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
Recruitment status was Recruiting
Sponsor:
University of Wisconsin, Madison
Collaborator:
Immunex Corporation
Information provided by:
University of Wisconsin, Madison
ClinicalTrials.gov Identifier:
NCT00205231
First received: September 13, 2005
Last updated: October 24, 2007
Last verified: September 2005
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Purpose
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 | Intervention |
---|---|
HIV Infections |
Drug: etanercept |
Study Type: | Interventional |
Study Design: | Allocation: Non-Randomized Intervention Model: Parallel Assignment Masking: Open Label |
Official Title: | A Pilot Study to Examine the Feasibility and Effect on Tumor Necrosis Factor (TNF) Inhibition on HIV Disease |
Resource links provided by NLM:
Further study details as provided by University of Wisconsin, Madison:
Eligibility
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
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.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00205231
Contacts
Contact: Andrew Urban, MD | 608-256-1901 ext 17472 | Andrew.Urban@med.va.gov |
Contact: Frank Graziano, MD, PhD | 608-263-6186 | fmg@medicine.wisc.edu |
Locations
United States, Wisconsin | |
University of Wisconsin Hospital and Clinics | Recruiting |
Madison, Wisconsin, United States, 53792 | |
Contact: Andrew Urban, MD 608-256-1901 ext 17472 andrew.urban@med.va.gov | |
Principal Investigator: Andrew Urban, MD |
Sponsors and Collaborators
University of Wisconsin, Madison
Immunex Corporation
Investigators
Principal Investigator: | Andrew Urban, MD | University of Wisconsin Hospital and Clinics |
More Information
No publications provided
Keywords provided by University of Wisconsin, Madison:
Additional relevant MeSH terms:
ClinicalTrials.gov processed this record on February 26, 2013
No publications provided
ClinicalTrials.gov Identifier: | NCT00205231 History of Changes |
Other Study ID Numbers: | 2001-557 |
Study First Received: | September 13, 2005 |
Last Updated: | October 24, 2007 |
Health Authority: | United States: Food and Drug Administration |
Keywords provided by University of Wisconsin, Madison:
HIV |
Additional relevant MeSH terms:
HIV Infections Acquired Immunodeficiency Syndrome Necrosis Lentivirus Infections Retroviridae Infections RNA Virus Infections Virus Diseases Sexually Transmitted Diseases, Viral Sexually Transmitted Diseases Immunologic Deficiency Syndromes Immune System Diseases Slow Virus Diseases Pathologic Processes TNFR-Fc fusion protein |
Anti-Inflammatory Agents, Non-Steroidal Analgesics, Non-Narcotic Analgesics Sensory System Agents Peripheral Nervous System Agents Physiological Effects of Drugs Pharmacologic Actions Anti-Inflammatory Agents Therapeutic Uses Antirheumatic Agents Gastrointestinal Agents Immunologic Factors Immunosuppressive Agents Central Nervous System Agents |
ClinicalTrials.gov processed this record on February 26, 2013