A Prospective and Retrospective Observational Study of Multidrug-Resistant Patient Outcomes With and Without Ibalizumab (PROMISE-US)
K
Kassem Bourgi, MD
Primary Investigator
Enrolling By Invitation
18 years and older
All
Phase
N/A
600 participants needed
1 Location
Brief description of study
The virological efficacy of ibalizumab has been clearly demonstrated in multiple clinical. 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 ibalizumabheterogeneous real-world patient population. Additional data on the efficacy and safetybalizumab 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 withher ARVs by comparing the virologic, immunologic and clinical outcomes of patientsving ibalizumab treatment versus patients not receiving ibalizumab.
Secondary Objective:
To assess the efficacy of ibalizumab in combination with other antiretrovirals by comparinghe virologic, immunologic, clinical and patient reported outcomes of patients before andhey 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 efficacyd safety in special populations that enroll.
Detailed description of study
Antiretroviral therapy (ART) for treatment of human immunodeficiency virus (HIV) has evolveddously over recent years. Newer medications have superior efficacy and tolerability,ding more convenient treatment regimens. The proportion of patients receivingviral (ARV) treatment that maintain viral suppression is approximately 85% in thed States. However, some patients may not be able to adhere to the prescribed ARV regimenharbour strains of HIV that are resistant to most currently available therapies.ulti-drug resistant (MDR) HIV may be transmitted or result from incomplete viraluppression, which leads to accumulation of mutations in the viral genome over time. Patients
with MDR HIV infection have significantly fewer available treatment options to construct aully suppressive regimen. This ultimately results in shorter life expectancy, greaterDR virus, increased morbidity and greater use of healthurces. These comparisons are valid for the general population as well as people infected
with non-MDR virus.
Ibalizumab, a humanized IgG4 monoclonal antibody that binds to a conformational epitope on
domain 2 of the extracellular portion of the CD4 receptor, belongs to a new class of ARVs,
CD4-directed post-attachment HIV-1 inhibitors, Ibalizumab exhibits no known cross-resistance
with other ARV medications. Ibalizumab was approved by the FDA on March 6, 2018 and isdicated in combination with other ARVs for the treatment of HIV-1 infection in heavilyd adults with MDR HIV-1 infection failing their current ARV regimen. It
has been available commercially from April 2018.
The safety, efficacy and durability of response to ibalizumab treatment in combination withher ARVs have been demonstrated in clinical trials. This registry is designed to better
understand the long-term efficacy and safety outcomes of MDR patients with and withoutbalizumab in a real-world scenario.
Eligibility of study
You may be eligible for this study if you meet the following criteria:
- Conditions: HIV Infections, Multi-Antiviral Resistance
-
Age: 18 Years
-
Gender: All
Inclusion Criteria:
- The patient is Heavily treatment-experienced (HTE), with limited treatment options andhistory of treatment failure;
- Based on recent or historical resistance assays and ARV history, patients must havedocumented Multi Drug Resistant (MDR) HIV-1 (e.g., laboratory report and documentedARV treatment);
- Received an appropriate HIV-1 resistance assay (genotypic or phenotypic testing) todevise an OBR (which may include an investigational ARV treatment) or will receive any prior to initiating ibalizumab treatment;
- Provide signed and dated informed consent to the Investigator, indicating that the(or, legally acceptable representative) has been informed of all pertinenthe study, and is capable of understanding and willing to comply with thegistry requirements. The consent will request to access the patient's medical,hospital, pharmacy, and vital statistics records as appropriate, as well as historicaldical data for the full retrospective time period (01 May 2018 to enrollment).Further, consent will be provided for access to all available historical resistanced 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 (primaryhysician, close relative or emergency contact) who can be contacted, should thebe lost to follow-up over the course of the study;
- Acknowledgement that in the event of their death, additional information can bebtained by contacting their primary care physician, a close relative, emergencyby consulting public or external databases (death registries, obituarygs) when available and verifiable. This is to be done in accordance with localgulatory requirements and laws;
- Exceptionally, patients who may have started ibalizumab outside of the approveddication can also be included in Cohort 2 of the registry at the discretion of thevestigator, 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.
Updated on
01 Aug 2024.
Study ID: TH-IBA-CTR-1003
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