- ICH GCP
- Registro degli studi clinici negli Stati Uniti
- Sperimentazione clinica 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.
Panoramica dello studio
Descrizione dettagliata
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.
Tipo di studio
Iscrizione
Fase
- Fase 2
Contatti e Sedi
Luoghi di studio
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California
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Downey, California, Stati Uniti, 902422814
- Kaiser Permanente / UCLA Med Ctr
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Long Beach, California, Stati Uniti, 90801
- Long Beach Memorial (Pediatric)
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Los Angeles, California, Stati Uniti, 900276016
- Children's Hosp of Los Angeles/UCLA Med Ctr
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Los Angeles, California, Stati Uniti, 905022004
- Harbor - UCLA Med Ctr / UCLA School of Medicine
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Los Angeles, California, Stati Uniti, 900951752
- UCLA Med Ctr / Pediatric
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Los Angeles, California, Stati Uniti, 900593019
- Martin Luther King Jr Gen Hosp / UCLA Med Ctr
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Menlo Park, California, Stati Uniti, 94025
- Stanford Univ School of Medicine
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Oakland, California, Stati Uniti, 946091809
- Children's Hosp of Oakland
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San Diego, California, Stati Uniti, 92103
- UCSD Treatment Ctr
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San Francisco, California, Stati Uniti, 94143
- Northern California Pediatric AIDS Treatment Ctr / UCSF
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Florida
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Miami, Florida, Stati Uniti, 331361013
- Univ of Miami School of Medicine
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Miami, Florida, Stati Uniti, 33136
- Univ of Miami School of Medicine
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Illinois
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Chicago, Illinois, Stati Uniti, 60612
- Cook County Hosp
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Chicago, Illinois, Stati Uniti, 606143394
- Chicago Children's Memorial Hosp
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Louisiana
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New Orleans, Louisiana, Stati Uniti, 70112
- Tulane Univ School of Medicine
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New Orleans, Louisiana, Stati Uniti, 70112
- Charity Hosp / Tulane Univ Med School
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Maryland
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Baltimore, Maryland, Stati Uniti, 21201
- Univ of Maryland at Baltimore / Univ Med Ctr
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Baltimore, Maryland, Stati Uniti, 212874933
- Johns Hopkins Hosp - Pediatric
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Massachusetts
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Boston, Massachusetts, Stati Uniti, 021155724
- Children's Hosp of Boston
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Minnesota
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Minneapolis, Minnesota, Stati Uniti, 55455
- Univ of Minnesota
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New Jersey
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Newark, New Jersey, Stati Uniti, 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, Stati Uniti, 10465
- Jack Weiler Hosp / Bronx Municipal Hosp
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Elmhurst, New York, Stati Uniti, 11373
- City Hosp Ctr at Elmhurst / Mount Sinai Hosp
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New York, New York, Stati Uniti, 10016
- Bellevue Hosp / New York Univ Med Ctr
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New York, New York, Stati Uniti, 10029
- Mount Sinai Med Ctr
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New York, New York, Stati Uniti, 10037
- Harlem Hosp Ctr
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New York, New York, Stati Uniti, 10003
- Beth Israel Med Ctr / Pediatrics
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New York, New York, Stati Uniti, 10032
- Columbia Univ Babies' Hosp
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North Carolina
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Durham, North Carolina, Stati Uniti, 277103499
- Duke Univ Med Ctr
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Ohio
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Columbus, Ohio, Stati Uniti, 432052696
- Columbus Children's Hosp
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Pennsylvania
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Hershey, Pennsylvania, Stati Uniti, 170330850
- Milton S Hershey Med Ctr
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Texas
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Houston, Texas, Stati Uniti, 77030
- Baylor College of Medicine
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Houston, Texas, Stati Uniti, 77030
- Hermann Hosp / Univ Texas Health Science Ctr
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Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
Accetta volontari sani
Sessi ammissibili allo studio
Descrizione
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.
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Trattamento
- Mascheramento: Doppio
Collaboratori e investigatori
Investigatori
- Cattedra di studio: P Weintrub
Studiare le date dei record
Studia le date principali
Completamento dello studio (Effettivo)
Date di iscrizione allo studio
Primo inviato
Primo inviato che soddisfa i criteri di controllo qualità
Primo Inserito (Stima)
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo verificato
Maggiori informazioni
Termini relativi a questo studio
Termini MeSH pertinenti aggiuntivi
- Infezioni da virus a RNA
- Malattie virali
- Infezioni
- Infezioni a trasmissione ematica
- Malattie trasmissibili
- Malattie sessualmente trasmissibili, virali
- Malattie trasmesse sessualmente
- Infezioni da lentivirus
- Infezioni da retroviridae
- Sindromi da deficit immunologico
- Malattie del sistema immunitario
- Infezioni da HIV
- Meccanismi molecolari dell'azione farmacologica
- Agenti antinfettivi
- Agenti antivirali
- Inibitori della trascrittasi inversa
- Inibitori della sintesi degli acidi nucleici
- Inibitori enzimatici
- Agenti anti-HIV
- Agenti antiretrovirali
- Antimetaboliti
- Zidovudina
Altri numeri di identificazione dello studio
- ACTG 052
- 11026 (Identificatore di registro: DAIDS ES Registry Number)
Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .
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