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

28 oktober 2021 uppdaterad av: 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.

Studieöversikt

Status

Avslutad

Betingelser

Intervention / Behandling

Detaljerad beskrivning

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.

Studietyp

Interventionell

Inskrivning

224

Fas

  • Fas 2

Kontakter och platser

Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.

Studieorter

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

Deltagandekriterier

Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.

Urvalskriterier

Åldrar som är berättigade till studier

3 månader till 12 år (Barn)

Tar emot friska volontärer

Nej

Kön som är behöriga för studier

Allt

Beskrivning

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.

Studieplan

Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.

Hur är studien utformad?

Designdetaljer

  • Primärt syfte: Behandling
  • Maskning: Dubbel

Samarbetspartners och utredare

Det är här du hittar personer och organisationer som är involverade i denna studie.

Sponsor

National Institute of Allergy and Infectious Diseases (NIAID)

Utredare

  • Studiestol: P Weintrub

Studieavstämningsdatum

Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.

Studera stora datum

Avslutad studie (Faktisk)

1 september 1992

Studieregistreringsdatum

Först inskickad

2 november 1999

Först inskickad som uppfyllde QC-kriterierna

30 augusti 2001

Första postat (Uppskatta)

31 augusti 2001

Uppdateringar av studier

Senaste uppdatering publicerad (Faktisk)

1 november 2021

Senaste inskickade uppdateringen som uppfyllde QC-kriterierna

28 oktober 2021

Senast verifierad

1 oktober 2021

Mer information

Termer relaterade till denna studie

Nyckelord

Ytterligare relevanta MeSH-villkor

Andra studie-ID-nummer

  • ACTG 052
  • 11026 (Registeridentifierare: DAIDS ES Registry Number)

Denna information hämtades direkt från webbplatsen clinicaltrials.gov utan några ändringar. Om du har några önskemål om att ändra, ta bort eller uppdatera dina studieuppgifter, vänligen kontakta register@clinicaltrials.gov. Så snart en ändring har implementerats på clinicaltrials.gov, kommer denna att uppdateras automatiskt även på vår webbplats .

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