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

HIV Infections Clinical Trial

Official title:

Randomized, Double-Blind, Placebo-Controlled Evaluation of the Safety and Efficacy of WF 10 IV Solution ( TCDO ) in the Management of Patients With Advanced HIV Disease

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00002152
• Other study ID #: 222B
• Secondary ID: WF10-94-US-002
• Status: Completed
• Phase: Phase 2
• First received: November 2, 1999
• Last updated: June 23, 2005

Study information

• Verified date: March 1996
• Source: NIH AIDS Clinical Trials Information Service
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Endpoint Classification: Safety Study, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• HIV Infections

Intervention

Drug:
• WF10

Locations

Country	Name	City	State
United States	Nashville Health Management Foundation / Vanderbilt Univ	Nashville	Tennessee

Sponsors (1)

Lead Sponsor	Collaborator
Oxo Chemie GmbH

Country where clinical trial is conducted

United States, 

References & Publications (3)

Busch HW, Christensen S, Reichelt D, Jahn S, Zidek W. Treatment of HIV-infected patients with advanced symptomatic disease with WF10 solution (TCDO). Int Conf AIDS. 1994 Aug 7-12;10(1):204 (abstract no PB0245)

Kahn JO, McGrath MS, Ching OM, Kuhne FW. A single center, phase 2 study evaluating the effects of WF10. Int Conf AIDS. 1998;12:349 (abstract no 22423)

Raffanti SP, Schaffner W, Federspiel CF, Blackwell RB, Ching OA, Kühne FW. Randomized, double-blind, placebo-controlled trial of the immune modulator WF10 in patients with advanced AIDS. Infection. 1998 Jul-Aug;26(4):202-7. — View Citation