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

HIV Infections Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00002119
• Other study ID #: 222A
• Secondary ID: WF10-92-US-001
• Status: Completed
• Phase: Phase 1
• 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 0
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Endpoint Classification: Safety Study, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Acquired Immunodeficiency Syndrome
• HIV Infections
• Infection

Intervention

Drug:
• WF10

Locations

Country	Name	City	State
United States	Oncol Med Associates	Houston	Texas

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