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)

NCT ID: NCT00002028

Last Updated: 2007-08-16

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Study Classification: INTERVENTIONAL

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

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Interventions

Didanosine

Intervention Type: DRUG

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.

Exclusion Criteria

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.

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).

• Minimum Eligible Age: 12 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Bristol-Myers Squibb

INDUSTRY

Sponsor Role: lead

Locations

Bristol - Myers Squibb Co

Princeton, New Jersey, United States

Countries

United States

References

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.

Reference Type: BACKGROUND

PMID: 1659189 (View on PubMed)

Other Identifiers

454-999-001

Identifier Type: -

Identifier Source: secondary_id

040A

Identifier Type: -

Identifier Source: org_study_id