A Phase I/II Clinical Study of WF 10 IV Solution ( TCDO ) in Patients With HIV Infection
Completed · Phase 1
Conditions studied: HIV Infections
In brief
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.
Key facts
- Study ID
- NCT00002119
- Run by
- Oxo Chemie GmbH
- Last updated by the study team
- 2005-06-24
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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.
You may not qualify if…
- 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.
Where it is running
- Oncol Med Associates — Houston, Texas, United States
Full record on ClinicalTrials.gov
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