A Phase I/II Clinical Study of WF 10 IV Solution ( TCDO ) in Patients With HIV Infection

Launched by OXO CHEMIE GMBH · Aug 30, 2001

Keywords

ClinConnect Summary

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Gender

ALL

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.