NCT00001993已完成2 期
Initial Phase II Efficacy and Safety Study of SC-48334 Administered in Combination With Low-Dose Zidovudine (AZT) to Symptomatic HIV-1 Infected Patients With = or > 200 to = or < 500 CD4+ Cells/mm3
G D Searle6 个研究点 分布在 1 个国家目标入组 120 人开始时间: 2001年8月31日最近更新:
适应症
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 120
- 试验地点
- 6
研究概览
简要总结
The primary objective of this study is to determine the preliminary efficacy and tolerability of combining a selected dose of SC-48334 with low-dose AZT in the treatment of symptomatic HIV+ patients with 200 to 500 CD4+ cells/mm3.
The secondary objective is to determine the pharmacokinetics and bioavailability of both SC-48334 and AZT, when administered together, in symptomatic HIV+ patients with 200 - 500 CD4+ cells/mm3.
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
- •Concurrent Medication:
- •Medications for the prophylaxis of opportunistic infections, such as:
- •Aerosolized pentamidine.
- •Trimethoprim/sulfamethoxazole.
- •Nystatin.
- •Clotrimazole.
- •Anti-mycobacterial agents.
- •Ganciclovir.
- •Topical acyclovir.
- •Patients must have the following:
- •CD4+ cells counts = or > 200 < 500 /cell mm
- •For purposes of inclusion the absolute CD4+ cell count must be = or > 200 < 500 cells/mm3 on the first sample and = or > 190 < 510 cells/mm3 on the second sample.
- •Have at least one of the following:
- •Oral candidiasis.
- •Herpes zoster during the last 3 years.
- •Oral hairy leukoplakia during the past three years.
- •Chronic ( > 30 day period), recurrent seborrheic dermatitis, or topical, pruritic folliculitis (itchy bumps).
- •Unintentional weight loss in excess of 10 pounds or 10 percent of usual body weight.
- •Chronic fatigue present for the past 6 months, which has interfered with normal activity at least 1 to 2 times per week.
- •HIV antibody positive as determined by federally licensed Enzyme-linked Immunosorbent Assay (ELISA).
- •Documented, written informed consent must be obtained prior to admission to the study.
- •Prior Medication:
- •Allowed for no more than 12 weeks prior to study entry:
- •Zidovudine (AZT).
排除标准
- •Co-existing Condition:
- •Patients with the following conditions or symptoms are excluded:
- •Malignancies, with the exception of basal cell carcinoma.
- •Significant organ dysfunction.
- •Concurrent Medication:
- •All anti-retroviral drugs with the exception of Zidovudine. Cancer chemotherapeutic agents.
- •Anti-metabolites and alkylating agents.
- •All investigational non-FDA approved drugs.
- •Patients with the following are excluded:
- •Clinically significant diarrhea (> 3 liquid stools per day for > 7 days) without definable cause, within 6 months prior to enrollment).
- •Diarrhea, as above, with known, non-HIV related cause occurring within one month prior to enrollment.
- •Meets CDC criteria for AIDS classification.
- •Chronic fever (> 38.5 C persisting for more than 14 consecutive days, or for more than 15 days in any 30-day interval prior to study entry).
- •Malignancies, with the exception of basal cell carcinoma.
- •Significant organ dysfunction.
- •Known hypersensitivity to SC-48334 or related compounds.
- •History of lactose intolerance.
- •Prior Medication:
- •Excluded within 30 days of study entry:
- •Any investigational medication.
- •Treatment with a drug (other than Zidovudine) with anti-HIV activity.
- •Excluded for > 12 weeks prior to study entry:
- •Zidovudine (AZT).
- •Excluded within 90 days of study entry:
- •Ribavirin.
- •Excluded within 6 months of study entry:
- •Cancer chemotherapy.
- •Excluded:
- •Treatment with SC-
- •Prior Treatment:
- •Excluded within 30 days of study entry:
- •Electron beam radiation.
- •Excluded within 6 months prior to study entry:
- •Required HIV-related blood transfusions.
- •Whole body radiation.
- •Current use of illicit substances; or current abuse of alcohol, the use of which would limit compliance with the protocol.
研究者
研究点 (6)
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