Investigator-Sponsored Protocol - Continued Use of Ibalizumab

NCT01056393 | Completed Phase 2

• 1 other identifier: 5460
• Study Type: interventional
• Target: 5
• Locations: 1 country
• Sites: 1

Brief Summary

This protocol serves to extend the successful treatment for HIV positive patients beyond the endpoints provided by the Phase 2b TaiMed Biologics-sponsored protocol TMB202 (entitled "A Phase 2b Randomized, Double-Blinded, 48-Week, Multicenter, Dose-Response Study of Ibalizumab Plus an Optimized Background Regimen in Treatment-Experienced Patients Infected with HIV-1 (Amended to 24 Week Study)"), for 24 weeks. Ibalizumab may be administered beyond 24 weeks under this protocol as supply permits and patients continue to demonstrate virologic response.

Conditions

HIV Infections

Keywords

HIV

Outcome Measures

Primary Outcomes (1)

• Laboratory testing that includes routine HIV-1 viral load and CD4+ cell counts will be completed to assess the continued benefit of ibalizumab to the patient's HIV treatment.

  Every two months

Study Arms (2)

ibalizumab 800mg Q2Weeks

EXPERIMENTAL

Subject will receive 800mg of ibalizumab every 2 weeks administered by intravenous infusion. All patients also will receive optimized background regimen

Drug: ibalizumab 800mg Q2Weeks

ibalizumab 2000mg Q4Weeks

EXPERIMENTAL

Subject will receive 2000mg of ibalizumab every 4 weeks administered by intravenous infusion. All patients also will receive optimized background regimen

Drug: ibalizumab 2000mg Q4Weeks

Interventions

ibalizumab 800mg Q2Weeks DRUG

Ibalizumab is a humanized IgG4 monoclonal antibody and is provided as a parenteral formulation at a concentration of 25mg/mL in a 10mL glass vial, 8mLs per vial, as the investigational product. Study drug will be administered via intravenous infusion at doses of 800mg every 2 weeks.

Also known as: TNX-355, TMB-355

ibalizumab 800mg Q2Weeks

ibalizumab 2000mg Q4Weeks DRUG

Ibalizumab is a humanized IgG4 monoclonal antibody and is provided as a parenteral formulation at a concentration of 25mg/mL in a 10mL glass vial, 8mLs per vial, as the investigational product. Study drug will be administered via intravenous infusion at doses of 2000mg every 4 weeks.

Also known as: TNX-355, TMB-355

ibalizumab 2000mg Q4Weeks

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Capable of understanding and have voluntarily signed the ICF
• Have documented HIV-1 infection
• Have successfully completed Protocol TMB202 (Amendment 2)(Week 16)
• Have had at least a 0.7 log10 decline in HIV-1 RNA from baseline at Week 16 and beyond while in TMB202 and are no longer eligible to participate in TMB-202 due to TMB-202 protocol-defined virologic failure
• Have not withdrawn or been discontinued from TMB202 9Amendment 2) for any reason
• Are able and willing to comply with all protocol requirements and procedures
• Are 18 years of age or older
• If sexually active, are willing to use an effective method of contraception during the study and for 30days after the last administration of the study drug.

You may not qualify if:

• Any active AIDS-defining illness per Category C except for cutaneous Kaposi's sarcoma and wasting due to HIV
• Any significant disease (other than HIV-1 infection) or clinically significant findings, including psychiatric and behavioral problems, medical history and/or physical examination that, in the investigator's opinion, would preclude the patient from participating in this study
• 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

Sponsors & Collaborators

• Kaiser Permanente: lead
• TaiMed Biologics Inc.: collaborator

Study Sites (1)

Kaiser Permanente Southern California

Los Angeles, California, 90027, United States

Location

MeSH Terms

Conditions

HIV Infections

Interventions

ibalizumab

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases

Study Officials

• William Towner, MD

  Kaiser Permanente

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Partner Physician

Study Record Dates

• First Submitted: January 22, 2010
• First Posted: January 26, 2010
• Study Start: November 1, 2009
• Primary Completion: December 15, 2016
• Study Completion: December 15, 2016
• Last Updated: July 12, 2018

Record last verified: 2018-07

Locations

US (1)