Compassionate Use of Ibalizumab for the Treatment of HIV Infection

NCT02028819 | Unknown

• 1 other identifier: 12-0003
• Study Type: expanded_access
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Human Immunodeficiency Virus (HIV)

Interventions

Dolutegravir Sodium Monohydrate DRUG

Dolutegravir taken 50mg orally twice daily

Also known as: TIVICAY

Ibalizumab DRUG

Ibalizumab will be administered intravenously at a dose of 800mg once every two weeks.

Also known as: TMB-355

Eligibility Criteria

• Age: 18 Years - 89 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Colorado, Denver: lead

Study Sites (1)

Denver Health

Denver, Colorado, 80204, United States

Location

MeSH Terms

Conditions

Acquired Immunodeficiency Syndrome

Interventions

dolutegravir; ibalizumab

Condition Hierarchy (Ancestors)

HIV Infections; Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Slow Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases

Study Officials

• Edward M Gardner, M.D.

  University of Colorado, Denver

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: expanded access
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 3, 2014
• First Posted: January 7, 2014
• Study Start: January 1, 2012
• Primary Completion: February 1, 2014
• Study Completion: February 1, 2014
• Last Updated: November 1, 2016

Record last verified: 2016-10

Locations

US (1)