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Comparison of GW433908/Ritonavir to Nelfinavir When Used With Abacavir and Lamivudine in Patients That Have Not Taken Antiretroviral Drugs

2005年6月23日 更新者：Glaxo Wellcome

A Randomized, Open-Label, Two Arm Trial to Compare the Safety and Antiviral Efficacy of GW433908/Ritonavir QD to Nelfinavir BID When Used in Combination With Abacavir and Lamivudine for 48 Weeks in Antiretroviral Therapy Naive HIV-1 Infected Subjects

The purpose of this study is to compare virus response to GW433908/ritonavir (RTV) to viral response to nelfinavir (NFV) when used with abacavir (ABC)/lamivudine (3TC) in patients that have not taken antiretroviral (ART) drugs.

研究概览

地位

未知

条件

干预/治疗

详细说明

Patients are randomized to 1 of 2 treatment arms. One arm is treated with GW433908/RTV plus ABC and 3TC. The other is treated with NFV plus ABC and 3TC. Each group is treated for 48 weeks. The following are compared in the 2 arms: 1) magnitude and durability of antiviral response; 2) safety, tolerance, and antiviral response after 24 and 48 weeks of therapy; 3) time to treatment failure; 4) immunologic response; 5) occurrence of events related to metabolic abnormalities; and 6) development of viral resistance in a subset of patients following treatment. Also studied are: 1) steady-state plasma drug trough concentrations; 2) demographic, virologic, immunologic, pharmacologic, and adherence factors that may be associated with treatment outcome; 3) patient adherence to the drug regimens; 4) study medication utilization; and 5) resource utilization.

研究类型

介入性

注册

624

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

  • 美国
    • California
      • Fountain Valley、California、美国、92708
        • Orange County Ctr for Special Immunology
      • Los Angeles、California、美国、90027
        • AIDS Healthcare Foundation
      • Los Angeles、California、美国、90028
        • LAGLC
      • Sacramento、California、美国、95825
        • Kaiser Hospital
      • San Diego、California、美国、92103
        • Park Ctr for Health / Keith Vrhel
      • West Hollywood、California、美国、90069
        • AIDS Research Alliance
    • District of Columbia
      • Washington、District of Columbia、美国、200091104
        • Dupont Circle Physicians Group
    • Florida
      • Altamonte Springs、Florida、美国、32701
        • Infectious Disease Consultants
      • Coral Gables、Florida、美国、33146
        • CRI of South Florida
      • Fort Lauderdale、Florida、美国、33316
        • Gary Richmond MD
      • Fort Lauderdale、Florida、美国、33308
        • Therafirst Med Ctr
      • Miami、Florida、美国、33142
        • Specialty Med Care Ctrs of South Florida Inc
      • Miami、Florida、美国、33136
        • Univ of Miami Dept of Medicine
      • Sarasota、Florida、美国、34239
        • Infectious Diseases Associates
      • St. Petersburg、Florida、美国、33710
        • Jeffrey Levenson
      • Tampa、Florida、美国、33614
        • Infectious Disease Research Inst
    • Georgia
      • Atlanta、Georgia、美国、30308
        • AIDS Research Consortium of Atlanta
      • Augusta、Georgia、美国、30912
        • Med College of Georgia
      • Conyers、Georgia、美国、30013
        • SMO USA
    • Indiana
      • Indianapolis、Indiana、美国、46202
        • Indiana Univ Med School
    • Massachusetts
      • Boston、Massachusetts、美国、02115
        • Brigham and Women's Hosp
      • New Bedford、Massachusetts、美国、02745
        • Hawthorne Med Associates / PAACA
    • Minnesota
      • Minneapolis、Minnesota、美国、55404
        • Abbott-Northwestern Hosp / Clinic 42
    • Missouri
      • St. Louis、Missouri、美国、63139
        • Southampton Healthcare Inc
    • New Jersey
      • East Orange、New Jersey、美国、07018
        • VAMC New Jersey Healthcare System
      • Newark、New Jersey、美国、071032842
        • North Jersey Community Research Initiative
    • New York
      • Bronx、New York、美国、10468
        • Bronx Veterans Affairs Med Ctr
      • Buffalo、New York、美国、14215
        • SUNY / Erie County Med Ctr at Buffalo
      • Manhasset、New York、美国、11030
        • North Shore Univ Hosp
      • New York、New York、美国、10019
        • St Lukes - Roosevelt Hosp Ctr
    • Ohio
      • Cincinnati、Ohio、美国、452670405
        • Univ of Cincinnati / Holmes Hosp
    • Pennsylvania
      • Hershey、Pennsylvania、美国、170330850
        • Milton S Hershey Med Ctr
      • Philadelphia、Pennsylvania、美国、19102
        • Hahnemann Univ Hosp
    • South Carolina
      • Columbia、South Carolina、美国、29206
        • Burnside Clinic
    • Tennessee
      • Memphis、Tennessee、美国、38104
        • Methodist Healthcare
    • Texas
      • Dallas、Texas、美国、75246
        • Nicholas Bellos
      • Houston、Texas、美国、77004
        • Joseph C Gathe

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 needed 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 (NNRTI) or protease inhibitor (PI). Mothers who have previously received 1 dose of the NNRTI nevirapine during pregnancy for prevention of mother-to-child HIV transmission are permitted to enter the study.
  • Have a viral load (amount of HIV in the blood) of 1,000 copies/ml or more.

Exclusion Criteria

Patients will not be eligible for this study if they:

  • Abuse drugs or alcohol in a way that would interfere with study requirements. Patients who are stable on methadone will be considered for the study.
  • 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 an 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

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。

赞助

Glaxo Wellcome

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23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

2002年3月1日

更多信息

与本研究相关的术语

关键字

其他相关的 MeSH 术语

其他研究编号

  • 316B
  • APV30002

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.

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条件

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