A Study of ddI in Children With AIDS Who Have Not Had Success With Zidovudine

NCT00002280 | Completed

• 2 other identifiers: 039CAI454-904
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to make didanosine (ddI) available to children with AIDS who are clinically deteriorating on zidovudine (AZT) or intolerant to AZT and cannot enter the Phase II ddI programs due to protocol exclusion or geographic location.

Conditions

HIV Infections

Keywords

Didanosine; Drugs, Investigational; Acquired Immunodeficiency Syndrome; Zidovudine

Interventions

Didanosine DRUG

Eligibility Criteria

• Age: 3 Months - 12 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Concurrent Medication:
• Allowed:
• Concomitant medications for the treatment of complications of AIDS.
• CAUTION:
• Concomitant use of ddI with the following drugs must be done with extreme caution:
• Other nucleosides (e.g., ganciclovir).
• Drugs with toxicities similar to those observed with ddI (e.g., phenytoin).
• Drugs with significant pancreatic toxicities, including many drugs used for treatment of major opportunistic infections.
• Use of Sulfonamides or intravenous pentamidine for treatment of acute Pneumocystis carinii pneumonia (PCP) requires discontinuation of ddI for a week following treatment of PCP.
• Caution should also be exercised with patients having intractable diarrhea or patients following a low sodium diet.
• Patients must have the following:
• \- Diagnosis of AIDS. Demonstrated either significant deterioration despite parenteral dosing with zidovudine (AZT) or significant intolerance to AZT.
• Signed informed consent by parent or legal guardian. Evaluations every 7-14 days while taking ddI for the first 4 months. Monthly follow-up is required thereafter.

You may not qualify if:

• Co-existing Condition:
• Patients with the following conditions or symptoms are excluded:
• Acute pancreatitis or any history of pancreatitis.
• Seizures or a history of seizure disorder.
• Grade I or greater peripheral neuropathy.
• Preexisting cardiomyopathy.
• Concurrent Medication:
• Excluded:
• Zidovudine (AZT).
• Chemotherapy with cytotoxic agents.
• AVOID:
• Those agents that may cause pancreatitis such as:
• Pentamidine.
• Sulfonamides.
• Antituberculosis drugs.

Sponsors & Collaborators

• Bristol-Myers Squibb: lead

Study Sites (1)

Bristol - Myers Squibb Co

Wallingford, Connecticut, 064927600, United States

Location

MeSH Terms

Conditions

HIV Infections; Acquired Immunodeficiency Syndrome

Interventions

Didanosine

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases; Slow Virus Diseases

Intervention Hierarchy (Ancestors)

Inosine; Purine Nucleosides; Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Dideoxynucleosides; Deoxyribonucleosides; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides; Ribonucleosides

Study Officials

• Bristol-Myers Squibb

  Bristol-Myers Squibb

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Masking: NONE
• Purpose: TREATMENT
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: November 2, 1999
• First Posted: August 31, 2001
• Study Completion: November 1, 1994
• Last Updated: August 5, 2011

Record last verified: 2011-08

Locations

US (1)