HIVPhase 3NCT02707861
Ibalizumab Plus Optimized Background Regimen in Treatment-Experienced Patients With Multi-Drug Resistant HIV-1
A Phase 3 study testing ibalizumab and Optimized Background Regimen in people with HIV, run by TaiMed Biologics Inc. at 32 sites in 2 countries.
Trial summary
Ibalizumab is a monoclonal antibody that works by blocking HIV entry into the immune system cells (CD4+ or T-cells) the virus typically infects. Ibalizumab is intended for use in combination with other anti-HIV drugs in people with multi-drug resistant HIV and limited treatment options. 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
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 79 participants
- Where
- 32 sitesin 2 countries
- Study dates
- Mar 2016to Nov 2018
- 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
- (Cohort 1)
- Currently receiving ibalizumab via other TaiMed-sponsored or investigator-Sponsored protocol
- Are capable of understanding and have voluntarily signed the informed consent document
- (Cohort 2)
- 18 years of age or older
- Are capable of understanding and have voluntarily signed the informed consent document
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- Have documented HIV-1 infection by official, signed, written history (e.g., laboratory report), otherwise an HIV-antibody test will be performed
- Are able and willing to comply with all protocol requirements and procedures
- 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 previous viral resistance testing (resistance testing is not provided by the study for qualification purposes)
- Have a history of at least 6 months on antiretroviral treatment
- Are receiving a failing antiretroviral regimen OR have failed and are off therapy
- Have viral sensitivity/susceptibility to at least one antiretroviral agent, other than ibalizumab, as determined by previous resistance test performed within 6 months of screening 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 resistance tests used for screening 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
- (Cohort 1)
- There are no Exclusion Criteria for patients meeting the Inclusion Criteria for Cohort 1
- (Cohort 2)
- Eligible for participation in other TaiMed-sponsored clinical trials of ibalizumab
- 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 first administration of investigational medication on this study
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- 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 4 weeks before Day 0
- Any prior exposure to ibalizumab (formerly TNX-355 and Hu5A8)
- Any vaccination within 7 days before Day 0
- 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 on this study
- Any clinically significant Grade 3 or 4 laboratory abnormality according to the Division of AIDS (DAIDS) grading scale, except for the following asymptomatic Grade 3 events:
- triglyceride elevation
- total cholesterol elevation
Trial locations and contacts
32 sites in 2 countries.
32 sites in 2 countries
United States31 sites
AIDS Research Consortium of Atlanta
Atlanta, Georgia, 30312
St. Hope Foundation Community Health Center
Bellaire, Texas, 77401
National Institute of Allergy & Infectious Diseases
Bethesda, Maryland, 20892
Howard Brown Health Center
Chicago, Illinois, 60613
North Texas Infectious Disease Consultants
Dallas, Texas, 75246
Gary Richmond, MD, PA
Fort Lauderdale, Florida, 33316
East Carolina University
Greenville, North Carolina, 27834
University of Hawaii - John A. Burns School of Medicine
Honolulu, Hawaii, 96813
Crofoot Research Center
Houston, Texas, 77098
Research Access Network
Houston, Texas, 77098
Long Beach Education and Research Consultants
Long Beach, California, 90813
Southern California Permanente Medical Group
Los Angeles, California, 90027
Ruane Clinical Research Institute Inc.
Los Angeles, California, 90036
Charles R. Drew University of Medicine and Science, Clinical and Translational Research Center
Los Angeles, California, 90059
Anthony Mills MD Inc.
Los Angeles, California, 90069
St. Jude's Children's Research Hospital
Memphis, Tennessee, 38105
AIDS Healthcare Foundation - Kinder Medical Group
Miami, Florida, 33133
AIDS Healthcare Foundation - South Beach
Miami, Florida, 33140
Yale University
New Haven, Connecticut, 06510
AIDS Healthcare Foundation - Manhattan Midtown HCC
New York, New York, 10001
Chelsea Village Medical
New York, New York, 10011
Orlando Immunology Center
Orlando, Florida, 32803
Palmtree Clinical Research, Inc.
Palm Springs, California, 92262
Philadelphia FIGHT
Philadelphia, Pennsylvania, 19107
eStudy Site
San Francisco, California, 94115
Kaiser Foundation Research Institute
San Francisco, California, 94118
ID Research Institute
Springfield, Massachusetts, 01105
Central West Clinical Research
St Louis, Missouri, 63108
Jacobi Medical Center
The Bronx, New York, 10461
Georgetown University School of Medicine
Washington D.C., District of Columbia, 20007
Triple O Research Institute
West Palm Beach, Florida, 33401
About this study
Official title: A Phase 3, Multicenter, Expanded Access Study of Ibalizumab Plus an Optimized Background Regimen (OBR) in Treatment-Experienced Patients Infected With Multi-Drug Resistant (MDR) HIV-1
Ibalizumab is a monoclonal antibody that works by blocking HIV entry into the immune system cells (CD4+ or T-cells) the virus typically infects. Ibalizumab is intended for use in combination with other anti-HIV drugs in people with multi-drug resistant HIV and limited treatment options. This study will collect further information on the safety and tolerability of intravenously administered (IV) ibalizumab combined with an optimized background regimen for treating multi-drug resistant HIV-1 infection, and will provide continuing access to ibalizumab for patients completing a prior ibalizumab clinical trial.
Read the detailed description
Participants will enroll into one of two study cohorts. Cohort 1 will provide continued administration of IV ibalizumab for patients completing a prior ibalizumab clinical trial (TaiMed-sponsored or Investigator-Sponsored). Patients will continue to receive IV infusions of ibalizumab at the dosage assigned in the previous study - either 800 mg once every two weeks, or 2000 mg once every four weeks.
Cohort 2 will provide IV ibalizumab, 800 mg once every two weeks, for qualifying patients with multi-drug resistant HIV-1 and limited treatment options who have never previously received ibalizumab.
Participants may continue in this study for 48 weeks, or until ibalizumab becomes commercially available, whichever occurs first.
- Conditions
- HIV
- Being tested
- ibalizumab, Optimized Background Regimen
- Keywords
- HIV, Resistant, Salvage, ibalizumab, antibody, AIDS
- Medical subject headings
- Acquired Immunodeficiency Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ibalizumabDrug
Also called TNX-355, Hu5A8
Intravenous infusion of humanized monoclonal antibody binding with a region of Domain 2 of CD4 receptor, blocking post-attachment conformational changes necessary for HIV cell entry
Optimized Background RegimenDrug
Also called antiretroviral therapy
An investigator-selected, standard-of-care combination regimen of antiretroviral agents for treating HIV-1 infection, selected based upon patient treatment history and the results of previous viral resistance testing. The combination must contain at least one agent other than ibalizumab to which the patient's virus is sensitive (susceptible).
| Study group | Role | What they receive |
|---|---|---|
| Cohort 1 | Experimental | IV ibalizumab (combined with optimized background regimen):
800 mg once every two weeks for patients receiving that dosage on prior, successfully completed ibalizumab clinical trial
OR
2000 mg once every four weeks for patients receiving that dosage on prior, successfully completed ibalizumab clinical trial
Administered for 48 weeks, or until ibalizumab becomes commercially available Receives: Drug: ibalizumab; Drug: Optimized Background Regimen |
| Cohort 2 | Experimental | IV ibalizumab (combined with optimized background regimen):
800 mg once every two weeks for qualifying patients who have never received ibalizumab
Administered for 48 weeks, or until ibalizumab becomes commercially available Receives: Drug: ibalizumab; Drug: Optimized Background Regimen |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety and Tolerability of Ibalizumab + OBR
Number of participants with Grade 3/4 adverse events possibly, probably, or definitely due to ibalizumab
Measured: Through 48 weeks
Discontinuations Due to Adverse Events Related to Ibalizumab
number of participants discontinuing ibalizumab treatment due to adverse events probably, possibly, or definitely related to ibalizumab
Measured: 48 weeks
Effectiveness of Ibalizumab + OBR (Cohort 2 Only)
Number of patients in Cohort 2 achieving at least a 0.5 log change from Baseline in viral load at Day 7 of the study
Measured: 7 days
Secondary outcomes (3)
Suppression to <50 Copies With Ibalizumab + OBR (Cohort 2 Only)
Number of patients in Cohort 2 with HIV-1 RNA levels <50 copies/mL at week 48
Measured: 48 weeks
Suppression to <400 Copies by Ibalizumab + OBR (Cohort 2 Only)
Number of patients in Cohort 2 with HIV-1 RNA levels <400 copies/mL at week 48
Measured: 48 weeks
Effectiveness of Ibalizumab + OBR by 1.0 Log10 Decrease in Viral Load From Baseline (Cohort 2 Only)
Number of patients in Cohort 2 achieving at least a 1.0 log10 decrease in viral load from Baseline measurement at all assessment time points
Measured: 48 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Mar 2016 (estimated)
- Study startMar 2016
- Primary completionNov 2018
- Study completionNov 2018
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.
- 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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 79 participants (actual)
Sponsor and investigators
- Lead sponsor
- TaiMed Biologics Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Westat
- Responsible party
- Sponsor
- Investigators
- Stanley T. Lewis, MD, MPH, Principal investigator, TaiMed Biologics Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02707861
- Sponsor's protocol ID
- TMB-311
- Status last verified
- Feb 2021
- First submitted
- 8 Mar 2016
- Last updated
- 11 Mar 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 3, Multicenter, Expanded Access Study of Ibalizumab Plus an Optimized Background Regimen (OBR) in Treatment-Experienced Patients Infected With Multi-Drug Resistant (MDR) HIV-1
- ClinicalTrials.gov ID
- NCT02707861
- Acronym / sponsor ID
- TMB-311
- Conditions
- HIV
- Keywords
- HIV, Resistant, Salvage, ibalizumab, antibody, AIDS
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 79 participants (actual)
- Lead sponsor
- TaiMed Biologics Inc.Industry (pharma, biotech, devices)
- Collaborators
- Westat
- Study start
- Mar 2016
- Primary completion
- Nov 2018 (actual)
- Study completion
- Nov 2018 (actual)
- First posted
- 14 Mar 2016 (estimated)
- Results
- Posted 11 Mar 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Ibalizumab is a monoclonal antibody that works by blocking HIV entry into the immune system cells (CD4+ or T-cells) the virus typically infects. Ibalizumab is intended for use in combination with other anti-HIV drugs in people with multi-drug resistant HIV and limited treatment options. This study will collect further information on the safety and tolerability of intravenously administered (IV) ibalizumab combined with an optimized background regimen for treating multi-drug resistant HIV-1 infection, and will provide continuing access to ibalizumab for patients completing a prior ibalizumab clinical trial.
Detailed description
Participants will enroll into one of two study cohorts. Cohort 1 will provide continued administration of IV ibalizumab for patients completing a prior ibalizumab clinical trial (TaiMed-sponsored or Investigator-Sponsored). Patients will continue to receive IV infusions of ibalizumab at the dosage assigned in the previous study - either 800 mg once every two weeks, or 2000 mg once every four weeks.
Cohort 2 will provide IV ibalizumab, 800 mg once every two weeks, for qualifying patients with multi-drug resistant HIV-1 and limited treatment options who have never previously received ibalizumab.
Participants may continue in this study for 48 weeks, or until ibalizumab becomes commercially available, whichever occurs first.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cohort 1 | Experimental | Drug: ibalizumab, Drug: Optimized Background RegimenIV ibalizumab (combined with optimized background regimen): 800 mg once every two weeks for patients receiving that dosage on prior, successfully completed ibalizumab clinical trial OR 2000 mg once every four weeks for patients receiving that dosage on prior, successfully completed ibalizumab clinical trial Administered for 48 weeks, or until ibalizumab becomes commercially available |
| Cohort 2 | Experimental | Drug: ibalizumab, Drug: Optimized Background RegimenIV ibalizumab (combined with optimized background regimen): 800 mg once every two weeks for qualifying patients who have never received ibalizumab Administered for 48 weeks, or until ibalizumab becomes commercially available |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- (Cohort 1)
- Currently receiving ibalizumab via other TaiMed-sponsored or investigator-Sponsored protocol
- Are capable of understanding and have voluntarily signed the informed consent document
- (Cohort 2)
- 18 years of age or older
Key exclusion criteria (17 listed)
- (Cohort 1)
- There are no Exclusion Criteria for patients meeting the Inclusion Criteria for Cohort 1
- (Cohort 2)
- Eligible for participation in other TaiMed-sponsored clinical trials of ibalizumab
- 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
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, Hu5A8Intravenous infusion of humanized monoclonal antibody binding with a region of Domain 2 of CD4 receptor, blocking post-attachment conformational changes necessary for HIV cell entry | Drug | Cohort 1, Cohort 2 |
| Optimized Background RegimenAlso: antiretroviral therapyAn investigator-selected, standard-of-care combination regimen of antiretroviral agents for treating HIV-1 infection, selected based upon patient treatment history and the results of previous viral resistance testing. The combination must contain at least one agent other than ibalizumab to which the patient's virus is sensitive (susceptible). | Drug | Cohort 1, Cohort 2 |
Primary outcome
Safety and Tolerability of Ibalizumab + OBR
Time frame: Through 48 weeks
Number of participants with Grade 3/4 adverse events possibly, probably, or definitely due to ibalizumab
Discontinuations Due to Adverse Events Related to Ibalizumab
Time frame: 48 weeks
number of participants discontinuing ibalizumab treatment due to adverse events probably, possibly, or definitely related to ibalizumab
Effectiveness of Ibalizumab + OBR (Cohort 2 Only)
Time frame: 7 days
Number of patients in Cohort 2 achieving at least a 0.5 log change from Baseline in viral load at Day 7 of the study
3 secondary outcomes
Suppression to <50 Copies With Ibalizumab + OBR (Cohort 2 Only)
Time frame: 48 weeks
Suppression to <400 Copies by Ibalizumab + OBR (Cohort 2 Only)
Time frame: 48 weeks
Effectiveness of Ibalizumab + OBR by 1.0 Log10 Decrease in Viral Load From Baseline (Cohort 2 Only)
Time frame: 48 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Mar 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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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.
Stanley T. Lewis, MD, MPH principal investigator
TaiMed Biologics Inc.
32 sites in 2 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 in people with HIV, run by TaiMed Biologics Inc. at 32 sites in 2 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 13 inclusion and 17 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 11 Mar 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 32 sites in United States, 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 11 Mar 2021). 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?
Safety and Tolerability of Ibalizumab + OBR (time frame: Through 48 weeks). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 11 Mar 2021.