To evaluate the clinical toxicity, safety, and MTD of WF 10 ( TCDO ) intravenous solution
administered to patients with HIV infection. To evaluate the potential anti-HIV activity of
- Aerosolized pentamidine (300 mg monthly) as prophylaxis for PCP only in patients with
CD4 count <= 200 cells/mm3.
- PCP prophylaxis with aerosolized pentamidine in patients with CD4 count > 200
cells/mm3, only at the discretion of the treating physician.
Patients must have:
- HIV positivity.
- Absolute CD4 count of 150 - 500 cells/mm3.
- At least 6 months of prior zidovudine therapy.
- No active opportunistic infection requiring ongoing therapy.
- Life expectancy of at least 6 months.
Patients with the following symptoms or conditions are excluded:
- Neoplasm other than basal cell carcinoma of the skin.
- Clinically significant cardiac disease.
- Abnormal neurological status by a standardized assessment including strength, reflex
testing, and sensory testing.
- Unwilling to comply with protocol requirements.
Patients with the following prior conditions are excluded:
History of myocardial infarction or arrhythmias.
Excluded within 2 weeks prior to study entry:
- Antiretroviral agent or interferon.
- Systemic biologic response modifiers, corticosteroids, cytotoxic chemotherapeutic
agents, or other drugs that can cause neutropenia or significant nephrotoxicity.
- Rifampin or rifampin derivatives.
- Systemic anti-infectives.
- At least 6 months of prior zidovudine. Active drug or alcohol abuse.