Safety and Efficacy of BAY 50-4798 in Patients With HIV Infection
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.
1 other identifier
interventional
56
3 countries
11
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_1 hiv-infections
Started Dec 2002
Typical duration for phase_1 hiv-infections
11 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
December 1, 2002
CompletedFirst Submitted
Initial submission to the registry
April 25, 2003
CompletedFirst Posted
Study publicly available on registry
June 2, 2003
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2005
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2005
CompletedDecember 23, 2014
December 1, 2014
2.2 years
April 25, 2003
December 18, 2014
Conditions
Keywords
Study Arms (2)
Arm 1
EXPERIMENTALArm 2
ACTIVE COMPARATORInterventions
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
- +4 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Bayerlead
Study Sites (11)
Unknown Facility
Birmingham, Alabama, 35294, United States
Unknown Facility
Davis, California, 95616, United States
Unknown Facility
Los Angeles, California, 90095, United States
Unknown Facility
Palo Alto, California, 94304-1207, United States
Unknown Facility
San Francisco, California, 94115, United States
Unknown Facility
Chicago, Illinois, 60611-2908, United States
Unknown Facility
Chicago, Illinois, 60612, United States
Unknown Facility
Bethesda, Maryland, 20892, United States
Unknown Facility
Cleveland, Ohio, 44106-2602, United States
Unknown Facility
Créteil, 94010, France
Unknown Facility
London, Greater London, SW10 9NH, United Kingdom
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Bayer Study Director
Bayer
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 25, 2003
First Posted
June 2, 2003
Study Start
December 1, 2002
Primary Completion
March 1, 2005
Study Completion
March 1, 2005
Last Updated
December 23, 2014
Record last verified: 2014-12