CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 113 enrolled
Drug / intervention
Ibalizumab +1 moredrug
Likely dose
Ibalizumab 800 mgfrom 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/NCT00784147
NCT00784147Phase 2Completed
CompareCT.gov

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-Weeks)

TaiMed Biologics Inc.·interventional·Posted Nov 3, 2008·Updated May 5, 2014

In Brief

A Phase 2 clinical trial evaluating Ibalizumab for HIV. Completed, enrolled 113 participants across 30 sites in 2 countries.

Detailed Summary

The investigational product, ibalizumab, is a humanized IgG4 monoclonal antibody administered via intravenous infusion at 800 mg every 2 weeks or at 2000 mg every 4 weeks. In addition to study drug, all patients will receive an optimized background regimen (OBR), which is a standard-of-care regimen selected by the investigator prior to randomization that is comprised of 2-4 antiretroviral agents. These agents must have been approved by the local regulatory agency or be available through expanded-access programs for treatment of human immunodeficiency virus (HIV).

Study Details

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

Timeline

Phase 2CompletedFinished
2009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedNov 3, 2008
Enrollment StartAug 1, 2008
Primary CompletionApr 1, 2011
TodayJul 2, 2026
Enrollment to primary: 2.7 yearsPosted 17.7 years ago

Interventions

Ibalizumabdrug

Ibalizumab 800 mg IV every 2 weeks

Ibalizumabdrug

Ibalizumab 2000 mg IV every 4 weeks