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Ibalizumab Plus Optimized Background Regimen in Patient With Multi-Drug Resistant HIV

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02475629
Recruitment Status : Completed
First Posted : June 19, 2015
Results First Posted : March 19, 2020
Last Update Posted : March 19, 2020
Sponsor:
Information provided by (Responsible Party):
TaiMed Biologics Inc.

Brief 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.

Condition or disease Intervention/treatment Phase
HIV Biological: ibalizumab Drug: Optimized Background Regimen (OBR) Phase 3

Detailed 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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 40 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Study Start Date : August 2015
Actual Primary Completion Date : October 2016
Actual Study Completion Date : December 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS

Arm Intervention/treatment
Experimental: Open-Label Ibalizumab plus OBR
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.
Biological: ibalizumab
2000mg intravenous ibalizumab (loading dose), followed 14 days later by 800mg intravenous ibalizumab every 2 weeks
Other Names:
  • TNX-355
  • Hu1A8

Drug: 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 Outcome Measures :
  1. Efficacy: Proportion of Participants Achieving a Viral Load Reduction of at Least 0.5 Log 10: ITT-MEF [ Time Frame: Day 14 ]
    Proportion of participants (%) achieving a viral load reduction of at least 0.5 log from baseline (Day 7)

  2. Efficacy: Proportion of Subjects With a Viral Load Decrease of at Least 0.5 Log 10 - Protocol Correct [ Time Frame: Day 14 ]
    Proportion of patients (%) with a viral load decrease of at least 0.5 log 10 from baseline (day 7)


Secondary Outcome Measures :
  1. Efficacy: Proportion of Patients With Undetectable Viral Load: ITT-MEF [ Time Frame: Week 25 /end of study ]
    Proportion of patients with undetectable Viral Load (<50 copies/mL, and <400 copies/mL)

  2. Efficacy: Proportion of Patients With Undetectable HIV-RNA Levels: Protocol Correct [ Time Frame: Week 25/End of Study ]
    Proportion of patients (%) with HIV-RNA levels < 50 copies/mL and < 400 copies/mL at Week 25/End of Study

  3. Mean Change in Viral Load as a Measure of Efficacy - ITT-MEF [ Time Frame: Day 7 and Day 14 ]
    Mean change from Day 7/Baseline in log 10 vial load measured at Day 14

  4. Mean Change in Viral Load as a Measure of Efficacy - Protocol Correct [ Time Frame: Day 7 and Day 14 ]
    Mean change from Day 7/Baseline in Log 10 viral load measured at Day 14

  5. End of Study Viral Load Reductions as a Measure of Efficacy - Intent to Treat Analysis [ Time Frame: at Week 25/End of Study ]
    Proportion of patients achieving a >/= 0.5 log10 and >/= 1.0 log10 decrease from Day 7/Baseline in viral load at Week 25/End of Study

  6. End of Study Viral Load Reductions as a Measure of Efficacy - Protocol Correct Analysis [ Time Frame: at Week 25/End of Study ]
    Proportion of patients achieving a >/= 0.5 log10 and >/= 1.0 log10 decrease from Day 7/Baseline in viral load at Week 25/End of Study

  7. Mean Change in CD4+ Cell Count as a Measure of Efficacy and Safety - ITT [ Time Frame: Day 7 and Week 25/End of Study ]
    Mean change from Day 7/Baseline in CD4+ cell count at Week 25/End of Study

  8. Mean Change in CD4+ Cell Count as a Measure of Efficacy and Safety - Protocol Correct [ Time Frame: Day 7 and Week 25/End of Study ]
    Mean change from Day 7/Baseline in CD4+ cell count at Week 25/End of Study

  9. Safety: Proportion of Participants Experiencing Adverse Events [ Time Frame: Through Week 25/End of Study ]
    Proportion of participants experiencing at least one treatment emergent adverse event to week 25/End of Study

  10. Proportion of Participants Experiencing Adverse Event Related to Study Drug as a Measure of Safety and Tolerability [ Time Frame: Through Week 25/End of Study ]
    Proportion of participants experiencing a treatment emergent adverse event determined by the investigator to be related to study drug

  11. Proportion of Participants Experiencing Serious Adverse Event as a Measure of Safety and Tolerability [ Time Frame: Through Week 25/End of Study ]
    Proportion of participants experiencing at least one serious treatment emergent adverse event, excluding death

  12. Proportion of Participants Discontinuing Study Drug Due to Adverse Event [ Time Frame: Through Week 25/End of Study ]
    Proportion of participants discontinuing study drug due to occurrence of treatment emergent adverse event

  13. Proportion of Participants Experiencing Adverse Event Grade 3 and Higher as a Measure of Safety and Tolerability [ Time Frame: Through Week 25/End of Study ]
    Proportion of participants experiencing treatment emergent adverse event Grade 3 and higher

  14. Proportion of Participants Experiencing Adverse Event With Death as Outcome as a Measure of Safety and Tolerability [ Time Frame: Through Week 25/End of Study ]
    Proportion of participants experiencing treatment emergent adverse event with death as the outcome, regardless of relationship to study drug

  15. Proportion of Participants Experiencing New AIDS-defining Adverse Event According to CDC Criteria as a Measure of Safety and Tolerability [ Time Frame: Through Week 25/End of Study ]
    Proportion of participants experiencing treatment emergent adverse event that is AIDS-defining by the CDC adverse event classification criteria for HIV infection


Other Outcome Measures:
  1. Pharmacodynamics: CD4 Receptor Occupancy [ Time Frame: At Week 25/End of Study ]
    % of CD receptors occupied by ibalizumab on CD4+ T-cells



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02475629


Locations
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Sponsors and Collaborators
TaiMed Biologics Inc.
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: TaiMed Biologics Inc.
ClinicalTrials.gov Identifier: NCT02475629    
Other Study ID Numbers: TMB-301
First Posted: June 19, 2015    Key Record Dates
Results First Posted: March 19, 2020
Last Update Posted: March 19, 2020
Last Verified: February 2020
Additional relevant MeSH terms:
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Ibalizumab
Anti-HIV Agents
Anti-Retroviral Agents
Antiviral Agents
Anti-Infective Agents