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

Not Applicable

Completed

• Conditions: HIV Infections

• Registration Number: NCT00205231
• Lead Sponsor: University of Wisconsin, Madison

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2002-05
• Primary Completion: 2004-05-01
• Study Completion: 2004-05-01
• Study First Submitted: 2005-09-13
• Study First Submitted QC: 2005-09-13
• Study First Posted: 2005-09-20
• Status Verified: 2019-03
• Last Update Submitted: 2019-03-20
• Last Update Posted: 2019-03-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 25

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
changes in CD4 counts
changes in HIV-RNA levels

Secondary Outcome Measures

Name	Time	Method
development of infections
degree of TNF inhibition by measuring TNF levels
changes in hematologic and biochemical laboratory tests

Trial Locations

Locations (1)

University of Wisconsin Hospital and Clinics; 🇺🇸 Madison, Wisconsin, United States