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.
Safety and Efficacy of BAY 50-4798 in Patients With HIV Infection
Sponsors
Source
Bayer
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.
Overall Status
Completed
Start Date
2002-12-01
Completion Date
2005-03-01
Primary Completion Date
2005-03-01
Phase
Phase 1/Phase 2
Study Type
Interventional
Enrollment
56
Condition
Intervention
Intervention Type
Drug
Intervention Name
Description
HAART and Bay 50-4798
Arm Group Label
Arm 1
Eligibility
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).
Gender
All
Minimum Age
18 Years
Maximum Age
N/A
Healthy Volunteers
No
Overall Official
Last Name |
Role |
Affiliation |
Bayer Study Director |
Study Director |
Bayer |
Location
Facility |
Birmingham Alabama 35294 United States |
Davis California 95616 United States |
Los Angeles California 90095 United States |
Palo Alto California 94304-1207 United States |
San Francisco California 94115 United States |
Chicago Illinois 60611-2908 United States |
Chicago Illinois 60612 United States |
Bethesda Maryland 20892 United States |
Cleveland Ohio 44106-2602 United States |
Creteil 94010 France |
London Greater London SW10 9NH United Kingdom |
Location Countries
Country
France
United Kingdom
United States
Verification Date
2014-12-01
Lastchanged Date
N/A
Firstreceived Date
N/A
Responsible Party
Responsible Party Type
Sponsor
Keyword
Has Expanded Access
No
Condition Browse
Number Of Arms
2
Intervention Browse
Mesh Term
Aldesleukin
Interleukin-2
Arm Group
Arm Group Label
Arm 1
Arm Group Type
Experimental
Arm Group Label
Arm 2
Arm Group Type
Active Comparator
Firstreceived Results Date
N/A
Nct Alias
NCT00048191
Firstreceived Results Disposition Date
N/A
Study Design Info
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Treatment
Masking
Double
Study First Submitted
April 25, 2003
Study First Submitted Qc
May 30, 2003
Study First Posted
June 2, 2003
Last Update Submitted
December 18, 2014
Last Update Submitted Qc
December 18, 2014
Last Update Posted
December 23, 2014
ClinicalTrials.gov processed this data on December 09, 2019
Conditions
Conditions usually refer to a disease, disorder, syndrome, illness, or injury. In ClinicalTrials.gov,
conditions include any health issue worth studying, such as lifespan, quality of life, health risks, etc.
Interventions
Interventions refer to the drug, vaccine, procedure, device, or other potential treatment being studied.
Interventions can also include less intrusive possibilities such as surveys, education, and interviews.
Study Phase
Most clinical trials are designated as phase 1, 2, 3, or 4, based on the type of questions
that study is seeking to answer:
In Phase 1 (Phase I) clinical trials, researchers test a new drug or treatment in a small group of people (20-80) for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
In Phase 2 (Phase II) clinical trials, the study drug or treatment is given to a larger group of people (100-300) to see if it is effective and to further evaluate its safety.
In Phase 3 (Phase III) clinical trials, the study drug or treatment is given to large groups of people (1,000-3,000) to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
In Phase 4 (Phase IV) clinical trials, post marketing studies delineate additional information including the drug's risks, benefits, and optimal use.
These phases are defined by the Food and Drug Administration in the Code of Federal Regulations.
In Phase 1 (Phase I) clinical trials, researchers test a new drug or treatment in a small group of people (20-80) for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
In Phase 2 (Phase II) clinical trials, the study drug or treatment is given to a larger group of people (100-300) to see if it is effective and to further evaluate its safety.
In Phase 3 (Phase III) clinical trials, the study drug or treatment is given to large groups of people (1,000-3,000) to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
In Phase 4 (Phase IV) clinical trials, post marketing studies delineate additional information including the drug's risks, benefits, and optimal use.
These phases are defined by the Food and Drug Administration in the Code of Federal Regulations.