NCT00002094已完成不适用
Prospective Open-Label Study of the Emergence of Drug Resistance in Patients Infected With HIV-1 Who Are Taking Oral U-87201E
Pharmacia and Upjohn1 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:
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 试验地点
- 1
研究概览
简要总结
To determine the time course of development of resistance to atevirdine mesylate ( U-87201E ) in patients with HIV isolates showing in vitro resistance to zidovudine ( AZT ). To determine the genotype changes in HIV reverse transcriptase associated with in vitro AZT resistance to U-87201E. To determine the genotype and phenotype effects of treatment with a nondideoxynucleoside agent on the alterations of the HIV-1 population associated with in vitro AZT resistance. To determine whether serial passage of patient pre-drug HIV isolates in the presence of U-87201E will generate the resistant mutants that may subsequently emerge in the patients.
研究设计
- 研究类型
- Interventional
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Patients must have:
- •Enrollment on protocol RV-43 (AZT resistance study).
- •Development of a primary RV-43 study endpoint-opportunistic infection.
- •HIV isolate with an AZT IC50 > 50 times that of the sensitive type strain.
- •Able to swallow tablets without difficulty.
- •Normal QTc interval on EKG.
排除标准
- •Co-existing Condition:
- •Patients with the following symptoms or conditions are excluded:
- •Clinically significant hypersensitivity to piperazine type drugs (Antepar, Stelazine).
- •Severe uncontrollable diarrhea or vomiting or known malabsorption.
- •Symptomatic hyperlipidemia.
- •Concurrent Medication:
- •Other experimental drugs.
- •AZT, ddI, ddC, foscarnet, immunomodulators or other agents with primary antiretroviral activity (exemptions by principal investigator permitted).
- •Patients with the following prior conditions are excluded:
- •History of clinically significant cardiovascular disease or nervous system or muscle disease, including seizures, peripheral neuropathy, dementia, or motor dysfunction.
- •Prior Medication:
- •Experimental drugs within 4 weeks prior to study entry.
研究者
研究点 (1)
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