- ICH GCP
- US-Register für klinische Studien
- Klinische Studie 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.
Studienübersicht
Detaillierte Beschreibung
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.
Studientyp
Einschreibung
Phase
- Phase 2
Kontakte und Standorte
Studienorte
-
-
-
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
-
-
-
-
California
-
Long Beach, California, Vereinigte Staaten, 90801
- Long Beach Memorial Med. Ctr., Miller Children's Hosp.
-
Los Angeles, California, Vereinigte Staaten, 90033
- Usc La Nichd Crs
-
Los Angeles, California, Vereinigte Staaten
- UCLA-Los Angeles/Brazil AIDS Consortium (LABAC) CRS
-
Oakland, California, Vereinigte Staaten, 94609
- Children's Hosp. & Research Ctr. Oakland, Ped. Clinical Research Ctr. & Research Lab.
-
San Diego, California, Vereinigte Staaten, 92093
- UCSD Maternal, Child, and Adolescent HIV CRS
-
San Francisco, California, Vereinigte Staaten, 94143
- UCSF Pediatric AIDS CRS
-
Torrance, California, Vereinigte Staaten
- Harbor - UCLA Med. Ctr. - Dept. of Peds., Div. of Infectious Diseases
-
-
Connecticut
-
Farmington, Connecticut, Vereinigte Staaten, 06032
- Univ. of Connecticut Health Ctr., Dept. of Ped.
-
New Haven, Connecticut, Vereinigte Staaten, 06504
- Yale Univ. School of Medicine - Dept. of Peds., Div. of Infectious Disease
-
-
District of Columbia
-
Washington, District of Columbia, Vereinigte Staaten, 20010
- Children's National Med. Ctr., ACTU
-
Washington, District of Columbia, Vereinigte Staaten, 20060
- Howard Univ. Washington DC NICHD CRS
-
-
Florida
-
Miami, Florida, Vereinigte Staaten, 33161
- Univ. of Miami Ped. Perinatal HIV/AIDS CRS
-
-
Georgia
-
Atlanta, Georgia, Vereinigte Staaten, 30306
- Emory Univ. School of Medicine, Dept. of Peds., Div. of Infectious Diseases
-
-
Illinois
-
Chicago, Illinois, Vereinigte Staaten, 60612
- Cook County Hosp.
-
Chicago, Illinois, Vereinigte Staaten, 60614
- Chicago Children's CRS
-
Chicago, Illinois, Vereinigte Staaten, 60637
- Univ. of Chicago - Dept. of Peds., Div. of Infectious Disease
-
Chicago, Illinois, Vereinigte Staaten, 60612
- Univ. of Illinois College of Medicine at Chicago, Dept. of Peds.
-
-
Louisiana
-
New Orleans, Louisiana, Vereinigte Staaten
- Tulane Med. Ctr. - Charity Hosp. of New Orleans, ACTU
-
New Orleans, Louisiana, Vereinigte Staaten
- Tulane/LSU Maternal/Child CRS
-
-
Maryland
-
Baltimore, Maryland, Vereinigte Staaten, 21201
- Univ. of Maryland Med. Ctr., Div. of Ped. Immunology & Rheumatology
-
Baltimore, Maryland, Vereinigte Staaten, 21287
- Johns Hopkins Hosp. & Health System - Dept. of Peds., Div. of Infectious Diseases
-
-
Massachusetts
-
Boston, Massachusetts, Vereinigte Staaten, 02115
- HMS - Children's Hosp. Boston, Div. of Infectious Diseases
-
Boston, Massachusetts, Vereinigte Staaten, 02118
- BMC, Div. of Ped Infectious Diseases
-
Springfield, Massachusetts, Vereinigte Staaten, 01199
- Baystate Health, Baystate Med. Ctr.
-
Worcester, Massachusetts, Vereinigte Staaten, 01655
- WNE Maternal Pediatric Adolescent AIDS CRS
-
-
Michigan
-
Detroit, Michigan, Vereinigte Staaten, 48201
- Children's Hospital of Michigan NICHD CRS
-
-
New Jersey
-
New Brunswick, New Jersey, Vereinigte Staaten
- UMDNJ - Robert Wood Johnson
-
Paterson, New Jersey, Vereinigte Staaten
- St. Joseph's Hosp. & Med. Ctr. of New Jersey
-
-
New York
-
Albany, New York, Vereinigte Staaten, 12208
- Children's Hospital at Albany Medical Center, Dept. of Peds.
-
Bronx, New York, Vereinigte Staaten, 10457
- Bronx-Lebanon Hosp. IMPAACT CRS
-
Brooklyn, New York, Vereinigte Staaten, 11203
- SUNY Downstate Med. Ctr., Children's Hosp. at Downstate NICHD CRS
-
Great Neck, New York, Vereinigte Staaten, 11021
- North Shore-Long Island Jewish Health System, Dept. of Peds.
-
New Hyde Park, New York, Vereinigte Staaten, 11040
- Schneider Children's Hosp., Div. of Infectious Diseases
-
New York, New York, Vereinigte Staaten, 10032
- Columbia IMPAACT CRS
-
New York, New York, Vereinigte Staaten, 10037
- Harlem Hosp. Ctr. NY NICHD CRS
-
New York, New York, Vereinigte Staaten, 10016
- NYU Med. Ctr., Dept. of Medicine
-
New York, New York, Vereinigte Staaten, 10032
- Incarnation Children's Ctr.
-
New York, New York, Vereinigte Staaten, 10029
- Metropolitan Hosp. NICHD CRS
-
Rochester, New York, Vereinigte Staaten, 14642
- Univ. of Rochester ACTG CRS
-
Stony Brook, New York, Vereinigte Staaten, 11794
- SUNY Stony Brook NICHD CRS
-
Syracuse, New York, Vereinigte Staaten, 13210
- SUNY Upstate Med. Univ., Dept. of Peds.
-
-
North Carolina
-
Durham, North Carolina, Vereinigte Staaten, 27710
- DUMC Ped. CRS
-
-
Ohio
-
Cleveland, Ohio, Vereinigte Staaten, 44106
- Case CRS
-
-
Pennsylvania
-
Philadelphia, Pennsylvania, Vereinigte Staaten, 19104
- The Children's Hosp. of Philadelphia IMPAACT CRS
-
Philadelphia, Pennsylvania, Vereinigte Staaten, 19134
- St. Christopher's Hosp. for Children
-
-
South Carolina
-
Charleston, South Carolina, Vereinigte Staaten, 29425
- Med. Univ. of South Carolina, Div. of Ped. Infectious Diseases
-
-
Texas
-
Dallas, Texas, Vereinigte Staaten, 75235
- Children's Med. Ctr. Dallas
-
Houston, Texas, Vereinigte Staaten, 77030
- Texas Children's Hosp. CRS
-
-
Washington
-
Seattle, Washington, Vereinigte Staaten, 98105
- UW School of Medicine - CHRMC
-
-
Teilnahmekriterien
Zulassungskriterien
Studienberechtigtes Alter
Akzeptiert gesunde Freiwillige
Studienberechtigte Geschlechter
Beschreibung
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.
Studienplan
Wie ist die Studie aufgebaut?
Designdetails
- Hauptzweck: Behandlung
Mitarbeiter und Ermittler
Mitarbeiter
Ermittler
- Studienstuhl: Frenkel LM
- Studienstuhl: Bryson Y
- Studienstuhl: Stiehm R
Publikationen und hilfreiche Links
Allgemeine Veröffentlichungen
- 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)
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
- Durch Blut übertragene Infektionen
- Übertragbare Krankheiten
- Sexuell übertragbare Krankheiten, viral
- Sexuell übertragbare Krankheiten
- Lentivirus-Infektionen
- Retroviridae-Infektionen
- Immunologische Mangelsyndrome
- Erkrankungen des Immunsystems
- Langsame Viruserkrankungen
- HIV-Infektionen
- Infektionen
- Erworbenes Immunschwächesyndrom
- Molekulare Mechanismen der pharmakologischen Wirkung
- Antiinfektiva
- Antivirale Mittel
- Reverse-Transkriptase-Inhibitoren
- Inhibitoren der Nukleinsäuresynthese
- Enzym-Inhibitoren
- Anti-HIV-Agenten
- Antiretrovirale Mittel
- Antimetaboliten
- Didanosin
Andere Studien-ID-Nummern
- ACTG 144
- 11119 (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 Didanosin
-
Institut de Recherche pour le DeveloppementAbgeschlossen
-
Mansoura University Children HospitalAbgeschlossen
-
Tuberculosis Research Centre, IndiaIndian Council of Medical Research; National AIDS Control OrganisationUnbekanntTuberkulose | Infektionen mit dem Human Immunodeficiency VirusIndien
-
University of ParmaUniversity of Birmingham; Azienda Ospedaliero-Universitaria di Parma; Centro de...AbgeschlossenKardiometabolische Gesundheit | Individuelle Variabilität im (Poly)PhenolstoffwechselItalien
-
Bristol-Myers SquibbAbgeschlossen
-
Bristol-Myers SquibbAbgeschlossenHIV-InfektionenVereinigte Staaten
-
Assistance Publique - Hôpitaux de ParisSuspendiertHIV-InfektionenFrankreich
-
National Institute of Allergy and Infectious Diseases...Bristol-Myers SquibbAbgeschlossen
-
National Institute of Allergy and Infectious Diseases...Abgeschlossen
-
National Institute of Allergy and Infectious Diseases...Bristol-Myers SquibbAbgeschlossenHIV-Infektionen | SchwangerschaftVereinigte Staaten, Puerto Rico