NCT00002079已完成2 期
Phase II Study of the Safety and Surrogate Marker Efficacy of Butyldeoxynojirimycin (SC-48334) and AZT in Symptomatic HIV-1 Infected Patients With 200 - 500 CD4+ Cells/mm3. (NOTE: Asymptomatic HIV-1 Infected Patients Also Eligible)
G D Searle9 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:
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相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 试验地点
- 9
研究概览
简要总结
To assess the dose-related antiviral effects of SC-48334 and zidovudine (AZT) administered in combination or individually in HIV-1 positive patients with 200 - 500 CD4+ cells/mm3. To determine the safety of escalating doses of SC-48334 when administered in combination with any of three doses of AZT to symptomatic HIV-1 positive patients with 200 - 500 CD4+ cells/mm3, and to assess the pharmacokinetics of the two drugs, given separately and in combination.
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:
- •Documented HIV infection.
- •CD4 cell count 200 - 500 cells/mm
- •Prior therapy with 12 - 48 weeks of AZT.
排除标准
- •Co-existing Condition:
- •Patients with the following symptoms or conditions are excluded:
- •Clinically significant diarrhea without definable cause (> 3 liquid stools per day for more than 7 days within 6 months prior to study entry).
- •Diarrhea, as above, with known non-HIV-related cause occurring within 1 month prior to study entry.
- •Symptoms meeting CDC criteria for AIDS classification.
- •Fever as a constitutional sign of HIV disease (> 38.5 degrees C persisting for more than 14 consecutive days or for more than 15 days in any given 30-day period prior to study entry).
- •Malignancies, other than basal cell carcinoma and Kaposi's sarcoma (provided patient has fewer than 10 Kaposi's sarcoma lesions, no non-skin lesions, and no requirement for systemic treatment).
- •Significant organ dysfunction.
- •Known hypersensitivity to SC-48334 or AZT or related compounds.
- •Concurrent Medication:
- •Any investigational drug other than SC-
- •Any anti-HIV drug other than AZT.
- •Cancer chemotherapy.
- •Patients with the following prior conditions are excluded:
- •History of cataracts or known increased risk of cataract formation.
- •Known hypersensitivity to SC-48334 or AZT or related compounds.
- •History of lactose intolerance.
- •Prior Medication:
- •Prior SC-
- •Cancer chemotherapy within 6 months prior to study entry.
- •Treatment with any investigational drug or any drug with anti-HIV activity, other than AZT, within 30 days prior to study entry.
- •Prior Treatment:
- •Whole-body irradiation within 6 months prior to study entry. Current use of illicit substances, or abuse of alcohol, which would limit compliance with the protocol.
研究者
研究点 (9)
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