A Pilot Study to Examine the Feasibility and Effect of Tumor Necrosis Factor (TNF) Inhibition on HIV Disease - NCT00205231-53792 (Clinical Trial 130188)
Permalink: http://www.ClinicalConnection.com/exp/ExpandedPatientViewStudy130188.aspx
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Madison |
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State:
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WI |
| Zip Code: |
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53792 |
| Conditions: |
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HIV Infections |
| Purpose: |
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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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| Study summary: |
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| Criteria: |
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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. |
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| Study is available at: |
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University of Wisconsin Hospital and Clinics
Madison, WI 53792
United States
Primary Contact:
Andrew Urban, MD
Email: andrew.urban@med.va.gov
Phone: 608-256-1901
Secondary Contact:
Andrew Urban, MD
Email: Andrew.Urban@med.va.gov
Phone: 608-256-1901 |
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If you are interested in this clinical trial please use the contact information above. If you would like to get additional information about this clinical trial please visit ClinicalTrials.gov.
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| Data Source: |
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ClinicalTrials.gov |
| Date Processed: |
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November 15, 2009 |
Modifications to
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Only selected fields are shown, please use the link
above to view all information about this clinical trial. |
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Clinical trials are medical research studies designed to test the safety and/or
effectiveness of new drugs, devices, or treatments in humans. These studies are
conducted worldwide for a range of conditions and illnesses. Learn more about
clinical research and participating in a study at
About Clinical Trials.
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