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Real-World data sought on ibalizumab for Tough-to-Treat HIV

NCT ID NCT05388474

Disease control Sponsor: Theratechnologies Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jul 28, 2026 · Updated 2 times

Summary

This study looks at how well the drug ibalizumab works for people with multidrug-resistant HIV in everyday medical practice. It compares patients who receive ibalizumab plus other HIV drugs to similar patients who do not receive ibalizumab. The goal is to understand long-term virus control, immune system health, and safety. About 168 heavily treatment-experienced adults with limited options are being followed.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Participants

168 people

The number who actually took part.

Started

Mar 2022

Finished

Jul 2026

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Who is studied

The study will enroll Heavily treatment-experienced (HTE) adult patients infected with MDR HIV-1. For Cohort 2, the study will accept patients prescribed ibalizumab across study sites, including patients previously enrolled in Cohort 1 who subsequently initiated ibalizumab treatment. The decision to include ibalizumab in the treatment regimen will be clinical and independent of patient inclusion in the study.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: 1. The patient is Heavily treatment-experienced (HTE), with limited treatment options and a history of treatment failure; 2. Based on recent or historical resistance assays and ARV history, patients must have documented Multi Drug Resistant (MDR) HIV-1 (e.g., laboratory report and documented past ARV treatment); 3. Received an appropriate HIV-1 resistance assay (genotypic or phenotypic testing) to devise an OBR (which may include an investigational ARV treatment) or will receive an appropriate resistance assay prior to initiating ibalizumab treatment; 4. Provide signed and dated informed consent to the Investigator, indicating that the patient (or, legally acceptable representative) has been informed of all pertinent aspects of the study, and is capable of understanding and willing to comply with the registry requirements. The consent will request to access the patient's medical, hospital, pharmacy, and vital statistics records as appropriate, as well as historical medical data for the full retrospective time period (01 May 2018 to enrollment). Further, consent will be provided for access to all available historical resistance and ARV treatment data; 5. ≥18 years of age or older at the time of screening; 6. Provide information on at least one alternate contact person of their choice (primary care physician, close relative or emergency contact) who can be contacted, should the patient be lost to follow-up over the course of the study; 7. Acknowledgement that in the event of their death, additional information can be obtained by contacting their primary care physician, a close relative, emergency contact or by consulting public or external databases (death registries, obituary listings) when available and verifiable. This is to be done in accordance with local regulatory requirements and laws; 8. Exceptionally, patients who may have started ibalizumab outside of the approved indication can also be included in Cohort 2 of the registry at the discretion of the investigator, provided they determine clinical utility. Exclusion Criteria: 1. Pregnant or breastfeeding; 2. Unable to provide informed consent; 3. Hypersensitivity to ibalizumab or any of the excipients in ibalizumab; 4. Previous ibalizumab experience (Cohort 1 only) 5. Previously enrolled in Cohort 2 of this registry.

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Conditions

The condition(s) this trial relates to.

HIV infectious disease

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

HIV infections Multi-antiviral resistance

Contacts and locations

Locations

  • Aids Healthcare Foundation

    Fort Lauderdale, Florida, 33308, United States

  • Amity Medical Group

    Charlotte, North Carolina, 28215, United States

  • BIOS Clinical Research

    Palm Springs, California, 92262, United States

  • Bliss Health

    Orlando, Florida, 32806, United States

  • Boston Medical Center

    Boston, Massachusetts, 02118, United States

  • CAN Community Health

    Tampa, Florida, 34232, United States

  • Can Community Health

    Tampa, Florida, 33614, United States

  • Circle Care Center

    Stamford, Connecticut, 06850, United States

  • Gary J. Richmond, M.D., PA

    Fort Lauderdale, Florida, 33316, United States

  • Georgetown University Medical Center

    Washington D.C., District of Columbia, 20007, United States

  • Henry Ford Hospital

    Detroit, Michigan, 48202, United States

  • I.D. Care Associates, PA

    Hillsborough, New Jersey, 08844, United States

  • Indiana University Health Inc.

    Bloomington, Indiana, 47405, United States

  • Las Vegas Research Center

    Las Vegas, Nevada, 89106, United States

  • Legacy Community Pharmacy Services

    Houston, Texas, 77074, United States

  • Medical University of South Carolina

    Charleston, South Carolina, 29425, United States

  • Midway Specialty Care Center Miami Beach

    Miami Beach, Florida, 33140, United States

  • Mills Clinical Research

    Los Angeles, California, 90046, United States

  • North Texas Infectious Diseases Consultants, P.A

    Dallas, Texas, 75246, United States

  • Orlando Immunology Center (OIC)

    Orlando, Florida, 32803, United States

  • Prime Healthcare Services - St Michael's Medical Center

    Newark, New Jersey, 07102, United States

  • Prism Health North Texas

    Dallas, Texas, 75204, United States

  • Ruane Clinical Research

    Los Angeles, California, 90036, United States

  • SUNY Upstate Medical Center

    Syracuse, New York, 13210, United States

  • St-Joseph's Comprehensive Research

    Tampa, Florida, 33614, United States

  • St. Hope Foundation

    Houston, Texas, 77036, United States

  • The Research Institute

    Springfield, Massachusetts, 01105, United States

  • The Roper St. Francis Ryan White Wellness Center

    Charleston, South Carolina, 29407, United States

  • Therapeutic Concepts, PA

    Houston, Texas, 77004, United States

  • Triple O Research Institute PA

    West Palm Beach, Florida, 33407, United States

  • UC San Diego Owen Clinic

    San Diego, California, 92103, United States

  • UT Health Houston

    Houston, Texas, 77030, United States

  • University of Maryland School of Medicine

    Baltimore, Maryland, 21201, United States

  • Waterbury Hospital

    Waterbury, Connecticut, 06702, United States

  • Whitman Walker Health

    Washington D.C., District of Columbia, 20005, United States

  • Yale University

    New Haven, Connecticut, 06520, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.