NCT00002238已完成3 期
Phase III Randomized Double-Blind Placebo Controlled Study To Evaluate the Safety and Efficacy of Betaseron in AIDS and Advanced ARC Patients Receiving a Reduced-Dose AZT Regimen
Bayer25 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
- 25
研究概览
简要总结
To evaluate the safety and efficacy of interferon beta (Betaseron) in AIDS and advanced AIDS related complex (ARC) patients receiving a reduced-dose zidovudine (AZT) regimen.
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:
- •Zidovudine (AZT).
- •Patient must have:
- •Uninterrupted therapy with reduced-dose AZT 500 - 600 mg/day for at least 3 weeks before entry.
- •Acceptable hepatic and renal function.
- •AMENDED to delete the following sentence:
- •Hematologic intolerance to full-dose zidovudine (AZT) (1000 - 1200 mg/day).
排除标准
- •Co-existing Condition:
- •Patients with the following are excluded:
- •Concurrent, ineffectively controlled opportunistic infections.
- •Extensive cutaneous and/or visceral Kaposi's sarcoma requiring systemic chemotherapy.
- •Proteinuria of 2+ or greater.
- •HIV encephalopathy.
- •HIV wasting syndrome.
- •New York Heart Classification III or IV.
- •Uncontrolled angina pectoris.
- •Evidence of clinically significant, multifocal uncontrolled cardiac dysrhythmias.
- •Concurrent Medication:
- •Antiretrovirals other than zidovudine (AZT) or Betaseron.
- •Chronic acyclovir therapy.
- •Acetaminophen.
- •Patients with the following are excluded:
- •Intolerance (hematologic or otherwise) to zidovudine (AZT) at a dose of 100 mg orally every 4 hours. AMENDED to:
- •Intolerance at a dose of 500 to 600 mg/day.
- •Medical or psychiatric conditions that compromise the patient's ability to give informed consent or complete the study.
- •Prior Medication:
- •Excluded within 30 days of study entry:
- •Cytotoxic chemotherapy.
- •Prior therapy with alpha, beta, or gamma interferons.
- •Active drug or alcohol abuse.
研究者
研究点 (25)
Loading locations...
相似试验
已完成
3 期
A Study to Compare Two Anti-HIV Drug Combinations in HIV-Infected Patients Who Have Previously Received Anti-HIV TreatmentHIV InfectionsNCT00004581Abbott300
进行中（未招募）
3 期
P1101 in Treating Patients With Early PMF or Overt PMF at Low or Intermediate-1 RiskPrimary MyelofibrosisMyeloproliferative NeoplasmNCT06468033PharmaEssentia160
已完成
3 期
Pegylated Interferon Alpha-2b Versus Hydroxyurea in Polycythemia VeraPolycythemia VeraNCT01949805AOP Orphan Pharmaceuticals AG257
已完成
3 期
Efficacy and Safety Study of Peginterferon Alfa-2b in Chinese Chronic Hepatitis C PatientsChronic Hepatitis CNCT01581398Xiamen Amoytop Biotech Co., Ltd.770
已完成
3 期
Efficacy and Safety of Peginterferon Alfa-2b in HBeAg Positive Chronic Hepatitis BChronic Hepatitis BNCT01760122Xiamen Amoytop Biotech Co., Ltd.820