Overview

This trial is active, not recruiting.

Condition hiv
Treatments ibalizumab, optimized background regimen (obr)
Phase phase 3
Sponsor TaiMed Biologics Inc.
Start date August 2015
End date October 2016
Trial size 40 participants
Trial identifier NCT02475629, TMB-301

Summary

This Phase 3, single arm, multicenter study will evaluate the safety and effectiveness of ibalizumab in treatment-experienced patients infected with multi-drug resistant HIV-1.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Endpoint classification safety/efficacy study
Intervention model single group assignment
Masking open label
Primary purpose treatment
Arm
(Experimental)
2000 mg intravenous ibalizumab (loading dose) on Day 7 followed in 14 days (on Day 21) by 800 mg intravenous ibalizumab administered once every two weeks, plus an Optimized Background Regimen (OBR) beginning on Day 14.
ibalizumab TNX-355
2000mg intravenous ibalizumab (loading dose), followed 14 days later by 800mg intravenous ibalizumab every 2 weeks
optimized background regimen (obr)
All participants will be prescribed an Optimized Background Regimen of antiretroviral medications selected on the basis of treatment history and the results of Screening viral resistance and tropism testing. The prescribed regimen must contain at least one agent to which the participant's virus is known to be sensitive.

Primary Outcomes

Measure
Day 14 Viral Load Reduction as a Measure of Efficacy
time frame: at Day 14

Secondary Outcomes

Measure
Undetectable Viral Load as a Measure of Efficacy
time frame: at Week 25/End of Study
Mean Change in Viral Load as a Measure of Efficacy
time frame: at Day 14 and Week 25/End of Study
End of Study Viral Load Reductions as a Measure of Efficacy
time frame: at Week 25/End of Study
Mean Change in CD4+ Cell Count as a Measure of Efficacy and Safety
time frame: at Week 25/End of Study
Viral Sensitivity/Susceptibility Changes Associated with Virologic Failure after Administration of Ibalizumab as a Measure of Efficacy
time frame: Through Week 25/End of Study
CD4 Receptor Density as a Measure of Pharmacodynamics
time frame: Through Week 25/End of Study
CD4 Receptor Occupancy as a Measure of Pharmacodynamics
time frame: Through Week 25/End of Study
Number of Participants with Physical Examination Abnormalities as a Measure of Safety and Tolerability
time frame: Through Week 25/End of Study
Number of Participants with Vital Sign Measurement Abnormalities as a Measure of Safety and Tolerability
time frame: Through Week 25/End of Study
Number of Participants with 12-Lead Electrocardiogram Abnormalities as a Measure of Safety and Tolerability
time frame: Through Week 25/End of Study
Number of Participants with Abnormal Clinical Laboratory Parameters as a Measure of Safety and Tolerability
time frame: Through Week 25/End of Study
Number of Participants with Adverse Events as a Measure of Safety and Tolerability
time frame: Through Week 25/End of Study
Number of Participants with Class C AIDS-Defining Events as a Measure of Safety and Tolerability
time frame: Through Week 25/End of Study
Immunogenicity of Ibalizumab as a Measure of Safety and Tolerability
time frame: Through Week 25/End of Study

Eligibility Criteria

Male or female participants at least 18 years old.

Inclusion Criteria: - 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 - Have no acquired immunodeficiency syndrome (AIDS)-defining events in the 3 months before Screening, other than cutaneous Kaposi's sarcoma or wasting syndrome due to HIV - Are able and willing to comply with all protocol requirements and procedures - Have a life expectancy that is >6 months. - 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 resistance testing - Have a history of at least 6 months on antiretroviral treatment - Are receiving a stable highly active antiretroviral regimen for at least 8 weeks before Screening and are willing to continue that regimen until Day 14, OR (in the past 8 weeks) have failed and are off therapy and are willing to stay off therapy until Day 14 - Have full viral sensitivity/susceptibility to at least one antiretroviral agent, other than ibalizumab, as determined by the screening resistance tests 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 screening resistance tests 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: - Any active AIDS-defining illness per Category C conditions according to the Centers for Disease Control and Prevention (CDC) Classification System for HIV Infection, with the following exceptions: cutaneous Kaposi's sarcoma and wasting syndrome due to HIV - 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 initial administration of study drug - 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 12 weeks before Enrollment - Any prior exposure to ibalizumab (formerly TNX-355 and Hu5A8) - Any vaccination within 7 days before Enrollment - 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 - Any Grade 3 or 4 laboratory abnormality according to the Division of AIDS grading scale, except for the following asymptomatic Grade 3 events triglyceride elevation total cholesterol elevation

Additional Information

Official title A Phase 3, Single Arm, 24-Week, Multicenter Study of Ibalizumab Plus an Optimized Background Regimen (OBR) in Treatment-Experienced Patients Infected With Multi-Drug Resistant HIV-1
Description This Phase 3, single arm, multicenter study will evaluate the safety and effectiveness of ibalizumab in treatment-experienced patients infected with multi-drug resistant HIV-1. Patients must have been treated with HAART for at least 6 months and be failing or have recently failed (i.e., in the last 8 weeks) therapy to determine baseline viral load. Days 0-6 of the study will be a "control period." During Days 0 through 6 patients will be monitored on current failing therapy (or no therapy, if the patient has failed and discontinued treatment within the 8 weeks preceding Screening). Days 7-13 of the study will be an "essential monotherapy period." During Days 7 through 13 patients will continue on current failing therapy and receive one 2000 mg dose (loading dose) of ibalizumab on Day 7. Day 7 is Baseline for the treatment period (Day 7-Week 25). Day 14-Week 25 of the study will be the "maintenance period." On Day 14 (primary endpoint), the OBR will be initiated and must include at least one agent to which the patient's virus is susceptible. Beginning at Day 21, 800 mg of ibalizumab will be administered every 2 weeks through Week 23. End of Study evaluations will be performed at Week 25, and a follow-up visit will be conducted at Week 29.
Trial information was received from ClinicalTrials.gov and was last updated in November 2016.
Information provided to ClinicalTrials.gov by TaiMed Biologics Inc..