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。

The Safety and Effectiveness of Zidovudine in the Treatment of HIV-Infected Children With Mild to Moderate Symptoms

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

A Multicenter Placebo-Controlled Trial To Evaluate the Safety and Efficacy of Oral Zidovudine in the Treatment of Children Infected With Human Immunodeficiency Virus With Mild to Moderate Symptoms (Including LIP)

To determine the safety and usefulness of zidovudine (AZT) for the treatment of children 3 months to 12 years of age. This study is designed to determine if children who are infected with HIV and who have a special type of lung disease called lymphocytic interstitial pneumonitis (LIP) or other early symptoms of HIV infection may derive benefit from treatment with AZT. It is hoped that this drug will prevent children from developing additional symptoms and infections and will help resolve already existing symptoms.

AZT has been shown in the laboratory to inhibit the infection of cells by HIV. AZT has been shown to decrease the mortality and the frequency of opportunistic infections in certain adult patients with symptomatic HIV infection. It is, therefore, likely that symptomatic HIV-infected children may also benefit from specific antiviral therapy.

研究概览

地位

完全的

条件

干预/治疗

详细说明

AZT has been shown in the laboratory to inhibit the infection of cells by HIV. AZT has been shown to decrease the mortality and the frequency of opportunistic infections in certain adult patients with symptomatic HIV infection. It is, therefore, likely that symptomatic HIV-infected children may also benefit from specific antiviral therapy.

Children who participate in the study are evaluated at a hospital outpatient clinic and are under the care of a specialist in pediatrics. Of the children who participate in the study, half receive AZT syrup and half receive a placebo (sugar solution). The investigator does not know which medication each child receives as this is decided by a random process. The children take the medication in a strawberry-flavored clear syrup every 6 hours (4 times a day), for a period of 2 years or 104 weeks. The children are monitored on an outpatient basis while receiving therapy and the tests performed on admission to the study are repeated several times during treatment. Blood samples are obtained once a week for the first 4 weeks, every other week for the next 4 weeks, and then monthly until the end of the study. At certain sites, Cerebrospinal fluid (CSF) is collected by lumbar puncture every 52 weeks to evaluate infection involving the brain and nervous system. An independent committee reviews the data collected on the children every 6 months. The drug is stopped or the dose reduced if unacceptable side effects develop. AMENDED: As of August 7, 1989 the study blind was broken, the placebo arm discontinued and the study closed to accrual as of September 25, 1989. The 6 children enrolled in the study have been offered AZT.

研究类型

介入性

注册

224

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

  • 美国
    • California
      • Downey、California、美国、902422814
        • Kaiser Permanente / UCLA Med Ctr
      • Long Beach、California、美国、90801
        • Long Beach Memorial (Pediatric)
      • Los Angeles、California、美国、900276016
        • Children's Hosp of Los Angeles/UCLA Med Ctr
      • Los Angeles、California、美国、905022004
        • Harbor - UCLA Med Ctr / UCLA School of Medicine
      • Los Angeles、California、美国、900951752
        • UCLA Med Ctr / Pediatric
      • Los Angeles、California、美国、900593019
        • Martin Luther King Jr Gen Hosp / UCLA Med Ctr
      • Menlo Park、California、美国、94025
        • Stanford Univ School of Medicine
      • Oakland、California、美国、946091809
        • Children's Hosp of Oakland
      • San Diego、California、美国、92103
        • UCSD Treatment Ctr
      • San Francisco、California、美国、94143
        • Northern California Pediatric AIDS Treatment Ctr / UCSF
    • Florida
      • Miami、Florida、美国、331361013
        • Univ of Miami School of Medicine
      • Miami、Florida、美国、33136
        • Univ of Miami School of Medicine
    • Illinois
      • Chicago、Illinois、美国、60612
        • Cook County Hosp
      • Chicago、Illinois、美国、606143394
        • Chicago Children's Memorial Hosp
    • Louisiana
      • New Orleans、Louisiana、美国、70112
        • Tulane Univ School of Medicine
      • New Orleans、Louisiana、美国、70112
        • Charity Hosp / Tulane Univ Med School
    • Maryland
      • Baltimore、Maryland、美国、21201
        • Univ of Maryland at Baltimore / Univ Med Ctr
      • Baltimore、Maryland、美国、212874933
        • Johns Hopkins Hosp - Pediatric
    • Massachusetts
      • Boston、Massachusetts、美国、021155724
        • Children's Hosp of Boston
    • Minnesota
      • Minneapolis、Minnesota、美国、55455
        • Univ of Minnesota
    • New Jersey
      • Newark、New Jersey、美国、071072198
        • Children's Hosp of New Jersey / UMDNJ - New Jersey Med Schl
    • New York
      • Bronx、New York、美国、10465
        • Jack Weiler Hosp / Bronx Municipal Hosp
      • Elmhurst、New York、美国、11373
        • City Hosp Ctr at Elmhurst / Mount Sinai Hosp
      • New York、New York、美国、10016
        • Bellevue Hosp / New York Univ Med Ctr
      • New York、New York、美国、10029
        • Mount Sinai Med Ctr
      • New York、New York、美国、10037
        • Harlem Hosp Ctr
      • New York、New York、美国、10003
        • Beth Israel Med Ctr / Pediatrics
      • New York、New York、美国、10032
        • Columbia Univ Babies' Hosp
    • North Carolina
      • Durham、North Carolina、美国、277103499
        • Duke Univ Med Ctr
    • Ohio
      • Columbus、Ohio、美国、432052696
        • Columbus Children's Hosp
    • Pennsylvania
      • Hershey、Pennsylvania、美国、170330850
        • Milton S Hershey Med Ctr
    • Texas
      • Houston、Texas、美国、77030
        • Baylor College of Medicine
      • Houston、Texas、美国、77030
        • Hermann Hosp / Univ Texas Health Science Ctr

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 12年 (孩子)

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 for Pneumocystis carinii pneumonia (PCP) in children with AIDS or CD4 cell count = or < 500 cells/mm3.

Children must demonstrate the following clinical and laboratory findings:

  • Laboratory evidence of HIV infection as demonstrated by either a positive viral culture or detectable serum p24 antigen or = or > two positive tests for HIV antibody, which must be determined by a federally licensed ELISA test and confirmed by Western blot.
  • Children < 15 months of age, who are thought to have acquired HIV through perinatal transmission and whose only laboratory evidence of HIV infection is a positive antibody test, must also have one or more of the following laboratory criteria indicative of immunologic abnormality:
  • hypergammaglobulinemia (IgG or IgA) defined as greater than the upper limit of normal for age-adjusted normals; absolute depression in the CD4+ cells to = or < 500 cells/mm3; decreased helper/suppressor ratio < 1.0; depressed in vitro mitogen response to at least one antigen/mitogen.
  • Absence of serious bacterial infections as defined in Exclusion Criteria requiring therapy at the time of entry.
  • Hemophiliacs are included.

Exclusion Criteria

Co-existing Condition:

Children will be excluded for the following reasons:

  • Recurrent or life-threatening toxicity. Several allergic reactions such as exfoliative erythroderma, anaphylaxis, or vascular collapse. The presence of one or more of the indicator diseases of AIDS, such as opportunistic infections, malignancy, recurrent bacterial infections, or encephalopathy. Development of two or more episodes of recurrent varicella zoster infection or chronic zoster defined as = or > 30 days duration. Development of AIDS related complex, with failure to thrive, persistent or recurrent oral candidiasis, plus at least one of the following:
  • Diarrhea that is either persistent or recurrent, lymphadenopathy at two or more noncontiguous sites, organomegaly, nephropathy manifested by nephrotic syndrome without evidence of renal failure, two or more episodes of herpes stomatitis or one or more episodes of herpes zoster within a 1 year period; plus at least one of the following:
  • hypergammaglobulinemia, depression in the CD4+ cells to = or < 500/mm3, decreased helper/suppressor ratio < 1.0, depressed in vitro mitogen response to at least one antigen/mitogen.

Concurrent Medication:

Excluded:

  • Hepatotoxic drugs.
  • Steroids for lymphocytic interstitial pneumonitis (LIP).
  • Prophylaxis for oral candidiasis, or otitis media.
  • Immunoglobulin therapy.
  • Chronic use of drugs that are metabolized by hepatic glucuronidation.

Concurrent Treatment:

Excluded:

  • Supplemental oxygen treatment for lymphocytic interstitial pneumonitis (LIP).

Children will be excluded from the study for the following reasons:

  • AIDS-defining opportunistic infection or neoplasm.
  • Unexplained recurrent, serious bacterial infections (= or > 2 within a 2-year period) including sepsis, meningitis, pneumonia, abscess of an internal organ, and bone/joint infections caused by Haemophilus, Streptococcus, or other pyogenic bacteria.
  • Encephalopathy.
  • One or both of the following:
  • Failure to thrive, defined as a child who crosses two percentile lines on the growth chart or a child who is less than the fifth percentile and does not follow the curve; and/or persistent (= or > 2 months) oral candidiasis despite appropriate topical therapy.
  • Children with lymphocytic interstitial pneumonitis (LIP) who are steroid dependent or requiring supplemental oxygen or who have a pretreatment PaO2 < 70 mmHg.
  • Children who qualify for the entrance criteria to open-label zidovudine (AZT) or AZT plus or minus gammaglobulin.

Prior Medication:

Excluded:

  • Rifampin or rifampin derivatives.
  • Antiretroviral agents.
  • Zidovudine (AZT).
  • Excluded within 2 weeks of study entry:
  • Other experimental therapy.
  • Drugs which cause prolonged neutropenia or significant nephrotoxicity.
  • Excluded within 4 weeks of study entry:
  • Immunomodulating agents including immunoglobulin, interferon, isoprinosine, and IL-2.

Prior Treatment:

Excluded within 4 weeks of study entry:

  • Lymphocyte transfusions.

Active alcohol or drug abuse.

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
  • 屏蔽：双倍的

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)

调查人员

  • 学习椅：P Weintrub

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)

1992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11月1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 052
  • 11026 (注册表标识符：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.

艾滋病毒感染的临床试验

齐多夫定的临床试验

搜索类似试验

赞助者和合作者

医疗条件

药物干预

CROs by country

CROs in Latvia

条件

罕见疾病

药物干预

膳食补充剂

赞助者/合作者

地点

订阅