NCT00002124已完成3 期
A Double-Blind, Randomized, Dose Response Study of Three Doses of Delavirdine Mesylate (U-90152S) in Combination With Zidovudine (ZDV) Versus ZDV Alone in HIV-1 Infected Individuals With CD4 Counts of 200-500mm3
Pharmacia and Upjohn171 个研究点 分布在 1 个国家目标入组 1,250 人开始时间: 2001年8月31日最近更新:
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相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 1,250
- 试验地点
- 171
研究概览
简要总结
PART I: To evaluate the safety, tolerance, efficacy, and pharmacokinetics of three fixed doses of delavirdine mesylate (DLV) in combination with zidovudine (AZT) versus AZT alone in HIV-positive patients.
PART II: To evaluate the safety, tolerance, efficacy, and pharmacokinetics of ZDV plus 3TC with or without DLV versus ZDV plus DLV in HIV-positive patients.
详细描述
PART I: Patients are originally randomized to receive ZDV plus DLV (DLV at 1 of 3 doses) or ZDV plus placebo.
AS PER AMENDMENT 3/7/96:
PART II: Patients are rerandomized from PART I. Arm I: ZDV plus 3TC plus placebo. Arm II: ZDV plus 3TC plus DLV. Arm III: ZDV plus DLV (DLV at a higher dose than in the original protocol). Arm IV: ZDV plus DLV (no change from original; same treatment as Arm III).
AS PER AMENDMENT 1/24/97: Approximately 450 more patients will be enrolled in one of these 3 revised arms on PART II. Half of these new patients will be anti-retroviral naive and half will be anti-retroviral experienced.
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
- •Patients must have:
- •HIV-1 seropositivity.
- •CD4 count 200-500 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.
- •PER AMENDMENT 3/7/96:
- •ZDV therapy for 0-6 months prior to study entry. (Part II)
- •Prior Medication:
- •Prior AZT (no more than 6 months total).
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 AZT in previously treated patients.
- •Prior Medication:
- •More than 6 months total of prior AZT.
- •Any prior ddC, d4T, 3TC, or ddI.
- •Prior non-nucleoside 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.
- •Any enzyme-inducing drugs known to affect cytochrome P450 3A, (e.g., ketoconazole, fluconazole, isoniazid, itraconazole, etc.) within 21 days prior to initial study drug dose.
- •Active substance abuse.
研究者
研究点 (171)
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