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Compassionate Use of Dolutegravir and Ibalizumab for the Treatment of HIV Infection

Expanded access is currently available for this treatment.
Verified January 2014 by University of Colorado, Denver
Sponsor:
Information provided by (Responsible Party):
University of Colorado, Denver
ClinicalTrials.gov Identifier:
NCT02028819
First received: January 3, 2014
Last updated: January 6, 2014
Last verified: January 2014

January 3, 2014
January 6, 2014
January 2012
February 2014   (final data collection date for primary outcome measure)
Not Provided
Suppression of plasma HIV-RNA (viral load) [ Time Frame: Week 2, 4, 8, 12, 36,48, 60, 72, 84, 96 ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT02028819 on ClinicalTrials.gov Archive Site
Not Provided
  • Improvement in the CD4+ lymphocyte count [ Time Frame: Week 2, 4, 8, 12, 36,48, 60, 72, 84, 96 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
Not Provided
Not Provided
 
Compassionate Use of Dolutegravir and Ibalizumab for the Treatment of HIV Infection
Compassionate Use of Dolutegravir and Ibalizumab for the Treatment of HIV Infection

Dolutegravir is a second-generation integrase inhibitor that is effective in suppressing HIV replication in individuals with resistance to first-generation integrase inhibitors. 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. Both Dolutegravir and ibalizumab have completed phase I and II clinical studies in HIV-negative and HIV-infected individuals showing that both are safe and effective for suppressing HIV replication.

  1. Dolutegravir is a second-generation integrase inhibitor that is effective in suppressing HIV replication in individuals with resistance to first-generation integrase inhibitors. 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. Both Dolutegravir and ibalizumab are in the pipeline for FDA approval to treat HIV infection. For both medications phase I and II clinical studies have been completed in HIV-negative and HIV-infected individuals showing that both are safe and effective for suppressing HIV replication.
  2. Use of these medications requires that a single patient IND be obtained from the FDA for each patient requiring dolutegravir and/or ibalizumab. Because treatment of HIV infection requires multiple active antiretroviral medications, the FDA requested that a single Investigational New Drug Application (IND) be utilized to cover both of these investigational medications. An individual use IND has been approved by the FDA; The IND number is 114515. The manufacturers of dolutegravir (ViiV Healthcare) and ibalizumab (TaiMed Biologics, Inc) will ship the drug directly to the Denver Health pharmacy.
Expanded Access
Phase 3
Not Provided
Human Immunodeficiency Virus (HIV)
  • Drug: Dolutegravir
    Dolutegravir taken 50mg orally twice daily
  • Drug: Ibalizumab
    Ibalizumab will be administered intravenously at a dose of 800mg once every two weeks.
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Available
Not Provided
February 2014
February 2014   (final data collection date for primary outcome measure)

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
Both
18 Years to 89 Years
No
Contact: Edward M Gardner, M.D. (303) 315-7424 EDWARD.GARDNER@UCDENVER.EDU
United States
 
NCT02028819
12-0003
Not Provided
University of Colorado, Denver
University of Colorado, Denver
Not Provided
Not Provided
University of Colorado, Denver
January 2014

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