A Pharmacokinetic Study of L-697,661 Alone and in Combination With Zidovudine
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 27
- 试验地点
- 5
研究概览
简要总结
Part 1: To study the potential safety and pharmacokinetic (blood level) effects of zidovudine (AZT) on L-697,661; to obtain additional pharmacokinetic information in humans with L-697,661; to study the effect of L-697,661 on hepatic enzyme induction. Part 2: To begin a study of the antiviral activity of L-697,661.
L-697,661 is a newly identified compound that inhibits HIV replication (reproduction and growth) in cell culture. It works together with AZT against HIV.
详细描述
L-697,661 is a newly identified compound that inhibits HIV replication (reproduction and growth) in cell culture. It works together with AZT against HIV.
Part 1: Twelve patients are randomly assigned to one of two groups. Group 1 patients receive AZT for 7 days, followed by AZT plus L-697,661 with food for 56 days. Group 2 patients receive no drug for 7 days, followed by L-697,661 with food for 56 days. Antipyrine is administered 1 hour prior to study drug on days 8, 22, and 35.
Part 2: Fifteen patients receive L-697,661 with food, for 8 weeks. Therapy with L-697,661 may be extended beyond 8 weeks for up to 24 weeks.
研究设计
- 研究类型
- Interventional
- 干预模型
- Parallel
- 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:
- •HIV infection.
- •Prior Medication: Included:
- •Patients in Part 1 must have received no previous zidovudine (AZT) or a stable dose of at least 500 mg/day without evidence of toxicity.
- •Patients in Part 2 must have received no previous AZT or = or > 300 mg/day for < 6 consecutive weeks within 1 year prior to study entry.
排除标准
- •Co-existing Condition:
- •Patients with the following conditions or symptoms are excluded:
- •Acute HIV-related opportunistic infection requiring ongoing treatment.
- •Diarrhea defined as 3 or more liquid stools/day for one week.
- •Wilson's or Gilbert's disease, porphyria, or other chronic or acute hepatic disease.
- •Potentially life-threatening allergic reactions to any of the components of zidovudine.
- •Acute or chronic medical conditions that in the opinion of the investigator would place patient at risk by participation in this study.
- •Concurrent Medication:
- •Systemic bronchodilators, acetaminophen, aspirin.
- •Prior Medication:
- •Didanosine (ddI) or dideoxycytidine (ddC) within 14 days prior to entry.
- •Immune modulators or investigational drugs within 30 days prior to entry.
- •Drugs known to induce hepatocellular enzymes, such as phenobarbital, phenytoin, warfarin, ketoconazole, and oral contraceptives, within 30 days prior to entry.
- •Patients in Part 2 only:
- •Zidovudine within 4 weeks prior to receiving first dose of study drug.
- •Risk Behavior:
- •Patients who the investigator feels would not comply with study requirements.
- •Patients may not have the following prior conditions:
- •Acute or chronic medical conditions that in the opinion of the investigator would place patient at risk by participation in this study.
- •Potentially life-threatening allergic reactions to any of the components of zidovudine.