Overview

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

Status:
Completed
Trial end date:
1969-12-31
Target enrollment:
0
Participant gender:
All
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.
Phase:
Phase 1
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Oxo Chemie GmbH
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.