A Study of Anti-HIV Monoclonal Antibody KD-247



Status:Archived
Conditions:HIV / AIDS
Therapuetic Areas:Immunology / Infectious Diseases
Healthy:No
Age Range:Any
Updated:7/1/2011
Start Date:September 2007

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A Study of the Safety, Tolerability, and Pharmacokinetics of KD-247, a Humanized Monoclonal Antibody That Recognizes the Principal Neutralizing Determinant of HIV-1, in Asymptomatic HIV-1 Seropositive Individuals Who Are Not Receiving Concurrent Antiretroviral Therapy


The purpose of this study is to evaluate the safety and tolerability of 3 infusions of
KD-247 over 2 weeks in HIV-1 seropositive individuals; to determine the pharmacokinetic
parameters of KD-247 when administered as above; and to assess the effect of KD-247
infusions on plasma HIV-1 ribonucleic acid (RNA) load and on CD4+ T cell counts.


A minimum of 6 active subjects and 3 placebo subjects for each dose cohort will complete 2
weeks of infusions. A maximum of 27 total subjects will be dosed with KD-247 and up to 9
total will receive placebo. Per cohort subjects randomized to active treatment will receive
iv infusions of KD 247 over 2 hours at each dosing visit. Subjects randomized to placebo
will receive 2-hour iv infusions of saline solution at each dosing visit. Following the
first infusion of KD-247 (or placebo) for each subject in the study, there will be a 24-hour
in-patient observation period before the next subject can be randomized within the study.
Dose escalation will proceed only after safety data through Day 18 for all subjects in the
lower-dose cohort is reviewed.


We found this trial at
14
sites
Tuscaloosa, Alabama
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Tuscaloosa, AL
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43 New Scotland Avenue
Albany, New York 12208
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Albany, NY
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900 East 30th Street
Austin, Texas 78705
512-480-9660
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Austin, TX
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3808 Riverside Drive
San Fernando Valley, California 91505
818-558-7555
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San Fernando Valley, CA
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110 Irving St NW # 3B28
Washington, Washington DC 20010
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Washington, DC
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Atlanta, Georgia 30308
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Atlanta, GA
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Beverly Hills, California 90211
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Beverly Hills, CA
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Chicago, Illinois 60657
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Chicago, IL
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Fort Lauderdale, Florida 33316
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Fort Lauderdale, FL
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Houston, Texas 77004
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Houston, TX
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Los Angeles, California 90036
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Los Angeles, CA
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New York, NY
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1701 North Mills Avenue
Orlando, Florida 32803
(407)647-3960
Orlando Immunology Center Orlando Immunology Center , or simply (OIC) is a part of Infectious...
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Orlando, FL
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Tamarac, Florida 33319
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Tamarac, FL
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