NCT00002333已完成2 期
A Randomized, Double-Blind, Multicenter, Parallel Study of Ro 31-8959 (Saquinavir; HIV Proteinase Inhibitor) Alone, HIVID (Dideoxycytidine; Zalcitabine, ddC) Alone, and Both in Combination, as Treatment for Advanced HIV Infection (CD4 50-300 Cells/mm3) in Patients Discontinuing or Unable to Take Retrovir (Zidovudine; AZT) Therapy
适应症
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 900
- 试验地点
- 47
研究概览
简要总结
To compare the safety, tolerance, and efficacy of saquinavir mesylate (Ro 31-8959) alone, zalcitabine (dideoxycytidine; ddC) alone, and both in combination, in patients discontinuing or unable to take zidovudine (AZT).
详细描述
Patients are randomized to one of three treatment regimens: ddC alone, Ro 31-8959 alone, and ddC plus Ro 31-8959. Treatment continues for at least 48 weeks. Patients are stratified by baseline CD4 count. (Per 09/26/94 amendment, a fourth arm, lower dose Ro 31-8959 plus ddC, was discontinued.)
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 Medication:
- •G-CSF and erythropoietin.
- •Prophylaxis or chronic suppression/maintenance therapy with dapsone, aerosolized pentamidine, isoniazid, rifampin, fluoroquinolones, pyrazinamide, ethambutol, fluconazole, itraconazole, acyclovir, clotrimazole, nystatin, trimethoprim/sulfamethoxazole, pyrimethamine, folic acid, sulfadiazine, clindamycin, and fansidar.
- •Concurrent Treatment:
- •Limited localized radiation therapy to the skin.
- •Patients must have:
- •Documented HIV infection.
- •CD4 count 50 - 300 cells/mm
- •Received prior AZT that has been discontinued at least 28 days prior to study entry.
- •No active opportunistic infection requiring immediate treatment.
排除标准
- •Co-existing Condition:
- •Patients with the following symptoms or conditions are excluded:
- •Signs or symptoms of peripheral neuropathy.
- •Malabsorption or inadequate oral intake (defined as unable to eat one or more meals daily because of chronic nausea, emesis, or abdominal/oral-esophageal discomfort.
- •Malignancy, visceral Kaposi's sarcoma, or lymphoma requiring systemic chemotherapy and/or radiotherapy within the next 48 weeks.
- •Any grade 3 or worse laboratory or clinical abnormality.
- •Inability to comply with protocol requirements.
- •Concurrent Medication:
- •Other antiretroviral drugs.
- •Experimental drugs.
- •Nephrotoxic or hepatotoxic drugs.
- •Drugs likely to cause peripheral neuropathy.
- •Antineoplastic agents.
- •Biologic response modifiers.
- •Concurrent Treatment:
- •Radiation therapy other than limited localized therapy to skin.
- •Patients with the following prior conditions are excluded:
- •History of non-Hodgkin's lymphoma.
- •Unexplained fever >= 38.5 C (101.5 F) persisting for 14 days or longer within the 28 days prior to study entry.
- •Unexplained, chronic diarrhea (defined as 3 or more loose stools daily) persisting for 14 days or longer within the 28 days prior to study entry.
- •History of grade 2 or worse peripheral neuropathy.
- •Prior Medication:
- •Prior HIV proteinase inhibitor.
- •Prior antiretroviral therapy other than AZT.
- •Acute therapy for opportunistic infection within 14 days prior to study entry.
- •Prior Treatment:
- •More than 3 units of blood in any 21-day period within 3 months prior to study entry.
- •Prior AZT.
研究者
研究点 (47)
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