A Study of ddI in Children With AIDS Who Have Not Had Success With Zidovudine - Full Text View

Sponsor:	Bristol-Myers Squibb
Information provided by:	Bristol-Myers Squibb
ClinicalTrials.gov Identifier:	NCT00002280

Purpose

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	Intervention
HIV Infections	Drug: Didanosine

Study Type:	Interventional
Study Design:	Masking: 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)

Resource links provided by NLM:

Genetics Home Reference related topics: complement factor I deficiency

MedlinePlus related topics: HIV/AIDS

Drug Information available for: Zidovudine Didanosine

U.S. FDA Resources

Further study details as provided by Bristol-Myers Squibb:

Study Completion Date:

November 1994

Eligibility

Ages Eligible for Study:	3 Months to 12 Years
Genders Eligible for Study:	Both
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

Please refer to this study by its ClinicalTrials.gov identifier: NCT00002280

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

More Information

Additional Information:

BMS Clinical Trials Disclosure This link exits the ClinicalTrials.gov site

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

No publications provided

Responsible Party:	Study Director, Bristol-Myers Squibb
ClinicalTrials.gov Identifier:	NCT00002280 History of Changes
Other Study ID Numbers:	039C, AI454-904
Study First Received:	November 2, 1999
Last Updated:	August 4, 2011
Health Authority:	United States: Food and Drug Administration

Keywords provided by Bristol-Myers Squibb:

Didanosine
Drugs, Investigational
Acquired Immunodeficiency Syndrome
Zidovudine

Additional relevant MeSH terms:

HIV Infections
Acquired Immunodeficiency Syndrome
Immunologic Deficiency Syndromes
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immune System Diseases
Slow Virus Diseases
Didanosine

Zidovudine
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Reverse Transcriptase Inhibitors
Nucleic Acid Synthesis Inhibitors
Enzyme Inhibitors
Anti-Retroviral Agents
Antiviral Agents
Anti-Infective Agents
Therapeutic Uses
Anti-HIV Agents

ClinicalTrials.gov processed this record on February 09, 2012