NCT00002163已完成3 期
A Phase III, Randomized, Double-Blind, Multicentre Study to Evaluate the Safety and Efficacy of 1592U89 in Patients With AIDS Dementia Complex
Glaxo Wellcome9 个研究点 分布在 2 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
- 9
研究概览
简要总结
To evaluate the benefit of adding 1592U89 to current antiretroviral therapies for AIDS dementia complex and to assess the safety and tolerance of the treatment regimens.
详细描述
Patients must be on stable antiretroviral treatment for at least 6 weeks prior to study entry and will then be stratified depending on whether their regimen contains zidovudine (ZDV). Each stratum will be randomized separately to receive 1592U89 or placebo for 12 weeks. For the subsequent 40 weeks, open-label 1592U89 will be offered.
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
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients must have:
- •Documented HIV infection.
- •Evidence of HIV - associated dementia.
- •Been on stable antiretroviral treatment for a minimum of 6 weeks prior to study entry.
排除标准
- •Co-existing Condition:
- •Patients with any of the following symptoms or conditions are excluded:
- •Debilitated as a result of their HIV disease, associated illness or therapies who the investigator determines will not be able to complete the 12 week randomized dosing period.
- •Memorial Sloan-Kettering (MSK) score of >= 3 for dementia.
- •Confounding neurological diseases which may interfere with interpretation of neurological and neurophysical assessments.
- •Malabsorption syndrome or other gastrointestinal dysfunction which renders them unable to take oral medication.
- •Chronic diseases such as diabetes, congestive heart failure, cardiomyopathy, other cardiac dysfunctions, etc., which in the investigator's opinion would compromise the safety of the patient.
- •Symptomatic AIDS-defining opportunistic infection not responsive to therapy.
- •Concurrent Medication:
- •Treatment with cytotoxic chemotherapeutic agents within the first 12 weeks of the study.
- •Treatment with nerve growth factor within the first 12 weeks of study.
- •The use of narcotic analgesics, sedatives, benzodiazepines, antidepressants, anti-psychotic agents and other psychoactive drugs which would interfere with the assessment of the neurological and neurophysical status of the patient.
- •Use of stavudine (d4T) during the first 12 weeks of the study.
- •Immunomodulating agents (except GM/G-CSF or epoietin).
- •Psychoactive drugs (at the investigator's discretion).
- •Concurrent Treatment:
- •Treatment with radiation therapy within the first 12 weeks of the study.
- •With the exception of local treatment for Kaposi's sarcoma.
- •Patients with any of the following prior conditions are excluded:
- •Previous neurological disease unrelated to HIV infection.
- •History of clinically apparent hepatitis within the last 6 months.
- •History of clinically apparent pancreatitis in the last 6 months.
- •Prior Medication:
- •Treatment with cytotoxic chemotherapeutic agents within 1 month of entry.
- •Participation in investigational antiretroviral trials within the past 3 months.
- •HIV vaccine within the past 3 months.
- •Treatment with immunomodulating agents such as systemic corticosteroids, interleukins, thalidomide, anticytokine agents, anti-oxidants or interferons within 1 month of study entry.
- •Nerve growth factor.
- •Prior Treatment:
- •Treatment with radiation therapy within 1 month of entry.
- •With the exception of local treatment for Kaposi's sarcoma.
- •Risk Behavior:
- •Current alcohol or illicit drug use which may interfere with the patient's ability to comply with the study protocol.
- •Stable antiretroviral treatment that has been ongoing for a minimum of 6 weeks prior to study entry, may or may not include ZDV.
- •Stable antiretroviral treatment for a minimum of 6 weeks prior to study entry.
研究者
研究点 (9)
Loading locations...
相似试验
已完成
2 期
A Study of the Safety and Effectiveness of Different Doses of 1592U89 in HIV-Infected PatientsHIV InfectionsNCT00002390Glaxo Wellcome
已完成
2 期
A Study of 1592U89 Combined With Other Anti-HIV Drugs in Patients Who Have Taken Anti-HIV DrugsHIV InfectionsNCT00002364Glaxo Wellcome40
已完成
1 期
Feasibility Study in Subjects With Mild to Moderate Alzheimer's DiseaseAlzheimer's DiseaseNCT02560753T3D Therapeutics, Inc.36
已完成
3 期
An Open Trial of Zidovudine (AZT) Treatment of the AIDS Dementia Complex in Patients With AIDS or Low CD4+ Lymphocyte CountsAIDS Dementia ComplexHIV InfectionsNCT00000709National Institute of Allergy and Infectious Diseases (NIAID)50
已完成
1 期
Phase I MAD, Fed-Fasted, CSF Study of UE2343 in Healthy SubjectsHealthy VolunteersNCT02616445Actinogen Medical40