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

Study Description

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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.

Condition or disease	Intervention/treatment	Phase
HIV Infections	Drug: Didanosine	Not Applicable

Study Design

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Study Type :	Interventional (Clinical Trial)
Masking:	None (Open Label)
Primary Purpose:	Treatment
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)
Actual Study Completion Date :	November 1994

Arms and Interventions

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Outcome Measures

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Eligibility Criteria

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Ages Eligible for Study:	3 Months to 12 Years (Child)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No

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).

Contacts and Locations

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Locations

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

Sponsors and Collaborators

Bristol-Myers Squibb

Investigators

Study Director:	Bristol-Myers Squibb	Bristol-Myers Squibb

More Information

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Additional Information:

BMS Clinical Trials Disclosure 

For FDA Safety Alerts and Recalls refer to the following link www.fda.gov/MEDWATCH/safety.htm 

Responsible Party:	Study Director, Bristol-Myers Squibb
ClinicalTrials.gov Identifier:	NCT00002280 History of Changes
Other Study ID Numbers:	039C; AI454-904
First Posted:	August 31, 2001
Last Update Posted:	August 5, 2011
Last Verified:	August 2011

Keywords provided by Bristol-Myers Squibb:

Didanosine; Drugs, Investigational; Acquired Immunodeficiency Syndrome; Zidovudine

Additional relevant MeSH terms:

HIV Infections; Immunologic Deficiency Syndromes; Acquired Immunodeficiency Syndrome; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Immune System Diseases; Slow Virus Diseases	Zidovudine; Didanosine; Antimetabolites; Molecular Mechanisms of Pharmacological Action; Reverse Transcriptase Inhibitors; Nucleic Acid Synthesis Inhibitors; Enzyme Inhibitors; Anti-Retroviral Agents; Antiviral Agents; Anti-Infective Agents; Anti-HIV Agents