- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00059462
Safety and Efficacy of BAY 50-4798 in Patients With HIV Infection
December 18, 2014 updated by: Bayer
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.
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
56
Phase
- Phase 2
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Creteil, France, 94010
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Greater London
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London, Greater London, United Kingdom, SW10 9NH
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Alabama
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Birmingham, Alabama, United States, 35294
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California
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Davis, California, United States, 95616
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Los Angeles, California, United States, 90095
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Palo Alto, California, United States, 94304-1207
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San Francisco, California, United States, 94115
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Illinois
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Chicago, Illinois, United States, 60612
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Chicago, Illinois, United States, 60611-2908
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Maryland
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Bethesda, Maryland, United States, 20892
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Ohio
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Cleveland, Ohio, United States, 44106-2602
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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).
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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Active Comparator: Arm 2
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HAART alone
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Experimental: Arm 1
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HAART and Bay 50-4798
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
December 1, 2002
Primary Completion (Actual)
March 1, 2005
Study Completion (Actual)
March 1, 2005
Study Registration Dates
First Submitted
April 25, 2003
First Submitted That Met QC Criteria
May 30, 2003
First Posted (Estimate)
June 2, 2003
Study Record Updates
Last Update Posted (Estimate)
December 23, 2014
Last Update Submitted That Met QC Criteria
December 18, 2014
Last Verified
December 1, 2014
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Pathologic Processes
- RNA Virus Infections
- Virus Diseases
- Blood-Borne Infections
- Sexually Transmitted Diseases, Viral
- Sexually Transmitted Diseases
- Lentivirus Infections
- Retroviridae Infections
- Immunologic Deficiency Syndromes
- Immune System Diseases
- Disease Attributes
- Slow Virus Diseases
- HIV Infections
- Infections
- Communicable Diseases
- Acquired Immunodeficiency Syndrome
- Physiological Effects of Drugs
- Peripheral Nervous System Agents
- Analgesics
- Sensory System Agents
- Analgesics, Non-Narcotic
- Antineoplastic Agents
- Interleukin-2
Other Study ID Numbers
- 10630
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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