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

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.