- ICH GCP
- US-Register für klinische Studien
- Klinische Studie 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.
Studienübersicht
Detaillierte Beschreibung
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.
Studientyp
Einschreibung
Phase
- Phase 2
Kontakte und Standorte
Studienorte
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California
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Downey, California, Vereinigte Staaten, 902422814
- Kaiser Permanente / UCLA Med Ctr
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Long Beach, California, Vereinigte Staaten, 90801
- Long Beach Memorial (Pediatric)
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Los Angeles, California, Vereinigte Staaten, 900276016
- Children's Hosp of Los Angeles/UCLA Med Ctr
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Los Angeles, California, Vereinigte Staaten, 905022004
- Harbor - UCLA Med Ctr / UCLA School of Medicine
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Los Angeles, California, Vereinigte Staaten, 900951752
- UCLA Med Ctr / Pediatric
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Los Angeles, California, Vereinigte Staaten, 900593019
- Martin Luther King Jr Gen Hosp / UCLA Med Ctr
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Menlo Park, California, Vereinigte Staaten, 94025
- Stanford Univ School of Medicine
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Oakland, California, Vereinigte Staaten, 946091809
- Children's Hosp of Oakland
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San Diego, California, Vereinigte Staaten, 92103
- UCSD Treatment Ctr
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San Francisco, California, Vereinigte Staaten, 94143
- Northern California Pediatric AIDS Treatment Ctr / UCSF
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Florida
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Miami, Florida, Vereinigte Staaten, 331361013
- Univ of Miami School of Medicine
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Miami, Florida, Vereinigte Staaten, 33136
- Univ of Miami School of Medicine
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Illinois
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Chicago, Illinois, Vereinigte Staaten, 60612
- Cook County Hosp
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Chicago, Illinois, Vereinigte Staaten, 606143394
- Chicago Children's Memorial Hosp
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Louisiana
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New Orleans, Louisiana, Vereinigte Staaten, 70112
- Tulane Univ School of Medicine
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New Orleans, Louisiana, Vereinigte Staaten, 70112
- Charity Hosp / Tulane Univ Med School
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Maryland
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Baltimore, Maryland, Vereinigte Staaten, 21201
- Univ of Maryland at Baltimore / Univ Med Ctr
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Baltimore, Maryland, Vereinigte Staaten, 212874933
- Johns Hopkins Hosp - Pediatric
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Massachusetts
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Boston, Massachusetts, Vereinigte Staaten, 021155724
- Children's Hosp of Boston
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Minnesota
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Minneapolis, Minnesota, Vereinigte Staaten, 55455
- Univ of Minnesota
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New Jersey
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Newark, New Jersey, Vereinigte Staaten, 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, Vereinigte Staaten, 10465
- Jack Weiler Hosp / Bronx Municipal Hosp
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Elmhurst, New York, Vereinigte Staaten, 11373
- City Hosp Ctr at Elmhurst / Mount Sinai Hosp
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New York, New York, Vereinigte Staaten, 10016
- Bellevue Hosp / New York Univ Med Ctr
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New York, New York, Vereinigte Staaten, 10029
- Mount Sinai Med Ctr
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New York, New York, Vereinigte Staaten, 10037
- Harlem Hosp Ctr
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New York, New York, Vereinigte Staaten, 10003
- Beth Israel Med Ctr / Pediatrics
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New York, New York, Vereinigte Staaten, 10032
- Columbia Univ Babies' Hosp
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North Carolina
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Durham, North Carolina, Vereinigte Staaten, 277103499
- Duke Univ Med Ctr
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Ohio
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Columbus, Ohio, Vereinigte Staaten, 432052696
- Columbus Children's Hosp
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Pennsylvania
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Hershey, Pennsylvania, Vereinigte Staaten, 170330850
- Milton S Hershey Med Ctr
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Texas
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Houston, Texas, Vereinigte Staaten, 77030
- Baylor College of Medicine
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Houston, Texas, Vereinigte Staaten, 77030
- Hermann Hosp / Univ Texas Health Science Ctr
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Teilnahmekriterien
Zulassungskriterien
Studienberechtigtes Alter
Akzeptiert gesunde Freiwillige
Studienberechtigte Geschlechter
Beschreibung
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.
Studienplan
Wie ist die Studie aufgebaut?
Designdetails
- Hauptzweck: Behandlung
- Maskierung: Doppelt
Mitarbeiter und Ermittler
Ermittler
- Studienstuhl: P Weintrub
Studienaufzeichnungsdaten
Haupttermine studieren
Studienabschluss (Tatsächlich)
Studienanmeldedaten
Zuerst eingereicht
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
Zuerst gepostet (Schätzen)
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Tatsächlich)
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
Zuletzt verifiziert
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Schlüsselwörter
Zusätzliche relevante MeSH-Bedingungen
- RNA-Virusinfektionen
- Viruserkrankungen
- Infektionen
- Durch Blut übertragene Infektionen
- Übertragbare Krankheiten
- Sexuell übertragbare Krankheiten, viral
- Sexuell übertragbare Krankheiten
- Lentivirus-Infektionen
- Retroviridae-Infektionen
- Immunologische Mangelsyndrome
- Erkrankungen des Immunsystems
- HIV-Infektionen
- Molekulare Mechanismen der pharmakologischen Wirkung
- Antiinfektiva
- Antivirale Mittel
- Reverse-Transkriptase-Inhibitoren
- Inhibitoren der Nukleinsäuresynthese
- Enzym-Inhibitoren
- Anti-HIV-Agenten
- Antiretrovirale Mittel
- Antimetaboliten
- Zidovudin
Andere Studien-ID-Nummern
- ACTG 052
- 11026 (Registrierungskennung: DAIDS ES Registry Number)
Diese Informationen wurden ohne Änderungen direkt von der Website clinicaltrials.gov abgerufen. Wenn Sie Ihre Studiendaten ändern, entfernen oder aktualisieren möchten, wenden Sie sich bitte an register@clinicaltrials.gov. Sobald eine Änderung auf clinicaltrials.gov implementiert wird, wird diese automatisch auch auf unserer Website aktualisiert .
Klinische Studien zur HIV-Infektionen
-
Duke UniversityAbgeschlossenCentral Line-associated Bloodstream Infection (CLABSI)Vereinigte Staaten
-
Catholic University of the Sacred HeartAbgeschlossenCentral Line-associated Bloodstream Infection (CLABSI)
-
Abbott Medical DevicesThoratec CorporationAbgeschlossenDriveline Heart-assisted Device Related InfectionVereinigte Staaten
-
Princess Maxima Center for Pediatric OncologyUMC Utrecht; Dutch Cancer SocietyRekrutierungCentral Line-associated Bloodstream Infection (CLABSI)Niederlande
-
University of MalayaTeleflexRekrutierungCLABSI – Central Line Associated Bloodstream InfectionMalaysia
-
National Taiwan University Hospital Hsin-Chu BranchAbgeschlossenCentral Line-associated Bloodstream Infection (CLABSI)
-
Johns Hopkins UniversityAbgeschlossenCLABSI – Central Line Associated Bloodstream InfectionVereinigte Staaten
-
National Taiwan University HospitalAbgeschlossenCentral Line-associated Bloodstream Infection (CLABSI)Taiwan
-
University of ZurichNoch keine RekrutierungCentral Line-associated Bloodstream Infection (CLABSI) | Katheterbedingte Blutstrominfektion
-
Princess Anna Mazowiecka Hospital, Warsaw, PolandNutricia FoundationAktiv, nicht rekrutierendWachstumsfehler | CLABSI – Central Line Associated Bloodstream InfectionPolen
Klinische Studien zur Zidovudin
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Glaxo WellcomeUnbekanntHIV-InfektionenVereinigte Staaten
-
Glaxo WellcomeAbgeschlossenHIV-InfektionenVereinigte Staaten, Puerto Rico
-
Institut de Recherche pour le DeveloppementEunice Kennedy Shriver National Institute of Child Health and Human Development... und andere MitarbeiterAbgeschlossenHIV-Infektionen | SchwangerschaftThailand
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National Institute of Allergy and Infectious Diseases...Eunice Kennedy Shriver National Institute of Child Health and Human Development...AbgeschlossenHIV-InfektionenVereinigte Staaten, Puerto Rico
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Glaxo WellcomeAbgeschlossenHIV-InfektionenVereinigte Staaten
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Glaxo WellcomeAbgeschlossenHIV-Infektionen | LipodystrophieVereinigte Staaten
-
ViiV HealthcareAbgeschlossen
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Universidad Peruana Cayetano HerediaMerck Sharp & Dohme LLCAbgeschlossenHTLV-I-Infektionen | Tropische spastische ParaparesePeru
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University of Colorado, DenverNational Institute of Allergy and Infectious Diseases (NIAID); University of...Abgeschlossen
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National Institute of Allergy and Infectious Diseases...Eunice Kennedy Shriver National Institute of Child Health and Human Development...AbgeschlossenHIV-InfektionenVereinigte Staaten, Puerto Rico