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

28 października 2021 zaktualizowane przez: 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.

Przegląd badań

Status

Zakończony

Warunki

Interwencja / Leczenie

Szczegółowy opis

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.

Typ studiów

Interwencyjne

Zapisy

224

Faza

  • Faza 2

Kontakty i lokalizacje

Ta sekcja zawiera dane kontaktowe osób prowadzących badanie oraz informacje o tym, gdzie badanie jest przeprowadzane.

Lokalizacje studiów

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

Kryteria uczestnictwa

Badacze szukają osób, które pasują do określonego opisu, zwanego kryteriami kwalifikacyjnymi. Niektóre przykłady tych kryteriów to ogólny stan zdrowia danej osoby lub wcześniejsze leczenie.

Kryteria kwalifikacji

Wiek uprawniający do nauki

3 miesiące do 12 lat (Dziecko)

Akceptuje zdrowych ochotników

Nie

Płeć kwalifikująca się do nauki

Wszystko

Opis

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.

Plan studiów

Ta sekcja zawiera szczegółowe informacje na temat planu badania, w tym sposób zaprojektowania badania i jego pomiary.

Jak projektuje się badanie?

Szczegóły projektu

  • Główny cel: Leczenie
  • Maskowanie: Podwójnie

Współpracownicy i badacze

Tutaj znajdziesz osoby i organizacje zaangażowane w to badanie.

Sponsor

National Institute of Allergy and Infectious Diseases (NIAID)

Śledczy

  • Krzesło do nauki: P Weintrub

Daty zapisu na studia

Daty te śledzą postęp w przesyłaniu rekordów badań i podsumowań wyników do ClinicalTrials.gov. Zapisy badań i zgłoszone wyniki są przeglądane przez National Library of Medicine (NLM), aby upewnić się, że spełniają określone standardy kontroli jakości, zanim zostaną opublikowane na publicznej stronie internetowej.

Główne daty studiów

Ukończenie studiów (Rzeczywisty)

1 września 1992

Daty rejestracji na studia

Pierwszy przesłany

2 listopada 1999

Pierwszy przesłany, który spełnia kryteria kontroli jakości

30 sierpnia 2001

Pierwszy wysłany (Oszacować)

31 sierpnia 2001

Aktualizacje rekordów badań

Ostatnia wysłana aktualizacja (Rzeczywisty)

1 listopada 2021

Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości

28 października 2021

Ostatnia weryfikacja

1 października 2021

Więcej informacji

Terminy związane z tym badaniem

Słowa kluczowe

Dodatkowe istotne warunki MeSH

Inne numery identyfikacyjne badania

  • ACTG 052
  • 11026 (Identyfikator rejestru: DAIDS ES Registry Number)

Te informacje zostały pobrane bezpośrednio ze strony internetowej clinicaltrials.gov bez żadnych zmian. Jeśli chcesz zmienić, usunąć lub zaktualizować dane swojego badania, skontaktuj się z register@clinicaltrials.gov. Gdy tylko zmiana zostanie wprowadzona na stronie clinicaltrials.gov, zostanie ona automatycznie zaktualizowana również na naszej stronie internetowej .

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