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A Study of ddI in Patients With AIDS Who Become Sicker While Taking Zidovudine | Clinical Trials | Clareo Health

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

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)

NCT00002274•Bristol-Myers Squibb

View on ClinicalTrials.gov

Summary

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.

Eligibility

Age

12 - No limit years

Sex

ALL

Healthy Volunteers

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:

Exclusion Criteria

•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.
•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.
+17 more criteria

Locations (1)

Bristol - Myers Squibb Co

Princeton, New Jersey, United States

Key Dates

Last Updated

October 2, 2007

Conditions

HIV InfectionsLeukoencephalopathy, Progressive Multifocal

Interventions

Didanosine

DRUG

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HIVHIV Infections

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RECRUITINGPHASE3

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RECRUITING

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: October 2, 2007Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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

Inclusion Criteria

Exclusion Criteria

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