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A Prospective and Retrospective Observational Study of Multidrug-Resistant Patient Outcomes With and Without Ibalizumab (PROMISE-US)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05388474
Recruitment Status : Recruiting
First Posted : May 24, 2022
Last Update Posted : February 2, 2023
Sponsor:
Collaborators:
Research Organization (KC) Ltd.
Excelsus Statistics Inc.
Health Psychology Research Group (HPR)
ICON Clinical Research
Information provided by (Responsible Party):
Theratechnologies

Study Description
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Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information
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 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.


Condition or disease Intervention/treatment
HIV Infections Multi-Antiviral Resistance Other: No ibalizumab or Pre-ibalizumab treatment Biological: On ibalizumab treatment

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 convenient treatment regimens. The proportion of patients receiving antiretroviral (ARV) treatment that maintain viral suppression is approximately 85% in the United States. However, some patients may not be able to adhere to the prescribed ARV regimen or harbour strains of HIV that are resistant to most currently available therapies. Multi-drug resistant (MDR) HIV may be transmitted or result from incomplete viral suppression, 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 a fully suppressive regimen. This ultimately results in shorter life expectancy, greater potential for transmission of MDR virus, increased morbidity and greater use of health resources. 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 is indicated in combination with other ARVs for the treatment of HIV-1 infection in heavily treatment-experienced 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 with other 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 without ibalizumab in a real-world scenario.

Study Design
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Study Type : Observational
Estimated Enrollment : 600 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: A Prospective and Retrospective Observational Study of Multidrug-Resistant Patient Outcomes With and Without Ibalizumab in a Real-World Setting: United States
Actual Study Start Date : March 22, 2022
Estimated Primary Completion Date : June 2025
Estimated Study Completion Date : December 2025

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS
Drug Information available for: Ibalizumab

Groups and Cohorts
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Group/Cohort Intervention/treatment
Cohort 1 (No ibalizumab or Pre-ibalizumab treatment):
This cohort will be comprised of Heavily treatment-experienced (HTE) patients with Multi Drug Resistant (MDR) HIV who are not receiving ibalizumab. These patients will roll-over into cohort 2 if a change to their ARV regimen is made to include ibalizumab.
 Other: No ibalizumab or Pre-ibalizumab treatment
Patient registry
Other Name: Ibalizumab
Cohort 2 (On ibalizumab treatment):
This cohort will be comprised of Heavily Treatment-Experienced patients (HTE) with Multi Drug Resistant (MDR) HIV who are starting treatment with an ARV regimen that includes ibalizumab. Patients already receiving ibalizumab prior to study entry may also be included in Cohort 2 if baseline viral load (VL) and cluster of differentiation 4 (CD4) count data are available prior to ibalizumab treatment. Recruited patients will be required to consent to provide their full retrospective ARV treatment and drug resistance history, as well as retrospective historical data from their medical records from 01 May 2018 to enrollment.
 Biological: On ibalizumab treatment
Patient registry
Other Name: Ibalizumab


Outcome Measures
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Primary Outcome Measures :
  1. Primary Outcome measures [ Time Frame: Maximum 36 months ]

    To compare the virologic, immunologic and clinical outcomes of patients receiving ibalizumab treatment vs. matched patients not receiving ibalizumab. And to evaluate the long-term efficacy and durability of ibalizumab in combination with other antiretrovirals. The following data will be collected:

    RELEVANT DISEASE AND PATIENT CHARACTERISTICS:

    • HIV Type
    • Duration of HIV infection
    • Gender
    • Age
    • Race/ethnicity
    • Vital signs (weight (kilograms), height (meters), systolic and diastolic blood pressure (mmHg))
    • Geographic location
    • AIDS-defining illnesses (CDC classification)
    • Comorbidities and other diagnoses
    • Concomitant medications

  2. Primary Outcome measures [ Time Frame: Maximum 36 months ]

    BASELINE DISEASE CHARACTERISTICS:

    • Pre-enrolment Viral Load (copies/ml)
    • Pre-enrolment CD4 count (cells/mm3)
    • Laboratory parameters: Hepatitis serology, CD4 (cells/mm3), CD8 (cells/mm3), HIV-RNA, HIV subtype
    • Historic Antiretroviral treatment (three years prior to enrolment)
    • Previous (three years prior to enrolment) and ongoing antiretroviral treatment
    • Genotypic and phenotypic resistance data and complete history
    • HIV subtype when available for patient

  3. Primary Outcome measures [ Time Frame: Maximum 36 months ]

    ON-TREATMENT INFORMATION:

    • CD4 count (cells/mm3)
    • Viral Load (copies/ml)
    • Weight (kilograms)
    • HIV subtype when available for patient
    • Concomitant medication review
    • Resistance testing review
    • Optimized Background Regimen review
    • New AIDS-Defining Events (CDC classification)
    • Adverse Reactions/Serious Adverse reactions review
    • Hospitalizations review
    • Ibalizumab discontinuation date and reason (e.g., lost to follow-up, death).


Other Outcome Measures:
  1. Secondary Outcome measures [ Time Frame: Maximum 36 months ]
    - Treatment satisfaction (associated with use of an ibalizumab-containing ARV regimen) will be assessed using the HIV Treatment Satisfaction Questionnaire status version (HIVTSQs12) at Ibalizumab day 0 treatment initiation (Day 0IBA) and at 6, 12 and 24 months following ibalizumab initiation for participants in cohort 2.

  2. Secondary Outcome measures [ Time Frame: Maximum 36 months ]
    - Change in treatment satisfaction (associated with the transition to an ibalizumab-containing ARV regimen) will be assessed using the HIV Treatment Satisfaction Questionnaire change version (HIVTSQc12) at 6 and 12 months after Day 0IBA for participants in cohort 2.

  3. Secondary Outcome measures [ Time Frame: Maximum 36 months ]
    - Adherence to Antiretroviral regimen, defined as the self-reported number of missed ARV doses in the prior week, will be assessed at Day 0IBA and at 6 and 12 months after Day 0IBA for all Cohort 2 patients starting ibalizumab treatment at the time of enrollment or transitioning from Cohort 1 to Cohort 2.

  4. Secondary Outcome measures [ Time Frame: Max 36 months ]
    - Cohort 2 patients will be asked whether they have had any difficulties with Ibalizumab IV infusions to evaluate the patient experience with IV administration.


Eligibility Criteria
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Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
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.
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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05388474


Contacts
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Contact: Diana Salazar, MSc.,MBA 438-858-3589 dsalazar@theratech.com
Contact: Michele Finn, MSc. 438-315-6602 mfinn@theratech.com

Locations
Show Show 39 study locations
Sponsors and Collaborators
Theratechnologies
Research Organization (KC) Ltd.
Excelsus Statistics Inc.
Health Psychology Research Group (HPR)
ICON Clinical Research
Investigators
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Principal Investigator: Princy N Kumar, MD Georgetown University
More Information
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Additional Information:

Publications:

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Responsible Party: Theratechnologies
ClinicalTrials.gov Identifier: NCT05388474    
Other Study ID Numbers: TH-IBA-CTR-1003
First Posted: May 24, 2022    Key Record Dates
Last Update Posted: February 2, 2023
Last Verified: January 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: Yearly interim analyses may be presented at scientific conferences and meetings.

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Keywords provided by Theratechnologies:
HIV
Drug resistance
Additional relevant MeSH terms:
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HIV Infections
Blood-Borne Infections
Communicable Diseases
Infections
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
 Immunologic Deficiency Syndromes
Immune System Diseases
Ibalizumab
Antibodies, Monoclonal
Anti-HIV Agents
Anti-Retroviral Agents
Antiviral Agents
Anti-Infective Agents
Immunologic Factors
Physiological Effects of Drugs