A Study of Stavudine in HIV-Infected Patients Who Have Not Had Success With Other Anti-HIV Drugs

Launched by BRISTOL-MYERS SQUIBB · Aug 30, 2001

Keywords

ClinConnect Summary

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Gender

ALL

Eligibility 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.