Expired Study
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Princeton, New Jersey 08543


To make stavudine (d4T) available to patients with advanced HIV disease for whom no alternative antiretroviral is satisfactory. To study the safety and efficacy of two dose levels in a twice-daily regimen.


Inclusion Criteria Patients must have: - HIV positivity with CD4 count < 300 cells/mm3. - Intolerance to or failure on approved antiretroviral therapy. - Ability to provide informed consent (of parent or guardian if appropriate). NOTE: - Incarcerated persons may be eligible to participate. Exclusion Criteria Co-existing Condition: Patients with the following symptoms or conditions are excluded: - Grade 2 or worse disease-related peripheral neuropathy. - Unresolved drug-related peripheral neuropathy of any severity that is attributable to other nucleoside analogs (AZT, ddC, ddI). - Malignancy likely to require systemic chemotherapy with myelosuppressive or neurotoxic drugs in the first 3 months of stavudine treatment. - Pregnancy (physicians of pregnant patients may contact Bristol-Myers to determine eligibility for stavudine therapy in another protocol). Strongly discouraged: - AZT, ddI, ddC, and other antiretroviral agents.



Primary Contact:

Principal Investigator
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Backup Contact:


Location Contact:

Princeton, New Jersey 08543
United States

There is no listed contact information for this specific location.

Site Status: N/A

Data Source: ClinicalTrials.gov

Date Processed: October 09, 2019

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