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A Study of ddI in Children With AIDS Who Have Not Had Success With Zidovudine
This study has been completed.
Sponsor:
Bristol-Myers Squibb
Information provided by:
Bristol-Myers Squibb
ClinicalTrials.gov Identifier:
NCT00002280
First received: November 2, 1999
Last updated: August 4, 2011
Last verified: August 2011
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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: 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) |
Resource links provided by NLM:
Further study details as provided by Bristol-Myers Squibb:
Eligibility| 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00002280
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 | Bristol-Myers Squibb |
More Information
Additional Information:
| 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 |
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 |
ClinicalTrials.gov processed this record on August 18, 2017