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A Pilot Study to Examine the Feasibility and Effect of Tumor Necrosis Factor (TNF) Inhibition on HIV Disease

The recruitment status of this study is unknown because the information has not been verified recently.
Verified September 2005 by University of Wisconsin, Madison.
Recruitment status was  Recruiting
Immunex Corporation
Information provided by (Responsible Party):
University of Wisconsin, Madison Identifier:
First received: September 13, 2005
Last updated: October 1, 2015
Last verified: September 2005

September 13, 2005
October 1, 2015
May 2002
Not Provided
  • changes in CD4 counts
  • changes in HIV-RNA levels
Same as current
Complete list of historical versions of study NCT00205231 on Archive Site
  • development of infections
  • degree of TNF inhibition by measuring TNF levels
  • changes in hematologic and biochemical laboratory tests
Same as current
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A Pilot Study to Examine the Feasibility and Effect of Tumor Necrosis Factor (TNF) Inhibition on HIV Disease
A Pilot Study to Examine the Feasibility and Effect on Tumor Necrosis Factor (TNF) Inhibition on HIV Disease
This pilot study will investigate the safety and effect of etanercept in HIV infection by studying HIV replication and immune function (as measured by CD4 counts) in individuals with HIV infection.
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Not Provided
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
HIV Infections
Drug: etanercept
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*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
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Not Provided

Inclusion Criteria:

  • Adults greater than 18 years of age with documented HIV infection
  • Highly active antiretroviral therapy (HAART) regimens as defined by the Department of Health and Human Services guidelines; stable regimens for 12 weeks.
  • CD4 greater than 200 at time of study enrollment
  • Stable monitoring labs (hematology survey with differential, ALT, creatinine)
  • Absolute neutrophil count within normal limits

Exclusion Criteria:

  • AIDS defining illness within the last 6 months
  • Acute bacterial, viral, or fungal infection within the last 1 month, or history of recurring infections
  • Women who are pregnant or nursing
  • Hypersensitivity to etanercept
  • Previous use of etanercept
  • Acute malignancy in the last 5 years excluding in situ cervical cancer (CA) and common skin cancers (non melanoma)
  • History of active or latent tuberculosis
  • History of demyelinating nerve disease
  • History of seizure disorder
  • Latex allergy
  • Subject has any of the following laboratory values within 30 days of baseline:

    • hemoglobin concentration < 10.0 g/dl for men and < 9.0 g/dl for women
    • platelet count < 75,000/mm3
    • AST or ALT > 5x upper limit of normal (ULN)
    • serum creatinine > 2.5x ULN
    • serum pancreatic amylase > 1.5 ULN
  • Subject requiring treatment with immunomodulating agents, such as systemic corticosteroids, interleukins, vaccines, or interferon
  • Subjects who chronically use any over-the-counter (OTC) or prescription medication (except vitamins) must not change the regimen or switch their medication within 3 days of drug administration and until discharged from the study.
18 Years and older   (Adult, Senior)
Not Provided
Contact: Andrew Urban, MD 608-256-1901 ext 17472
Contact: Frank Graziano, MD, PhD 608-263-6186
United States
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Not Provided
University of Wisconsin, Madison
University of Wisconsin, Madison
Immunex Corporation
Principal Investigator: Andrew Urban, MD University of Wisconsin, Madison
University of Wisconsin, Madison
September 2005

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