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)

HIV Infections Clinical Trial

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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00002028
• Other study ID #: 040A
• Secondary ID: 454-999-001
• Status: Completed
• Phase: N/A
• First received: November 2, 1999
• Last updated: August 15, 2007

Study information

• Verified date: August 2007
• Source: Bristol-Myers Squibb
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 0
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 12 Years and older

Eligibility

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).

Study Design

Allocation: Non-Randomized, Endpoint Classification: Bio-equivalence Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Acquired Immunodeficiency Syndrome
• AIDS-Related Complex
• HIV Infections
• Immunologic Deficiency Syndromes

Intervention

Drug:
• Didanosine

Locations

Country	Name	City	State
United States	Bristol - Myers Squibb Co	Princeton	New Jersey

Sponsors (1)

Lead Sponsor	Collaborator
Bristol-Myers Squibb

Country where clinical trial is conducted

United States, 

References & Publications (1)

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)

External Links

•   BMS Clinical Trials Disclosure
•   For FDA Safety Alerts and Recalls refer to the following link www.fda.gov/MEDWATCH/safety.htm