A Pilot Study to Examine the Feasibility and Effect on 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.