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A Study of ddI in Patients With AIDS Who Become Sicker While Taking Zidovudine

This study has been completed.
Sponsor:
Information provided by:
Bristol-Myers Squibb
ClinicalTrials.gov Identifier:
NCT00002274
First received: November 2, 1999
Last updated: October 1, 2007
Last verified: October 2007
  Purpose

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
HIV Infections
Leukoencephalopathy, Progressive Multifocal
Drug: Didanosine

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
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)

Resource links provided by NLM:


Further study details as provided by Bristol-Myers Squibb:

  Eligibility

Ages Eligible for Study:   12 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria

Concurrent Medication:

Allowed:

  • Concurrent medications for treatment of complications of AIDS are allowed.
  • Aerosolized pentamidine.
  • Phenytoin, but with caution.
  • Note:
  • Extreme caution should be exercised in the use of didanosine (ddI) in any patient receiving concurrent therapies, particularly those receiving other nucleosides (e.g., ganciclovir), drugs with toxicities similar to those observed with ddI (list included under concomitant medications section of protocol), and other drugs with significant toxicities, including many drugs used for treatment of major opportunistic infections.

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:

  • Extreme caution should be exercised in the use of ddI in any patient receiving concomitant therapies, particularly those receiving other nucleosides (e.g., ganciclovir), drugs with toxicities similar to those observed with ddI (list included under concomitant medications section of protocol), and other drugs with significant toxicities, including many drugs used for treatment of major opportunistic infections.

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:

  • Received therapy in the preceding 15 days with any other antiretroviral except zidovudine (AZT).
  • Taking AZT concomitantly.
  • Acute pancreatitis.
  • Poorly controlled seizure disorder.
  • Taking phenytoin concomitantly.
  • Grade B or greater peripheral neuropathy.

Concurrent Medication:

Excluded:

  • Zidovudine (AZT).

Patients with any one of the following criteria are excluded:

  • Received therapy in the preceding 15 days with any other antiretroviral except zidovudine (AZT).
  • Taking AZT concomitantly.
  • Taking phenytoin concomitantly.
  • Acute pancreatitis.
  • Poorly controlled seizure disorder.
  • Grade B or greater peripheral neuropathy.

Prior Medication:

Excluded within 15 days of study entry:

  • Any antiretroviral 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: NCT00002274

Locations
United States, New Jersey
Bristol - Myers Squibb Co
Princeton, New Jersey, United States, 085434500
Sponsors and Collaborators
Bristol-Myers Squibb
Investigators
Study Director: Bristol-Myers Squibb Bristol-Myers Squibb
  More Information

Additional Information:
Publications:
ClinicalTrials.gov Identifier: NCT00002274     History of Changes
Other Study ID Numbers: 039A, 454-999-002
Study First Received: November 2, 1999
Last Updated: October 1, 2007
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:
Acquired Immunodeficiency Syndrome
HIV Infections
Immunologic Deficiency Syndromes
Leukoencephalopathies
Leukoencephalopathy, Progressive Multifocal
Brain Diseases
Central Nervous System Diseases
Central Nervous System Infections
Central Nervous System Viral Diseases
DNA Virus Infections
Demyelinating Diseases
Encephalitis
Encephalitis, Viral
Immune System Diseases
Lentivirus Infections
Nervous System Diseases
Polyomavirus Infections
RNA Virus Infections
Retroviridae Infections
Sexually Transmitted Diseases
Sexually Transmitted Diseases, Viral
Slow Virus Diseases
Virus Diseases
Didanosine
Zidovudine
Anti-HIV Agents
Anti-Infective Agents
Anti-Retroviral Agents
Antimetabolites
Antiviral Agents

ClinicalTrials.gov processed this record on November 20, 2014