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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.
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Inclusion and exclusion criteria
Inclusion Criteria
Concurrent Medication:
Allowed:
Patients must:
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:
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:
Exclusion Criteria
Co-existing Condition:
Patients with the following conditions or symptoms are excluded:
Concurrent Medication:
Excluded:
Patients with the following are excluded:
Prior Medication:
Excluded within 15 days of study entry:
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Data sourced from clinicaltrials.gov
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