NCT00199121Unknown4 期
An Open, Single-Arm, Multi-Center, Phase IV Pilot Study of Treatment of Antiretroviral Naive HIV-1 Infected Patients With Tenofovir Disoproxil Fumarate in Combination With Emtricitabine and Zidovudine
Johann Wolfgang Goethe University Hospital2 个研究点 分布在 1 个国家开始时间: 2005年9月20日最近更新:
适应症
相关药物
试验速览
- 阶段
- 4 期
- 发起方
- 试验地点
- 2
研究概览
简要总结
The purpose of this study is to evaluate the antiviral effect and durability of antiviral response (HIV-1 RNA PCR) and safety of a triple NtRTI/NsRTI therapy in antiretroviral naive patients. Patients will receive TDF plus FTC plus AZT for at least 48 weeks. Further objectives are to evaluate resistance pathways in failing patients treated with TDF/FTC/AZT and to evaluate a treatment strategy of sparing PIs and NNRTIs for later treatment.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
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
- •18 years and older
- •HIV-1 positive
- •antiretroviral treatment naive
- •one CD4 count >200/ul within 14d prior to study drug administration
- •one HIV-1 RNA PCR value >5000 and <100.000 cop/ml within 14d prior to study drug administration
- •women of child bearing potential: negative serum pregnancy test within 14d of study
- •ability to understand and provide written informed consent
- •overall stable disease
- •absence of clinical signs of lipodystrophy
排除标准
- •alcohol or illicit drug use
- •malabsorption syndrome or other gastrointestinal dysfunction
- •clinically relevant pancreatitis/hepatitis within the last 6 months
- •receiving other investigational drugs
- •abnormal hemoglobin, neutrophil, platelet, AST/ALT, pancreatic amylase, creatinine clearance, total bilirubine levels within 14d prior to study
- •pregnancy/breast-feeding
- •radiation therapy or cytotoxic chemotherapeutic agents within 30d of study
- •prior antiretroviral therapy at any time, investigational antiretrovirals trial at any time, HIV vaccine within 90d prior to study
- •immunomodulating agents
- •serious medical condition (diabetes, congestive heart failure, cardiomyopathy, or other cardiac dysfunction)
- •active diagnosis of AIDS (except for cutaneous Kaposi Sarcoma)
- •foscarnet therapy or other agent with documented activity against HIV-1
研究者
研究点 (2)
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