Compassionate Use of Ibalizumab for the Treatment of HIV Infection

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NO_LONGER_AVAILABLE

Study Classification

EXPANDED_ACCESS

Study Start Date

2012-01-31

Study Completion Date

2014-02-28

Brief Summary

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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

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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

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Human Immunodeficiency Virus (HIV)

Interventions

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Dolutegravir Sodium Monohydrate

Dolutegravir taken 50mg orally twice daily

Intervention Type DRUG

Ibalizumab

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

Intervention Type DRUG

Other Intervention Names

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TIVICAY TMB-355

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

89 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Edward M Gardner, M.D.

Role: PRINCIPAL_INVESTIGATOR

University of Colorado, Denver

Locations

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Denver Health

Denver, Colorado, United States

Site Status

Countries

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United States

Other Identifiers

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12-0003

Identifier Type: -

Identifier Source: org_study_id