Status:
ACTIVE_NOT_RECRUITING
A Prospective and Retrospective Observational Study of Multidrug-Resistant Patient Outcomes With and Without Ibalizumab
Lead Sponsor:
Theratechnologies
Collaborating Sponsors:
Excelsus Statistics Inc.
Health Psychology Research Group (HPR)
Conditions:
HIV Infections
Multi-Antiviral Resistance
Eligibility:
All Genders
18+ years
Brief Summary
The virological efficacy of ibalizumab has been clearly demonstrated in multiple clinical trials. This study will expand ibalizumab's clinical data set and allow a better understanding of the virologi...
Detailed Description
Antiretroviral therapy (ART) for treatment of human immunodeficiency virus (HIV) has evolved tremendously over recent years. Newer medications have superior efficacy and tolerability, affording more c...
Eligibility Criteria
Inclusion
- The patient is Heavily treatment-experienced (HTE), with limited treatment options and a history of treatment failure;
- 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);
- 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;
- 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;
- ≥18 years of age or older at the time of screening;
- 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;
- 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;
- 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
- Pregnant or breastfeeding;
- Unable to provide informed consent;
- Hypersensitivity to ibalizumab or any of the excipients in ibalizumab;
- Previous ibalizumab experience (Cohort 1 only)
- Previously enrolled in Cohort 2 of this registry.
Key Trial Info
Start Date :
March 22 2022
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
June 1 2026
Estimated Enrollment :
168 Patients enrolled
Trial Details
Trial ID
NCT05388474
Start Date
March 22 2022
End Date
June 1 2026
Last Update
January 2 2026
Active Locations (36)
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1
Ruane Clinical Research
Los Angeles, California, United States, 90036
2
Mills Clinical Research
Los Angeles, California, United States, 90046
3
BIOS Clinical Research
Palm Springs, California, United States, 92262
4
UC San Diego Owen Clinic
San Diego, California, United States, 92103