NCT00002123已完成3 期
A Double-Blind, Randomized, Comparative Study of Delavirdine Mesylate (U-90152S) in Combination With Didanosine (ddI) Versus ddI Alone in HIV-1 Infected Individuals With CD4 Counts of <= 300/mm3
Pharmacia and Upjohn168 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
- 3 期
- 状态
- 已完成
- 发起方
- 试验地点
- 168
研究概览
简要总结
To evaluate the safety, tolerance, pharmacokinetics, and efficacy of delavirdine mesylate (U-90152S) in combination with didanosine (ddI) versus ddI alone in HIV-positive patients.
研究设计
- 研究类型
- Interventional
- 主要目的
- Treatment
- 盲法
- Double
入排标准
- 年龄范围
- 14 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Concurrent Medication:
- •Patients must have:
- •HIV-1 seropositivity.
- •CD4 count <= 300 cells/mm
- •No active or acute (onset within the past month) opportunistic infections such as active cryptococcosis, pneumocystis carinii, herpes zoster, histoplasmosis, or cytomegalovirus (CMV).
- •Consent of parent or guardian if less than 18 years of age.
- •Understanding of potential risk to fetus related to study participation.
- •Acceptable medical history, physical exam, EKG, and chest x-ray during screening.
- •Patients with cutaneous Kaposi's sarcoma requiring no systemic therapy are permitted.
排除标准
- •Co-existing Condition:
- •Patients with the following symptoms or conditions are excluded:
- •Active tuberculosis that is sensitive to rifampin.
- •Inability to swallow numerous tablets.
- •Clinically significant active or acute medical problems, including progressive multifocal leukoencephalopathy, lymphoma, or malignancy requiring systemic therapy.
- •Clinically significant hypersensitivity to piperazine-type drugs (e.g., Antepar and Stelazine).
- •Grade 2 or worse baseline organ function. NOTE:
- •Hemophiliacs with grade 2 bilirubin, alkaline phosphatase, SGOT, or SGPT will be considered if these values have been stable over the past year. NOTE:
- •Patients with suspected Gilbert's syndrome will be considered if bilirubin is grade 2 or better.
- •Patients with the following prior conditions are excluded:
- •History of pancreatitis within the past 2 years.
- •History of clinically significant nervous system or muscle disease, seizure disorder, AIDS dementia, or psychiatric disorder that would preclude study compliance.
- •History of grade 2 or worse peripheral neuropathy.
- •Intolerance to ddI in previous treated patients.
- •Prior Medication:
- •More than 4 months total of prior ddI.
- •Any prior ddC, d4T, or 3TC.
- •Prior nonnucleoside reverse transcriptase inhibitors, including L-drugs, nevirapine, TIBO, HEPT, delavirdine, atevirdine, and alpha-APA.
- •Other investigational antiretroviral medications (including foscarnet) or immunomodulators (including all interferons) within 21 days prior to initial study drug dose.
- •Prior prophylactic or therapeutic HIV-1 gp120 or 160 vaccines.
- •Rifampin, rifabutin, astemizole, loratadine, or terfenadine within 21 days prior to initial study drug dose.
- •Any unapproved investigational medication for any indication within 21 days prior to initial study drug dose.
- •AZT therapy at some time prior to screening. Active substance abuse.
研究者
研究点 (168)
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