NCT00002351已完成1 期
An Open-Labeled, Multiple Dose, Multicenter Study to Investigate the Safety, Tolerability, and Plasma Concentration Profile of L-735,524 Capsules in HIV-Seropositive Older Children and Adolescent Patients
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 12
- 试验地点
- 1
研究概览
简要总结
To evaluate the safety, tolerability, and plasma concentration profiles of indinavir sulfate ( MK-639; Crixivan ) in HIV-seropositive older children and adolescents. To compare the plasma concentration profile after the initial dose with data from a historical group of adults. To obtain preliminary data on antiviral activity of MK-639.
详细描述
Patients receive MK-639 for 14 and one-third days. Repeat plasma samples are collected up to 8 hours following the first and last dose. Urine samples are collected on days 1 and 5.
研究设计
- 研究类型
- Interventional
- 主要目的
- Treatment
入排标准
- 年龄范围
- 10 Years 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients must have:
- •HIV positivity.
- •No active opportunistic infection within the past 30 days, other than superficial candidiasis of the oral cavity or vagina.
- •Body surface area at least 1.0 sqm.
- •Consent of parent or guardian.
- •Prior Medication:
- •Aerosolized pentamidine.
- •Topical antifungals.
- •TMP / SMX.
排除标准
- •Co-existing Condition:
- •Patients with the following symptoms or conditions are excluded:
- •Significant hepatic disease including HBsAg or hepatitis C positivity.
- •Significant neurologic disease such as loss of intellectual ability, motor deficits, or seizure disorder.
- •Significant cardiac disease including dysrhythmia or cardiomyopathy.
- •Significant medical condition or laboratory abnormality that may pose additional risk to patient on study or confound the results.
- •Has a social situation that may interfere with study participation.
- •Concurrent Medication:
- •Oral contraceptives.
- •Patients with the following prior conditions are excluded:
- •History of serious allergic drug reactions.
- •History of significant cardiac disease.
- •Participation on another clinical trial within the past 4 weeks.
- •Donated blood within the past 4 weeks.
- •Prior Medication:
- •Excluded within the past 4 weeks:
- •Hematopoietic growth factors.
- •Excluded within the past 2 weeks:
- •Antiretroviral agent other than zidovudine.
- •Oral contraceptives.
- •Prophylaxis for opportunistic infections, other than aerosolized pentamidine, topical antifungals, and TMP/SMX.
- •Any other medication unless approved by Merck clinical monitor. Current illicit drug use.
研究者
研究点 (1)
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