NCT02028819

Compassionate Use of Ibalizumab for the Treatment of HIV Infection

• Status: No Longer Available
• Phase: —
• Study type: Expanded Access
• Enrollment: —
• Sponsor: University of Colorado, Denver · Academic / Other
• Sex: All
• Age: 18 Years – 89 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Human Immunodeficiency Virus (HIV)

Interventions

Type	Name	Description
DRUG	Dolutegravir Sodium Monohydrate	Dolutegravir taken 50mg orally twice daily
DRUG	Ibalizumab	Ibalizumab will be administered intravenously at a dose of 800mg once every two weeks.

Timeline

• Start date: 2012-01-01
• Primary completion: 2014-02-01
• Completion: 2014-02-01
• First posted: 2014-01-07
• Last updated: 2016-11-01

Locations

1 site across 1 country: United States