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

HIV Infections Clinical Trial

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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00002280
• Other study ID #: 039C
• Secondary ID: AI454-904
• Status: Completed
• Phase: N/A
• First received: November 2, 1999
• Last updated: August 4, 2011
• Est. completion date: November 1994

Study information

• Verified date: August 2011
• Source: Bristol-Myers Squibb
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 0
• Est. completion date: November 1994
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 3 Months to 12 Years

Eligibility

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 Design

Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Acquired Immunodeficiency Syndrome
• HIV Infections
• Immunologic Deficiency Syndromes

Intervention

Drug:
• Didanosine

Locations

Country	Name	City	State
United States	Bristol - Myers Squibb Co	Wallingford	Connecticut

Sponsors (1)

Lead Sponsor	Collaborator
Bristol-Myers Squibb

Country where clinical trial is conducted

United States, 

External Links

•   BMS Clinical Trials Disclosure
•   For FDA Safety Alerts and Recalls refer to the following link www.fda.gov/MEDWATCH/safety.htm