Overview

This trial is active, not recruiting.

Condition hiv infections
Treatment ibalizumab
Phase phase 2
Sponsor Kaiser Permanente
Collaborator TaiMed Biologics Inc.
Start date November 2009
End date May 2017
Trial size 4 participants
Trial identifier NCT01056393, 5460

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Intervention model parallel assignment
Masking open label
Primary purpose treatment
Arm
(Experimental)
Subject will receive 800mg of ibalizumab every 2 weeks administered by intravenous infusion. All patients also will receive optimized background regimen
ibalizumab TNX-355
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 q2weeks, or 2000mg q4weeks.
(Experimental)
Subject will receive 2000mg of ibalizumab every 4 weeks administered by intravenous infusion. All patients also will receive optimized background regimen
ibalizumab TNX-355
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 q2weeks, or 2000mg q4weeks.

Primary Outcomes

Measure
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.
time frame: Every two months

Eligibility Criteria

Male or female participants at least 18 years old.

Inclusion Criteria: - 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. Exclusion Criteria: - 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

Additional Information

Official title Investigator-Sponsored Protocol - Continued Use of Ibalizumab
Principal investigator William Towner, MD
Description Ibalizumab is to be administered to HIV-infected patients that have responded (defined as a minimum 0.7 log10 decline in HIV-1 viral load from TMB-202 Baseline) on the TMB-202 protocol. In addition to the investigator-selected Optimized Background Regimen, patient(s) will continue to receive the TMB-202 randomized dose of ibalizumab in open-labeled fashion (800mg IV every two weeks or 2000mg IV every four weeks) as per their original drug assignment for the TMB-202 protocol.
Trial information was received from ClinicalTrials.gov and was last updated in September 2016.
Information provided to ClinicalTrials.gov by Kaiser Permanente.