Ibalizumab Plus Optimized Background Regimen in Patient With Multi-Drug Resistant HIV

Summary

This Phase 3, single arm, multicenter study will evaluate the safety and effectiveness of ibalizumab in treatment-experienced patients infected with multi-drug resistant HIV-1.

Timeline

Start

2015-08

Primary completion

2016-10

Completion

2016-12

Outcome

Met primary endpoint

paper 33 (83%) had a decrease in viral load of at least 0.5 log10 copies per milliliter from baseline (P<0.001 for the comparison with the control period). PMID 30110589 ↗

Publications

• Emu B, Fessel J, Schrader S, Kumar P, Richmond G, Win S, Weinheimer S, Marsolais C, Lewis S. Phase 3 Study of Ibalizumab for Multidrug-Resistant HIV-1. N Engl J Med. 2018 Aug 16;379(7):645-654. doi: 10.1056/NEJMoa1711460.

Drugs

Indications