A Prospective and Retrospective Observational Study of Multidrug-Resistant Patient Outcomes With and Without Ibalizumab
NCT ID: NCT05388474
Last Updated: 2026-01-02
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
168 participants
OBSERVATIONAL
2022-03-22
2026-06-30
Brief Summary
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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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Detailed Description
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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.
Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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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.
No ibalizumab or Pre-ibalizumab treatment
Patient registry
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.
On ibalizumab treatment
Patient registry
Interventions
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No ibalizumab or Pre-ibalizumab treatment
Patient registry
On ibalizumab treatment
Patient registry
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
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
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.
18 Years
ALL
No
Sponsors
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Theratechnologies
INDUSTRY
Excelsus Statistics Inc.
UNKNOWN
Health Psychology Research Group (HPR)
UNKNOWN
ICON Clinical Research
INDUSTRY
Responsible Party
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Principal Investigators
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Princy N Kumar, MD
Role: PRINCIPAL_INVESTIGATOR
Georgetown University
Locations
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Ruane Clinical Research
Los Angeles, California, United States
Mills 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
Whitman Walker Health
Washington D.C., District of Columbia, United States
Georgetown University Medical Center
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
Orlando Immunology Center (OIC)
Orlando, Florida, United States
Bliss Health
Orlando, Florida, United States
Can Community Health
Tampa, Florida, United States
St-Joseph's Comprehensive Research
Tampa, Florida, United States
CAN Community Health
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
The Roper St. Francis Ryan White Wellness Center
Charleston, South Carolina, United States
Medical University of South Carolina
Charleston, South Carolina, United States
Prism Health North Texas
Dallas, Texas, United States
North Texas Infectious Diseases Consultants, P.A
Dallas, Texas, United States
Therapeutic Concepts, PA
Houston, Texas, United States
UT Health Houston
Houston, Texas, United States
St. Hope Foundation
Houston, Texas, United States
Legacy Community Pharmacy Services
Houston, Texas, United States
Countries
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References
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Armenia D, Di Carlo D, Flandre P, Bouba Y, Borghi V, Forbici F, Bertoli A, Gori C, Fabeni L, Gennari W, Pinnetti C, Mondi A, Cicalini S, Gagliardini R, Vergori A, Bellagamba R, Malagnino V, Montella F, Colafigli M, Latini A, Marocco R, Licthner M, Andreoni M, Mussini C, Ceccherini-Silberstein F, Antinori A, Perno CF, Santoro MM. HIV MDR is still a relevant issue despite its dramatic drop over the years. J Antimicrob Chemother. 2020 May 1;75(5):1301-1310. doi: 10.1093/jac/dkz554.
Burkly LC, Olson D, Shapiro R, Winkler G, Rosa JJ, Thomas DW, Williams C, Chisholm P. Inhibition of HIV infection by a novel CD4 domain 2-specific monoclonal antibody. Dissecting the basis for its inhibitory effect on HIV-induced cell fusion. J Immunol. 1992 Sep 1;149(5):1779-87.
Freeman MM, Seaman MS, Rits-Volloch S, Hong X, Kao CY, Ho DD, Chen B. Crystal structure of HIV-1 primary receptor CD4 in complex with a potent antiviral antibody. Structure. 2010 Dec 8;18(12):1632-41. doi: 10.1016/j.str.2010.09.017.
Gathe JC, Hardwicke RL, Garcia F, Weinheimer S, Lewis ST, Cash RB. Efficacy, Pharmacokinetics, and Safety Over 48 Weeks With Ibalizumab-Based Therapy in Treatment-Experienced Adults Infected With HIV-1: A Phase 2a Study. J Acquir Immune Defic Syndr. 2021 Apr 1;86(4):482-489. doi: 10.1097/QAI.0000000000002591.
Kilby JM, Eron JJ. Novel therapies based on mechanisms of HIV-1 cell entry. N Engl J Med. 2003 May 29;348(22):2228-38. doi: 10.1056/NEJMra022812. No abstract available.
Moore JP, Sattentau QJ, Klasse PJ, Burkly LC. A monoclonal antibody to CD4 domain 2 blocks soluble CD4-induced conformational changes in the envelope glycoproteins of human immunodeficiency virus type 1 (HIV-1) and HIV-1 infection of CD4+ cells. J Virol. 1992 Aug;66(8):4784-93. doi: 10.1128/JVI.66.8.4784-4793.1992.
Pearce N. Analysis of matched case-control studies. BMJ. 2016 Feb 25;352:i969. doi: 10.1136/bmj.i969.
Reimann KA, Burkly LC, Burrus B, Waite BC, Lord CI, Letvin NL. In vivo administration to rhesus monkeys of a CD4-specific monoclonal antibody capable of blocking AIDS virus replication. AIDS Res Hum Retroviruses. 1993 Mar;9(3):199-207. doi: 10.1089/aid.1993.9.199.
Reimann KA, Lin W, Bixler S, Browning B, Ehrenfels BN, Lucci J, Miatkowski K, Olson D, Parish TH, Rosa MD, Oleson FB, Hsu YM, Padlan EA, Letvin NL, Burkly LC. A humanized form of a CD4-specific monoclonal antibody exhibits decreased antigenicity and prolonged plasma half-life in rhesus monkeys while retaining its unique biological and antiviral properties. AIDS Res Hum Retroviruses. 1997 Jul 20;13(11):933-43. doi: 10.1089/aid.1997.13.933.
Raymond S, Piffaut M, Bigot J, Cazabat M, Montes B, Bertrand K, Martin-Blondel G, Izopet J, Delobel P. Sexual transmission of an extensively drug-resistant HIV-1 strain. Lancet HIV. 2020 Aug;7(8):e529-e530. doi: 10.1016/S2352-3018(20)30205-8. No abstract available.
Reimann KA, Khunkhun R, Lin W, Gordon W, Fung M. A humanized, nondepleting anti-CD4 antibody that blocks virus entry inhibits virus replication in rhesus monkeys chronically infected with simian immunodeficiency virus. AIDS Res Hum Retroviruses. 2002 Jul 20;18(11):747-55. doi: 10.1089/08892220260139486.
Sattentau QJ, Moore JP. The role of CD4 in HIV binding and entry. Philos Trans R Soc Lond B Biol Sci. 1993 Oct 29;342(1299):59-66. doi: 10.1098/rstb.1993.0136.
Song R, Franco D, Kao CY, Yu F, Huang Y, Ho DD. Epitope mapping of ibalizumab, a humanized anti-CD4 monoclonal antibody with anti-HIV-1 activity in infected patients. J Virol. 2010 Jul;84(14):6935-42. doi: 10.1128/JVI.00453-10. Epub 2010 May 12.
World Medical Association. World Medical Association Declaration of Helsinki: ethical principles for medical research involving human subjects. JAMA. 2013 Nov 27;310(20):2191-4. doi: 10.1001/jama.2013.281053. No abstract available.
Zhang XQ, Sorensen M, Fung M, Schooley RT. Synergistic in vitro antiretroviral activity of a humanized monoclonal anti-CD4 antibody (TNX-355) and enfuvirtide (T-20). Antimicrob Agents Chemother. 2006 Jun;50(6):2231-3. doi: 10.1128/AAC.00761-05.
Related Links
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EACS (2019). European Aids Clinical Society (EACS) Guidelines version 10.
UNAIDS, 2019. Global AIDS Update 2019. Communities at the centre. Defending rights, breaking barriers, reaching people with HIV services
Other Identifiers
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TH-IBA-CTR-1003
Identifier Type: -
Identifier Source: org_study_id
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