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Safety and Efficacy of BAY 50-4798 in Patients With HIV Infection

This study has been completed.

Sponsored by: Bayer
Information provided by: Bayer
ClinicalTrials.gov Identifier: NCT00059462
  Purpose

The purpose of this study is to evaluate the safety of the experimental drug Bay 50-4798 in HIV positive patients receiving HAART and to test the drug’s effect on the CD4+ T-cell count.


Condition Intervention Phase
HIV Infections
Drug: Interleukin-2 SA
Phase I
Phase II

MedlinePlus related topics:   AIDS   

Drug Information available for:   Aldesleukin    Interleukin-2   

U.S. FDA Resources

Study Type:   Interventional
Study Design:   Treatment, Randomized, Double-Blind, Active Control

Further study details as provided by Bayer:

Estimated Enrollment:   100
Study Start Date:   December 2002

Detailed Description:

The immune systems of patients with HIV infection do not produce enough interleukin-2 (IL-2). IL-2 is a protein that helps to activate CD4+ T cells to respond to various infections, including HIV. Bay 50-4798 is a modified recombinant form of IL-2 which may prove to have a tolerable adverse event profile.

  Eligibility
Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

Criteria

INCLUSION CRITERIA:

  • Documented HIV infection (positive enzyme linked immuno assay (EIA) confirmed by Western Blot).
  • Age greater than or equal to 18 years.
  • Plasma HIV viral load less than 10,000 copies/ml (by bDNA assay or less than 14,000 copies/ml by RT-PCR) on at least 2 occasions within 8 weeks prior to study entry with no more than a 0.5 log increase between the most recent and the earlier viral load measurements.
  • CD4 + T-cell count greater than or equal to 200/mm(3) on at least 2 occasions within 8 weeks of study entry.
  • On a stable HAART regimen for greater than or equal to 8 weeks.
  • Karnofsky Score greater than or equal to 80.
  • Written informed consent.

EXCLUSION CRITERIA:

  • Prior treatment with IL-2 or an IL-2 analogue.
  • Pregnancy or breastfeeding.
  • Use of any known immunomodulators, cytokines, growth factors or systemic corticosteroids (e.g. prednisone greater than or equal to 15 mg/day or equivalent) within 4 weeks prior to study enrollment.
  • History of an AIDS defining illness by the Centers for Disease Control (CDC) definition within 8 weeks prior to study entry.
  • Acute bacterial or viral infection within 4 weeks prior to enrollment.
  • Received an immunization within 4 weeks prior to enrollment.
  • History of autoimmune disease including psoriasis, inflammatory bowel disease.
  • Medical history of transplantation (solid organ or bone marrow).
  • Received an investigational drug in the past 30 days other than Food and Drug Administration (FDA) sanctioned treatment IND antiretroviral agents.
  • Renal insufficiency with a serum creatinine level greater than 1.5 times the upper limit of normal.
  • Bone marrow suppression as defined by one or more of the following: granulocyte count less than 1,000 cells/µL; hemoglobin less than 9.0g (females) or less than 9.5g (males); or platelet count less than 75,000 cells/µL.
  • Evidence of hepatic disease indicated by one or more of the following: SGOT (AST) and/or SGPT (ALT) greater than 5 times the upper limit of normal. Bilirubin greater than 2 times the upper limit of normal (except for patients with known Gilbert's syndrome or those receiving indinavir who may be enrolled if the serum bilirubin is less than or equal to 5 times the upper limit of normal).
  • Active cardiac disease (coronary artery disease, congestive heart failure or cardiomyopathy) requiring treatment with any of the following medications: antiarrhythmic agents including digitalis, anti-anginal drugs including topical or systemic nitrates, calcium channel blockers, and beta blockers, and afterload reducers including ACE inhibitors. Patients requiring any of these medications solely for the treatment of hypertension remain eligible for the study.
  • Presence of significant cardiac insufficiency (greater than or equal to New York Heart Association Grade 2).
  • Diagnosis of an active malignancy requiring treatment with systemic cytotoxic chemotherapy.
  • Active alcohol or substance abuse which, in the opinion of the investigator, will seriously compromise the subject's ability to adhere with the demands of the study.
  • Any central nervous system (CNS) disease that requires active treatment with anticonvulsants.
  • Use of an antimetabolite such as hydroxyurea within 4 weeks prior to study entry.
  • Known co-infection with Hepatitis B or C virus unless serum transaminases are less than or equal to 2 times the upper limit of normal on at least two occasions within 8 weeks prior to study entry.
  • Known CD4 Nadir less than 50 cells/mm(3).
  Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00059462

Locations
United States, Alabama
UAB - Medical Center    
      Birmingham, Alabama, United States, 35294-2050
United States, California
Quest Clinical Research    
      San Francisco, California, United States, 94115
Veteran Affairs Palo Alto Health Care System    
      Palo Alto, California, United States, 94304
UCLA Care Center    
      Los Angeles, California, United States, 90095
UC Davis Medical Center ACTU at CARES    
      Sacramento, California, United States, 95814
United States, Illinois
Northwestern University Medical School / Northwestern Memorial Hospital    
      Chicago, Illinois, United States, 60611
United States, Maryland
National Institutes of Health    
      Bethesda, Maryland, United States, 20892-1880
United States, Ohio
University Hospitals of Cleveland    
      Cleveland, Ohio, United States, 44106
United Kingdom
Chelsea and Westminster Hospital    
      London, United Kingdom, SW10 9NH

Sponsors and Collaborators
Bayer
  More Information


Information about clinical research, including listings of more than 41,000 active industry and government-sponsored clinical trials, as well as new drug therapies in research and those recently approved by the FDA.  This link exits the ClinicalTrials.gov site
 

Study ID Numbers:   10630
First Received:   April 25, 2003
Last Updated:   October 26, 2006
ClinicalTrials.gov Identifier:   NCT00059462
Health Authority:   United States: Food and Drug Administration

Keywords provided by Bayer:
Treatment experienced  

Study placed in the following topic categories:
Virus Diseases
Sexually Transmitted Diseases, Viral
Aldesleukin
Interleukin-2
HIV Infections
Sexually Transmitted Diseases
Acquired Immunodeficiency Syndrome
Retroviridae Infections
Immunologic Deficiency Syndromes

Additional relevant MeSH terms:
Communicable Diseases
RNA Virus Infections
Slow Virus Diseases
Immune System Diseases
Antineoplastic Agents
Physiological Effects of Drugs
Infection
Pharmacologic Actions
Analgesics, Non-Narcotic
Sensory System Agents
Therapeutic Uses
Lentivirus Infections
Analgesics
Peripheral Nervous System Agents
Central Nervous System Agents

ClinicalTrials.gov processed this record on November 30, 2008




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