Human Immunodeficiency Virus (HIV) Clinical Trial
Official title:
Compassionate Use of Ibalizumab for the Treatment of HIV Infection
Ibalizumab is a humanized immunoglobulin G monoclonal antibody directed against a human T-cell receptor (CD4) and thus suppresses HIV replication by blocking entry of HIV into CD4+ lymphocytes. Ibalizumab has completed phase I and II clinical studies in HIV-negative and HIV-infected individuals showing safety and efficacy for suppressing HIV replication.
1. Ibalizumab is a humanized immunoglobulin G monoclonal antibody directed against a human
T-cell receptor (CD4) and thus suppresses HIV replication by blocking entry of HIV into
CD4+ lymphocytes. Ibalizumab is in the pipeline for FDA approval to treat HIV
infection. Phase I and II clinical studies have been completed in HIV-negative and
HIV-infected individuals showing safety and efficacy for suppressing HIV replication.
2. Use of this medication requires that a single patient IND be obtained from the FDA for
each patient requiring ibalizumab. An individual use IND has been approved by the FDA
for one patient on treatment through this protocol; The IND number is 114515. The
manufacturer of ibalizumab (TaiMed Biologics, Inc) will ship the drug directly to the
Denver Health pharmacy.
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