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Compassionate Use of Ibalizumab for the Treatment of HIV Infection

Primary Purpose

Human Immunodeficiency Virus (HIV)

Status
No longer available
Phase
Locations
United States
Study Type
Expanded Access
Intervention
Dolutegravir Sodium Monohydrate
Ibalizumab
Sponsored by
University of Colorado, Denver
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an expanded access trial for Human Immunodeficiency Virus (HIV)

Eligibility Criteria

18 Years - 89 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Denver Health

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
January 3, 2014
Last Updated
October 31, 2016
Sponsor
University of Colorado, Denver
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1. Study Identification

Unique Protocol Identification Number
NCT02028819
Brief Title
Compassionate Use of Ibalizumab for the Treatment of HIV Infection
Official Title
Compassionate Use of Ibalizumab for the Treatment of HIV Infection
Study Type
Expanded Access

2. Study Status

Record Verification Date
October 2016
Overall Recruitment Status
No longer available
Study Start Date
January 2012 (undefined)
Primary Completion Date
February 2014 (Anticipated)
Study Completion Date
February 2014 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Colorado, Denver

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Human Immunodeficiency Virus (HIV)

7. Study Design

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
Dolutegravir Sodium Monohydrate
Other Intervention Name(s)
TIVICAY
Intervention Description
Dolutegravir taken 50mg orally twice daily
Intervention Type
Drug
Intervention Name(s)
Ibalizumab
Other Intervention Name(s)
TMB-355
Intervention Description
Ibalizumab will be administered intravenously at a dose of 800mg once every two weeks.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
89 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Edward M Gardner, M.D.
Organizational Affiliation
University of Colorado, Denver
Official's Role
Principal Investigator
Facility Information:
Facility Name
Denver Health
City
Denver
State/Province
Colorado
ZIP/Postal Code
80204
Country
United States

12. IPD Sharing Statement

Learn more about this trial

Compassionate Use of Ibalizumab for the Treatment of HIV Infection

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