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

NCT00002119 | Completed Phase 1

• 2 other identifiers: 222AWF10-92-US-001
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

HIV Infections

Keywords

Acquired Immunodeficiency Syndrome; AIDS-Related Complex; Antiviral Agents

Interventions

WF10 DRUG

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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:

Sponsors & Collaborators

• Oxo Chemie GmbH: lead

Study Sites (1)

Oncol Med Associates

Houston, Texas, 77074, United States

Location

Related 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)

  BACKGROUND

• 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)

  BACKGROUND

• Raffanti SP, Schaffner W, Federspiel CF, Blackwell RB, Ching OA, Kuhne 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. doi: 10.1007/BF02962364.

  PMID: 9717676 BACKGROUND

MeSH Terms

Conditions

HIV Infections; Acquired Immunodeficiency Syndrome; AIDS-Related Complex

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases; Slow Virus Diseases

Study Design

• Study Type: interventional
• Phase: phase 1
• Purpose: TREATMENT
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: November 2, 1999
• First Posted: August 31, 2001
• Last Updated: June 24, 2005

Record last verified: 1996-03

Locations

US (1)