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)

NCT00002028 | Completed

• 2 other identifiers: 040A454-999-001
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

HIV Infections

Keywords

Didanosine; Drugs, Investigational; Acquired Immunodeficiency Syndrome; AIDS-Related Complex; 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:
• 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.

You may not qualify if:

• 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).
• 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.

Sponsors & Collaborators

• Bristol-Myers Squibb: lead

Study Sites (1)

Bristol - Myers Squibb Co

Princeton, New Jersey, 085434500, United States

Location

Related Publications (1)

• Connolly KJ, Allan JD, Fitch H, Jackson-Pope L, McLaren C, Canetta R, Groopman JE. Phase I study of 2'-3'-dideoxyinosine administered orally twice daily to patients with AIDS or AIDS-related complex and hematologic intolerance to zidovudine. Am J Med. 1991 Nov;91(5):471-8. doi: 10.1016/0002-9343(91)90182-w.

  PMID: 1659189 BACKGROUND

MeSH Terms

Conditions

HIV Infections; Acquired Immunodeficiency Syndrome; AIDS-Related Complex

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; Slow Virus 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 Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• 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: August 16, 2007

Record last verified: 2007-08

Locations

US (1)