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History of Changes for Study: NCT00000963
A Study of Dideoxyinosine (ddI) in HIV-Infected Children Who Have Not Had Success With Zidovudine or Who Cannot Take Zidovudine
Latest version (submitted October 28, 2021) on ClinicalTrials.gov
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Study Record Versions
Version A B Submitted Date Changes
1 June 23, 2005 None (earliest Version on record)
2 August 1, 2008 Study Status
3 February 24, 2011 Study Status
4 March 28, 2012 Contacts/Locations, Study Status, Sponsor/Collaborators and Study Identification
5 October 28, 2021 Study Status and Study Identification
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Study NCT00000963
Submitted Date:  June 23, 2005 (v1)

Open or close this module Study Identification
Unique Protocol ID: ACTG 144
Brief Title: A Study of Dideoxyinosine (ddI) in HIV-Infected Children Who Have Not Had Success With Zidovudine or Who Cannot Take Zidovudine
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
Secondary IDs:
Open or close this module Study Status
Record Verification: January 2003
Overall Status: Completed
Study Start:
Primary Completion:
Study Completion:
First Submitted: November 2, 1999
First Submitted that
Met QC Criteria:
August 30, 2001
First Posted: August 31, 2001 [Estimate]
Last Update Submitted that
Met QC Criteria:
June 23, 2005
Last Update Posted: June 24, 2005 [Estimate]
Open or close this module Sponsor/Collaborators
Sponsor: National Institute of Allergy and Infectious Diseases (NIAID)
Responsible Party:
Collaborators: Bristol-Myers Squibb
Open or close this module Oversight
U.S. FDA-regulated Drug:
U.S. FDA-regulated Device:
Data Monitoring:
Open or close this module Study Description
Brief Summary:

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.

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.

Open or close this module Conditions
Conditions: HIV Infections
Keywords: Didanosine
Drug Evaluation
Acquired Immunodeficiency Syndrome
AIDS-Related Complex
Zidovudine
Open or close this module Study Design
Study Type: Interventional
Primary Purpose: Treatment
Study Phase: Phase 2
Interventional Study Model:
Number of Arms:
Masking: (masked roles unspecified)
Enrollment: 300
Open or close this module Arms and Interventions
Intervention Details:
Drug: Didanosine
Open or close this module Outcome Measures
Open or close this module Eligibility
Minimum Age: 3 Months
Maximum Age: 18 Years
Sex: All
Gender Based:
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.
Open or close this module Contacts/Locations
Study Officials: Frenkel LM
Study Chair
Bryson Y
Study Chair
Stiehm R
Study Chair
Locations: United States, Alabama
Univ of Alabama at Birmingham Schl of Med / Pediatrics
Birmingham, Alabama, United States, 35294
United States, California
UCSD Med Ctr / Pediatrics / Clinical Sciences
La Jolla, California, United States, 920930672
Long Beach Memorial (Pediatric)
Long Beach, California, United States, 90801
Los Angeles County - USC Med Ctr
Los Angeles, California, United States, 90033
Cedars Sinai / UCLA Med Ctr
Los Angeles, California, United States, 900481804
UCLA Med Ctr / Pediatric
Los Angeles, California, United States, 900951752
Harbor - UCLA Med Ctr / UCLA School of Medicine
Los Angeles, California, United States, 905022004
Children's Hosp of Oakland
Oakland, California, United States, 946091809
UCSF / Moffitt Hosp - Pediatric
San Francisco, California, United States, 941430105
United States, Colorado
Children's Hosp of Denver
Denver, Colorado, United States, 802181088
United States, Connecticut
Connecticut Children's Med Ctr
Farmington, Connecticut, United States, 060303805
Univ of Connecticut Health Ctr
Farmington, Connecticut, United States, 06032
Yale Univ Med School
New Haven, Connecticut, United States, 06504
United States, District of Columbia
Georgetown Univ Med Ctr
Washington, District of Columbia, United States, 200072197
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
Howard Univ Hosp
Washington, District of Columbia, United States, 20060
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
Cook County Hosp
Chicago, Illinois, United States, 60612
Univ of Illinois College of Medicine / Pediatrics
Chicago, Illinois, United States, 60612
Chicago Children's Memorial Hosp
Chicago, Illinois, United States, 606143394
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
Baystate Med Ctr of Springfield
Springfield, Massachusetts, United States, 01199
Univ of Massachusetts Med Ctr
Worcester, Massachusetts, United States, 01655
United States, Michigan
Children's Hosp of Michigan
Detroit, Michigan, United States, 48201
United States, New Jersey
Saint Joseph's Hosp and Med Ctr/UMDNJ - New Jersey Med Schl
Newark, New Jersey, United States, 07103
Children's Hosp of New Jersey / UMDNJ - New Jersey Med Schl
Newark, New Jersey, United States, 071072198
United States, New York
Children's Hosp at Albany Med Ctr
Albany, New York, United States, 12208
Bronx Lebanon Hosp Ctr / Pediatrics
Bronx, New York, United States, 10457
Bronx Lebanon Hosp Ctr
Bronx, New York, United States, 10457
Albert Einstein College of Medicine
Bronx, New York, United States, 10461
SUNY - Brooklyn
Brooklyn, New York, United States, 11203
SUNY / Health Sciences Ctr at Brooklyn / Pediatrics
Brooklyn, New York, United States, 11203
North Shore Univ Hosp
Great Neck, New York, United States, 11021
Schneider Children's Hosp
New Hyde Park, New York, United States, 11040
Beth Israel Med Ctr / Pediatrics
New York, New York, United States, 10003
Bellevue Hosp / New York Univ Med Ctr
New York, New York, United States, 10016
Cornell Univ Med College
New York, New York, United States, 10021
Metropolitan Hosp Ctr
New York, New York, United States, 10029
Mount Sinai Med Ctr / Pediatrics
New York, New York, United States, 10029
Columbia Presbyterian Med Ctr
New York, New York, United States, 10032
Incarnation Children's Ctr / Columbia Presbyterian Med Ctr
New York, New York, United States, 10032
Harlem Hosp Ctr
New York, New York, United States, 10037
Univ of Rochester Medical Center
Rochester, New York, United States, 14642
State Univ of New York at Stony Brook
Stony Brook, New York, United States, 117948111
SUNY Health Sciences Ctr at Syracuse / Pediatrics
Syracuse, New York, United States, 13210
Westchester Hosp
Valhalla, New York, United States, 10595
United States, North Carolina
Duke Univ Med Ctr
Durham, North Carolina, United States, 277103499
United States, Ohio
Cincinnati Children's Hosp / Univ Hosp
Cincinnati, Ohio, United States, 452292899
Case Western Reserve Univ
Cleveland, Ohio, United States, 44106
Columbus Children's Hosp
Columbus, Ohio, United States, 432052696
United States, Pennsylvania
Children's Hosp of Philadelphia
Philadelphia, Pennsylvania, United States, 191044318
Saint Christopher's Hosp for Children
Philadelphia, Pennsylvania, United States, 191341095
Hemophilia Ctr of Western PA / Univ of Pittsburgh
Pittsburgh, Pennsylvania, United States, 15219
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
Univ of Puerto Rico / Univ Children's Hosp AIDS
San Juan, Puerto Rico, 009365067
UPR Children's Hosp / UPR School of Medicine
San Juan, Puerto Rico, 009365067
San Juan City Hosp
San Juan, Puerto Rico, 009367344
Open or close this module IPDSharing
Plan to Share IPD:
Open or close this module References
Citations: 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)
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. PubMed 21037891
Links:
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