Who is sponsoring NCT02475629?

NCT02475629 is sponsored by TaiMed Biologics Inc..

What drugs are being tested in NCT02475629?

Interventions: ibalizumab, Optimized Background Regimen (OBR).

What is the status of NCT02475629?

NCT02475629 is currently COMPLETED.

Last reviewed 2020-03-10 · How we verify

A Phase 3, Single Arm, 24-Week, Multicenter Study of Ibalizumab Plus an Optimized Background Regimen (OBR) in Treatment-Experienced Patients Infected With Multi-Drug Resistant HIV-1

NCT02475629 Phase 3 COMPLETED Results posted

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.

Details

Lead sponsor	TaiMed Biologics Inc.
Phase	Phase 3
Status	COMPLETED
Enrolment	40
Start date	2015-08
Completion	2016-12

Conditions

Interventions

ibalizumab
Optimized Background Regimen (OBR)

Primary outcomes

Efficacy: Proportion of Participants Achieving a Viral Load Reduction of at Least 0.5 Log 10: ITT-MEF — Day 14
Proportion of participants (%) achieving a viral load reduction of at least 0.5 log from baseline (Day 7)
Efficacy: Proportion of Subjects With a Viral Load Decrease of at Least 0.5 Log 10 - Protocol Correct — Day 14
Proportion of patients (%) with a viral load decrease of at least 0.5 log 10 from baseline (day 7)

Countries

United States, Puerto Rico, Taiwan