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A Study of Dideoxyinosine (ddI) in HIV-Infected Children Who Have Not Had Success With Zidovudine or Who Cannot Take Zidovudine

2021年10月28日 更新者：National Institute of Allergy and Infectious Diseases (NIAID)

A Randomized Comparative Trial of Two Doses of 2',3'-Dideoxyinosine (ddI) in Children With Symptomatic HIV Infection Who Are Either Unresponsive to Zidovudine and/or Who Are Intolerant to Zidovudine

To evaluate the effectiveness, safety, and tolerance of two doses of didanosine (ddI) in the treatment of children with symptomatic HIV disease who have had to discontinue zidovudine (AZT) because of intolerance and/or who have experienced progressive disease while on AZT.

The progression of immunodeficiency due to HIV infection can be delayed by using AZT. The benefits of AZT in adults with AIDS and severe AIDS-related complex (ARC) appear to last for approximately 12 to 18 months, at which time most patients have progressive deterioration. Recently published literature has described a reduced sensitivity of HIV isolated from patients after prolonged AZT treatment. Although the clinical significance of this is unclear, it makes the development of new antiretroviral drugs important.

研究概览

地位

完全的

条件

干预/治疗

详细说明

The progression of immunodeficiency due to HIV infection can be delayed by using AZT. The benefits of AZT in adults with AIDS and severe AIDS-related complex (ARC) appear to last for approximately 12 to 18 months, at which time most patients have progressive deterioration. Recently published literature has described a reduced sensitivity of HIV isolated from patients after prolonged AZT treatment. Although the clinical significance of this is unclear, it makes the development of new antiretroviral drugs important.

Children who show AZT intolerance and/or progressive disease after 6 months of AZT therapy receive oral ddI at 1 of 2 doses for a minimum of 48 weeks, with a 48-week extension. Patients are seen for clinical and laboratory evaluations at scheduled times during the study. (Per 5/12/92 amendment, new patients will not be enrolled in the pharmacokinetics studies.) Per 10/31/94 amendment: Patients are eligible to receive blinded study drug for an additional 8-16 weeks after the final on-study visit, but no later than 2/15/95.

研究类型

介入性

注册

300

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

  • 波多黎各
      • Bayamon、波多黎各、00956
        • Univ. Hosp. Ramón Ruiz Arnau, Dept. of Peds.
      • San Juan、波多黎各
        • Univ. of Puerto Rico Ped. HIV/AIDS Research Program CRS
      • San Juan、波多黎各、00936
        • San Juan City Hosp. PR NICHD CRS
  • 美国
    • California
      • Long Beach、California、美国、90801
        • Long Beach Memorial Med. Ctr., Miller Children's Hosp.
      • Los Angeles、California、美国、90033
        • Usc La Nichd Crs
      • Los Angeles、California、美国
        • UCLA-Los Angeles/Brazil AIDS Consortium (LABAC) CRS
      • Oakland、California、美国、94609
        • Children's Hosp. & Research Ctr. Oakland, Ped. Clinical Research Ctr. & Research Lab.
      • San Diego、California、美国、92093
        • UCSD Maternal, Child, and Adolescent HIV CRS
      • San Francisco、California、美国、94143
        • UCSF Pediatric AIDS CRS
      • Torrance、California、美国
        • Harbor - UCLA Med. Ctr. - Dept. of Peds., Div. of Infectious Diseases
    • Connecticut
      • Farmington、Connecticut、美国、06032
        • Univ. of Connecticut Health Ctr., Dept. of Ped.
      • New Haven、Connecticut、美国、06504
        • Yale Univ. School of Medicine - Dept. of Peds., Div. of Infectious Disease
    • District of Columbia
      • Washington、District of Columbia、美国、20010
        • Children's National Med. Ctr., ACTU
      • Washington、District of Columbia、美国、20060
        • Howard Univ. Washington DC NICHD CRS
    • Florida
      • Miami、Florida、美国、33161
        • Univ. of Miami Ped. Perinatal HIV/AIDS CRS
    • Georgia
      • Atlanta、Georgia、美国、30306
        • Emory Univ. School of Medicine, Dept. of Peds., Div. of Infectious Diseases
    • Illinois
      • Chicago、Illinois、美国、60612
        • Cook County Hosp.
      • Chicago、Illinois、美国、60614
        • Chicago Children's CRS
      • Chicago、Illinois、美国、60637
        • Univ. of Chicago - Dept. of Peds., Div. of Infectious Disease
      • Chicago、Illinois、美国、60612
        • Univ. of Illinois College of Medicine at Chicago, Dept. of Peds.
    • Louisiana
      • New Orleans、Louisiana、美国
        • Tulane Med. Ctr. - Charity Hosp. of New Orleans, ACTU
      • New Orleans、Louisiana、美国
        • Tulane/LSU Maternal/Child CRS
    • Maryland
      • Baltimore、Maryland、美国、21201
        • Univ. of Maryland Med. Ctr., Div. of Ped. Immunology & Rheumatology
      • Baltimore、Maryland、美国、21287
        • Johns Hopkins Hosp. & Health System - Dept. of Peds., Div. of Infectious Diseases
    • Massachusetts
      • Boston、Massachusetts、美国、02115
        • HMS - Children's Hosp. Boston, Div. of Infectious Diseases
      • Boston、Massachusetts、美国、02118
        • BMC, Div. of Ped Infectious Diseases
      • Springfield、Massachusetts、美国、01199
        • Baystate Health, Baystate Med. Ctr.
      • Worcester、Massachusetts、美国、01655
        • WNE Maternal Pediatric Adolescent AIDS CRS
    • Michigan
      • Detroit、Michigan、美国、48201
        • Children's Hospital of Michigan NICHD CRS
    • New Jersey
      • New Brunswick、New Jersey、美国
        • UMDNJ - Robert Wood Johnson
      • Paterson、New Jersey、美国
        • St. Joseph's Hosp. & Med. Ctr. of New Jersey
    • New York
      • Albany、New York、美国、12208
        • Children's Hospital at Albany Medical Center, Dept. of Peds.
      • Bronx、New York、美国、10457
        • Bronx-Lebanon Hosp. IMPAACT CRS
      • Brooklyn、New York、美国、11203
        • SUNY Downstate Med. Ctr., Children's Hosp. at Downstate NICHD CRS
      • Great Neck、New York、美国、11021
        • North Shore-Long Island Jewish Health System, Dept. of Peds.
      • New Hyde Park、New York、美国、11040
        • Schneider Children's Hosp., Div. of Infectious Diseases
      • New York、New York、美国、10032
        • Columbia IMPAACT CRS
      • New York、New York、美国、10037
        • Harlem Hosp. Ctr. NY NICHD CRS
      • New York、New York、美国、10016
        • NYU Med. Ctr., Dept. of Medicine
      • New York、New York、美国、10032
        • Incarnation Children's Ctr.
      • New York、New York、美国、10029
        • Metropolitan Hosp. NICHD CRS
      • Rochester、New York、美国、14642
        • Univ. of Rochester ACTG CRS
      • Stony Brook、New York、美国、11794
        • SUNY Stony Brook NICHD CRS
      • Syracuse、New York、美国、13210
        • SUNY Upstate Med. Univ., Dept. of Peds.
    • North Carolina
      • Durham、North Carolina、美国、27710
        • DUMC Ped. CRS
    • Ohio
      • Cleveland、Ohio、美国、44106
        • Case CRS
    • Pennsylvania
      • Philadelphia、Pennsylvania、美国、19104
        • The Children's Hosp. of Philadelphia IMPAACT CRS
      • Philadelphia、Pennsylvania、美国、19134
        • St. Christopher's Hosp. for Children
    • South Carolina
      • Charleston、South Carolina、美国、29425
        • Med. Univ. of South Carolina, Div. of Ped. Infectious Diseases
    • Texas
      • Dallas、Texas、美国、75235
        • Children's Med. Ctr. Dallas
      • Houston、Texas、美国、77030
        • Texas Children's Hosp. CRS
    • Washington
      • Seattle、Washington、美国、98105
        • UW School of Medicine - CHRMC

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

3个月 至 18年 (孩子、成人)

接受健康志愿者

不

有资格学习的性别

全部

描述

Inclusion Criteria

Concurrent Medication:

Allowed:

  • Prophylaxis treatment for Pneumocystis carinii pneumonia (PCP).
  • Immunoglobulin.
  • Maintenance therapy with amphotericin B (l mg/kg) up to 5 days/week.

Concurrent Treatment:

Allowed:

  • Blood transfusions.

Prior Medication:

Allowed:

  • Prophylaxis treatment for Pneumocystis carinii pneumonia (PCP).

Patients enrolled in ACTG 128 and ACTG 138 must meet study end points or meet protocol definitions for being permanently off zidovudine (AZT) before enrolling in this study.

  • Patients currently enrolled in ACTG 051 who have not reached the study end points but who meet the entry criteria for ACTG 144 may be co-enrolled in ACTG 144.
  • Patient or guardian available to give written informed consent.

Exclusion Criteria

Co-existing Condition:

Patients with the following conditions or symptoms are excluded.

  • Hypersensitivity to didanosine (ddI).
  • Symptomatic cardiomyopathy.
  • Seizures that are not well controlled by ongoing anticonvulsant therapy.
  • Symptomatic pancreatitis.
  • Grade 1 or higher peripheral neuropathy.
  • Active malignancy requiring chemotherapy.

Concurrent Medication:

Excluded:

  • Zidovudine (AZT), other antiretroviral agents, biological modifiers, and investigational medications.

Avoid:

  • Drugs with potential to cause peripheral neuropathy or pancreatitis.

Patients with the following are excluded:

  • Active malignancy requiring concomitant chemotherapy.

Prior Medication:

Excluded:

  • Antiretroviral agents other than zidovudine (AZT) or dideoxycytidine (ddC) within 4 weeks of study entry.
  • Immunomodulating agents such as interferons, isoprinosine, or interleukin-2 within 2 weeks of entry.
  • Any other experimental therapy within 1 week of entry.
  • Drugs that have or will cause prolonged neutropenia, significant pancreatitis, significant nephrotoxicity, or peripheral neuropathy within 1 week of entry.

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

National Institute of Allergy and Infectious Diseases (NIAID)

合作者

Bristol-Myers Squibb

调查人员

  • 学习椅：Frenkel LM
  • 学习椅：Bryson Y
  • 学习椅：Stiehm R

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

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

研究完成 (实际的)

1995年9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 (实际的)

2021年10月29日

上次提交的符合 QC 标准的更新

2021年10月28日

最后验证

2021年10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

  • ACTG 144
  • 11119 (DAIDS ES Registry Number)

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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