Dose-Response Study of Ibalizumab (Monoclonal Antibody) Plus Optimized Background Regimen in Patients With HIV-1 (TMB-202)
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|ClinicalTrials.gov Identifier: NCT00784147|
Recruitment Status : Completed
First Posted : November 3, 2008
Results First Posted : April 17, 2014
Last Update Posted : May 5, 2014
|Condition or disease||Intervention/treatment||Phase|
|HIV||Drug: Ibalizumab||Phase 2|
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
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||113 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|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-1(Amended to 24-Weeks)|
|Study Start Date :||August 2008|
|Actual Primary Completion Date :||April 2011|
|Actual Study Completion Date :||April 2011|
Active Comparator: Ibalizumab 800 mg
every 2 weeks, combined with an Optimized Background Regimen
Ibalizumab 800 mg IV every 2 weeks
Other Name: TNX-355; Hu5A8
Active Comparator: Ibalizumab 2000 mg
every 4 weeks, combined with an Optimized Background Regimen
Ibalizumab 2000 mg IV every 4 weeks
Other Name: TNX-355; Hu5A8
- The Proportion of Patients Achieving Undetectable Viral Loads at Week 24. [ Time Frame: 24 weeks ]For the primary efficacy analysis, "undetectable" was defined as having HIV-1 RNA below the limit of assay detection at <50 copies/mL. The primary efficacy endpoint was analyzed using Fisher exact test. The primary analysis was performed using the ITT population and both the missing data equals treatment failure (MEF) and last observation carried forward (LOCF) methods. The more conservative MEF results are recorded here.
- Mean Change From Baseline in Viral Load (log10) at Week 24/EOS [ Time Frame: Week 24 / End of Study ]The mean change in HIV-1 RNA (log10) from the Baseline measurement was analyzed at Week 24/End of Study using a generalized linear model at each scheduled study visit.
- Mean Change From Baseline in CD4+ T-Cell Count at Week 24/EOS [ Time Frame: Week 24 / End of Study ]The mean change in CD4+ T-cell count from the Baseline measurement at Week 24/End of Study was summarized at each scheduled time point by treatment group.
- Proportion of Patients With Viral Load <200 Copies/mL at Week 24 [ Time Frame: Week 24 ]This measure was assessed in the same manner as the primary efficacy analysis for the proportion of patients achieving HIV-1 RNA levels below 200 copies/mL at Week 24 of the study.
- Proportion of Patients With Viral Load <400 Copies/mL at Week 24 [ Time Frame: Week 24 ]This efficacy measure was assessed in the same manner as the primary efficacy analysis to determine the proportion of the total population achieving HIV-1 RNA levels <400 copies at Week 24 of the study.
- Proportion of Patients With a 1.0 log10 or Greater Reduction in Viral Load at Week 24 [ Time Frame: Week 24 ]This efficacy assessment was performed in the same manner as the primary efficacy analysis for the proportion of the total population achieving at least a 1.0 log10 reduction from Baseline in HIV-1 RNA.
- Proportion of Patients With a 0.5 log10 or Greater Reduction in Viral Load at Week 24 [ Time Frame: Week 24 ]This efficacy assessment was performed in the same manner as the primary efficacy analysis for the proportion of the total population achieving at least a 0.5 log10 reduction from the Baseline measurement in HIV-1 RNA at Week 24 of the study.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00784147
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|Study Director:||Stanley T. Lewis, MD||TaiMed Biologics Inc.|