A Phase I/II Clinical Study of WF 10 IV Solution ( TCDO ) in Patients With HIV Infection
HIV Infections
About this trial
This is an interventional treatment trial for HIV Infections focused on measuring Acquired Immunodeficiency Syndrome, AIDS-Related Complex, Antiviral Agents
Eligibility Criteria
Inclusion Criteria Concurrent Medication: Required: Aerosolized pentamidine (300 mg monthly) as prophylaxis for PCP only in patients with CD4 count <= 200 cells/mm3. Allowed: 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. Exclusion Criteria Co-existing Condition: 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. Prior Medication: 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. Required: At least 6 months of prior zidovudine. Active drug or alcohol abuse.
Sites / Locations
- Oncol Med Associates