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

• Sponsor: Oxo Chemie GmbH (Industry)
• Overall Status: Completed
• CT.gov ID: NCT00002152
• Collaborator: (none)
• Enrollment: 60
• Location: 1

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
HIV Infections	Drug: WF10	Phase 2

Study Design

• Study Type: Interventional
• Masking: Double
• Primary Purpose: Treatment
• 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

Outcome Measures

Primary Outcome Measures

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Nashville Health Management Foundation / Vanderbilt Univ	Nashville	Tennessee	United States	37203

Sponsors and Collaborators

• Oxo Chemie GmbH

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

• 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.

• ClinicalTrials.gov Identifier: NCT00002152
• Other Study ID Numbers: 222B; WF10-94-US-002
• First Posted: Aug 31, 2001
• Last Update Posted: Jun 24, 2005
• Last Verified: Mar 1, 1996

• Keywords provided by , ,: Acquired Immunodeficiency Syndrome; Antiviral Agents
• Additional relevant MeSH terms: HIV Infections; Acquired Immunodeficiency Syndrome

Study Results

No Results Posted as of Jun 24, 2005