A Prospective and Retrospective Observational Study of Multidrug-Resistant Patient Outcomes With … (NCT05388474) | Clinical Trial Compass
Active — Not RecruitingNot Applicable
A Prospective and Retrospective Observational Study of Multidrug-Resistant Patient Outcomes With and Without Ibalizumab
United States168 participantsStarted 2022-03-22
Plain-language 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 virologic response durability on ARV regimens with or without ibalizumab in a heterogeneous real-world patient population. Additional data on the efficacy and safety of ibalizumab and its impact on patient reported outcomes will be captured until study end.
Primary Objective:
To evaluate the long-term efficacy, safety, and durability of ibalizumab in combination with other ARVs by comparing the virologic, immunologic and clinical outcomes of patients receiving ibalizumab treatment versus patients not receiving ibalizumab.
Secondary Objective:
To assess the efficacy of ibalizumab in combination with other antiretrovirals by comparing the virologic, immunologic, clinical and patient reported outcomes of patients before and after they receive ibalizumab treatment.
To assess the long-term safety and tolerability of ibalizumab.
Other Objectives:
To assess risk factors/predictors of virologic and immunologic response. To assess efficacy and safety in special populations that enroll.
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. 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 criteria
✕. 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.