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.