Ibalizumab Plus Optimized Background Regimen in Treatment-Experienced Patients With Multi-Drug Resistant HIV-1
Condition: HIV
Intervention: ibalizumab; Optimized Background Regimen
Intervention description: 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; 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).
Intervention MeSH terms: Ibalizumab
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 79.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: HIV; Resistant; Salvage; ibalizumab; antibody; AIDS

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.
    

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