drugset / Trial / NCT01056393

Investigator-Sponsored Protocol - Continued Use of Ibalizumab

NCT01056393

Phase 2 Completed 5 enrolled Kaiser Permanente TaiMed Biologics Inc. · collab
RandomizedParallel-groupOpen-labelTreatment

Summary

This protocol serves to extend the successful treatment for HIV positive patients beyond the endpoints provided by the Phase 2b TaiMed Biologics-sponsored protocol TMB202 (entitled "A Phase 2b Randomized, Double-Blinded, 48-Week, Multicenter, Dose-Response Study of Ibalizumab Plus an Optimized Background Regimen in Treatment-Experienced Patients Infected with HIV-1 (Amended to 24 Week Study)"), for 24 weeks. Ibalizumab may be administered beyond 24 weeks under this protocol as supply permits and patients continue to demonstrate virologic response.

Timeline

Start
2009-11
Primary completion
2016-12-15
Completion
2016-12-15

Drugs

EvaluationDrugModalityDoseRoute
Subject ibalizumab Monoclonal antibody 800 mg Intravenous
Subject ibalizumab Monoclonal antibody 2000 mg Intravenous