A Study of ddI in Patients With AIDS Who Become Sicker While Taking Zidovudine

October 1, 2007 updated by: Bristol-Myers Squibb

An Open Label Study Regimen of Videx (2',3'-Dideoxyinosine, ddI) in Patients With Acquired Immunodeficiency Syndrome (AIDS) Exhibiting Significant Deterioration While Taking Zidovudine (Retrovir)

The objective of this open-label study regimen is to make didanosine (ddI) available to patients with AIDS who are clinically deteriorating on zidovudine (AZT) and cannot enter the Phase II ddI programs due to protocol exclusion or geographic location.

Study Overview

Status

Completed

Intervention / Treatment

Study Type

Interventional

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • New Jersey
      • Princeton, New Jersey, United States, 085434500
        • Bristol - Myers Squibb Co

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

12 years and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria

Concurrent Medication:

Allowed:

  • Concurrent medications for treatment of complications of AIDS are allowed.
  • Aerosolized pentamidine.
  • Phenytoin, but with caution.
  • Note:
  • Extreme caution should be exercised in the use of didanosine (ddI) in any patient receiving concurrent 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 be:

- Not suitable for entry into ddI phase II studies by reason of inclusion or exclusion criteria or by reason of geographic location.

Able to provide signed informed consent (parent/guardian as appropriate). Available for monthly follow-up while taking ddI. Meet required baseline laboratory values 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 these patients must perform clinical and laboratory evaluations every 7-10 days for the first 2 months of ddI therapy. Should any adverse effect of any severity be detected during this period of intensive clinical and laboratory monitoring, the physician must call Bristol-Myers Squibb (1-800-662-7999). If the patient continues ddI therapy, Bristol-Myers Squibb will require submission of follow-up and adverse experience report forms every 10 days. Although data are not available to fully assess the risks associated with the use of ddI in high-risk patients (for example, patients with preexisting disorders of body systems known to be adversely affected by ddI, particularly those with history of peripheral neuropathy, pancreatitis, seizure disorder, cardiac abnormalities, gout, and significant elevations of liver function test results), all such patients must have clinical and laboratory evaluations performed every 10 days and results submitted to Bristol-Myers Squibb on the case report forms provided.

Exclusion Criteria

Co-existing Condition:

Patients with any one of the following criteria are excluded:

  • Received therapy in the preceding 15 days with any other antiretroviral except zidovudine (AZT).
  • Taking AZT concomitantly.
  • Acute pancreatitis.
  • Poorly controlled seizure disorder.
  • Taking phenytoin concomitantly.
  • Grade B or greater peripheral neuropathy.

Concurrent Medication:

Excluded:

  • Zidovudine (AZT).

Patients with any one of the following criteria are excluded:

  • Received therapy in the preceding 15 days with any other antiretroviral except zidovudine (AZT).
  • Taking AZT concomitantly.
  • Taking phenytoin concomitantly.
  • Acute pancreatitis.
  • Poorly controlled seizure disorder.
  • Grade B or greater peripheral neuropathy.

Prior Medication:

Excluded within 15 days of study entry:

  • Any antiretroviral except zidovudine (AZT).

Required:

  • Zidovudine (AZT).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

First Submitted

November 2, 1999

First Submitted That Met QC Criteria

August 30, 2001

First Posted (Estimate)

August 31, 2001

Study Record Updates

Last Update Posted (Estimate)

October 2, 2007

Last Update Submitted That Met QC Criteria

October 1, 2007

Last Verified

October 1, 2007

More Information

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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