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

Primary Purpose

HIV Infections

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Didanosine
Sponsored by
Bristol-Myers Squibb
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for HIV Infections focused on measuring Didanosine, Drugs, Investigational, Acquired Immunodeficiency Syndrome, Zidovudine

Eligibility Criteria

3 Months - 12 Years (Child)All SexesDoes not accept healthy volunteers

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).

Sites / Locations

  • Bristol - Myers Squibb Co

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
November 2, 1999
Last Updated
August 4, 2011
Sponsor
Bristol-Myers Squibb
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1. Study Identification

Unique Protocol Identification Number
NCT00002280
Brief Title
A Study of ddI in Children With AIDS Who Have Not Had Success With Zidovudine
Official Title
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)
Study Type
Interventional

2. Study Status

Record Verification Date
August 2011
Overall Recruitment Status
Completed
Study Start Date
undefined (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
November 1994 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Bristol-Myers Squibb

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
HIV Infections
Keywords
Didanosine, Drugs, Investigational, Acquired Immunodeficiency Syndrome, Zidovudine

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Masking
None (Open Label)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
Didanosine

10. Eligibility

Sex
All
Minimum Age & Unit of Time
3 Months
Maximum Age & Unit of Time
12 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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).
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bristol-Myers Squibb
Organizational Affiliation
Bristol-Myers Squibb
Official's Role
Study Director
Facility Information:
Facility Name
Bristol - Myers Squibb Co
City
Wallingford
State/Province
Connecticut
ZIP/Postal Code
064927600
Country
United States

12. IPD Sharing Statement

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

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