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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
This study has been completed.
First Received: November 2, 1999   Last Updated: August 1, 2008   History of Changes
Sponsor: National Institute of Allergy and Infectious Diseases (NIAID)
Collaborator: Bristol-Myers Squibb
Information provided by: National Institute of Allergy and Infectious Diseases (NIAID)
ClinicalTrials.gov Identifier: NCT00000963
  Purpose

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.


Condition Intervention Phase
HIV Infections
Drug: Didanosine
Phase II

Study Type: Interventional
Study Design: Treatment
Official Title: 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

Resource links provided by NLM:


Further study details as provided by National Institute of Allergy and Infectious Diseases (NIAID):

Estimated Enrollment: 300
Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   3 Months to 18 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00000963

  Hide Study Locations
Locations
United States, Alabama
Univ of Alabama at Birmingham Schl of Med / Pediatrics
Birmingham, Alabama, United States, 35294
United States, California
UCSF / Moffitt Hosp - Pediatric
San Francisco, California, United States, 941430105
UCSD Med Ctr / Pediatrics / Clinical Sciences
La Jolla, California, United States, 920930672
Harbor - UCLA Med Ctr / UCLA School of Medicine
Los Angeles, California, United States, 905022004
Los Angeles County - USC Med Ctr
Los Angeles, California, United States, 90033
UCLA Med Ctr / Pediatric
Los Angeles, California, United States, 900951752
Cedars Sinai / UCLA Med Ctr
Los Angeles, California, United States, 900481804
Children's Hosp of Oakland
Oakland, California, United States, 946091809
Long Beach Memorial (Pediatric)
Long Beach, California, United States, 90801
United States, Colorado
Children's Hosp of Denver
Denver, Colorado, United States, 802181088
United States, Connecticut
Univ of Connecticut Health Ctr
Farmington, Connecticut, United States, 06032
Yale Univ Med School
New Haven, Connecticut, United States, 06504
Connecticut Children's Med Ctr
Farmington, Connecticut, United States, 060303805
United States, District of Columbia
Georgetown Univ Med Ctr
Washington, District of Columbia, United States, 200072197
Howard Univ Hosp
Washington, District of Columbia, United States, 20060
Children's Hosp of Washington DC
Washington, District of Columbia, United States, 200102916
Children's Hosp of Washington DC / Children's Natl Med Ctr
Washington, District of Columbia, United States, 20010
United States, Florida
Univ of Miami (Pediatric)
Miami, Florida, United States, 33161
United States, Georgia
Emory Univ Hosp / Pediatrics
Atlanta, Georgia, United States, 30306
United States, Illinois
Chicago Children's Memorial Hosp
Chicago, Illinois, United States, 606143394
Cook County Hosp
Chicago, Illinois, United States, 60612
Univ of Illinois College of Medicine / Pediatrics
Chicago, Illinois, United States, 60612
Univ of Chicago Children's Hosp
Chicago, Illinois, United States, 606371470
United States, Maryland
Univ of Maryland at Baltimore / Univ Med Ctr
Baltimore, Maryland, United States, 21201
Johns Hopkins Hosp - Pediatric
Baltimore, Maryland, United States, 212874933
United States, Massachusetts
Children's Hosp of Boston
Boston, Massachusetts, United States, 021155724
Boston City Hosp / Pediatrics
Boston, Massachusetts, United States, 02118
Univ of Massachusetts Med Ctr
Worcester, Massachusetts, United States, 01655
Baystate Med Ctr of Springfield
Springfield, Massachusetts, United States, 01199
United States, Michigan
Children's Hosp of Michigan
Detroit, Michigan, United States, 48201
United States, New Jersey
Children's Hosp of New Jersey / UMDNJ - New Jersey Med Schl
Newark, New Jersey, United States, 071072198
Saint Joseph's Hosp and Med Ctr/UMDNJ - New Jersey Med Schl
Newark, New Jersey, United States, 07103
United States, New York
Harlem Hosp Ctr
New York, New York, United States, 10037
SUNY - Brooklyn
Brooklyn, New York, United States, 11203
Cornell Univ Med College
New York, New York, United States, 10021
North Shore Univ Hosp
Great Neck, New York, United States, 11021
Westchester Hosp
Valhalla, New York, United States, 10595
Schneider Children's Hosp
New Hyde Park, New York, United States, 11040
Bronx Lebanon Hosp Ctr / Pediatrics
Bronx, New York, United States, 10457
Univ of Rochester Medical Center
Rochester, New York, United States, 14642
Bellevue Hosp / New York Univ Med Ctr
New York, New York, United States, 10016
Columbia Presbyterian Med Ctr
New York, New York, United States, 10032
Mount Sinai Med Ctr / Pediatrics
New York, New York, United States, 10029
State Univ of New York at Stony Brook
Stony Brook, New York, United States, 117948111
Metropolitan Hosp Ctr
New York, New York, United States, 10029
Children's Hosp at Albany Med Ctr
Albany, New York, United States, 12208
SUNY Health Sciences Ctr at Syracuse / Pediatrics
Syracuse, New York, United States, 13210
Bronx Lebanon Hosp Ctr
Bronx, New York, United States, 10457
Incarnation Children's Ctr / Columbia Presbyterian Med Ctr
New York, New York, United States, 10032
SUNY / Health Sciences Ctr at Brooklyn / Pediatrics
Brooklyn, New York, United States, 11203
Albert Einstein College of Medicine
Bronx, New York, United States, 10461
Beth Israel Med Ctr / Pediatrics
New York, New York, United States, 10003
United States, North Carolina
Duke Univ Med Ctr
Durham, North Carolina, United States, 277103499
United States, Ohio
Case Western Reserve Univ
Cleveland, Ohio, United States, 44106
Cincinnati Children's Hosp / Univ Hosp
Cincinnati, Ohio, United States, 452292899
Columbus Children's Hosp
Columbus, Ohio, United States, 432052696
United States, Pennsylvania
Saint Christopher's Hosp for Children
Philadelphia, Pennsylvania, United States, 191341095
Hemophilia Ctr of Western PA / Univ of Pittsburgh
Pittsburgh, Pennsylvania, United States, 15219
Children's Hosp of Philadelphia
Philadelphia, Pennsylvania, United States, 191044318
United States, South Carolina
Med Univ of South Carolina
Charleston, South Carolina, United States, 29425
United States, Texas
Children's Med Ctr of Dallas
Dallas, Texas, United States, 75235
Hermann Hosp / Univ Texas Health Science Ctr
Houston, Texas, United States, 77030
Texas Children's Hosp / Baylor Univ
Houston, Texas, United States, 77030
United States, Washington
Children's Hosp of Seattle
Seattle, Washington, United States, 98105
Puerto Rico
Ramon Ruiz Arnau Univ Hosp / Pediatrics
Bayamon, Puerto Rico, 00956
UPR Children's Hosp / UPR School of Medicine
San Juan, Puerto Rico, 009365067
Univ of Puerto Rico / Univ Children's Hosp AIDS
San Juan, Puerto Rico, 009365067
San Juan City Hosp
San Juan, Puerto Rico, 009367344
Sponsors and Collaborators
Bristol-Myers Squibb
Investigators
Study Chair: Frenkel LM
Study Chair: Bryson Y
Study Chair: Stiehm R
  More Information

Additional Information:
Publications:
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)
Dankner WM, Lindsey JC, Levin MJ. Correlates of opportunistic infections in children infected with the human immunodeficiency virus managed before highly active antiretroviral therapy. Pediatr Infect Dis J. 2001 Jan;20(1):40-8.

Study ID Numbers: ACTG 144
Study First Received: November 2, 1999
Last Updated: August 1, 2008
ClinicalTrials.gov Identifier: NCT00000963     History of Changes
Health Authority: United States: Federal Government

Keywords provided by National Institute of Allergy and Infectious Diseases (NIAID):
Didanosine
Drug Evaluation
Acquired Immunodeficiency Syndrome
AIDS-Related Complex
Zidovudine

Additional relevant MeSH terms:
Antimetabolites
Communicable Diseases
Anti-Infective Agents
Sexually Transmitted Diseases, Viral
Slow Virus Diseases
Molecular Mechanisms of Pharmacological Action
Zidovudine
Infection
Reverse Transcriptase Inhibitors
Anti-Retroviral Agents
Therapeutic Uses
Retroviridae Infections
Nucleic Acid Synthesis Inhibitors
RNA Virus Infections
Anti-HIV Agents
Immune System Diseases
Acquired Immunodeficiency Syndrome
Enzyme Inhibitors
Antiviral Agents
Immunologic Deficiency Syndromes
Pharmacologic Actions
Virus Diseases
Didanosine
HIV Infections
Sexually Transmitted Diseases
Lentivirus Infections

ClinicalTrials.gov processed this record on November 27, 2009