Search / Trial NCT00002028

A Treatment IND (Investigational New Drug) Protocol for the Use of Videx (2',3'-Dideoxyinosine, ddI) in Patients With Acquired Immunodeficiency Syndrome (AIDS) or AIDS- Related Complex (ARC) Who Are Intolerant to Zidovudine (Retrovir)

Launched by BRISTOL-MYERS SQUIBB · Aug 30, 2001

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Trial Information

Current as of December 06, 2024

Completed

Keywords

Didanosine Drugs, Investigational Acquired Immunodeficiency Syndrome Aids Related Complex Zidovudine

ClinConnect Summary

No description provided

Gender

ALL

Eligibility criteria

  • • Inclusion Criteria
  • Concurrent Medication:
  • Allowed:
  • • Concomitant medications for the treatment of AIDS or ARC (including aerosolized pentamidine).
  • • Phenytoin, but with caution.
  • * 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.
  • Patients must:
  • • - Have a diagnosis of AIDS or be symptomatic, HIV positive, and have a CD4 cell count \< 200 cells/mm3.
  • • Be intolerant to zidovudine (AZT) therapy. Not be suitable for study entry into the phase II didanosine (ddI) study by reason of inclusion or exclusion criteria or by reason of geographic location.
  • • Be able to provide signed informed consent (parent/guardian as appropriate). Be available for monthly follow-up while taking ddI. Meet baseline lab criteria 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 patients must perform clinical and laboratory evaluations every 7 - 10 days for the first 2 months of ddI therapy. All high-risk patients (for example, patients with preexisting disorders of body systems known to be adversely affected by ddI, particularly those with a history of peripheral neuropathy, pancreatitis, seizure disorder, cardiac abnormalities, gout, and significant elevations of liver function test results), must have clinical and laboratory evaluations performed every 10 days and results submitted to Bristol-Myers Squibb on the case report forms provided.
  • Prior Medication:
  • Allowed:
  • • Anti-emetic medication.
  • * Required:
  • • Zidovudine (AZT).
  • • Exclusion Criteria
  • Co-existing Condition:
  • Patients with the following conditions or symptoms are excluded:
  • • Malignancy likely to require chemotherapy in the first 3 months of ddI treatment.
  • • Acute pancreatitis.
  • • A poorly controlled seizure disorder.
  • • Grade B or greater peripheral neuropathy.
  • Concurrent Medication:
  • Excluded:
  • • Zidovudine (AZT).
  • • Chemotherapy in the first 3 months of ddI treatment.
  • Patients with the following are excluded:
  • • Malignancy likely to require systemic chemotherapy in the first 3 months of ddI treatment.
  • • Acute pancreatitis.
  • • A poorly controlled seizure disorder.
  • • Grade B or greater peripheral neuropathy.
  • Prior Medication:
  • Excluded within 15 days of study entry:
  • • Any antiretroviral drug except zidovudine (AZT).

About Bristol Myers Squibb

Bristol-Myers Squibb (BMS) is a global biopharmaceutical company dedicated to discovering, developing, and delivering innovative medicines that help patients prevail over serious diseases. With a robust portfolio of products across multiple therapeutic areas, including oncology, immunology, cardiovascular, and fibrotic diseases, BMS emphasizes cutting-edge research and a commitment to advancing medical science through clinical trials. The company is driven by a mission to provide transformative therapies, leveraging collaboration and scientific expertise to address unmet medical needs and improve patient outcomes worldwide.

Locations

Princeton, New Jersey, United States

People applied

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

Discussion 0

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