Expired Study
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Princeton, New Jersey 08543


Purpose:

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.


Criteria:

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.


NCT ID:

NCT00002308


Primary Contact:

Principal Investigator
. .
.


Backup Contact:

N/A


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 23, 2017

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