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

This study is currently recruiting participants.

Verified by University of Wisconsin, Madison, September 2005

Sponsors and Collaborators:	University of Wisconsin, Madison Immunex Corporation
Information provided by:	University of Wisconsin, Madison
ClinicalTrials.gov Identifier:	NCT00205231

Purpose

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.

Condition	Intervention
HIV Infections	Drug: etanercept

MedlinePlus related topics: AIDS Cancer

Drug Information available for: Etanercept Tumor Necrosis Factors

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Non-Randomized, Open Label, Dose Comparison, Parallel Assignment
Official Title:	A Pilot Study to Examine the Feasibility and Effect on Tumor Necrosis Factor (TNF) Inhibition on HIV Disease

Further study details as provided by University of Wisconsin, Madison:

Primary Outcome Measures:

changes in CD4 counts
changes in HIV-RNA levels

Secondary Outcome Measures:

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

Estimated Enrollment:	25
Study Start Date:	May 2002

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00205231

Contacts

Contact: Andrew Urban, MD	608-256-1901 ext 17472	Andrew.Urban@med.va.gov
Contact: Frank Graziano, MD, PhD	608-263-6186	fmg@medicine.wisc.edu

Locations

United States, Wisconsin
University of Wisconsin Hospital and Clinics	Recruiting
Madison, Wisconsin, United States, 53792
Contact: Andrew Urban, MD 608-256-1901 ext 17472 andrew.urban@med.va.gov
Principal Investigator: Andrew Urban, MD

Sponsors and Collaborators

University of Wisconsin, Madison

Immunex Corporation

Investigators

Principal Investigator:

Andrew Urban, MD

University of Wisconsin Hospital and Clinics

More Information

Study ID Numbers:	2001-557
Study First Received:	September 13, 2005
Last Updated:	October 24, 2007
ClinicalTrials.gov Identifier:	NCT00205231
Health Authority:	United States: Food and Drug Administration

Keywords provided by University of Wisconsin, Madison:

HIV

Study placed in the following topic categories:

Virus Diseases
Sexually Transmitted Diseases, Viral
Necrosis
HIV Infections
Sexually Transmitted Diseases

Acquired Immunodeficiency Syndrome
TNFR-Fc fusion protein
Retroviridae Infections
Immunologic Deficiency Syndromes

Additional relevant MeSH terms:

Anti-Inflammatory Agents
RNA Virus Infections
Slow Virus Diseases
Immunologic Factors
Immune System Diseases
Physiological Effects of Drugs
Gastrointestinal Agents
Infection
Immunosuppressive Agents
Pharmacologic Actions

Analgesics, Non-Narcotic
Sensory System Agents
Therapeutic Uses
Lentivirus Infections
Anti-Inflammatory Agents, Non-Steroidal
Analgesics
Peripheral Nervous System Agents
Antirheumatic Agents
Central Nervous System Agents

ClinicalTrials.gov processed this record on January 16, 2009