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A Study of Didanosine Use Alone or in Combination With Zidovudine in Infants Exposed to or Infected With HIV

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

A Phase I Evaluation of the Safety and Toxicity of Zidovudine and Didanosine in Combination in HIV-Infected or Exposed Infants and a Phase II Study of the Effect of Didanosine vs. Combination Therapy With Zidovudine and Didanosine on HIV-1 RNA in Infants With HIV Infection

To determine the pharmacokinetics, safety, and efficacy of didanosine (ddI) alone or in combination with zidovudine (AZT) in HIV-infected infants.

PER AMENDMENT 4/8/97: Part A study objectives are completed. Part B objectives: To assess the safety, toxicity, and tolerability and to compare anti-HIV activity, as measured by change in log10 RNA, of the two study arms.

Early treatment of HIV-infected infants with antiretroviral agents may prevent the early and rapid decline of CD4 count and immunologic function. Combination therapy may be preferred over monotherapy, since resistance to a single agent can develop rapidly. Currently, there is little information on ddI monotherapy in young infants less than 90 days and no information on the use of combination therapy in this population.

研究概览

地位

完全的

条件

干预/治疗

详细说明

Early treatment of HIV-infected infants with antiretroviral agents may prevent the early and rapid decline of CD4 count and immunologic function. Combination therapy may be preferred over monotherapy, since resistance to a single agent can develop rapidly. Currently, there is little information on ddI monotherapy in young infants less than 90 days and no information on the use of combination therapy in this population.

In Part A, a cohort of patients younger than 28 days (was less than 120 days; amended 6/20/95) of age receives open-label ddI monotherapy for 1 week before initiation of AZT/ddI combination therapy. After pharmacokinetic data are obtained, an additional cohort of patients receives ddI at a higher dose. An age-adjusted dose for ddI is determined for use in Part B. (NOTE: As of 2/13/95, Part A has completed accrued for infants 29 to 120 days of age.) Part B patients less than 90 days of age (was less than 180 days of age; amended 6/20/95) are randomized, on a double-blind basis, to receive ddI or AZT/ddI. All patients continue treatment until 12 months after the last patient on Part B is enrolled. PER AMENDMENT 4/8/97: Part A of this protocol is closed with accrual objectives met. Part B of the study will remain open for patient accrual until 6/2/97. Part B is designed as a 2-arm, randomized, double-blind study to assess safety, toxicity and tolerability as well as anti-HIV activity of ddI or AZT/ddI.

研究类型

介入性

注册

180

阶段

  • 阶段1

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
      • San Juan、波多黎各、009367344
        • San Juan City Hosp
      • San Juan、波多黎各、009365067
        • Univ of Puerto Rico / Univ Children's Hosp AIDS
  • 美国
    • Alabama
      • Birmingham、Alabama、美国、35294
        • Univ of Alabama at Birmingham Schl of Med / Pediatrics
    • California
      • La Jolla、California、美国、920930672
        • UCSD Med Ctr / Pediatrics / Clinical Sciences
      • Long Beach、California、美国、90801
        • Long Beach Memorial (Pediatric)
      • Los Angeles、California、美国、90033
        • Los Angeles County - USC Med Ctr
      • Los Angeles、California、美国、905022004
        • Harbor - UCLA Med Ctr / UCLA School of Medicine
      • Oakland、California、美国、946091809
        • Children's Hosp of Oakland
      • San Francisco、California、美国、94110
        • San Francisco Gen Hosp
      • San Francisco、California、美国、941430105
        • UCSF / Moffitt Hosp - Pediatric
    • Colorado
      • Denver、Colorado、美国、802181088
        • Children's Hosp of Denver
    • Connecticut
      • Farmington、Connecticut、美国、06032
        • Univ of Connecticut / Farmington
    • District of Columbia
      • Washington、District of Columbia、美国、200102916
        • Children's Hosp of Washington DC
      • Washington、District of Columbia、美国、20060
        • Howard Univ Hosp
    • Florida
      • Fort Lauderdale、Florida、美国、33311
        • North Broward Hosp District
      • Jacksonville、Florida、美国、32209
        • Univ of Florida Health Science Ctr / Pediatrics
      • Miami、Florida、美国、33161
        • Univ of Miami (Pediatric)
      • Riviera Beach、Florida、美国、33404
        • Palm Beach County Health Dept
    • Illinois
      • Chicago、Illinois、美国、60612
        • Cook County Hosp
      • Chicago、Illinois、美国、606143394
        • Chicago Children's Memorial Hosp
      • Chicago、Illinois、美国、606371470
        • Univ of Chicago Children's Hosp
      • Chicago、Illinois、美国、60612
        • Univ of Illinois College of Medicine / Pediatrics
    • Louisiana
      • New Orleans、Louisiana、美国、701122699
        • Tulane Univ / Charity Hosp of New Orleans
    • Maryland
      • Baltimore、Maryland、美国、21201
        • Univ of Maryland at Baltimore / Univ Med Ctr
    • Massachusetts
      • Boston、Massachusetts、美国、021155724
        • Children's Hosp of Boston
      • Springfield、Massachusetts、美国、01199
        • Baystate Med Ctr of Springfield
      • Worcester、Massachusetts、美国、016550001
        • Univ of Massachusetts Med School
    • Michigan
      • Detroit、Michigan、美国、48201
        • Children's Hosp of Michigan
    • New Jersey
      • Newark、New Jersey、美国、071032714
        • Univ of Medicine & Dentistry of New Jersey / Univ Hosp
      • Newark、New Jersey、美国、07103
        • Saint Joseph's Hosp and Med Ctr/UMDNJ - New Jersey Med Schl
      • Newark、New Jersey、美国、071072198
        • Children's Hosp of New Jersey / UMDNJ - New Jersey Med Schl
    • New York
      • Albany、New York、美国、12208
        • Children's Hosp at Albany Med Ctr
      • Bronx、New York、美国、10457
        • Bronx Lebanon Hosp Ctr
      • New Hyde Park、New York、美国、11040
        • Schneider Children's Hosp
      • New York、New York、美国、10029
        • Metropolitan Hosp Ctr
      • New York、New York、美国、10032
        • Columbia Presbyterian Med Ctr
      • New York、New York、美国、10032
        • Incarnation Children's Ctr / Columbia Presbyterian Med Ctr
      • New York、New York、美国、10037
        • Harlem Hosp Ctr
      • New York、New York、美国、10029
        • Mount Sinai Med Ctr / Pediatrics
      • Rochester、New York、美国、14642
        • Univ of Rochester Medical Center
      • Syracuse、New York、美国、13210
        • SUNY Health Sciences Ctr at Syracuse / Pediatrics
    • North Carolina
      • Durham、North Carolina、美国、277103499
        • Duke Univ Med Ctr
    • Pennsylvania
      • Philadelphia、Pennsylvania、美国、191044318
        • Children's Hosp of Philadelphia
      • Philadelphia、Pennsylvania、美国、191341095
        • Saint Christopher's Hosp for Children
    • South Carolina
      • Charleston、South Carolina、美国、294253312
        • Med Univ of South Carolina
    • Virginia
      • Norfolk、Virginia、美国、23507
        • Children's Hosp of the King's Daughters
      • Richmond、Virginia、美国、23219
        • Med College of Virginia

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

1天 至 3个月 (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:

Recommended:

  • PCP prophylaxis.

Allowed:

  • Acetaminophen if not on a continual basis.

NOTE:

  • Drugs that are metabolized by hepatic glucuronidation or that are associated with occurrence of pancreatitis are allowed but should be used with caution.

Patients must have at least one of the following:

  • Documented HIV infection.
  • Been born to an HIV-infected woman and receiving AZT.

PER AMENDMENT 4/8/97:

  • Number 2 above no longer required with closure of Part A of study.
  • Patients must have signed, informed consent of parent or legal guardian.

PER 6/20/95 AMENDMENT, patients in Part A must be less than 28 days of age and those in Part B must be less than 90 days of age.

PER 7/7/94 AMENDMENT, patients in Part A were less than 120 days of age and those in Part B were less than 180 days of age.

NOTE:

  • All patients must have been more than 34 weeks gestation at birth.

Prior Medication:

Allowed:

  • Prior vaccine therapy.

Exclusion Criteria

Co-existing Condition:

Patients with the following symptoms or conditions are excluded:

  • Pancreatitis.
  • Clinically unstable condition.
  • Current participation on a vaccine trial or, for Part A, a perinatal trial if of indeterminate infection status.

Concurrent Medication:

Excluded:

  • Vaccine therapy.

Patients with the following prior condition are excluded:

  • Pancreatitis at any time since birth.

Prior Medication:

Excluded in Part B patients only:

  • More than 90 days of prior antiretroviral or immunomodulator therapy, exclusive of therapy received in utero.

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：A Kovacs
  • 学习椅：R Husson

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

  • McKinney RE Jr. Ongoing and future trials of antiretroviral therapy in the pediatric AIDS clinical trials group (PACTG). Conf Retroviruses Opportunistic Infect. 1996 Jan 28-Feb 1;3rd:173

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)

1998年6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 239
  • 11216 (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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赞助者和合作者

医疗条件

药物干预

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条件

罕见疾病

药物干预

膳食补充剂

赞助者/合作者

地点

3
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