Ignite Creation Date:
2024-05-05 @ 8:02 PM
Last Modification Date:
2024-10-26 @ 9:57 AM
Study NCT ID:
NCT00784147
Status:
COMPLETED
Last Update Posted:
2014-05-05
First Post:
2008-10-30
Brief Title:
Dose-Response Study of Ibalizumab Monoclonal Antibody Plus Optimized Background Regimen in Patients With HIV-1
Sponsor:
TaiMed Biologics Inc
Organization:
TaiMed Biologics Inc
Study Overview
Official Title:
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-1Amended to 24-Weeks
Status:
COMPLETED
Status Verified Date:
2014-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
TMB-202
Brief 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 sensitivitysusceptibility 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
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 sensitivitysusceptibility 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None