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

18 Years
Open (Enrolling)
HIV Infections

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Trial Information

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.

Type of Study:


Study Design:

Allocation: Non-Randomized, Intervention Model: Parallel Assignment, Masking: Open Label

Outcome Measure:

changes in CD4 counts

Principal Investigator

Andrew Urban, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

University of Wisconsin Hospital and Clinics


United States: Food and Drug Administration

Study ID:




Start Date:

May 2002

Completion Date:

Related Keywords:

  • HIV Infections
  • HIV
  • HIV Infections
  • Acquired Immunodeficiency Syndrome
  • Necrosis



University of Wisconsin Hospital and Clinics Madison, Wisconsin  53792-0001