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

August 4, 2011 updated by: Bristol-Myers Squibb

An Open Label Study Regimen of Videx (2',3'-Dideoxyinosine, ddI) in Children With Acquired Immunodeficiency Syndrome (AIDS) Who Have Demonstrated Significant Deterioration or Intolerance to Zidovudine (Retrovir)

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Connecticut
      • Wallingford, Connecticut, United States, 064927600
        • Bristol - Myers Squibb Co

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

3 months to 12 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria

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.

Exclusion Criteria

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.
  • Cimetidine.
  • Ranitidine.
  • Corticosteroids.
  • NOTE the cautionary statement in Patient Inclusion Concurrent Medication.

Patients with the following are excluded:

  • Acute pancreatitis or any history of pancreatitis.
  • Seizures or a history of seizure disorder.
  • Grade I or greater peripheral neuropathy.
  • Preexisting cardiomyopathy.

Prior Medication:

Excluded within 15 days of study entry:

  • Any anti-retroviral except zidovudine (AZT).

Required:

  • Zidovudine (AZT).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Masking: None (Open Label)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Bristol-Myers Squibb

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Completion (Actual)

November 1, 1994

Study Registration Dates

First Submitted

November 2, 1999

First Submitted That Met QC Criteria

August 30, 2001

First Posted (Estimate)

August 31, 2001

Study Record Updates

Last Update Posted (Estimate)

August 5, 2011

Last Update Submitted That Met QC Criteria

August 4, 2011

Last Verified

August 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 039C
  • AI454-904

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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