RECRUITING

A Prospective and Retrospective Observational Study of Multidrug-Resistant Patient Outcomes With and Without Ibalizumab

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Conditions

HIV InfectionsMulti-Antiviral ResistanceHIVDrug resistance

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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

Quick Facts

Study Start:2022-03-22
Study Completion:2025-12
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05388474

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. 1. The patient is Heavily treatment-experienced (HTE), with limited treatment options and a history of treatment failure;
  2. 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. 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. 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. 5. ≥18 years of age or older at the time of screening;
  6. 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. 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. 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.
  1. 1. Pregnant or breastfeeding;
  2. 2. Unable to provide informed consent;
  3. 3. Hypersensitivity to ibalizumab or any of the excipients in ibalizumab;
  4. 4. Previous ibalizumab experience (Cohort 1 only)
  5. 5. Previously enrolled in Cohort 2 of this registry.

Contacts and Locations

Study Contact

Kaitlin Anstett, Ph.D.
CONTACT
647-539-8713
kanstett@theratech.com
Nathalie Turgeon
CONTACT
438-315-6602
nturgeon@theratech.com

Principal Investigator

Princy N Kumar, MD
PRINCIPAL_INVESTIGATOR
Georgetown University

Study Locations (Sites)

Ruane Clinical Research
Los Angeles, California, 90036
United States
Mills Clinical Research
Los Angeles, California, 90046
United States
BIOS Clinical Research
Palm Springs, California, 92262
United States
UC San Diego Owen Clinic
San Diego, California, 92103
United States
Yale University
New Haven, Connecticut, 06520
United States
Circle Care Center
Stamford, Connecticut, 06850
United States
Waterbury Hospital
Waterbury, Connecticut, 06702
United States
Whitman Walker Health
Washington, District of Columbia, 20005
United States
Georgetown University Medical Center
Washington, District of Columbia, 20007
United States
Aids Healthcare Foundation
Fort Lauderdale, Florida, 33308
United States
Gary J. Richmond, M.D., PA
Fort Lauderdale, Florida, 33316
United States
Midway Specialty Care Center Miami Beach
Miami Beach, Florida, 33140
United States
Orlando Immunology Center (OIC)
Orlando, Florida, 32803
United States
Bliss Health
Orlando, Florida, 32806
United States
Midtown Medical Center
Tampa, Florida, 33614
United States
St-Joseph's Comprehensive Research
Tampa, Florida, 33614
United States
CAN Community Health
Tampa, Florida, 34232
United States
Triple O Research Institute PA
West Palm Beach, Florida, 33407
United States
Indiana University
Bloomington, Indiana, 47405
United States
University of Maryland School of Medicine
Baltimore, Maryland, 21201
United States
Boston Medical Center
Boston, Massachusetts, 02118
United States
The Research Institute
Springfield, Massachusetts, 01105
United States
Henry Ford Hospital
Detroit, Michigan, 48202
United States
Las Vegas Research Center
Las Vegas, Nevada, 89106
United States
I.D. Care Associates, PA
Hillsborough, New Jersey, 08844
United States
Prime Healthcare Services - St Michael's Medical Center
Newark, New Jersey, 07102
United States
SUNY Upstate Medical Center
Syracuse, New York, 13210
United States
Amity Medical Group
Charlotte, North Carolina, 28215
United States
The Roper St. Francis Ryan White Wellness Center
Charleston, South Carolina, 29407
United States
Medical University of South Carolina
Charleston, South Carolina, 29425
United States
Prism Health North Texas
Dallas, Texas, 75204
United States
North Texas Infectious Diseases Consultants, P.A
Dallas, Texas, 75246
United States
Therapeutic Concepts, PA
Houston, Texas, 77004
United States
UT Health Houston
Houston, Texas, 77030
United States
St. Hope Foundation
Houston, Texas, 77036
United States
Legacy Community Pharmacy Services
Houston, Texas, 77074
United States

Collaborators and Investigators

Sponsor: Theratechnologies

  • Princy N Kumar, MD, PRINCIPAL_INVESTIGATOR, Georgetown University

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2022-03-22
Study Completion Date2025-12

Study Record Updates

Study Start Date2022-03-22
Study Completion Date2025-12

Terms related to this study

Keywords Provided by Researchers

  • HIV
  • Drug resistance

Additional Relevant MeSH Terms

  • HIV Infections
  • Multi-Antiviral Resistance