Dose-Response Study of Ibalizumab (Monoclonal Antibody) Plus Optimized Background Regimen in Patients With HIV-1 (TMB-202)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
TaiMed Biologics Inc.
ClinicalTrials.gov Identifier:
NCT00784147
First received: October 30, 2008
Last updated: March 11, 2014
Last verified: March 2014
Results First Received: March 11, 2014  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Pharmacokinetics/Dynamics Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition: HIV
Intervention: Drug: Ibalizumab

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Over the period from late 2008 through early 2010, a total of 113 patients were enrolled into the study from 35 study sites in the United States and Taiwan. The study sites were private medical practices, not-for-profit community clinics and university hospital clinics delivering HIV primary care.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Ibalizumab 800 mg

every 2 weeks, combined with an Optimized Background Regimen

Ibalizumab : Ibalizumab 800 mg IV every 2 weeks

Ibalizumab 2000 mg

every 4 weeks, combined with an Optimized Background Regimen

Ibalizumab : Ibalizumab 2000 mg IV every 4 weeks


Participant Flow:   Overall Study
    Ibalizumab 800 mg     Ibalizumab 2000 mg  
STARTED     59     54  
COMPLETED     51     45  
NOT COMPLETED     8     9  
Lost to Follow-up                 2                 4  
Withdrawal by Subject                 1                 3  
Physician Decision                 2                 1  
Protocol Violation                 1                 1  
Death                 2                 0  



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Baseline measures were assessed using the Intent-to-Treat (ITT) population, defined as all randomized patients regardless of whether a dose of study medication was received.

Reporting Groups
  Description
Ibalizumab 800 mg

every 2 weeks, combined with an Optimized Background Regimen

Ibalizumab : Ibalizumab 800 mg IV every 2 weeks

Ibalizumab 2000 mg

every 4 weeks, combined with an Optimized Background Regimen

Ibalizumab : Ibalizumab 2000 mg IV every 4 weeks

Total Total of all reporting groups

Baseline Measures
    Ibalizumab 800 mg     Ibalizumab 2000 mg     Total  
Number of Participants  
[units: participants]
  59     54     113  
Age  
[units: participants]
     
<=18 years     0     0     0  
Between 18 and 65 years     58     54     112  
>=65 years     1     0     1  
Age  
[units: years]
Mean ( Full Range )
  48.3  
  ( 29.6 to 69.5 )  
  47.9  
  ( 32.6 to 62.3 )  
  48.1  
  ( 29.6 to 69.5 )  
Gender  
[units: participants]
     
Female     8     4     12  
Male     51     50     101  
Race (NIH/OMB)  
[units: participants]
     
American Indian or Alaska Native     0     0     0  
Asian     1     3     4  
Native Hawaiian or Other Pacific Islander     0     0     0  
Black or African American     12     15     27  
White     42     28     70  
More than one race     0     0     0  
Unknown or Not Reported     4     8     12  
HIV-1 RNA (viral load)  
[units: copies/mL]
Mean ( Full Range )
  114,675.3  
  ( 58.0 to 1,087,333.3 )  
  136,452.8  
  ( 1,893.3 to 1,573,333.3 )  
  125,082.2  
  ( 58.0 to 1,573,333.3 )  
CD4+ T-cell count  
[units: cells/mL]
Mean ± Standard Deviation
  106.4  ± 91.3     112.4  ± 118.5     109.3  ± 104.7  
Number of active agents in OBR  
[units: Pharmaceutical¬†Agents]
Mean ± Standard Deviation
  1.9  ± 0.8     1.8  ± 0.7     1.8  ± 0.7  
Time from initial documented HIV infection [1]
[units: years]
Mean ± Standard Deviation
  17.0  ± 4.4     16.9  ± 6.2     17.0  ± 5.4  
[1] Time elapsed from initial documentation of HIV infection - when known - to the first administration of study drug. This information was available and recorded for slightly less than half of the study participants (N = 52).



  Outcome Measures
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1.  Primary:   The Proportion of Patients Achieving Undetectable Viral Loads at Week 24.   [ Time Frame: 24 weeks ]

2.  Secondary:   Mean Change From Baseline in Viral Load (log10) at Week 24/EOS   [ Time Frame: Week 24 / End of Study ]

3.  Secondary:   Mean Change From Baseline in CD4+ T-Cell Count at Week 24/EOS   [ Time Frame: Week 24 / End of Study ]

4.  Other Pre-specified:   Proportion of Patients With Viral Load <200 Copies/mL at Week 24   [ Time Frame: Week 24 ]

5.  Other Pre-specified:   Proportion of Patients With Viral Load <400 Copies/mL at Week 24   [ Time Frame: Week 24 ]

6.  Other Pre-specified:   Proportion of Patients With a 1.0 log10 or Greater Reduction in Viral Load at Week 24   [ Time Frame: Week 24 ]

7.  Other Pre-specified:   Proportion of Patients With a 0.5 log10 or Greater Reduction in Viral Load at Week 24   [ Time Frame: Week 24 ]


  Serious Adverse Events


  Other Adverse Events


  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed.


Limitations and Caveats
Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
ACTG Adherence Questionnaire data were incomplete due to insufficient data collection methods. No clinically meaningful information was gained upon review of these results.  


Results Point of Contact:  
Name/Title: Stanley T. Lewis, Jr., MD
Organization: TaiMed Biologics, Inc.
phone: 949-769-6543 ext 108
e-mail: stlewis@taimedbiologics.com


No publications provided


Responsible Party: TaiMed Biologics Inc.
ClinicalTrials.gov Identifier: NCT00784147     History of Changes
Other Study ID Numbers: TMB-202 Amendment 2
Study First Received: October 30, 2008
Results First Received: March 11, 2014
Last Updated: March 11, 2014
Health Authority: United States: Food and Drug Administration