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

NCT00002274 | Completed

• 2 other identifiers: 039A454-999-002
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

HIV Infections; Leukoencephalopathy, Progressive Multifocal

Keywords

Didanosine; Drugs, Investigational; Acquired Immunodeficiency Syndrome; Zidovudine

Interventions

Didanosine DRUG

Eligibility Criteria

• Age: 12 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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:

You may not qualify if:

• 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.
• 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).

Sponsors & Collaborators

• Bristol-Myers Squibb: lead

Study Sites (1)

Bristol - Myers Squibb Co

Princeton, New Jersey, 085434500, United States

Location

Related Publications (1)

• Abrams DI. Treatment options in zidovudine intolerance or failure. AIDS. 1994 Sep;8 Suppl 3:S3-7. doi: 10.1097/00002030-199409001-00002.

  PMID: 7840914 BACKGROUND

MeSH Terms

Conditions

HIV Infections; Leukoencephalopathy, Progressive Multifocal; Acquired Immunodeficiency Syndrome

Interventions

Didanosine

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases; Encephalitis, Viral; Central Nervous System Viral Diseases; Central Nervous System Infections; Infectious Encephalitis; Polyomavirus Infections; DNA Virus Infections; Slow Virus Diseases; Encephalitis; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Leukoencephalopathies; Demyelinating Diseases; Neuroinflammatory Diseases

Intervention Hierarchy (Ancestors)

Inosine; Purine Nucleosides; Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Dideoxynucleosides; Deoxyribonucleosides; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides; Ribonucleosides

Study Officials

• Bristol-Myers Squibb

  Bristol-Myers Squibb

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: November 2, 1999
• First Posted: August 31, 2001
• Last Updated: October 2, 2007

Record last verified: 2007-10

Locations

US (1)