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.
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).
- Incarcerated persons may be eligible to participate.
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).
- AZT, ddI, ddC, and other antiretroviral agents.