Comparison of GW433908 and Nelfinavir in HIV Patients Who Have Not Had Antiretroviral Therapy
2005年6月23日 更新者:Glaxo Wellcome
A Phase III, Randomised, Multicenter, Parallel, Open-Label Study to Compare the Efficacy, Safety, and Tolerability of GW433908 (1400 Mg Bid) and Nelfinavir (1250 Mg Bid) Over 48 Weeks in Antiretroviral Therapy Naive HIV-1 Infected Adults
The purpose of this study is to compare GW433908 and nelfinavir when each is given with abacavir and lamivudine to HIV patients who have not taken antiretroviral drugs.
研究概览
详细说明
Patients are randomized in a 2:1 scheme to 1 of 2 treatment groups.
Group 1 receives GW433908 plus abacavir (ABC) plus lamivudine (3TC); Group 2 receives nelfinavir (NFV) plus ABC plus 3TC.
Patients undergo safety and efficacy assessments at the Screening Visit, Day 1 (Entry), and Weeks 1, 2, 4, 8, 12, 16, 20, 24, and every 8 weeks thereafter.
A follow-up visit is performed 4 weeks after the permanent discontinuation of study drug.
Detailed assessments for the development of lipodystrophy/fat redistribution occur at Day 1, Week 24, Week 48, and every 16 weeks thereafter.
Patients have examinations and laboratory tests performed at visits.
研究类型
介入性
注册
210
阶段
- 第三阶段
联系人和位置
本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。
学习地点
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California
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Concord、California、美国、94520
- East Bay Clinical Trial Ctr
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Long Beach、California、美国、90803
- Ocean View Internal Medicine
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Florida
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Orlando、Florida、美国、32801
- Florida ID Group
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Tampa、Florida、美国、33617
- Clinical Pharmacology Services
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Tampa、Florida、美国、33602
- Hillsborough County Health Dept
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Illinois
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Chicago、Illinois、美国、60064
- Veterans Affairs Med Ctr of North Chicago
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Kansas
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Kansas City、Kansas、美国、661607415
- Univ of Kansas Med Ctr
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New Jersey
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Newark、New Jersey、美国、07102
- Saint Michael's Med Ctr
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Newark、New Jersey、美国、071032757
- UMDNJ - New Jersey Med School
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New York
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Bronx、New York、美国、10461
- Bronx Municipal Hosp Ctr/Jacobi Med Ctr
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Brooklyn、New York、美国、112123198
- Brookdale Univ Hosp and Med Ctr
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Brooklyn、New York、美国、11201
- Addiction Research and Treatment Corp
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New York、New York、美国、10029
- Mount Sinai School of Medicine
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New York、New York、美国、10011
- Howard Grossman
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New York、New York、美国、10011
- Gervais Frechette
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Rochester、New York、美国、14642
- Univ of Rochester Med Ctr
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North Carolina
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Charlotte、North Carolina、美国、28211
- SMO-USA Inc
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Oregon
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Eugene、Oregon、美国、97401
- Advanced Clinical Trials Inc
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Pennsylvania
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Philadelphia、Pennsylvania、美国、19107
- Thomas Jefferson Univ
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Texas
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Galveston、Texas、美国、775550835
- Univ of Texas Med Branch
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Houston、Texas、美国、77054
- MacGregor Med Association
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Irving、Texas、美国、75038
- Walter Gaman
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San Antonio、Texas、美国、78229
- Southwest Texas Methodist Hosp
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参与标准
研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
13年 及以上 (孩子、成人、年长者)
接受健康志愿者
不
有资格学习的性别
全部
描述
Inclusion Criteria
Patients may be eligible for this study if they:
- Are at least 13 years old (consent of parent or guardian required if under 18).
- Agree to use a proven barrier method of birth control (e.g., spermicide plus condom) during the study period (hormonal birth control will not be accepted), if able to have children.
- Have received less than 4 weeks treatment with any nucleoside reverse transcriptase inhibitor (NRTI) and have never received any nonnucleoside reverse transcriptase inhibitor (NNRT) or protease inhibitor (PI).
- Have a viral load (amount of HIV in the blood) of 5,000 copies/ml or more, or have a positive result at the screening visit.
Exclusion Criteria
Patients will not be eligible for this study if they:
- Abuse drugs or alcohol in a way that would interfere with the study, in the opinion of the doctor. Patients stable on methadone will be considered for participation.
- Have an active/acute CDC Category C event.
- Are unable to absorb or take medicines by mouth.
- Are pregnant or breast-feeding.
- Have a serious medical condition (such as diabetes, heart problem, hepatitis) that might affect the safety of the patient.
- Have had pancreatitis or hepatitis within the last 6 months.
- Have been treated with radiation or chemotherapy within 28 days before the study drug will be taken, or will have the need for these during the study.
- Have taken drugs that affect the immune system (such as corticosteroids, interleukins, interferons) or that have anti-HIV activity (such as hydroxyurea or foscarnet) within 28 days before the study drug will be taken.
- Have received HIV vaccine within 3 months before the study drug will be taken.
- Have received certain other drugs within 28 days before the study drug will be taken, or think that they will be needed during the study.
- Have received experimental treatments.
- Have allergies which might interfere with the study, in the opinion of the doctor.
学习计划
本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。
研究是如何设计的?
设计细节
- 主要用途:治疗
- 介入模型:并行分配
合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始
2000年11月1日
研究注册日期
首次提交
2001年1月13日
首先提交符合 QC 标准的
2001年8月30日
首次发布 (估计)
2001年8月31日
研究记录更新
最后更新发布 (估计)
2005年6月24日
上次提交的符合 QC 标准的更新
2005年6月23日
最后验证
2001年7月1日
更多信息
此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.
艾滋病毒感染的临床试验
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Hospital Clinic of Barcelona完全的
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National Institute of Allergy and Infectious Diseases...完全的HIV-1 感染 | HIV抗体 | 中和抗体 | 病毒载量 | 单克隆抗体美国
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Rajavithi Hospital未知研究在放疗前和放疗最后一周接受放疗的 HIV 癌症患者的免疫状态 | 研究在放疗前和放疗最后一周接受放疗的 HIV 癌症患者的 HIV 病毒载量泰国
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AIDS Healthcare FoundationUniversity of California, Los Angeles完全的
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Janssen Pharmaceutica N.V., Belgium完全的
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Merck Sharp & Dohme LLC完全的
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Janssen Research & Development, LLC完全的
拉米夫定的临床试验
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Shanghai Public Health Clinical Center尚未招聘
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Thomas Benfield招聘中
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Merck Sharp & Dohme LLC完全的HIV-1 感染美国, 智利, 法国, 英国
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Merck Sharp & Dohme LLC完全的