HIVPhase 3NCT02475629
Ibalizumab Plus Optimized Background Regimen in Patient With Multi-Drug Resistant HIV
A Phase 3 study testing ibalizumab and Optimized Background Regimen (OBR) in people with HIV, run by TaiMed Biologics Inc. at 30 sites in 3 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- HIV
- What is being tested?
- ibalizumab and Optimized Background Regimen (OBR)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 30 sitesin 3 countries
- Study dates
- Aug 2015to Dec 2016
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Show all 10Show fewer
- 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
Who cannot join
- 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)
Show all 12Show fewer
- 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
Trial locations and contacts
30 sites in 3 countries.
30 sites in 3 countries
United States27 sites
AIDS Research Consortium of Atlanta
Atlanta, Georgia, 30312
University of Maryland, Institute of Human Virology
Baltimore, Maryland, 21201
Carolinas HealthCare System
Charlotte, North Carolina, 28232
North Texas Infectious Disease Consultants
Dallas, Texas, 75246
Henry Ford Health Systems
Detroit, Michigan, 48202
Gary Richmond, MD, PA
Fort Lauderdale, Florida, 33316
Midway Immunology and Research Center
Ft. Pierce, Florida, 34982
Research Access Network
Houston, Texas, 77098
Long Beach Education and Research Consultants
Long Beach, California, 90813
W King Health Care Group
Los Angeles, California, 90008
Southern California Permanente Medical Group
Los Angeles, California, 90027
Ruane Medical and Clinical Research Institute
Los Angeles, California, 90036
Charles R. Drew Univ. of Med. & Science Clinical and Translational Research Center
Los Angeles, California, 90059
Anthony Mills, MD, Inc.
Los Angeles, California, 90069
AIDS Healthcare Foundation
Los Angeles, California, 90211
University of Miami
Miami, Florida, 33136
Yale University
New Haven, Connecticut, 06510
ACRIA
New York, New York, 10018
Circle Care Center, LLC
Norwalk, Connecticut, 06850
Orlando Immunology Center
Orlando, Florida, 32803
Palmtree Clinical Research Inc.
Palm Springs, California, 92262
Quest Clinical Research
San Francisco, California, 94115
Kaiser Foundation Research Institute
San Francisco, California, 94118
St. John Hospital and Medical Center
Southfield, Michigan, 48075
Montefiore Medical Center
The Bronx, New York, 10467
Georgetown University School of Medicine
Washington D.C., District of Columbia, 20007
Triple O Research Institute
West Palm Beach, Florida, 33401
Taiwan2 sites
E-Da Hospital
Kaohsiung City, 82445
National Taiwan University Hospital
Taipei, 10002
About this study
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
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.
Read the 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.
- Conditions
- HIV
- Being tested
- ibalizumab, Optimized Background Regimen (OBR)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ibalizumabBiological
Also called TNX-355, Hu1A8
2000mg intravenous ibalizumab (loading dose), followed 14 days later by 800mg intravenous ibalizumab every 2 weeks
Optimized Background Regimen (OBR)Drug
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.
| Study group | Role | What they receive |
|---|---|---|
| Open-Label Ibalizumab plus OBR | 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. Receives: Biological: ibalizumab; Drug: Optimized Background Regimen (OBR) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Efficacy: Proportion of Participants Achieving a Viral Load Reduction of at Least 0.5 Log 10: ITT-MEF
Proportion of participants (%) achieving a viral load reduction of at least 0.5 log from baseline (Day 7)
Measured: Day 14
Efficacy: Proportion of Subjects With a Viral Load Decrease of at Least 0.5 Log 10 - Protocol Correct
Proportion of patients (%) with a viral load decrease of at least 0.5 log 10 from baseline (day 7)
Measured: Day 14
Secondary outcomes (15)
Efficacy: Proportion of Patients With Undetectable Viral Load: ITT-MEF
Proportion of patients with undetectable Viral Load (<50 copies/mL, and <400 copies/mL)
Measured: Week 25 /end of study
Efficacy: Proportion of Patients With Undetectable HIV-RNA Levels: Protocol Correct
Proportion of patients (%) with HIV-RNA levels < 50 copies/mL and < 400 copies/mL at Week 25/End of Study
Measured: Week 25/End of Study
Mean Change in Viral Load as a Measure of Efficacy - ITT-MEF
Mean change from Day 7/Baseline in log 10 vial load measured at Day 14
Measured: Day 7 and Day 14
Mean Change in Viral Load as a Measure of Efficacy - Protocol Correct
Mean change from Day 7/Baseline in Log 10 viral load measured at Day 14
Measured: Day 7 and Day 14
End of Study Viral Load Reductions as a Measure of Efficacy - Intent to Treat Analysis
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
Measured: at Week 25/End of Study
End of Study Viral Load Reductions as a Measure of Efficacy - Protocol Correct Analysis
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
Measured: at Week 25/End of Study
Mean Change in CD4+ Cell Count as a Measure of Efficacy and Safety - ITT
Mean change from Day 7/Baseline in CD4+ cell count at Week 25/End of Study
Measured: Day 7 and Week 25/End of Study
Mean Change in CD4+ Cell Count as a Measure of Efficacy and Safety - Protocol Correct
Mean change from Day 7/Baseline in CD4+ cell count at Week 25/End of Study
Measured: Day 7 and Week 25/End of Study
Safety: Proportion of Participants Experiencing Adverse Events
Proportion of participants experiencing at least one treatment emergent adverse event to week 25/End of Study
Measured: Through Week 25/End of Study
Proportion of Participants Experiencing Adverse Event Related to Study Drug as a Measure of Safety and Tolerability
Proportion of participants experiencing a treatment emergent adverse event determined by the investigator to be related to study drug
Measured: Through Week 25/End of Study
Proportion of Participants Experiencing Serious Adverse Event as a Measure of Safety and Tolerability
Proportion of participants experiencing at least one serious treatment emergent adverse event, excluding death
Measured: Through Week 25/End of Study
Proportion of Participants Discontinuing Study Drug Due to Adverse Event
Proportion of participants discontinuing study drug due to occurrence of treatment emergent adverse event
Measured: Through Week 25/End of Study
Proportion of Participants Experiencing Adverse Event Grade 3 and Higher as a Measure of Safety and Tolerability
Proportion of participants experiencing treatment emergent adverse event Grade 3 and higher
Measured: Through Week 25/End of Study
Proportion of Participants Experiencing Adverse Event With Death as Outcome as a Measure of Safety and Tolerability
Proportion of participants experiencing treatment emergent adverse event with death as the outcome, regardless of relationship to study drug
Measured: Through Week 25/End of Study
Proportion of Participants Experiencing New AIDS-defining Adverse Event According to CDC Criteria as a Measure of Safety and Tolerability
Proportion of participants experiencing treatment emergent adverse event that is AIDS-defining by the CDC adverse event classification criteria for HIV infection
Measured: Through Week 25/End of Study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jun 2015 (estimated)
- Study startAug 2015
- Primary completionOct 2016
- Study completionDec 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for HIVStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- TaiMed Biologics Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02475629
- Sponsor's protocol ID
- TMB-301
- Status last verified
- Feb 2020
- First submitted
- 11 Jun 2015
- Last updated
- 19 Mar 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
Emu B, Fessel J, Schrader S, Kumar P, Richmond G, Win S, Weinheimer S, Marsolais C, Lewis S. Phase 3 Study of Ibalizumab for Multidrug-Resistant HIV-1. N Engl J Med. 2018 Aug 16;379(7):645-654. doi: 10.1056/NEJMoa1711460.
PubMed 30110589
Study at a glance
From the registry record, last updated by the sponsor on 19 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02475629
- Acronym / sponsor ID
- TMB-301
- Conditions
- HIV
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- TaiMed Biologics Inc.Industry (pharma, biotech, devices)
- Study start
- Aug 2015
- Primary completion
- Oct 2016 (actual)
- Study completion
- Dec 2016 (actual)
- First posted
- 19 Jun 2015 (estimated)
- Results
- Posted 19 Mar 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Open-Label Ibalizumab plus OBR | Experimental | Biological: ibalizumab, Drug: Optimized Background Regimen (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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 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.
Key exclusion criteria (12 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ibalizumabAlso: TNX-355, Hu1A82000mg intravenous ibalizumab (loading dose), followed 14 days later by 800mg intravenous ibalizumab every 2 weeks | Biological | Open-Label Ibalizumab plus OBR |
| 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. | Drug | Open-Label Ibalizumab plus OBR |
Primary outcome
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)
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)
15 secondary outcomes
Efficacy: Proportion of Patients With Undetectable Viral Load: ITT-MEF
Time frame: Week 25 /end of study
Efficacy: Proportion of Patients With Undetectable HIV-RNA Levels: Protocol Correct
Time frame: Week 25/End of Study
Mean Change in Viral Load as a Measure of Efficacy - ITT-MEF
Time frame: Day 7 and Day 14
Mean Change in Viral Load as a Measure of Efficacy - Protocol Correct
Time frame: Day 7 and Day 14
End of Study Viral Load Reductions as a Measure of Efficacy - Intent to Treat Analysis
Time frame: at Week 25/End of Study
End of Study Viral Load Reductions as a Measure of Efficacy - Protocol Correct Analysis
Time frame: at Week 25/End of Study
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 in CD4+ Cell Count as a Measure of Efficacy and Safety - Protocol Correct
Time frame: Day 7 and Week 25/End of Study
Safety: Proportion of Participants Experiencing Adverse Events
Time frame: Through Week 25/End of Study
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 Serious Adverse Event as a Measure of Safety and Tolerability
Time frame: Through Week 25/End of Study
Proportion of Participants Discontinuing Study Drug Due to Adverse Event
Time frame: Through Week 25/End of Study
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 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 New AIDS-defining Adverse Event According to CDC Criteria as a Measure of Safety and Tolerability
Time frame: Through Week 25/End of Study
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Mar 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 30110589Emu B, Fessel J, Schrader S, Kumar P, Richmond G, Win S, Weinheimer S, Marsolais C, Lewis S. Phase 3 Study of Ibalizumab for Multidrug-Resistant HIV-1. N Engl J Med. 2018 Aug 16;379(7):645-654. doi: 10.1056/NEJMoa1711460.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
30 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing ibalizumab and Optimized Background Regimen (OBR) in people with HIV, run by TaiMed Biologics Inc. at 30 sites in 3 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Mar 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 30 sites in United States, Taiwan, Puerto Rico. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 19 Mar 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Efficacy: Proportion of Participants Achieving a Viral Load Reduction of at Least 0.5 Log 10: ITT-MEF (time frame: Day 14). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02475629, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Mar 2020.