Expired Study
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Madison, Wisconsin 53792


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.


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.


Study is Available At:


Original ID:

2001-557


NCT ID:

NCT00205231


Secondary ID:


Study Acronym:


Brief Title:

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


Official Title:

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


Overall Status:

Completed


Study Phase:

N/A


Genders:

N/A


Minimum Age:

18 Years


Maximum Age:

N/A


Quick Facts

Healthy Volunteers
Oversight Has DMC
Study Is FDA Regulated
Study Is Section 801
Has Expanded Access

Study Source:

University of Wisconsin, Madison


Oversight Authority:

United States: Food and Drug Administration


Reasons Why Stopped:


Study Type:

Interventional


Study Design:


Number of Arms:

0


Number of Groups:

0


Total Enrollment:

25


Enrollment Type:

Actual


Overall Contact Information

Official Name:Andrew Urban, MD
Principal Investigator
University of Wisconsin, Madison

Study Dates

Start Date:May 2002
Completion Date:May 1, 2004
Completion Type:Actual
Primary Completion Date:May 1, 2004
Primary Completion Type:Actual
Verification Date:March 2019
Last Changed Date:March 20, 2019
First Received Date:September 13, 2005

Study Outcomes

Outcome Type:Secondary Outcome
Measure:changes in hematologic and biochemical laboratory tests
Safety Issues:False
Outcome Type:Secondary Outcome
Measure:degree of TNF inhibition by measuring TNF levels
Safety Issues:False
Outcome Type:Secondary Outcome
Measure:development of infections
Safety Issues:False
Outcome Type:Primary Outcome
Measure:changes in HIV-RNA levels
Safety Issues:False
Outcome Type:Primary Outcome
Measure:changes in CD4 counts
Safety Issues:False

Study Interventions

Intervention Type:Drug
Name:etanercept

Study Arms

There are no available Study Arms

Study Agencies

Agency Class:Other
Agency Type:Lead Sponsor
Agency Name:University of Wisconsin, Madison
Agency Class:Industry
Agency Type:Collaborator
Agency Name:Immunex Corporation

Sample and Retention Information

There are no available Sample and Retention Information

Study References

There are no available Study References

Data Source: ClinicalTrials.gov

Date Processed: January 21, 2020

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