A Study of WF 10 IV Solution in Patients With Advanced HIV Disease

Oxo Chemie

Status and phase: Completed; Phase 2

Conditions: HIV Infections

Treatments: Drug: WF10

Study type: Interventional

Funder types: Industry

Identifiers

NCT00002152

222B

WF10-94-US-002

Details and patient eligibility

About

The purpose of this study is to see if it is safe and effective to give WF 10 (TCDO) to patients with advanced HIV disease who cannot or will not take zidovudine, didanosine, zalcitabine, or stavudine. This study also examines how TCDO affects the levels of HIV in the body. TCDO is a solution delivered through a vein.

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria

Concurrent Medication:

Allowed:

• Approved drugs at a stabilized dose except those specifically excluded.
• Aerosolized pentamidine (300 mg) once a month for PCP prophylaxis.

Patients must have:

• HIV positivity.
• Absolute CD4 count < 200 cells/mm3.
• Intolerance to or refusal to take AZT, ddI, ddC, or d4T.
• No active opportunistic infection requiring ongoing therapy.
• Life expectancy at least 3 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.
• Anemia.

Concurrent Medication:

Excluded:

• Cytotoxic chemotherapy.
• Corticosteroids.

Patients with the following prior conditions are excluded:

History of myocardial infarction or arrhythmias.

Prior Medication:

Excluded within 2 weeks prior to study entry:

• Any antiretroviral agent.
• Interferon.
• Systemic therapy with biologic response modifiers, corticosteroids, cytotoxic chemotherapy, or neutropenic or nephrotoxic drugs.

Excluded within 30 days prior to study entry:

• Investigational drugs.

Prior Treatment:

Excluded within 2 weeks prior to study entry:

• Radiation therapy. Active drug or alcohol abuse.