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

Study Overview
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Brief Summary
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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.

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

Conditions
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HIV Infections

Intervention / Treatment
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* Drug: etanercept


Participation Criteria
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Eligibility 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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: etanercept|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| changes in CD4 counts |  |  | 
| changes in HIV-RNA levels |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| development of infections |  |  | 
| degree of TNF inhibition by measuring TNF levels |  |  | 
| changes in hematologic and biochemical laboratory tests |  |  | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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HIV