The Safety and Effectiveness of Zidovudine in the Treatment of HIV-Infected Children With Mild to Moderate Symptoms
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.
調査の概要
詳細な説明
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.
研究の種類
入学
段階
- フェーズ2
連絡先と場所
研究場所
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California
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Downey、California、アメリカ、902422814
- Kaiser Permanente / UCLA Med Ctr
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Long Beach、California、アメリカ、90801
- Long Beach Memorial (Pediatric)
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Los Angeles、California、アメリカ、900276016
- Children's Hosp of Los Angeles/UCLA Med Ctr
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Los Angeles、California、アメリカ、905022004
- Harbor - UCLA Med Ctr / UCLA School of Medicine
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Los Angeles、California、アメリカ、900951752
- UCLA Med Ctr / Pediatric
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Los Angeles、California、アメリカ、900593019
- Martin Luther King Jr Gen Hosp / UCLA Med Ctr
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Menlo Park、California、アメリカ、94025
- Stanford Univ School of Medicine
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Oakland、California、アメリカ、946091809
- Children's Hosp of Oakland
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San Diego、California、アメリカ、92103
- UCSD Treatment Ctr
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San Francisco、California、アメリカ、94143
- Northern California Pediatric AIDS Treatment Ctr / UCSF
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Florida
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Miami、Florida、アメリカ、331361013
- Univ of Miami School of Medicine
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Miami、Florida、アメリカ、33136
- Univ of Miami School of Medicine
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Illinois
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Chicago、Illinois、アメリカ、60612
- Cook County Hosp
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Chicago、Illinois、アメリカ、606143394
- Chicago Children's Memorial Hosp
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Louisiana
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New Orleans、Louisiana、アメリカ、70112
- Tulane Univ School of Medicine
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New Orleans、Louisiana、アメリカ、70112
- Charity Hosp / Tulane Univ Med School
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Maryland
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Baltimore、Maryland、アメリカ、21201
- Univ of Maryland at Baltimore / Univ Med Ctr
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Baltimore、Maryland、アメリカ、212874933
- Johns Hopkins Hosp - Pediatric
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Massachusetts
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Boston、Massachusetts、アメリカ、021155724
- Children's Hosp of Boston
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Minnesota
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Minneapolis、Minnesota、アメリカ、55455
- Univ of Minnesota
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New Jersey
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Newark、New Jersey、アメリカ、071072198
- Children's Hosp of New Jersey / UMDNJ - New Jersey Med Schl
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New York
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Bronx、New York、アメリカ、10465
- Jack Weiler Hosp / Bronx Municipal Hosp
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Elmhurst、New York、アメリカ、11373
- City Hosp Ctr at Elmhurst / Mount Sinai Hosp
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New York、New York、アメリカ、10016
- Bellevue Hosp / New York Univ Med Ctr
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New York、New York、アメリカ、10029
- Mount Sinai Med Ctr
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New York、New York、アメリカ、10037
- Harlem Hosp Ctr
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New York、New York、アメリカ、10003
- Beth Israel Med Ctr / Pediatrics
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New York、New York、アメリカ、10032
- Columbia Univ Babies' Hosp
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North Carolina
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Durham、North Carolina、アメリカ、277103499
- Duke Univ Med Ctr
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Ohio
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Columbus、Ohio、アメリカ、432052696
- Columbus Children's Hosp
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Pennsylvania
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Hershey、Pennsylvania、アメリカ、170330850
- Milton S Hershey Med Ctr
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Texas
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Houston、Texas、アメリカ、77030
- Baylor College of Medicine
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Houston、Texas、アメリカ、77030
- Hermann Hosp / Univ Texas Health Science Ctr
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参加基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
説明
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.
研究計画
研究はどのように設計されていますか?
デザインの詳細
- 主な目的:処理
- マスキング:ダブル
協力者と研究者
捜査官
- スタディチェア:P Weintrub
研究記録日
主要日程の研究
研究の完了 (実際)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (見積もり)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。
HIV感染症の臨床試験
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University of Alabama at BirminghamMobile County Health Deparment; Alabama Department of Public Health募集HIV | HIV検査 | HIV とケアの関係 | HIV治療アメリカ
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French National Agency for Research on AIDS and...Elizabeth Glaser Pediatric AIDS Foundation完了パートナーの HIV 検査 | カップルの HIV カウンセリング | カップルのコミュニケーション | HIV の発生率カメルーン, ドミニカ共和国, グルジア, インド
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University of Minnesota引きこもったHIV感染症 | HIV/エイズ | HIV | AIDS | エイズ・HIV問題 | エイズと感染症アメリカ
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Africa Health Research InstituteLondon School of Hygiene and Tropical Medicine; University College, London; University of Southampton と他の協力者募集
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ANRS, Emerging Infectious DiseasesHopital Universitaire Robert-Debre; Institut de Recherche pour le Developpement; Centre Pasteur... と他の協力者わからないHIV | HIVに感染していない子供たち | HIVにさらされた子供たちカメルーン
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Erasmus Medical Centerまだ募集していません
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University of Maryland, Baltimore引きこもった
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Hospital Clinic of Barcelona完了
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University of WashingtonNational Institute of Mental Health (NIMH)募集