapy.
- •Patients must have:
- •HIV seropositivity.
- •Diagnosis of AIDS, ARC, PGL, or asymptomatic infection.
- •CD4 count > 50 to <= 300 cells/mm
- •Life expectancy of at least 6 months.
- •Prior AZT therapy.
排除标准
- •Co-existing Condition:
- •Patients with the following symptoms or conditions are excluded:
- •Acute serious opportunistic infections requiring immediate treatment, including (but not limited to) tuberculosis, CMV, cryptococcal meningitis, disseminated MAC, cerebral toxoplasmosis, and Pneumocystis carinii pneumonia.
- •Known intolerance to Ro 31-8959, AZT, or ddC.
- •Symptoms suggestive of pancreatitis.
- •Moderate or severe peripheral neuropathy as evidenced by discomfort from numbness, tingling, burning or pain of the extremities or any related symptoms that are accompanied by an objective finding.
- •Visceral Kaposi's sarcoma.
- •Lymphoma that will require therapy within the next 6 months.
- •Transfusion dependence.
- •Concurrent Medication:
- •Investigational or antineoplastic agents.
- •Concurrent Treatment:
- •Radiotherapy (other than local skin radiotherapy).
- •Transfusions.
- •Prior Medication:
- •Any antiretroviral agent (other than AZT) or immunomodulatory therapy within 14 days prior to study entry.
- •Prior treatment with an HIV proteinase inhibitor.
研究者
研究点 (19)
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