Compassionate Use of Ibalizumab for the Treatment of HIV Infection

Expanded access is no longer available for this treatment.

Sponsor:

Information provided by (Responsible Party):

University of Colorado, Denver

ClinicalTrials.gov Identifier:

NCT02028819

First received: January 3, 2014

Last updated: October 31, 2016

Last verified: October 2016

History of Changes

Tracking Information

First Received Date ^ICMJE

January 3, 2014

Last Updated Date

October 31, 2016

Start Date ^ICMJE

January 2012

Estimated Primary Completion Date

February 2014 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Not Provided

Original Primary Outcome Measures ^ICMJE

Suppression of plasma HIV-RNA (viral load) [ Time Frame: Week 2, 4, 8, 12, 36,48, 60, 72, 84, 96 ]

Change History

Complete list of historical versions of study NCT02028819 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Not Provided

Original Secondary Outcome Measures ^ICMJE

Improvement in the CD4+ lymphocyte count [ Time Frame: Week 2, 4, 8, 12, 36,48, 60, 72, 84, 96 ]
Assessment for toxicity with tests of liver and kidney function and blood clots [ Time Frame: Week 2, 4, 8, 12, 36,48, 60, 72, 84, 96 ]

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

Compassionate Use of Ibalizumab for the Treatment of HIV Infection

Official Title ^ICMJE

Compassionate Use of Ibalizumab for the Treatment of HIV Infection

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.

Detailed Description

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.
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.

Study Type ^ICMJE

Expanded Access

Study Phase

Not Provided

Study Design ^ICMJE

Not Provided

Condition ^ICMJE

Human Immunodeficiency Virus (HIV)

Intervention ^ICMJE

Drug: Dolutegravir Sodium Monohydrate
Dolutegravir taken 50mg orally twice daily

Other Name: TIVICAY
Drug: Ibalizumab
Ibalizumab will be administered intravenously at a dose of 800mg once every two weeks.

Other Name: TMB-355

Study Arms

Not Provided

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

No longer available

Enrollment ^ICMJE

Not Provided

Estimated Completion Date

February 2014

Estimated Primary Completion Date

February 2014 (Final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Sex/Gender

Sexes Eligible for Study:

All

Ages

18 Years to 89 Years (Adult, Senior)

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Listed Location Countries ^ICMJE

United States

Removed Location Countries

Administrative Information

NCT Number ^ICMJE

NCT02028819

Other Study ID Numbers ^ICMJE

12-0003

Has Data Monitoring Committee

Not Provided

U.S. FDA-regulated Product

Not Provided

IPD Sharing Statement

Not Provided

Responsible Party

University of Colorado, Denver

Study Sponsor ^ICMJE

University of Colorado, Denver

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Principal Investigator:

Edward M Gardner, M.D.

University of Colorado, Denver

PRS Account

University of Colorado, Denver

Verification Date

October 2016

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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