CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 40 enrolled
Drug / intervention
ibalizumab +1 morebiological
Likely dose
ibalizumab 2000mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02475629
NCT02475629Phase 3Completed
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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

TaiMed Biologics Inc.·interventional·Posted Jun 19, 2015·Updated Mar 19, 2020

In Brief

A Phase 3 clinical trial evaluating ibalizumab and Optimized Background Regimen (OBR) for HIV. Completed, enrolled 40 participants across 30 sites in 3 countries.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHIV
CountriesPuerto Rico, Taiwan, United States
Collaborators--

Timeline

Phase 3CompletedFinished
20162017201820192020202120222023202420252026
First PostedJun 19, 2015
Enrollment StartAug 1, 2015
Primary CompletionOct 1, 2016
Study CompletionDec 1, 2016
TodayJul 2, 2026
Enrollment to primary: 1.2 yearsPosted 11.0 years ago

Interventions

ibalizumabbiological

2000mg intravenous ibalizumab (loading dose), followed 14 days later by 800mg intravenous ibalizumab every 2 weeks

Optimized Background Regimen (OBR)drug

All participants will be prescribed an Optimized Background Regimen of antiretroviral medications selected on the basis of treatment history and the results of Screening viral resistance and tropism testing. The prescribed regimen must contain at least one agent to which the participant's virus is known to be sensitive.