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

This study has been completed.
Sponsor:
Information provided by:
NIH AIDS Clinical Trials Information Service
ClinicalTrials.gov Identifier:
NCT00002152
First received: November 2, 1999
Last updated: June 23, 2005
Last verified: March 1996

November 2, 1999
June 23, 2005
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Complete list of historical versions of study NCT00002152 on ClinicalTrials.gov Archive Site
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A Study of WF 10 IV Solution in Patients With Advanced HIV Disease
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

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.

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Interventional
Phase 2
Endpoint Classification: Safety Study
Masking: Double-Blind
Primary Purpose: Treatment
HIV Infections
Drug: WF10
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
60
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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.
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00002152
222B, WF10-94-US-002
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Oxo Chemie GmbH
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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