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

NCT ID: NCT00205231

Last Updated: 2019-03-22

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 25 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2002-05-31
• Study Completion Date: 2004-05-01

Brief Summary

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.

Conditions

HIV Infections

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Interventions

etanercept

Intervention Type: DRUG

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Immunex Corporation

INDUSTRY

Sponsor Role: collaborator

University of Wisconsin, Madison

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Andrew Urban, MD

Role: PRINCIPAL_INVESTIGATOR

University of Wisconsin, Madison

Locations

University of Wisconsin Hospital and Clinics

Madison, Wisconsin, United States

Countries

United States

Other Identifiers

2001-557

Identifier Type: -

Identifier Source: org_study_id