Ibalizumab Plus Optimized Background Regimen in Treatment-Experienced Patients With Multi-Drug Resistant HIV-1

HIV Clinical Trial

Official title:

A Phase 3, Multicenter, Expanded Access Study of Ibalizumab Plus an Optimized Background Regimen (OBR) in Treatment-Experienced Patients Infected With Multi-Drug Resistant (MDR) HIV-1

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02707861
• Other study ID #: TMB-311
• Status: Completed
• Phase: Phase 3
• Start date: March 2016
• Est. completion date: November 2018

Study information

• Verified date: February 2021
• Source: TaiMed Biologics Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Ibalizumab is a monoclonal antibody that works by blocking HIV entry into the immune system cells (CD4+ or T-cells) the virus typically infects. Ibalizumab is intended for use in combination with other anti-HIV drugs in people with multi-drug resistant HIV and limited treatment options. This study will collect further information on the safety and tolerability of intravenously administered (IV) ibalizumab combined with an optimized background regimen for treating multi-drug resistant HIV-1 infection, and will provide continuing access to ibalizumab for patients completing a prior ibalizumab clinical trial.

Description:

Participants will enroll into one of two study cohorts. Cohort 1 will provide continued administration of IV ibalizumab for patients completing a prior ibalizumab clinical trial (TaiMed-sponsored or Investigator-Sponsored). Patients will continue to receive IV infusions of ibalizumab at the dosage assigned in the previous study - either 800 mg once every two weeks, or 2000 mg once every four weeks.

Cohort 2 will provide IV ibalizumab, 800 mg once every two weeks, for qualifying patients with multi-drug resistant HIV-1 and limited treatment options who have never previously received ibalizumab.

Participants may continue in this study for 48 weeks, or until ibalizumab becomes commercially available, whichever occurs first.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 79
• Est. completion date: November 2018
• Est. primary completion date: November 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

(Cohort 1)

• Currently receiving ibalizumab via other TaiMed-sponsored or investigator-Sponsored protocol

• Are capable of understanding and have voluntarily signed the informed consent document

(Cohort 2)

• 18 years of age or older

• Are capable of understanding and have voluntarily signed the informed consent document

• Have documented HIV-1 infection by official, signed, written history (e.g., laboratory report), otherwise an HIV-antibody test will be performed

• Are able and willing to comply with all protocol requirements and procedures

• Have a viral load >1,000 copies/mL and documented resistance to at least one antiretroviral medication from each of three classes of antiretroviral medications as measured by previous viral resistance testing (resistance testing is not provided by the study for qualification purposes)

• Have a history of at least 6 months on antiretroviral treatment

• Are receiving a failing antiretroviral regimen OR have failed and are off therapy

• Have viral sensitivity/susceptibility to at least one antiretroviral agent, other than ibalizumab, as determined by previous resistance test performed within 6 months of screening and be willing and able to be treated with at least one agent to which the patient's viral isolate is fully sensitive/susceptible according to the resistance tests used for screening as a component of OBR

• If sexually active, are willing to use an effective method of contraception during the study and for 30 days after the last administration of the study drug

Exclusion Criteria:

(Cohort 1)

• There are no Exclusion Criteria for patients meeting the Inclusion Criteria for Cohort 1

(Cohort 2)

• Eligible for participation in other TaiMed-sponsored clinical trials of ibalizumab

• Any significant diseases (other than HIV-1 infection) or clinically significant findings, including psychiatric and behavioral problems, determined from screening, medical history and/or physical examination that, in the investigator's opinion, would preclude the patient from participating in this study

• Any significant acute illness within 1 week before the first administration of investigational medication on this study

• Any active infection secondary to HIV requiring acute therapy; however, patients that require maintenance therapy (i.e., secondary prophylaxis for opportunistic infections) will be eligible for the study.

• Any immunomodulating therapy (including interferon), systemic steroids, or systemic chemotherapy within 4 weeks before Day 0

• Any prior exposure to ibalizumab (formerly TNX-355 and Hu5A8)

• Any vaccination within 7 days before Day 0

• Any female patient who either is pregnant, intends to become pregnant, or is currently breastfeeding

• Any current alcohol or illicit drug use that, in the investigator's opinion, will interfere with the patient's ability to comply with the study schedule and protocol evaluations

• Any previous clinically significant allergy or hypersensitivity to any excipient in the ibalizumab formulation

• Any radiation therapy during the 28 days before first administration of investigational medication on this study

• Any clinically significant Grade 3 or 4 laboratory abnormality according to the Division of AIDS (DAIDS) grading scale, except for the following asymptomatic Grade 3 events:

• triglyceride elevation

• total cholesterol elevation

Related Conditions & MeSH terms

• HIV

Intervention

Drug:
• ibalizumab
Intravenous infusion of humanized monoclonal antibody binding with a region of Domain 2 of CD4 receptor, blocking post-attachment conformational changes necessary for HIV cell entry
• Optimized Background Regimen
An investigator-selected, standard-of-care combination regimen of antiretroviral agents for treating HIV-1 infection, selected based upon patient treatment history and the results of previous viral resistance testing. The combination must contain at least one agent other than ibalizumab to which the patient's virus is sensitive (susceptible).

Locations

Country	Name	City	State
Puerto Rico	Clinical Research PR, Inc.	San Juan
United States	AIDS Research Consortium of Atlanta	Atlanta	Georgia
United States	St. Hope Foundation Community Health Center	Bellaire	Texas
United States	National Institute of Allergy & Infectious Diseases	Bethesda	Maryland
United States	Jacobi Medical Center	Bronx	New York
United States	Howard Brown Health Center	Chicago	Illinois
United States	North Texas Infectious Disease Consultants	Dallas	Texas
United States	Gary Richmond, MD, PA	Fort Lauderdale	Florida
United States	East Carolina University	Greenville	North Carolina
United States	University of Hawaii - John A. Burns School of Medicine	Honolulu	Hawaii
United States	Crofoot Research Center	Houston	Texas
United States	Research Access Network	Houston	Texas
United States	Long Beach Education and Research Consultants	Long Beach	California
United States	Anthony Mills MD Inc.	Los Angeles	California
United States	Charles R. Drew University of Medicine and Science, Clinical and Translational Research Center	Los Angeles	California
United States	Ruane Clinical Research Institute Inc.	Los Angeles	California
United States	Southern California Permanente Medical Group	Los Angeles	California
United States	St. Jude's Children's Research Hospital	Memphis	Tennessee
United States	AIDS Healthcare Foundation - Kinder Medical Group	Miami	Florida
United States	AIDS Healthcare Foundation - South Beach	Miami	Florida
United States	Yale University	New Haven	Connecticut
United States	AIDS Healthcare Foundation - Manhattan Midtown HCC	New York	New York
United States	Chelsea Village Medical	New York	New York
United States	Orlando Immunology Center	Orlando	Florida
United States	Palmtree Clinical Research, Inc.	Palm Springs	California
United States	Philadelphia FIGHT	Philadelphia	Pennsylvania
United States	Central West Clinical Research	Saint Louis	Missouri
United States	eStudy Site	San Francisco	California
United States	Kaiser Foundation Research Institute	San Francisco	California
United States	ID Research Institute	Springfield	Massachusetts
United States	Georgetown University School of Medicine	Washington	District of Columbia
United States	Triple O Research Institute	West Palm Beach	Florida

Sponsors (2)

Lead Sponsor	Collaborator
TaiMed Biologics Inc.	Westat

Countries where clinical trial is conducted

United States,  Puerto Rico, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Safety and Tolerability of Ibalizumab + OBR	Number of participants with Grade 3/4 adverse events possibly, probably, or definitely due to ibalizumab	Through 48 weeks
Primary	Discontinuations Due to Adverse Events Related to Ibalizumab	number of participants discontinuing ibalizumab treatment due to adverse events probably, possibly, or definitely related to ibalizumab	48 weeks
Primary	Effectiveness of Ibalizumab + OBR (Cohort 2 Only)	Number of patients in Cohort 2 achieving at least a 0.5 log change from Baseline in viral load at Day 7 of the study	7 days
Secondary	Suppression to <50 Copies With Ibalizumab + OBR (Cohort 2 Only)	Number of patients in Cohort 2 with HIV-1 RNA levels <50 copies/mL at week 48	48 weeks
Secondary	Suppression to <400 Copies by Ibalizumab + OBR (Cohort 2 Only)	Number of patients in Cohort 2 with HIV-1 RNA levels <400 copies/mL at week 48	48 weeks
Secondary	Effectiveness of Ibalizumab + OBR by 1.0 Log10 Decrease in Viral Load From Baseline (Cohort 2 Only)	Number of patients in Cohort 2 achieving at least a 1.0 log10 decrease in viral load from Baseline measurement at all assessment time points	48 weeks