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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Bayer
ClinicalTrials.gov Identifier:
NCT00059462
First received: April 25, 2003
Last updated: October 9, 2013
Last verified: October 2013
  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
Drug: HAART
Phase 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Official Title: Phase I/II Randomized, Double Blind, Dose Escalation Study of the Safety, Tolerability, Pharmacokinetics and Efficacy of Subcutaneous Bay 50-4798 Administration in Patients With HIV Infection on Highly Active Antiretroviral Therapy (HAART) Compared to Patients on HAART Alone.

Resource links provided by NLM:


Further study details as provided by Bayer:

Enrollment: 82
Study Start Date: December 2002
Study Completion Date: March 2005
Primary Completion Date: March 2005 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Arm 1 Drug: Interleukin-2 SA
HAART and Bay 50-4798
Active Comparator: Arm 2 Drug: HAART
HAART alone

  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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Locations
United States, Alabama
Birmingham, Alabama, United States, 35294
United States, California
Davis, California, United States, 95616
Los Angeles, California, United States, 90095
Palo Alto, California, United States, 94304-1207
San Francisco, California, United States, 94115
United States, Illinois
Chicago, Illinois, United States, 60612
Chicago, Illinois, United States, 60611-2908
United States, Maryland
Bethesda, Maryland, United States, 20892
United States, Ohio
Cleveland, Ohio, United States, 44106-2602
France
Creteil, France, 94010
United Kingdom
London, Greater London, United Kingdom, SW10 9NH
Sponsors and Collaborators
Bayer
Investigators
Study Director: Bayer Study Director Bayer
  More Information

Additional Information:
No publications provided

Responsible Party: Bayer
ClinicalTrials.gov Identifier: NCT00059462     History of Changes
Obsolete Identifiers: NCT00048191
Other Study ID Numbers: 10630
Study First Received: April 25, 2003
Last Updated: October 9, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by Bayer:
Treatment experienced

Additional relevant MeSH terms:
HIV Infections
Acquired Immunodeficiency Syndrome
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Slow Virus Diseases
Aldesleukin
Interleukin-2
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Central Nervous System Agents
Anti-HIV Agents
Anti-Retroviral Agents
Antiviral Agents
Anti-Infective Agents

ClinicalTrials.gov processed this record on August 28, 2014