NCT00002152已完成2 期
Randomized, Double-Blind, Placebo-Controlled Evaluation of the Safety and Efficacy of WF 10 IV Solution ( TCDO ) in the Management of Patients With Advanced HIV Disease
Oxo Chemie GmbH2 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2001年8月31日最近更新:
适应症
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 60
- 试验地点
- 2
研究概览
简要总结
The purpose of this study is to see if it is safe and effective to give WF 10 (TCDO) to patients with advanced HIV disease who cannot or will not take zidovudine, didanosine, zalcitabine, or stavudine. This study also examines how TCDO affects the levels of HIV in the body. TCDO is a solution delivered through a vein.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Concurrent Medication:
- •Approved drugs at a stabilized dose except those specifically excluded.
- •Aerosolized pentamidine (300 mg) once a month for PCP prophylaxis.
- •Patients must have:
- •HIV positivity.
- •Absolute CD4 count < 200 cells/mm
- •Intolerance to or refusal to take AZT, ddI, ddC, or d4T.
- •No active opportunistic infection requiring ongoing therapy.
- •Life expectancy at least 3 months.
排除标准
- •Co-existing Condition:
- •Patients with the following symptoms or conditions are excluded:
- •Neoplasm other than basal cell carcinoma of the skin.
- •Clinically significant cardiac disease.
- •Concurrent Medication:
- •Cytotoxic chemotherapy.
- •Corticosteroids.
- •Patients with the following prior conditions are excluded:
- •History of myocardial infarction or arrhythmias.
- •Prior Medication:
- •Excluded within 2 weeks prior to study entry:
- •Any antiretroviral agent.
- •Interferon.
- •Systemic therapy with biologic response modifiers, corticosteroids, cytotoxic chemotherapy, or neutropenic or nephrotoxic drugs.
- •Excluded within 30 days prior to study entry:
- •Investigational drugs.
- •Prior Treatment:
- •Excluded within 2 weeks prior to study entry:
- •Radiation therapy. Active drug or alcohol abuse.
研究者
研究点 (2)
Loading locations...
相似试验
已完成
2 期
12 Week Evaluation of the Safety and Efficacy of 3 Doses of CP-526,555 and Placebo for Smoking CessationSmoking CessationNCT00139750Pfizer600
已完成
1 期
Single Rising Dose Study to Assess Safety, Tolerability and Pharmacokinetics of BI 661051.HealthyNCT01343719Boehringer Ingelheim64
已完成
4 期
Trial Comparing Treatment With Tiotropium Inhalation Capsules to Combivent® Inhalation Aerosol in COPD Patients.Pulmonary Disease, Chronic ObstructiveNCT00388882Boehringer Ingelheim327
已完成
3 期
Efficacy and Safety of 2 Doses of Tiotropium Via Respimat Compared to Placebo in Adolescents With Moderate Persistent AsthmaAsthmaNCT01257230Boehringer Ingelheim398
已完成
3 期
A Study to Compare Tenofovir Disoproxil Fumarate Versus Adefovir Dipivoxil for the Treatment of HBeAg-Positive Chronic Hepatitis BChronic Hepatitis BNCT00116805Gilead Sciences266