Clinical trialNCT05388474CompletedObservational

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

SponsorTheratechnologiesEnrollment168HIV InfectionsMulti-Antiviral Resistance

View the registry record on ClinicalTrials.gov

Summary

The lay summary the sponsor registered on ClinicalTrials.gov.

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.

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Investigators

The overall officials registered on this study. Names that resolve to a findmyKOL profile link to it; the rest are shown as registered.

Princy N Kumar, MD
Georgetown University
Principal Investigator
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A profile link is shown only when the registered name resolves to a person record with a confident, namesake-checked match; ambiguous names stay unlinked.

Sites

36 registered facilities, with the per-site recruitment status where the registry publishes one. ClinicalTrials.gov does not publish per-site enrollment counts.

United States

Mills Clinical Research
Los Angeles, California, United States
Ruane Clinical Research
Los Angeles, California, United States
Bios Clinical Research
Palm Springs, California, United States
Uc San Diego Owen Clinic
San Diego, California, United States
Yale University
New Haven, Connecticut, United States
Circle Care Center
Stamford, Connecticut, United States
Waterbury Hospital
Waterbury, Connecticut, United States
Georgetown University Medical Center
Washington D.C., District of Columbia, United States
Whitman Walker Health
Washington D.C., District of Columbia, United States
Aids Healthcare Foundation
Fort Lauderdale, Florida, United States
Gary J. Richmond, M.D., Pa
Fort Lauderdale, Florida, United States
Midway Specialty Care Center Miami Beach
Miami Beach, Florida, United States
Bliss Health
Orlando, Florida, United States
Orlando Immunology Center (oic)
Orlando, Florida, United States
Can Community Health
Tampa, Florida, United States
Can Community Health
Tampa, Florida, United States
St-Joseph'S Comprehensive Research
Tampa, Florida, United States
Triple O Research Institute Pa
West Palm Beach, Florida, United States
Indiana University Health Inc.
Bloomington, Indiana, United States
University of Maryland School of Medicine
Baltimore, Maryland, United States
Boston Medical Center
Boston, Massachusetts, United States
the Research Institute
Springfield, Massachusetts, United States
Henry Ford Hospital
Detroit, Michigan, United States
Las Vegas Research Center
Las Vegas, Nevada, United States
I.D. Care Associates, Pa
Hillsborough, New Jersey, United States
Prime Healthcare Services - St Michael'S Medical Center
Newark, New Jersey, United States
Suny Upstate Medical Center
Syracuse, New York, United States
Amity Medical Group
Charlotte, North Carolina, United States
Medical University of South Carolina
Charleston, South Carolina, United States
the Roper St. Francis Ryan White Wellness Center
Charleston, South Carolina, United States
North Texas Infectious Diseases Consultants, P.A
Dallas, Texas, United States
Prism Health North Texas
Dallas, Texas, United States
Legacy Community Pharmacy Services
Houston, Texas, United States
St. Hope Foundation
Houston, Texas, United States
Therapeutic Concepts, Pa
Houston, Texas, United States
Ut Health Houston
Houston, Texas, United States

Site investigator names are published by ClinicalTrials.gov only while a study recruits, so completed studies list sites without them.

Drugs studied

The drug and biological interventions registered on this study, normalized to their RxNorm ingredient where possible.

On ibalizumab treatment

Linked drugs open the directory filtered to KOLs working with them.clinicaltrials.gov ↗

Registration & key dates

Registry attributes as recorded on the ClinicalTrials.gov study record.

Start: 22 Mar 2022
Primary completion: 2 Jul 2026
Completion: 2 Jul 2026
Last update posted: 27 Jul 2026
Registered enrollment: 168
Registry id: NCT05388474

clinicaltrials.gov ↗

Source: ClinicalTrials.gov, via the CTTI AACT database, data as of 24 Aug 2026. Registry facts are shown as registered by the study sponsor; findmyKOL does not interpret them.