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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00205231
First Posted: September 20, 2005
Last Update Posted: October 27, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Immunex Corporation
Information provided by (Responsible Party):
University of Wisconsin, Madison
September 13, 2005
September 20, 2005
October 27, 2016
May 2002
July 2008   (Final data collection date for primary outcome measure)
  • changes in CD4 counts
  • changes in HIV-RNA levels
Same as current
Complete list of historical versions of study NCT00205231 on ClinicalTrials.gov Archive Site
  • development of infections
  • degree of TNF inhibition by measuring TNF levels
  • changes in hematologic and biochemical laboratory tests
Same as current
Not Provided
Not Provided
 
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.
Not Provided
Interventional
Not Provided
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
HIV Infections
Drug: etanercept
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
25
Not Provided
July 2008   (Final data collection date for primary outcome measure)

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.
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT00205231
2001-557
Not Provided
Not Provided
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