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

Sponsor

Bristol-Myers Squibb (Industry)

Overall Status

Completed

CT.gov ID

NCT00002280

Collaborator

(none)

Location

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
HIV Infections	Drug: Didanosine	N/A

Study Design

Study Type:

Interventional

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 :

Nov 1, 1994

Outcome Measures

Primary Outcome Measures

Eligibility Criteria

Criteria

Ages Eligible for Study:

3 Months to 12 Years

Sexes Eligible for Study:

All

Accepts 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).

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Bristol - Myers Squibb Co	Wallingford	Connecticut	United States	064927600

Sponsors and Collaborators

Bristol-Myers Squibb

Investigators

Study Director: Bristol-Myers Squibb, Bristol-Myers Squibb

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

, ,

ClinicalTrials.gov Identifier:

NCT00002280

Other Study ID Numbers:

039C
AI454-904

First Posted:

Aug 31, 2001

Last Update Posted:

Aug 5, 2011

Last Verified:

Aug 1, 2011

Keywords provided by , ,

Didanosine

Drugs, Investigational

Acquired Immunodeficiency Syndrome

Zidovudine

Additional relevant MeSH terms:

Acquired Immunodeficiency Syndrome

Didanosine

Study Results

No Results Posted as of Aug 5, 2011