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

Sponsor

Oxo Chemie GmbH (Industry)

Overall Status

Completed

CT.gov ID

NCT00002119

Collaborator

(none)

Location

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
HIV Infections	Drug: WF10	Phase 1

Study Design

Study Type:

Interventional

Primary Purpose:

Treatment

Official Title:

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

Outcome Measures

Primary Outcome Measures

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.