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Sponsored by: |
Bristol-Myers Squibb |
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Information provided by: | Bristol-Myers Squibb |
ClinicalTrials.gov Identifier: | NCT00002274 |
The objective of this open-label study regimen is to make didanosine (ddI) available to patients with AIDS who are clinically deteriorating on zidovudine (AZT) and cannot enter the Phase II ddI programs due to protocol
exclusion or geographic location.
Condition | Intervention |
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HIV Infections Leukoencephalopathy, Progressive Multifocal |
Drug: Didanosine |
Study Type: | Interventional |
Study Design: | Treatment, Open Label, Single Group Assignment |
Official Title: | An Open Label Study Regimen of Videx (2',3'-Dideoxyinosine, ddI) in Patients With Acquired Immunodeficiency Syndrome (AIDS) Exhibiting Significant Deterioration While Taking Zidovudine (Retrovir) |
Ages Eligible for Study: | 12 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria
Concurrent Medication:
Allowed:
Patients must be:
- Not suitable for entry into ddI phase II studies by reason of inclusion or exclusion criteria or by reason of geographic location. Able to provide signed informed consent (parent/guardian as appropriate). Available for monthly follow-up while taking ddI. Meet required baseline laboratory values within 14 days prior to initial drug dosing.
Note:
Caution should also be exercised in a patient having intractable diarrhea or patients following a low-sodium diet. Physicians caring for these patients must perform clinical and laboratory evaluations every 7-10 days for the first 2 months of ddI therapy. Should any adverse effect of any severity be detected during this period of intensive clinical and laboratory monitoring, the physician must call Bristol-Myers Squibb (1-800-662-7999). If the patient continues ddI therapy, Bristol-Myers Squibb will require submission of follow-up and adverse experience report forms every 10 days. Although data are not available to fully assess the risks associated with the use of ddI in high-risk patients (for example, patients with preexisting disorders of body systems known to be adversely affected by ddI, particularly those with history of peripheral neuropathy, pancreatitis, seizure disorder, cardiac abnormalities, gout, and significant elevations of liver function test results), all such patients must have clinical and laboratory evaluations performed every 10 days and results submitted to Bristol-Myers Squibb on the case report forms provided.
Exclusion Criteria
Co-existing Condition:
Patients with any one of the following criteria are excluded:
Concurrent Medication:
Excluded:
Patients with any one of the following criteria are excluded:
Prior Medication:
Excluded within 15 days of study entry:
Required:
United States, New Jersey | |
Bristol - Myers Squibb Co | |
Princeton, New Jersey, United States, 085434500 |
Study Director: | Bristol-Myers Squibb | Bristol-Myers Squibb |
Study ID Numbers: | 039A, 454-999-002 |
Study First Received: | November 2, 1999 |
Last Updated: | October 1, 2007 |
ClinicalTrials.gov Identifier: | NCT00002274 History of Changes |
Health Authority: | United States: Food and Drug Administration |
Didanosine Drugs, Investigational Acquired Immunodeficiency Syndrome Zidovudine |
Antimetabolites Anti-Infective Agents Sexually Transmitted Diseases, Viral Anti-HIV Agents Demyelinating Diseases Acquired Immunodeficiency Syndrome Zidovudine Leukoencephalopathy, Progressive Multifocal Polyomavirus Infections Central Nervous System Diseases Antiviral Agents Immunologic Deficiency Syndromes |
Encephalitis Reverse Transcriptase Inhibitors Virus Diseases Didanosine Anti-Retroviral Agents Progressive Multifocal Leukoencephalopathy Central Nervous System Infections HIV Infections Sexually Transmitted Diseases DNA Virus Infections Retroviridae Infections |
Antimetabolites Anti-Infective Agents Sexually Transmitted Diseases, Viral Slow Virus Diseases Molecular Mechanisms of Pharmacological Action Polyomavirus Infections Zidovudine Central Nervous System Viral Diseases Infection Reverse Transcriptase Inhibitors Encephalitis, Viral Anti-Retroviral Agents Therapeutic Uses Retroviridae Infections Nucleic Acid Synthesis Inhibitors |
RNA Virus Infections Anti-HIV Agents Immune System Diseases Demyelinating Diseases Acquired Immunodeficiency Syndrome Nervous System Diseases Leukoencephalopathy, Progressive Multifocal Central Nervous System Diseases Enzyme Inhibitors Antiviral Agents Pharmacologic Actions Immunologic Deficiency Syndromes Encephalitis Virus Diseases Didanosine |