- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT00000990
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.
연구 개요
상세 설명
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.
연구 유형
등록
단계
- 2 단계
연락처 및 위치
연구 장소
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California
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Downey, California, 미국, 902422814
- Kaiser Permanente / UCLA Med Ctr
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Long Beach, California, 미국, 90801
- Long Beach Memorial (Pediatric)
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Los Angeles, California, 미국, 900276016
- Children's Hosp of Los Angeles/UCLA Med Ctr
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Los Angeles, California, 미국, 905022004
- Harbor - UCLA Med Ctr / UCLA School of Medicine
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Los Angeles, California, 미국, 900951752
- UCLA Med Ctr / Pediatric
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Los Angeles, California, 미국, 900593019
- Martin Luther King Jr Gen Hosp / UCLA Med Ctr
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Menlo Park, California, 미국, 94025
- Stanford Univ School of Medicine
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Oakland, California, 미국, 946091809
- Children's Hosp of Oakland
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San Diego, California, 미국, 92103
- UCSD Treatment Ctr
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San Francisco, California, 미국, 94143
- Northern California Pediatric AIDS Treatment Ctr / UCSF
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Florida
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Miami, Florida, 미국, 331361013
- Univ of Miami School of Medicine
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Miami, Florida, 미국, 33136
- Univ of Miami School of Medicine
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Illinois
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Chicago, Illinois, 미국, 60612
- Cook County Hosp
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Chicago, Illinois, 미국, 606143394
- Chicago Children's Memorial Hosp
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Louisiana
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New Orleans, Louisiana, 미국, 70112
- Tulane Univ School of Medicine
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New Orleans, Louisiana, 미국, 70112
- Charity Hosp / Tulane Univ Med School
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Maryland
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Baltimore, Maryland, 미국, 21201
- Univ of Maryland at Baltimore / Univ Med Ctr
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Baltimore, Maryland, 미국, 212874933
- Johns Hopkins Hosp - Pediatric
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Massachusetts
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Boston, Massachusetts, 미국, 021155724
- Children's Hosp of Boston
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Minnesota
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Minneapolis, Minnesota, 미국, 55455
- Univ of Minnesota
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New Jersey
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Newark, New Jersey, 미국, 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, 미국, 10465
- Jack Weiler Hosp / Bronx Municipal Hosp
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Elmhurst, New York, 미국, 11373
- City Hosp Ctr at Elmhurst / Mount Sinai Hosp
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New York, New York, 미국, 10016
- Bellevue Hosp / New York Univ Med Ctr
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New York, New York, 미국, 10029
- Mount Sinai Med Ctr
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New York, New York, 미국, 10037
- Harlem Hosp Ctr
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New York, New York, 미국, 10003
- Beth Israel Med Ctr / Pediatrics
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New York, New York, 미국, 10032
- Columbia Univ Babies' Hosp
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North Carolina
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Durham, North Carolina, 미국, 277103499
- Duke Univ Med Ctr
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Ohio
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Columbus, Ohio, 미국, 432052696
- Columbus Children's Hosp
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Pennsylvania
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Hershey, Pennsylvania, 미국, 170330850
- Milton S Hershey Med Ctr
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Texas
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Houston, Texas, 미국, 77030
- Baylor College of Medicine
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Houston, Texas, 미국, 77030
- Hermann Hosp / Univ Texas Health Science Ctr
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
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.
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 마스킹: 더블
공동 작업자 및 조사자
수사관
- 연구 의자: P Weintrub
연구 기록 날짜
연구 주요 날짜
연구 완료 (실제)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (추정)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
키워드
추가 관련 MeSH 약관
기타 연구 ID 번호
- ACTG 052
- 11026 (레지스트리 식별자: DAIDS ES Registry Number)
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .
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