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A Study of Dideoxyinosine (ddI) in HIV-Infected Children Who Have Not Had Success With Zidovudine or Who Cannot Take Zidovudine

28 ottobre 2021 aggiornato da: National Institute of Allergy and Infectious Diseases (NIAID)

A Randomized Comparative Trial of Two Doses of 2',3'-Dideoxyinosine (ddI) in Children With Symptomatic HIV Infection Who Are Either Unresponsive to Zidovudine and/or Who Are Intolerant to Zidovudine

To evaluate the effectiveness, safety, and tolerance of two doses of didanosine (ddI) in the treatment of children with symptomatic HIV disease who have had to discontinue zidovudine (AZT) because of intolerance and/or who have experienced progressive disease while on AZT.

The progression of immunodeficiency due to HIV infection can be delayed by using AZT. The benefits of AZT in adults with AIDS and severe AIDS-related complex (ARC) appear to last for approximately 12 to 18 months, at which time most patients have progressive deterioration. Recently published literature has described a reduced sensitivity of HIV isolated from patients after prolonged AZT treatment. Although the clinical significance of this is unclear, it makes the development of new antiretroviral drugs important.

Panoramica dello studio

Stato

Completato

Condizioni

Intervento / Trattamento

Descrizione dettagliata

The progression of immunodeficiency due to HIV infection can be delayed by using AZT. The benefits of AZT in adults with AIDS and severe AIDS-related complex (ARC) appear to last for approximately 12 to 18 months, at which time most patients have progressive deterioration. Recently published literature has described a reduced sensitivity of HIV isolated from patients after prolonged AZT treatment. Although the clinical significance of this is unclear, it makes the development of new antiretroviral drugs important.

Children who show AZT intolerance and/or progressive disease after 6 months of AZT therapy receive oral ddI at 1 of 2 doses for a minimum of 48 weeks, with a 48-week extension. Patients are seen for clinical and laboratory evaluations at scheduled times during the study. (Per 5/12/92 amendment, new patients will not be enrolled in the pharmacokinetics studies.) Per 10/31/94 amendment: Patients are eligible to receive blinded study drug for an additional 8-16 weeks after the final on-study visit, but no later than 2/15/95.

Tipo di studio

Interventistico

Iscrizione

300

Fase

  • Fase 2

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Luoghi di studio

  • Porto Rico
      • Bayamon, Porto Rico, 00956
        • Univ. Hosp. Ramón Ruiz Arnau, Dept. of Peds.
      • San Juan, Porto Rico
        • Univ. of Puerto Rico Ped. HIV/AIDS Research Program CRS
      • San Juan, Porto Rico, 00936
        • San Juan City Hosp. PR NICHD CRS
  • Stati Uniti
    • California
      • Long Beach, California, Stati Uniti, 90801
        • Long Beach Memorial Med. Ctr., Miller Children's Hosp.
      • Los Angeles, California, Stati Uniti, 90033
        • Usc La Nichd Crs
      • Los Angeles, California, Stati Uniti
        • UCLA-Los Angeles/Brazil AIDS Consortium (LABAC) CRS
      • Oakland, California, Stati Uniti, 94609
        • Children's Hosp. & Research Ctr. Oakland, Ped. Clinical Research Ctr. & Research Lab.
      • San Diego, California, Stati Uniti, 92093
        • UCSD Maternal, Child, and Adolescent HIV CRS
      • San Francisco, California, Stati Uniti, 94143
        • UCSF Pediatric AIDS CRS
      • Torrance, California, Stati Uniti
        • Harbor - UCLA Med. Ctr. - Dept. of Peds., Div. of Infectious Diseases
    • Connecticut
      • Farmington, Connecticut, Stati Uniti, 06032
        • Univ. of Connecticut Health Ctr., Dept. of Ped.
      • New Haven, Connecticut, Stati Uniti, 06504
        • Yale Univ. School of Medicine - Dept. of Peds., Div. of Infectious Disease
    • District of Columbia
      • Washington, District of Columbia, Stati Uniti, 20010
        • Children's National Med. Ctr., ACTU
      • Washington, District of Columbia, Stati Uniti, 20060
        • Howard Univ. Washington DC NICHD CRS
    • Florida
      • Miami, Florida, Stati Uniti, 33161
        • Univ. of Miami Ped. Perinatal HIV/AIDS CRS
    • Georgia
      • Atlanta, Georgia, Stati Uniti, 30306
        • Emory Univ. School of Medicine, Dept. of Peds., Div. of Infectious Diseases
    • Illinois
      • Chicago, Illinois, Stati Uniti, 60612
        • Cook County Hosp.
      • Chicago, Illinois, Stati Uniti, 60614
        • Chicago Children's CRS
      • Chicago, Illinois, Stati Uniti, 60637
        • Univ. of Chicago - Dept. of Peds., Div. of Infectious Disease
      • Chicago, Illinois, Stati Uniti, 60612
        • Univ. of Illinois College of Medicine at Chicago, Dept. of Peds.
    • Louisiana
      • New Orleans, Louisiana, Stati Uniti
        • Tulane Med. Ctr. - Charity Hosp. of New Orleans, ACTU
      • New Orleans, Louisiana, Stati Uniti
        • Tulane/LSU Maternal/Child CRS
    • Maryland
      • Baltimore, Maryland, Stati Uniti, 21201
        • Univ. of Maryland Med. Ctr., Div. of Ped. Immunology & Rheumatology
      • Baltimore, Maryland, Stati Uniti, 21287
        • Johns Hopkins Hosp. & Health System - Dept. of Peds., Div. of Infectious Diseases
    • Massachusetts
      • Boston, Massachusetts, Stati Uniti, 02115
        • HMS - Children's Hosp. Boston, Div. of Infectious Diseases
      • Boston, Massachusetts, Stati Uniti, 02118
        • BMC, Div. of Ped Infectious Diseases
      • Springfield, Massachusetts, Stati Uniti, 01199
        • Baystate Health, Baystate Med. Ctr.
      • Worcester, Massachusetts, Stati Uniti, 01655
        • WNE Maternal Pediatric Adolescent AIDS CRS
    • Michigan
      • Detroit, Michigan, Stati Uniti, 48201
        • Children's Hospital of Michigan NICHD CRS
    • New Jersey
      • New Brunswick, New Jersey, Stati Uniti
        • UMDNJ - Robert Wood Johnson
      • Paterson, New Jersey, Stati Uniti
        • St. Joseph's Hosp. & Med. Ctr. of New Jersey
    • New York
      • Albany, New York, Stati Uniti, 12208
        • Children's Hospital at Albany Medical Center, Dept. of Peds.
      • Bronx, New York, Stati Uniti, 10457
        • Bronx-Lebanon Hosp. IMPAACT CRS
      • Brooklyn, New York, Stati Uniti, 11203
        • SUNY Downstate Med. Ctr., Children's Hosp. at Downstate NICHD CRS
      • Great Neck, New York, Stati Uniti, 11021
        • North Shore-Long Island Jewish Health System, Dept. of Peds.
      • New Hyde Park, New York, Stati Uniti, 11040
        • Schneider Children's Hosp., Div. of Infectious Diseases
      • New York, New York, Stati Uniti, 10032
        • Columbia IMPAACT CRS
      • New York, New York, Stati Uniti, 10037
        • Harlem Hosp. Ctr. NY NICHD CRS
      • New York, New York, Stati Uniti, 10016
        • NYU Med. Ctr., Dept. of Medicine
      • New York, New York, Stati Uniti, 10032
        • Incarnation Children's Ctr.
      • New York, New York, Stati Uniti, 10029
        • Metropolitan Hosp. NICHD CRS
      • Rochester, New York, Stati Uniti, 14642
        • Univ. of Rochester ACTG CRS
      • Stony Brook, New York, Stati Uniti, 11794
        • SUNY Stony Brook NICHD CRS
      • Syracuse, New York, Stati Uniti, 13210
        • SUNY Upstate Med. Univ., Dept. of Peds.
    • North Carolina
      • Durham, North Carolina, Stati Uniti, 27710
        • DUMC Ped. CRS
    • Ohio
      • Cleveland, Ohio, Stati Uniti, 44106
        • Case CRS
    • Pennsylvania
      • Philadelphia, Pennsylvania, Stati Uniti, 19104
        • The Children's Hosp. of Philadelphia IMPAACT CRS
      • Philadelphia, Pennsylvania, Stati Uniti, 19134
        • St. Christopher's Hosp. for Children
    • South Carolina
      • Charleston, South Carolina, Stati Uniti, 29425
        • Med. Univ. of South Carolina, Div. of Ped. Infectious Diseases
    • Texas
      • Dallas, Texas, Stati Uniti, 75235
        • Children's Med. Ctr. Dallas
      • Houston, Texas, Stati Uniti, 77030
        • Texas Children's Hosp. CRS
    • Washington
      • Seattle, Washington, Stati Uniti, 98105
        • UW School of Medicine - CHRMC

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

Da 3 mesi a 18 anni (Bambino, Adulto)

Accetta volontari sani

No

Sessi ammissibili allo studio

Tutto

Descrizione

Inclusion Criteria

Concurrent Medication:

Allowed:

  • Prophylaxis treatment for Pneumocystis carinii pneumonia (PCP).
  • Immunoglobulin.
  • Maintenance therapy with amphotericin B (l mg/kg) up to 5 days/week.

Concurrent Treatment:

Allowed:

  • Blood transfusions.

Prior Medication:

Allowed:

  • Prophylaxis treatment for Pneumocystis carinii pneumonia (PCP).

Patients enrolled in ACTG 128 and ACTG 138 must meet study end points or meet protocol definitions for being permanently off zidovudine (AZT) before enrolling in this study.

  • Patients currently enrolled in ACTG 051 who have not reached the study end points but who meet the entry criteria for ACTG 144 may be co-enrolled in ACTG 144.
  • Patient or guardian available to give written informed consent.

Exclusion Criteria

Co-existing Condition:

Patients with the following conditions or symptoms are excluded.

  • Hypersensitivity to didanosine (ddI).
  • Symptomatic cardiomyopathy.
  • Seizures that are not well controlled by ongoing anticonvulsant therapy.
  • Symptomatic pancreatitis.
  • Grade 1 or higher peripheral neuropathy.
  • Active malignancy requiring chemotherapy.

Concurrent Medication:

Excluded:

  • Zidovudine (AZT), other antiretroviral agents, biological modifiers, and investigational medications.

Avoid:

  • Drugs with potential to cause peripheral neuropathy or pancreatitis.

Patients with the following are excluded:

  • Active malignancy requiring concomitant chemotherapy.

Prior Medication:

Excluded:

  • Antiretroviral agents other than zidovudine (AZT) or dideoxycytidine (ddC) within 4 weeks of study entry.
  • Immunomodulating agents such as interferons, isoprinosine, or interleukin-2 within 2 weeks of entry.
  • Any other experimental therapy within 1 week of entry.
  • Drugs that have or will cause prolonged neutropenia, significant pancreatitis, significant nephrotoxicity, or peripheral neuropathy within 1 week of entry.

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

  • Scopo principale: Trattamento

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Sponsor

National Institute of Allergy and Infectious Diseases (NIAID)

Collaboratori

Bristol-Myers Squibb

Investigatori

  • Cattedra di studio: Frenkel LM
  • Cattedra di studio: Bryson Y
  • Cattedra di studio: Stiehm R

Pubblicazioni e link utili

La persona responsabile dell'inserimento delle informazioni sullo studio fornisce volontariamente queste pubblicazioni. Questi possono riguardare qualsiasi cosa relativa allo studio.

Pubblicazioni generali

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Completamento dello studio (Effettivo)

1 settembre 1995

Date di iscrizione allo studio

Primo inviato

2 novembre 1999

Primo inviato che soddisfa i criteri di controllo qualità

30 agosto 2001

Primo Inserito (Stima)

31 agosto 2001

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

29 ottobre 2021

Ultimo aggiornamento inviato che soddisfa i criteri QC

28 ottobre 2021

Ultimo verificato

1 ottobre 2021

Maggiori informazioni

Termini relativi a questo studio

Parole chiave

Termini MeSH pertinenti aggiuntivi

Altri numeri di identificazione dello studio

  • ACTG 144
  • 11119 (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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