Clinical trial NCT02707861: Ibalizumab Plus Optimized Background Regimen in Treatment-Experienced Patients With Multi-Drug Resistant HIV-1
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: HIV
Keywords: HIV
Resistant
Salvage
ibalizumab
antibody
AIDS
Lead sponsor: TaiMed Biologics Inc.
Sponsor class: INDUSTRY
Collaborators: name: Westat
First posted: 2016-03-14
Enrollment: 79
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Safety and Tolerability of Ibalizumab + OBR
timeFrame: Through 48 weeks
measure: Discontinuations Due to Adverse Events Related to Ibalizumab
timeFrame: 48 weeks
measure: Effectiveness of Ibalizumab + OBR (Cohort 2 Only)
timeFrame: 7 days
Secondary outcomes:
measure: Suppression to <50 Copies With Ibalizumab + OBR (Cohort 2 Only)
timeFrame: 48 weeks
measure: Suppression to <400 Copies by Ibalizumab + OBR (Cohort 2 Only)
timeFrame: 48 weeks
measure: Effectiveness of Ibalizumab + OBR by 1.0 Log10 Decrease in Viral Load From Baseline (Cohort 2 Only)
timeFrame: 48 weeks
Other outcomes:
Locations:
city: Long Beach
country: United States
facility: Long Beach Education and Research Consultants
state: California
city: Los Angeles
country: United States
facility: Southern California Permanente Medical Group
state: California
city: Los Angeles
country: United States
facility: Ruane Clinical Research Institute Inc.
state: California
city: Los Angeles
country: United States
facility: Charles R. Drew University of Medicine and Science, Clinical and Translational Research Center
state: California
city: Los Angeles
country: United States
facility: Anthony Mills MD Inc.
state: California
city: Palm Springs
country: United States
facility: Palmtree Clinical Research, Inc.
state: California
city: San Francisco
country: United States
facility: eStudy Site
state: California
city: San Francisco
country: United States
facility: Kaiser Foundation Research Institute
state: California
city: New Haven
country: United States
facility: Yale University
state: Connecticut
city: Washington
country: United States
facility: Georgetown University School of Medicine
state: District of Columbia
city: Fort Lauderdale
country: United States
facility: Gary Richmond, MD, PA
state: Florida
city: Miami
country: United States
facility: AIDS Healthcare Foundation - Kinder Medical Group
state: Florida
city: Miami
country: United States
facility: AIDS Healthcare Foundation - South Beach
state: Florida
city: Orlando
country: United States
facility: Orlando Immunology Center
state: Florida
city: West Palm Beach
country: United States
facility: Triple O Research Institute
state: Florida
city: Atlanta
country: United States
facility: AIDS Research Consortium of Atlanta
state: Georgia
city: Honolulu
country: United States
facility: University of Hawaii - John A. Burns School of Medicine
state: Hawaii
city: Chicago
country: United States
facility: Howard Brown Health Center
state: Illinois
city: Bethesda
country: United States
facility: National Institute of Allergy & Infectious Diseases
state: Maryland
city: Springfield
country: United States
facility: ID Research Institute
state: Massachusetts
city: Saint Louis
country: United States
facility: Central West Clinical Research
state: Missouri
city: Bronx
country: United States
facility: Jacobi Medical Center
state: New York
city: New York
country: United States
facility: AIDS Healthcare Foundation - Manhattan Midtown HCC
state: New York
city: New York
country: United States
facility: Chelsea Village Medical
state: New York
city: Greenville
country: United States
facility: East Carolina University
state: North Carolina
city: Philadelphia
country: United States
facility: Philadelphia FIGHT
state: Pennsylvania
city: Memphis
country: United States
facility: St. Jude's Children's Research Hospital
state: Tennessee
city: Bellaire
country: United States
facility: St. Hope Foundation Community Health Center
state: Texas
city: Dallas
country: United States
facility: North Texas Infectious Disease Consultants
state: Texas
city: Houston
country: United States
facility: Crofoot Research Center
state: Texas
city: Houston
country: United States
facility: Research Access Network
state: Texas
city: San Juan
country: Puerto Rico
facility: Clinical Research PR, Inc.
Study officials:
affiliation: TaiMed Biologics Inc.
name: Stanley T. Lewis, MD, MPH
role: PRINCIPAL_INVESTIGATOR
References: