此页面是自动翻译的，不保证翻译的准确性。请参阅英文版对于源文本。

Study of a New Protease Inhibitor, BMS-232632, in Combination With Other Anti-HIV Drugs

2011年4月28日更新者：Bristol-Myers Squibb

Evaluation of the Safety and Antiviral Efficacy of a Novel HIV-1 Protease Inhibitor, BMS-232632, Alone and in Combination With d4T and ddI as Compared to a Reference Combination Regimen

The purpose of this study is to evaluate a new protease inhibitor known as BMS-232632. This drug will be given in combination with 2 other anti-HIV drugs (stavudine and didanosine). The effectiveness of BMS-232632 against HIV infection will be compared to that of nelfinavir, a protease inhibitor that is already commonly prescribed.

研究概览

地位

完全的

条件

艾滋病毒感染

干预/治疗

详细说明

Patients are randomized to receive one of two drug regimens: BMS-232632, ddI, and d4T or NFV, ddI, and d4T. Three different doses of BMS-232632 are used in this study. Randomization is stratified for HIV RNA level (less than 30,000 copies/ml versus 30,000 or greater copies/ml). Patients remain on their drug regimen for 48 weeks.

研究类型

介入性

阶段

阶段2

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

加拿大
- Ontario
  - Ottawa、Ontario、加拿大
    - Ottawa General Hospital
美国
- Alabama
  - Birmingham、Alabama、美国、35294
    - Univ of Alabama at Birmingham
  - Birmingham、Alabama、美国、35203
    - Clinsites / Sorra Research Ctr
- California
  - San Diego、California、美国、92103
    - UCSD Treatment Ctr
  - San Francisco、California、美国、94110
    - UCSF - San Francisco Gen Hosp
- Colorado
  - Denver、Colorado、美国、80262
    - Univ of Colorado / Health Science Ctr
- District of Columbia
  - Washington、District of Columbia、美国、20009
    - ViRx / Dupont Circle Physicians Group
- Georgia
  - Atlanta、Georgia、美国、30308
    - AIDS Research Consortium of Atlanta
- Illinois
  - Chicago、Illinois、美国、60612
    - Rush Presbyterian - Saint Luke's Med Ctr
- Missouri
  - St Louis、Missouri、美国、63108
    - Washington Univ School Of Medicine
- New York
  - Albany、New York、美国、12208
    - Albany Med College
  - New York、New York、美国、10003
    - Beth Israel Med Ctr
  - New York、New York、美国、10032
    - Columbia Presbyterian Med Ctr
- Ohio
  - Cleveland、Ohio、美国、44106
    - Case Western Reserve Univ
- Texas
  - Dallas、Texas、美国、75235
    - Univ of Texas Southwestern Med Ctr of Dallas
  - Dallas、Texas、美国、75219
    - Oak Lawn Physicians Group
  - Galveston、Texas、美国、77555
    - Univ TX Galveston Med Branch

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

18年及以上 (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 HIV-positive.
Have an HIV blood level between 2,000 and 200,000 copies/ml.
Have a CD4 cell count of at least 100 cells/mm3.
Are 18 years of age or older.
Are available for follow-up for at least 48 weeks.
Agree to use a barrier method of birth control (such as condoms) during the study.

Exclusion Criteria

Patients will not be eligible for this study if they:

Have ever received anti-HIV (antiretroviral) treatment.
Have an HIV-related opportunistic infection or condition at the time of study entry.
Have primary HIV infection, meaning they have recently been infected.
Have had severe diarrhea within the 30 days before study entry.
Have hemophilia.
Have a history of pancreatitis, hepatitis, or a peripheral neuropathy.
Are unable to tolerate oral medication.
Are pregnant or breast-feeding.
Abuse alcohol or drugs.

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

Bristol-Myers Squibb

出版物和有用的链接

负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。

一般刊物

Piliero P, et al. AI424-007: Atazanavir: an HIV protease inhibitor (PI) that does not cause lipid elevations. International Symposium on Drugs Affecting Lipid Metabolism. 2001 Sept 9 - 12
Gatell JM, et al. AI424-007: Atazanavir (BMS-232632): Absence of serum lipid changes after 48 weeks of treatment in treatment-naive HIV-positive subjects (Trial AI424007). 8th European Conf on Clinical Aspects and Treatment of HIV Infection (8th ECCATHI). 2001 Oct 28 - 31 (abstract no 223)
Piliero P, et al. AI424-007: BMS-232632 - Clinical Trial AI424007: Safety, Efficacy of a Once-Daily Protease Inhibitor at 24 Weeks. 5th International Congress on Drug Therapy in HIV Infection. 2000 Octr 22 - 26
Sanne I, Piliero P, Wood R, Kelleher T, Cross A, Mongillo A, Schnittman S. AI424-007: Safety and Antiviral Efficacy of a Novel Once-Daily HIV-1 Protease Inhibitor BMS-232632: Preliminary Results from a Phase II Clinical Trial. 7th Conf Retroviruses and Opportunistic Infect. 2000 Jan 30-Feb 2 (abstract no 672)
Squires K, Gatell J, Piliero P, Sanne I, Wood R, Schnittman SM. AI424-007: 48-week safety and efficacy results from a phase II study of a once-daily HIV-1 protease inhibitor (PI), BMS-232632. 8th Conf Retro and Opportun Infect. 2001 Feb 4-8 (abstract no 15)
Sanne I, Piliero P, Wood R, Kelleher T, Cross A, Mongillo A, Schnittman S. AI424-007: Safety and Antiviral Efficacy of a Once-Daily HIV-1 Protease Inhibitor BMS-232632: 24 Week Results from a Phase II Clinical Trial. 40th Interscience Conf on Antimicrobial Agents and Chemotherapy. 2000 September 17-20 (abstract no 691)
Piliero P, Cahn P, Pantaleo G, Gatell JM, Squires K, Percival L, Sanne I, Wood R, Phanuphak P, Shelton S, Lazzarin A, Thiry A, Kelleher T, Giordano M, Schnittman SM. AI424-007: Atazanavir: A Once-Daily Protease Inhibitor with a Superior Lipid Profile-Results of Clinical Trials Beyond Week 48. 9th Conf on Retroviruses and Opportunistic Infect. 2002 Feb 24 - 28 (abstract no 706-T)

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

1999年3月1日

初级完成 (实际的)

2001年12月1日

研究完成 (实际的)

2001年12月1日

研究注册日期

首次提交

1999年11月2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)

2011年5月4日

上次提交的符合 QC 标准的更新

2011年4月28日

最后验证

2011年4月1日