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

HIV Infections Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00205231
• Other study ID #: 2001-557
• Status: Completed
• Phase: N/A
• Start date: May 2002
• Est. completion date: May 1, 2004

Study information

• Verified date: March 2019
• Source: University of Wisconsin, Madison
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 25
• Est. completion date: May 1, 2004
• Est. primary completion date: May 1, 2004
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Acquired Immunodeficiency Syndrome
• HIV Infections
• Necrosis

Intervention

Drug:
• etanercept

Locations

Country	Name	City	State
United States	University of Wisconsin Hospital and Clinics	Madison	Wisconsin

Sponsors (2)

Lead Sponsor	Collaborator
University of Wisconsin, Madison	Immunex Corporation

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	changes in CD4 counts
Primary	changes in HIV-RNA levels
Secondary	development of infections
Secondary	degree of TNF inhibition by measuring TNF levels
Secondary	changes in hematologic and biochemical laboratory tests