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.
Sponsor:
Collaborator:
Bristol-Myers Squibb
Information provided by (Responsible Party):
National Institute of Allergy and Infectious Diseases (NIAID)
ClinicalTrials.gov Identifier:
NCT00000963
First received: November 2, 1999
Last updated: March 28, 2012
Last verified: March 2012
  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 2

Study Type: Interventional
Study Design: Primary Purpose: 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
Study Completion Date: September 1995
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

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

Responsible Party: National Institute of Allergy and Infectious Diseases (NIAID)
ClinicalTrials.gov Identifier: NCT00000963     History of Changes
Other Study ID Numbers: ACTG 144, 11119
Study First Received: November 2, 1999
Last Updated: March 28, 2012
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:
Acquired Immunodeficiency Syndrome
Communicable Diseases
HIV Infections
Infection
Immune System Diseases
Immunologic Deficiency Syndromes
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Sexually Transmitted Diseases
Sexually Transmitted Diseases, Viral
Slow Virus Diseases
Virus Diseases
Didanosine
Zidovudine
Anti-HIV Agents
Anti-Infective Agents
Anti-Retroviral Agents
Antimetabolites
Antiviral Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Nucleic Acid Synthesis Inhibitors
Pharmacologic Actions
Reverse Transcriptase Inhibitors
Therapeutic Uses

ClinicalTrials.gov processed this record on October 20, 2014