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A Phase I/II Clinical Study of WF 10 IV Solution ( TCDO ) in Patients With HIV Infection
This study has been completed.
Study NCT00002119   Information provided by NIH AIDS Clinical Trials Information Service
First Received: November 2, 1999   Last Updated: June 23, 2005   History of Changes

November 2, 1999
June 23, 2005
 
 
 
 
Complete list of historical versions of study NCT00002119 on ClinicalTrials.gov Archive Site
 
 
 
A Phase I/II Clinical Study of WF 10 IV Solution ( TCDO ) in Patients With HIV Infection
A Phase I/II Clinical Study of WF 10 IV Solution ( TCDO ) in Patients With HIV Infection

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.

 
Phase I
Interventional
Treatment, Dose Comparison, Safety Study
HIV Infections
Drug: WF10
 
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.

*   Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
 
Completed
 
 
 

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.
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00002119
 
222A, WF10-92-US-001
Oxo Chemie GmbH
 
 
NIH AIDS Clinical Trials Information Service
March 1996

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP