NCT00784147

Dose-Response Study of Ibalizumab (Monoclonal Antibody) Plus Optimized Background Regimen in Patients With HIV-1

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)

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 113 (actual)
• Sponsor: TaiMed Biologics Inc. · Industry
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

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).

Detailed description

The primary objectives of this study are to: * Evaluate the dose-response relationship of antiviral activity of the ibalizumab dose regimens at Week 24 in order to determine the optimal dose and regimen. The primary evaluation of effectiveness will be based on the proportion of patients achieving undetectable viral loads at Week 24. * Evaluate the safety and tolerability of two dose regimens of ibalizumab for dose selection The secondary objectives of this study are to: * Evaluate changes from Baseline in viral load, CD4+ cell counts, and time to loss of virologic response (TLOVR) * Characterize HIV-1 sensitivity/susceptibility changes associated with ibalizumab administration in combination with OBR * Determine the presence and significance of anti-ibalizumab antibodies, if any (immunogenicity of ibalizumab) * Assess CD4 receptor density and occupancy * Determine the impact of ibalizumab on quality of life as assessed by patient-reported outcomes on questionnaires * Evaluate the pharmacokinetic profile of two dose regimens of ibalizumab at steady state

Conditions

• HIV

Interventions

Type	Name	Description
DRUG	Ibalizumab	Ibalizumab 800 mg IV every 2 weeks
DRUG	Ibalizumab	Ibalizumab 2000 mg IV every 4 weeks

Timeline

• Start date: 2008-08-01
• Primary completion: 2011-04-01
• Completion: 2011-04-01
• First posted: 2008-11-03
• Last updated: 2014-05-05
• Results posted: 2014-04-17

Locations

30 sites across 2 countries: United States, Puerto Rico