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

NCT00205231 | Completed

• 1 other identifier: 2001-557
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 1

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

Keywords

HIV

Outcome Measures

Primary Outcomes (2)

• changes in CD4 counts

• changes in HIV-RNA levels

Secondary Outcomes (3)

• development of infections

• degree of TNF inhibition by measuring TNF levels

• changes in hematologic and biochemical laboratory tests

Interventions

etanercept DRUG

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Wisconsin, Madison: lead
• Immunex Corporation: collaborator

Study Sites (1)

University of Wisconsin Hospital and Clinics

Madison, Wisconsin, 53792, United States

Location

MeSH Terms

Conditions

HIV Infections

Interventions

Etanercept

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases

Intervention Hierarchy (Ancestors)

Immunoglobulin Fc Fragments; Immunoglobulin Fragments; Peptide Fragments; Peptides; Amino Acids, Peptides, and Proteins; Immunoglobulin Constant Regions; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Serum Globulins; Globulins; Receptors, Tumor Necrosis Factor; Receptors, Cytokine; Receptors, Immunologic; Receptors, Cell Surface; Membrane Proteins

Study Officials

• Andrew Urban, MD

  University of Wisconsin, Madison

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 13, 2005
• First Posted: September 20, 2005
• Study Start: May 1, 2002
• Primary Completion: May 1, 2004
• Study Completion: May 1, 2004
• Last Updated: March 22, 2019

Record last verified: 2019-03

Locations

US (1)