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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
Sponsor:
Information provided by (Responsible Party):
TaiMed Biologics Inc.

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition HIV
Intervention Drug: Ibalizumab
Enrollment 113

Recruitment Details 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  
Arm/Group Title Ibalizumab 800 mg Ibalizumab 2000 mg
Hide Arm/Group Description

every 2 weeks, combined with an Optimized Background Regimen

Ibalizumab : Ibalizumab 800 mg IV every 2 weeks

every 4 weeks, combined with an Optimized Background Regimen

Ibalizumab : Ibalizumab 2000 mg IV every 4 weeks

Period Title: Overall Study
Started 59 54
Completed 51 45
Not Completed 8 9
Reason Not Completed
Lost to Follow-up             2             4
Withdrawal by Subject             1             3
Physician Decision             2             1
Protocol Violation             1             1
Death             2             0
Arm/Group Title Ibalizumab 800 mg Ibalizumab 2000 mg Total
Hide Arm/Group Description

every 2 weeks, combined with an Optimized Background Regimen

Ibalizumab : Ibalizumab 800 mg IV every 2 weeks

every 4 weeks, combined with an Optimized Background Regimen

Ibalizumab : Ibalizumab 2000 mg IV every 4 weeks

Total of all reporting groups
Overall Number of Baseline Participants 59 54 113
Hide Baseline Analysis Population Description
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.
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 59 participants 54 participants 113 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
58
  98.3%
54
 100.0%
112
  99.1%
>=65 years
1
   1.7%
0
   0.0%
1
   0.9%
Age, Continuous  
Mean (Full Range)
Unit of measure:  Years
Number Analyzed 59 participants 54 participants 113 participants
48.3
(29.6 to 69.5)
47.9
(32.6 to 62.3)
48.1
(29.6 to 69.5)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 59 participants 54 participants 113 participants
Female
8
  13.6%
4
   7.4%
12
  10.6%
Male
51
  86.4%
50
  92.6%
101
  89.4%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 59 participants 54 participants 113 participants
American Indian or Alaska Native
0
   0.0%
0
   0.0%
0
   0.0%
Asian
1
   1.7%
3
   5.6%
4
   3.5%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
12
  20.3%
15
  27.8%
27
  23.9%
White
42
  71.2%
28
  51.9%
70
  61.9%
More than one race
0
   0.0%
0
   0.0%
0
   0.0%
Unknown or Not Reported
4
   6.8%
8
  14.8%
12
  10.6%
HIV-1 RNA (viral load)  
Mean (Full Range)
Unit of measure:  copies/mL
Number Analyzed 59 participants 54 participants 113 participants
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  
Mean (Standard Deviation)
Unit of measure:  cells/mL
Number Analyzed 59 participants 54 participants 113 participants
106.4  (91.3) 112.4  (118.5) 109.3  (104.7)
Number of active agents in OBR  
Mean (Standard Deviation)
Unit of measure:  Pharmaceutical Agents
Number Analyzed 59 participants 54 participants 113 participants
1.9  (0.8) 1.8  (0.7) 1.8  (0.7)
Time from initial documented HIV infection   [1] 
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 59 participants 54 participants 113 participants
17.0  (4.4) 16.9  (6.2) 17.0  (5.4)
[1]
Measure Description: 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).
1.Primary Outcome
Title The Proportion of Patients Achieving Undetectable Viral Loads at Week 24.
Hide Description 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.
Time Frame 24 weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Ibalizumab 800 mg Ibalizumab 2000 mg
Hide Arm/Group Description:

every 2 weeks, combined with an Optimized Background Regimen

Ibalizumab : Ibalizumab 800 mg IV every 2 weeks

every 4 weeks, combined with an Optimized Background Regimen

Ibalizumab : Ibalizumab 2000 mg IV every 4 weeks

Overall Number of Participants Analyzed 59 54
Measure Type: Number
Unit of Measure: percentage of participants
44 28
2.Secondary Outcome
Title Mean Change From Baseline in Viral Load (log10) at Week 24/EOS
Hide Description 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.
Time Frame Week 24 / End of Study
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Ibalizumab 800 mg Ibalizumab 2000 mg
Hide Arm/Group Description:

every 2 weeks, combined with an Optimized Background Regimen

Ibalizumab : Ibalizumab 800 mg IV every 2 weeks

every 4 weeks, combined with an Optimized Background Regimen

Ibalizumab : Ibalizumab 2000 mg IV every 4 weeks

Overall Number of Participants Analyzed 59 54
Mean (Standard Deviation)
Unit of Measure: log10 copies/mL
-1.6  (1.3) -1.5  (1.4)
3.Secondary Outcome
Title Mean Change From Baseline in CD4+ T-Cell Count at Week 24/EOS
Hide Description 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.
Time Frame Week 24 / End of Study
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Ibalizumab 800 mg Ibalizumab 2000 mg
Hide Arm/Group Description:

every 2 weeks, combined with an Optimized Background Regimen

Ibalizumab : Ibalizumab 800 mg IV every 2 weeks

every 4 weeks, combined with an Optimized Background Regimen

Ibalizumab : Ibalizumab 2000 mg IV every 4 weeks

Overall Number of Participants Analyzed 59 54
Mean (Standard Deviation)
Unit of Measure: cell/mL
36.5  (63.0) 39.8  (80.1)
4.Other Pre-specified Outcome
Title Proportion of Patients With Viral Load <200 Copies/mL at Week 24
Hide Description 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.
Time Frame Week 24
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Ibalizumab 800 mg Ibalizumab 2000 mg
Hide Arm/Group Description:

every 2 weeks, combined with an Optimized Background Regimen

Ibalizumab : Ibalizumab 800 mg IV every 2 weeks

every 4 weeks, combined with an Optimized Background Regimen

Ibalizumab : Ibalizumab 2000 mg IV every 4 weeks

Overall Number of Participants Analyzed 59 54
Measure Type: Number
Unit of Measure: percentage of patients
53 43
5.Other Pre-specified Outcome
Title Proportion of Patients With Viral Load <400 Copies/mL at Week 24
Hide Description 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.
Time Frame Week 24
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Ibalizumab 800 mg Ibalizumab 2000 mg
Hide Arm/Group Description:

every 2 weeks, combined with an Optimized Background Regimen

Ibalizumab : Ibalizumab 800 mg IV every 2 weeks

every 4 weeks, combined with an Optimized Background Regimen

Ibalizumab : Ibalizumab 2000 mg IV every 4 weeks

Overall Number of Participants Analyzed 59 54
Measure Type: Number
Unit of Measure: percentage of patients
58 46
6.Other Pre-specified Outcome
Title Proportion of Patients With a 1.0 log10 or Greater Reduction in Viral Load at Week 24
Hide Description 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.
Time Frame Week 24
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Ibalizumab 800 mg Ibalizumab 2000 mg
Hide Arm/Group Description:

every 2 weeks, combined with an Optimized Background Regimen

Ibalizumab : Ibalizumab 800 mg IV every 2 weeks

every 4 weeks, combined with an Optimized Background Regimen

Ibalizumab : Ibalizumab 2000 mg IV every 4 weeks

Overall Number of Participants Analyzed 59 54
Measure Type: Number
Unit of Measure: percentage of patients
63 59
7.Other Pre-specified Outcome
Title Proportion of Patients With a 0.5 log10 or Greater Reduction in Viral Load at Week 24
Hide Description 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.
Time Frame Week 24
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Ibalizumab 800 mg Ibalizumab 2000 mg
Hide Arm/Group Description:

every 2 weeks, combined with an Optimized Background Regimen

Ibalizumab : Ibalizumab 800 mg IV every 2 weeks

every 4 weeks, combined with an Optimized Background Regimen

Ibalizumab : Ibalizumab 2000 mg IV every 4 weeks

Overall Number of Participants Analyzed 59 54
Measure Type: Number
Unit of Measure: percentage of patients
68 59
Time Frame Through Week 24 of the Study
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Ibalizumab 800 mg Ibalizumab 2000 mg
Hide Arm/Group Description

every 2 weeks, combined with an Optimized Background Regimen

Ibalizumab : Ibalizumab 800 mg IV every 2 weeks

every 4 weeks, combined with an Optimized Background Regimen

Ibalizumab : Ibalizumab 2000 mg IV every 4 weeks

All-Cause Mortality
Ibalizumab 800 mg Ibalizumab 2000 mg
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Ibalizumab 800 mg Ibalizumab 2000 mg
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   7/59 (11.86%)      3/54 (5.56%)    
Gastrointestinal disorders     
Gastroenteritis * 1 [1]  1/59 (1.69%)  1 0/54 (0.00%)  0
Immune system disorders     
End-stage AIDS * 1 [2]  1/59 (1.69%)  1 0/54 (0.00%)  0
Infections and infestations     
Cerebral Toxoplasmosis * 1 [3]  0/59 (0.00%)  0 1/54 (1.85%)  1
CMV Viremia * 1 [4]  0/59 (0.00%)  0 2/54 (3.70%)  3
Injury, poisoning and procedural complications     
Road Traffic Accident * 1 [5]  1/59 (1.69%)  1 0/54 (0.00%)  0
Nervous system disorders     
Paraesthesias * 1 [3]  1/59 (1.69%)  1 0/54 (0.00%)  0
Renal and urinary disorders     
Acute Renal Failure * 1 [6]  1/59 (1.69%)  1 0/54 (0.00%)  0
Respiratory, thoracic and mediastinal disorders     
Chronic Obstructive Pulmonary Disease * 1 [7]  1/59 (1.69%)  1 0/54 (0.00%)  0
Acute Respiratory Distress Syndrome * 1 [8]  1/59 (1.69%)  1 0/54 (0.00%)  0
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA 10.0
[1]
Severe. Unrelated to Study Drug Administration.
[2]
Fatal. Unrelated to Study Drug Administration.
[3]
Moderate. Unrelated to Study Drug Administration.
[4]
One instance of moderate severity, two severe occurrences. Unrelated to Study Drug Administration.
[5]
Life-threatening. Unrelated to Study Drug Administration.
[6]
Severe. Unrelated to Study Drug Administration
[7]
Moderate Severity Unrelated to Study Drug Administration
[8]
Fatal. Unrelated to Study Drug Administration
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 2%
Ibalizumab 800 mg Ibalizumab 2000 mg
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   46/59 (77.97%)      44/54 (81.48%)    
Eye disorders     
Conjunctivitis * 1  1/59 (1.69%)  1 2/54 (3.70%)  2
Gastrointestinal disorders     
Diarrhea * 1  3/59 (5.08%)  3 6/54 (11.11%)  6
Nausea * 1  2/59 (3.39%)  2 7/54 (12.96%)  7
Vomiting * 1  1/59 (1.69%)  1 3/54 (5.56%)  3
General disorders     
Headache * 1  2/59 (3.39%)  2 4/54 (7.41%)  4
Fatigue * 1  3/59 (5.08%)  3 3/54 (5.56%)  3
Dizziness * 1  4/59 (6.78%)  4 1/54 (1.85%)  1
Chills * 1  1/59 (1.69%)  1 2/54 (3.70%)  2
Infections and infestations     
Oral Candidiasis * 1  2/59 (3.39%)  2 4/54 (7.41%)  4
Musculoskeletal and connective tissue disorders     
Low Back Pain * 1  2/59 (3.39%)  2 2/54 (3.70%)  2
Respiratory, thoracic and mediastinal disorders     
Upper Respiratory Tract Infection * 1  4/59 (6.78%)  4 3/54 (5.56%)  3
Cough * 1  6/59 (10.17%)  6 0/54 (0.00%)  0
Nasopharyngitis * 1  2/59 (3.39%)  2 3/54 (5.56%)  3
Sinusitis * 1  2/59 (3.39%)  2 2/54 (3.70%)  2
Rhinitis Allergic * 1  2/59 (3.39%)  2 1/54 (1.85%)  1
Skin and subcutaneous tissue disorders     
Rash * 1  5/59 (8.47%)  5 9/54 (16.67%)  9
Folliculitis * 1  1/59 (1.69%)  1 3/54 (5.56%)  3
Dermatitis * 1  1/59 (1.69%)  1 2/54 (3.70%)  2
Injection Site Reaction * 1  2/59 (3.39%)  2 1/54 (1.85%)  1
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA 10.0
ACTG Adherence Questionnaire data were incomplete due to insufficient data collection methods. No clinically meaningful information was gained upon review of these results.
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.
Results Point of Contact
Name/Title: Stanley T. Lewis, Jr., MD
Organization: TaiMed Biologics, Inc.
Phone: 949-769-6543 ext 108
Responsible Party: TaiMed Biologics Inc.
ClinicalTrials.gov Identifier: NCT00784147     History of Changes
Other Study ID Numbers: TMB-202 Amendment 2
First Submitted: October 30, 2008
First Posted: November 3, 2008
Results First Submitted: March 11, 2014
Results First Posted: April 17, 2014
Last Update Posted: May 5, 2014