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

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.
 
ClinicalTrials.gov Identifier: NCT00205231
Recruitment Status : Completed
First Posted : September 20, 2005
Last Update Posted : March 22, 2019
Sponsor:
Collaborator:
Immunex Corporation
Information provided by (Responsible Party):
University of Wisconsin, Madison

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
HIV Infections Drug: etanercept Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 25 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Pilot Study to Examine the Feasibility and Effect on Tumor Necrosis Factor (TNF) Inhibition on HIV Disease
Study Start Date : May 2002
Actual Primary Completion Date : May 1, 2004
Actual Study Completion Date : May 1, 2004

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS
Drug Information available for: Etanercept




Primary Outcome Measures :
  1. changes in CD4 counts
  2. changes in HIV-RNA levels

Secondary Outcome Measures :
  1. development of infections
  2. degree of TNF inhibition by measuring TNF levels
  3. changes in hematologic and biochemical laboratory tests


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00205231


Locations
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United States, Wisconsin
University of Wisconsin Hospital and Clinics
Madison, Wisconsin, United States, 53792
Sponsors and Collaborators
University of Wisconsin, Madison
Immunex Corporation
Investigators
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Principal Investigator: Andrew Urban, MD University of Wisconsin, Madison

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Responsible Party: University of Wisconsin, Madison
ClinicalTrials.gov Identifier: NCT00205231    
Other Study ID Numbers: 2001-557
First Posted: September 20, 2005    Key Record Dates
Last Update Posted: March 22, 2019
Last Verified: March 2019
Keywords provided by University of Wisconsin, Madison:
HIV
Additional relevant MeSH terms:
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Necrosis
Pathologic Processes
Etanercept
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents
Gastrointestinal Agents
Immunosuppressive Agents
Immunologic Factors