drugset / Trial / NCT01056393
Investigator-Sponsored Protocol - Continued Use of Ibalizumab
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
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | ibalizumab | Monoclonal antibody | 800 mg | Intravenous |
| Subject | ibalizumab | Monoclonal antibody | 2000 mg | Intravenous |