- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT00000963
A Study of Dideoxyinosine (ddI) in HIV-Infected Children Who Have Not Had Success With Zidovudine or Who Cannot Take Zidovudine
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.
Studieoversigt
Detaljeret beskrivelse
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.
Undersøgelsestype
Tilmelding
Fase
- Fase 2
Kontakter og lokationer
Studiesteder
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California
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Long Beach, California, Forenede Stater, 90801
- Long Beach Memorial Med. Ctr., Miller Children's Hosp.
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Los Angeles, California, Forenede Stater, 90033
- Usc La Nichd Crs
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Los Angeles, California, Forenede Stater
- UCLA-Los Angeles/Brazil AIDS Consortium (LABAC) CRS
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Oakland, California, Forenede Stater, 94609
- Children's Hosp. & Research Ctr. Oakland, Ped. Clinical Research Ctr. & Research Lab.
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San Diego, California, Forenede Stater, 92093
- UCSD Maternal, Child, and Adolescent HIV CRS
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San Francisco, California, Forenede Stater, 94143
- UCSF Pediatric AIDS CRS
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Torrance, California, Forenede Stater
- Harbor - UCLA Med. Ctr. - Dept. of Peds., Div. of Infectious Diseases
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Connecticut
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Farmington, Connecticut, Forenede Stater, 06032
- Univ. of Connecticut Health Ctr., Dept. of Ped.
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New Haven, Connecticut, Forenede Stater, 06504
- Yale Univ. School of Medicine - Dept. of Peds., Div. of Infectious Disease
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District of Columbia
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Washington, District of Columbia, Forenede Stater, 20010
- Children's National Med. Ctr., ACTU
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Washington, District of Columbia, Forenede Stater, 20060
- Howard Univ. Washington DC NICHD CRS
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Florida
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Miami, Florida, Forenede Stater, 33161
- Univ. of Miami Ped. Perinatal HIV/AIDS CRS
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Georgia
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Atlanta, Georgia, Forenede Stater, 30306
- Emory Univ. School of Medicine, Dept. of Peds., Div. of Infectious Diseases
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Illinois
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Chicago, Illinois, Forenede Stater, 60612
- Cook County Hosp.
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Chicago, Illinois, Forenede Stater, 60614
- Chicago Children's CRS
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Chicago, Illinois, Forenede Stater, 60637
- Univ. of Chicago - Dept. of Peds., Div. of Infectious Disease
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Chicago, Illinois, Forenede Stater, 60612
- Univ. of Illinois College of Medicine at Chicago, Dept. of Peds.
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Louisiana
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New Orleans, Louisiana, Forenede Stater
- Tulane Med. Ctr. - Charity Hosp. of New Orleans, ACTU
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New Orleans, Louisiana, Forenede Stater
- Tulane/LSU Maternal/Child CRS
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Maryland
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Baltimore, Maryland, Forenede Stater, 21201
- Univ. of Maryland Med. Ctr., Div. of Ped. Immunology & Rheumatology
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Baltimore, Maryland, Forenede Stater, 21287
- Johns Hopkins Hosp. & Health System - Dept. of Peds., Div. of Infectious Diseases
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Massachusetts
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Boston, Massachusetts, Forenede Stater, 02115
- HMS - Children's Hosp. Boston, Div. of Infectious Diseases
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Boston, Massachusetts, Forenede Stater, 02118
- BMC, Div. of Ped Infectious Diseases
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Springfield, Massachusetts, Forenede Stater, 01199
- Baystate Health, Baystate Med. Ctr.
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Worcester, Massachusetts, Forenede Stater, 01655
- WNE Maternal Pediatric Adolescent AIDS CRS
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Michigan
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Detroit, Michigan, Forenede Stater, 48201
- Children's Hospital of Michigan NICHD CRS
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New Jersey
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New Brunswick, New Jersey, Forenede Stater
- UMDNJ - Robert Wood Johnson
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Paterson, New Jersey, Forenede Stater
- St. Joseph's Hosp. & Med. Ctr. of New Jersey
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New York
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Albany, New York, Forenede Stater, 12208
- Children's Hospital at Albany Medical Center, Dept. of Peds.
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Bronx, New York, Forenede Stater, 10457
- Bronx-Lebanon Hosp. IMPAACT CRS
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Brooklyn, New York, Forenede Stater, 11203
- SUNY Downstate Med. Ctr., Children's Hosp. at Downstate NICHD CRS
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Great Neck, New York, Forenede Stater, 11021
- North Shore-Long Island Jewish Health System, Dept. of Peds.
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New Hyde Park, New York, Forenede Stater, 11040
- Schneider Children's Hosp., Div. of Infectious Diseases
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New York, New York, Forenede Stater, 10032
- Columbia IMPAACT CRS
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New York, New York, Forenede Stater, 10037
- Harlem Hosp. Ctr. NY NICHD CRS
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New York, New York, Forenede Stater, 10016
- NYU Med. Ctr., Dept. of Medicine
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New York, New York, Forenede Stater, 10032
- Incarnation Children's Ctr.
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New York, New York, Forenede Stater, 10029
- Metropolitan Hosp. NICHD CRS
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Rochester, New York, Forenede Stater, 14642
- Univ. of Rochester ACTG CRS
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Stony Brook, New York, Forenede Stater, 11794
- SUNY Stony Brook NICHD CRS
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Syracuse, New York, Forenede Stater, 13210
- SUNY Upstate Med. Univ., Dept. of Peds.
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North Carolina
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Durham, North Carolina, Forenede Stater, 27710
- DUMC Ped. CRS
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Ohio
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Cleveland, Ohio, Forenede Stater, 44106
- Case CRS
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Pennsylvania
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Philadelphia, Pennsylvania, Forenede Stater, 19104
- The Children's Hosp. of Philadelphia IMPAACT CRS
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Philadelphia, Pennsylvania, Forenede Stater, 19134
- St. Christopher's Hosp. for Children
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South Carolina
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Charleston, South Carolina, Forenede Stater, 29425
- Med. Univ. of South Carolina, Div. of Ped. Infectious Diseases
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Texas
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Dallas, Texas, Forenede Stater, 75235
- Children's Med. Ctr. Dallas
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Houston, Texas, Forenede Stater, 77030
- Texas Children's Hosp. CRS
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Washington
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Seattle, Washington, Forenede Stater, 98105
- UW School of Medicine - CHRMC
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Bayamon, Puerto Rico, 00956
- Univ. Hosp. Ramón Ruiz Arnau, Dept. of Peds.
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San Juan, Puerto Rico
- Univ. of Puerto Rico Ped. HIV/AIDS Research Program CRS
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San Juan, Puerto Rico, 00936
- San Juan City Hosp. PR NICHD CRS
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Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Beskrivelse
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
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
Samarbejdspartnere og efterforskere
Samarbejdspartnere
Efterforskere
- Studiestol: Frenkel LM
- Studiestol: Bryson Y
- Studiestol: Stiehm R
Publikationer og nyttige links
Generelle publikationer
- Perrier M, Schwarz T, Gonzalez O, Brounts S. Squamous cell carcinoma invading the right temporomandibular joint in a Belgian mare. Can Vet J. 2010 Aug;51(8):885-7.
- Carey VJ, Yong F, Frenkel L, McKinney R. Enhancing the prognostic value of bodily growth histories in HIV-positive pediatric cohorts. Int Conf AIDS. 1996 Jul 7-12;11(2):134 (abstract no WeC3444)
Datoer for undersøgelser
Studer store datoer
Studieafslutning (Faktiske)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Skøn)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Yderligere relevante MeSH-vilkår
- RNA-virusinfektioner
- Virussygdomme
- Blodbårne infektioner
- Overførbare sygdomme
- Seksuelt overførte sygdomme, virale
- Seksuelt overførte sygdomme
- Lentivirus infektioner
- Retroviridae infektioner
- Immunologiske mangelsyndromer
- Sygdomme i immunsystemet
- Langsomme virussygdomme
- HIV-infektioner
- Infektioner
- Erhvervet immundefektsyndrom
- Molekylære mekanismer for farmakologisk virkning
- Anti-infektionsmidler
- Antivirale midler
- Reverse transkriptasehæmmere
- Nukleinsyresyntesehæmmere
- Enzymhæmmere
- Anti-HIV-midler
- Anti-retrovirale midler
- Antimetabolitter
- Didanosin
Andre undersøgelses-id-numre
- ACTG 144
- 11119 (DAIDS ES Registry Number)
Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .
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Institut de Recherche pour le DeveloppementAfsluttet
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Mansoura University Children HospitalAfsluttet
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Tuberculosis Research Centre, IndiaIndian Council of Medical Research; National AIDS Control OrganisationUkendtTuberkulose | Humane immundefektvirusinfektionerIndien
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Bristol-Myers SquibbAfsluttet
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Bristol-Myers SquibbAfsluttetHIV-infektionerForenede Stater
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National Institute of Allergy and Infectious Diseases...Afsluttet
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National Institute of Allergy and Infectious Diseases...Bristol-Myers SquibbAfsluttetHIV-infektioner | GraviditetForenede Stater, Puerto Rico
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Bristol-Myers SquibbAfsluttetHIV-infektioner | Leukoencefalopati, progressiv multifokalForenede Stater