8 completed, 1 active not recruiting, 1 no longer available, 1 unknown. 3 Phase 2, 3 Phase 3, 2 Phase 1.
| Phase | Trials | Status |
|---|---|---|
| Phase 2 | 3 | Completed 2, Unknown 1 |
| Phase 3 | 3 | Completed 3 |
| Phase 1 | 2 | Active not recruiting 1, Completed 1 |
Follow ibalizumab: new trials by email Literature Review of ibalizumab trials Research Report on ibalizumab
Tick up to 5 trials to compare them side by side (eligibility, arms, endpoints, adverse events) in a Literature Matrix.
| Trial | Phase | Status | Sponsor | Enrollment | Start | Updated |
|---|---|---|---|---|---|---|
| 10E8.4/iMab Bispecific Antibody and VRC07-523LS Monoclonal Antibody in HIV-infected Adults ART, 10E8.4/iMab, VRC07-523LS - HIV-1-infection | Phase 1 | Active not recruiting | David Ho | 20 | 2023-11-28 | 2026-06-02 |
| External Comparison of Ibalizumab in Trials vs. Other Regimens in OPERA Ibalizumab - HIV-1-infection | Completed | Epividian | 141 | 2022-08-05 | 2023-09-07 | |
| A Prospective and Retrospective Observational Study of Multidrug-Resistant Patient Outcomes With and Without Ibalizumab No ibalizumab or Pre-ibalizumab treatment, On ibalizumab treatment - HIV Infections, Multi-Antiviral Resistance | Completed | Theratechnologies | 168 | 2022-03-22 | 2026-07-27 | |
| Study of the Safety of Trogarzo™ Administered as an Undiluted "IV Push" or an Intramuscular Injection ibalizumab-uiyk - HIV-1-infection | Phase 3 | Completed | TaiMed Biologics Inc. | 43 | 2019-05-30 | 2025-10-20 |
| Ibalizumab Plus Optimized Background Regimen in Treatment-Experienced Patients With Multi-Drug Resistant HIV-1 ibalizumab, Optimized Background Regimen - HIV | Phase 3 | Completed | TaiMed Biologics Inc. | 79 | 2016-03-01 | 2021-03-11 |
| Ibalizumab Plus Optimized Background Regimen in Patient With Multi-Drug Resistant HIV ibalizumab, Optimized Background Regimen (OBR) - HIV | Phase 3 | Completed | TaiMed Biologics Inc. | 40 | 2015-08-01 | 2020-03-19 |
| Compassionate Use of Ibalizumab for the Treatment of HIV Infection Dolutegravir Sodium Monohydrate, Ibalizumab - Human Immunodeficiency Virus (HIV) | No longer available | University of Colorado, Denver | 2012-01-01 | 2016-11-01 | ||
| Safety Study of Ibalizumab Subcutaneous Injection in Healthy Volunteers ibalizumab (biologic/MAb) for SC Injection or placebo - Prevention of Infection With HIV-1 | Phase 1 | Completed | TaiMed Biologics Inc. | 25 | 2011-02-01 | 2012-12-18 |
| Investigator-Sponsored Protocol - Continued Use of Ibalizumab ibalizumab 800mg Q2Weeks, ibalizumab 2000mg Q4Weeks - HIV Infections | Phase 2 | Completed | Kaiser Permanente | 5 | 2009-11-01 | 2018-07-12 |
| Dose-Response Study of Ibalizumab (Monoclonal Antibody) Plus Optimized Background Regimen in Patients With HIV-1 Ibalizumab - HIV | Phase 2 | Completed | TaiMed Biologics Inc. | 113 | 2008-08-01 | 2014-05-05 |
| TNX-355 With Optimized Background Therapy (OBT) in Treatment-Experienced Subjects With HIV-1 TNX-355 - HIV Infections | Phase 2 | Unknown | Tanox | 80 | 2004-03-01 | 2005-06-24 |
Acquired Immunodeficiency Syndrome (3) · HIV Infections (3)
TaiMed Biologics Inc. (5) · David Ho (1) · Epividian (1) · Kaiser Permanente (1) · Tanox (1) · Theratechnologies (1) · University of Colorado, Denver (1)
United States (10) · Puerto Rico (4) · Canada (1) · Taiwan (1) · Tanzania (1)
David D. Ho, MD (1) · Edward M Gardner, M.D. (1) · Marco Missanga, MD (1) · Martin Markowitz, MD (1) · Princy N Kumar, MD (1) · Stanley T Lewis, MD, MPH (1) · Stanley T. Lewis, MD (1) · Stanley T. Lewis, MD, MPH (1) · Trevor A. Crowell, MD, PhD (1) · William Towner, MD (1)