Home › Trials › NCT05388474

Evaluating outcomes of multidrug-resistant HIV patients with and without ibalizumab

A Prospective and Retrospective Observational Study of Multidrug-Resistant Patient Outcomes With and Without Ibalizumab in a Real-World Setting: United States

Observational Theratechnologies · NCT05388474

This study is testing whether adding ibalizumab to other HIV treatments can help people with multidrug-resistant HIV feel better and stay healthier compared to those who don’t receive ibalizumab.

Quick facts

Study typeObservational
Enrollment200 (estimated)
Ages18 Years and up
SexAll
SponsorTheratechnologies Industry-sponsored
Drugs / interventionsibalizumab
Locations36 sites (Los Angeles, California and 35 other locations)
Trial IDNCT05388474 on ClinicalTrials.gov

What this trial studies

This observational study aims to assess the long-term efficacy, safety, and durability of ibalizumab in combination with other antiretroviral therapies (ART) for patients with multidrug-resistant HIV. It will compare the virologic, immunologic, and clinical outcomes of patients receiving ibalizumab treatment against those who are not. The study will also capture patient-reported outcomes and additional data on the efficacy and safety of ibalizumab until the study concludes. By expanding the clinical data set for ibalizumab, the study seeks to provide insights into its impact on treatment regimens in a diverse patient population.

Who should consider this trial

Good fit: Ideal candidates for this study are heavily treatment-experienced patients with documented multidrug-resistant HIV and limited treatment options.

Not a fit: Patients with non-multidrug-resistant HIV or those who are not heavily treatment-experienced may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide new treatment options and improved outcomes for patients with multidrug-resistant HIV.

How similar studies have performed: Other studies have shown promising results with ibalizumab, indicating its potential effectiveness in treating multidrug-resistant HIV.

Eligibility criteria

Show full inclusion / exclusion criteria 
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.

Where this trial is running

Los Angeles, California and 35 other locations

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions HIV InfectionsMulti-Antiviral ResistanceHIVDrug resistance
Last reviewed 2026-06-13 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.