HIV Infections
Conditions
Keywords
Acquired Immunodeficiency Syndrome, AIDS-Related Complex, Antiviral Agents
Brief summary
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 TCDO.
Interventions
DRUGWF10
Sponsors
Oxo Chemie GmbH
Study design
Primary purpose
TREATMENT
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Countries
United States
Outcome results
None listed