A Pilot Study to Examine the Feasibility and Effect of Tumor Necrosis Factor (TNF) Inhibition on HIV Disease
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Ages Eligible for Study:
18 Years and older (Adult, Older Adult)
Sexes Eligible for Study:
Accepts Healthy Volunteers:
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
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
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.