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

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

sites

Peter J. Ruane, MD, Inc.

Los Angeles, California 90036

from

Los Angeles, CA