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)

This study has been completed.
Sponsor:
Information provided by:
Bristol-Myers Squibb
ClinicalTrials.gov Identifier:
NCT00002028
First received: November 2, 1999
Last updated: August 15, 2007
Last verified: August 2007
  Purpose

The objective of this treatment IND protocol is to make didanosine (ddI) available to patients with HIV infection (suffering from AIDS related complex (ARC) or AIDS) who have developed documented intolerance to zidovudine (AZT) and cannot enter a Phase II ddI program due to protocol exclusion or geographic location.


Condition Intervention
HIV Infections
Drug: Didanosine

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Bio-equivalence Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: 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)

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:

  • 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).
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00002028

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

Additional Information:
Publications:
Connolly KJ, Allan JD, Fitch H, Jackson-Pope L, McLaren C, Groopman J. A phase I study of 2'-3'-dideoxyinosine (ddI) administered orally twice daily to patients with AIDS or ARC and hematologic intolerance to azidothymidine (AZT). Int Conf AIDS. 1990 Jun 20-23;6(3):204 (abstract no SB473)

ClinicalTrials.gov Identifier: NCT00002028     History of Changes
Other Study ID Numbers: 040A, 454-999-001
Study First Received: November 2, 1999
Last Updated: August 15, 2007
Health Authority: United States: Food and Drug Administration

Keywords provided by Bristol-Myers Squibb:
Didanosine
Drugs, Investigational
Acquired Immunodeficiency Syndrome
AIDS-Related Complex
Zidovudine

Additional relevant MeSH terms:
Acquired Immunodeficiency Syndrome
HIV Infections
AIDS-Related Complex
Immunologic Deficiency Syndromes
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Slow Virus Diseases
Immune System Diseases
Didanosine
Zidovudine
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Reverse Transcriptase Inhibitors
Nucleic Acid Synthesis Inhibitors
Enzyme Inhibitors
Anti-Retroviral Agents
Antiviral Agents
Anti-Infective Agents
Therapeutic Uses
Anti-HIV Agents

ClinicalTrials.gov processed this record on April 17, 2014