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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 oktober 2021 uppdaterad av: 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.

Studieöversikt

Status

Avslutad

Betingelser

Intervention / Behandling

Detaljerad beskrivning

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.

Studietyp

Interventionell

Inskrivning

300

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

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 18 år (Barn, Vuxen)

Tar emot friska volontärer

Nej

Kön som är behöriga för studier

Allt

Beskrivning

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.

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

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)

Samarbetspartners

Bristol-Myers Squibb

Utredare

  • Studiestol: Frenkel LM
  • Studiestol: Bryson Y
  • Studiestol: Stiehm R

Publikationer och användbara länkar

Den som ansvarar för att lägga in information om studien tillhandahåller frivilligt dessa publikationer. Dessa kan handla om allt som har med studien att göra.

Allmänna publikationer

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 1995

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)

29 oktober 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 144
  • 11119 (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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