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A Phase 3, Multicenter, Expanded Access Study of Ibalizumab Plus an Optimized Background Regimen (OBR) in Treatment-Experienced Patients Infected With Multi-Drug Resistant (MDR) HIV-1
Ibalizumab is a monoclonal antibody that works by blocking HIV entry into the immune system cells (CD4+ or T-cells) the virus typically infects. Ibalizumab is intended for use in combination with other anti-HIV drugs in people with multi-drug resistant HIV and limited treatment options. This study will collect further information on the safety and tolerability of intravenously administered (IV) ibalizumab combined with an optimized background regimen for treating multi-drug resistant HIV-1 infection, and will provide continuing access to ibalizumab for patients completing a prior ibalizumab clinical trial.
Details
| Lead sponsor | TaiMed Biologics Inc. |
|---|---|
| Phase | Phase 3 |
| Status | COMPLETED |
| Enrolment | 79 |
| Start date | 2016-03 |
| Completion | 2018-11 |
Conditions
- HIV
Interventions
- ibalizumab
- Optimized Background Regimen
Primary outcomes
- Safety and Tolerability of Ibalizumab + OBR — Through 48 weeks
Number of participants with Grade 3/4 adverse events possibly, probably, or definitely due to ibalizumab - Discontinuations Due to Adverse Events Related to Ibalizumab — 48 weeks
number of participants discontinuing ibalizumab treatment due to adverse events probably, possibly, or definitely related to ibalizumab - Effectiveness of Ibalizumab + OBR (Cohort 2 Only) — 7 days
Number of patients in Cohort 2 achieving at least a 0.5 log change from Baseline in viral load at Day 7 of the study
Countries
United States, Puerto Rico