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

University of Wisconsin (UW)

Status

Completed

Conditions

HIV Infections

Treatments

Drug: etanercept

Study type

Interventional

Funder types

Other

Industry

Identifiers

NCT00205231

2001-557

Details and patient eligibility

About

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.

Enrollment

25 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.