Compassionate Use of Ibalizumab for the Treatment of HIV Infection

Human Immunodeficiency Virus (HIV) Clinical Trial

Official title:

Compassionate Use of Ibalizumab for the Treatment of HIV Infection

Clinical Trial Details — Status: No longer available

Administrative data

• NCT number: NCT02028819
• Other study ID #: 12-0003
• Status: No longer available
• Phase: Phase 3
• First received: January 3, 2014
• Last updated: October 31, 2016
• Start date: January 2012
• Est. completion date: February 2014

Study information

• Verified date: October 2016
• Source: University of Colorado, Denver
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Expanded Access

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: No longer available
• Enrollment: 0
• Est. completion date: February 2014
• Est. primary completion date: February 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 89 Years

Eligibility

Inclusion Criteria:

• Adult patients with a diagnosis of HIV-infection with resistance or intolerance to currently available antiretroviral medications available in the United States or in whom additional drugs need to be added to their regimen because of inadequate response to existing therapy

• Patients with HIV infection that is expected to be sensitive to dolutegravir and ibalizumab

• Patients who do not qualify for or who are otherwise ineligible for clinical trials of medications not currently approved for treatment of HIV infection in the U.S.

Exclusion Criteria:

• Patients who are allergic to or have had a severe adverse reaction to dolutegravir or ibalizumab in the past.

• Age <18 years or >89 years

• Women may not be pregnant

• Prisoners and decisionally challenged patients will be excluded

Study Design

N/A

Related Conditions & MeSH terms

• Acquired Immunodeficiency Syndrome
• HIV Infections
• Human Immunodeficiency Virus (HIV)
• Immunologic Deficiency Syndromes

Intervention

Drug:
• Dolutegravir Sodium Monohydrate
Dolutegravir taken 50mg orally twice daily
• Ibalizumab
Ibalizumab will be administered intravenously at a dose of 800mg once every two weeks.

Locations

Country	Name	City	State
United States	Denver Health	Denver	Colorado

Sponsors (1)

Lead Sponsor	Collaborator
University of Colorado, Denver

Country where clinical trial is conducted

United States,