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Ibalizumab Plus Optimized Background Regimen in Patient With Multi-Drug Resistant HIV

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02475629
Recruitment Status : Completed
First Posted : June 19, 2015
Results First Posted : March 19, 2020
Last Update Posted : March 19, 2020
Sponsor:
Information provided by (Responsible Party):
TaiMed Biologics Inc.

Study Type Interventional
Study Design Allocation: N/A;   Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition HIV
Interventions Biological: ibalizumab
Drug: Optimized Background Regimen (OBR)
Enrollment 40
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Open-Label Ibalizumab Plus OBR
Hide Arm/Group Description

2000 mg intravenous ibalizumab (loading dose) on Day 7 followed in 14 days (on Day 21) by 800 mg intravenous ibalizumab administered once every two weeks, plus an Optimized Background Regimen (OBR) beginning on Day 14.

ibalizumab: 2000mg intravenous ibalizumab (loading dose), followed 14 days later by 800mg intravenous ibalizumab every 2 weeks

Optimized Background Regimen (OBR): All participants will be prescribed an Optimized Background Regimen of antiretroviral medications selected on the basis of treatment history and the results of Screening viral resistance and tropism testing. The prescribed regimen must contain at least one agent to which the participant's virus is known to be sensitive.

Period Title: Overall Study
Started 40
Completed 31
Not Completed 9
Reason Not Completed
Adverse Event             1
Death             4
Physician Decision             1
Withdrawal by Subject             1
Lost to Follow-up             1
Subject non-compliance             1
Arm/Group Title Open-Label Ibalizumab Plus OBR
Hide Arm/Group Description

2000 mg intravenous ibalizumab (loading dose) on Day 7 followed in 14 days (on Day 21) by 800 mg intravenous ibalizumab administered once every two weeks, plus an Optimized Background Regimen (OBR) beginning on Day 14.

ibalizumab: 2000mg intravenous ibalizumab (loading dose), followed 14 days later by 800mg intravenous ibalizumab every 2 weeks

Optimized Background Regimen (OBR): All participants will be prescribed an Optimized Background Regimen of antiretroviral medications selected on the basis of treatment history and the results of Screening viral resistance and tropism testing. The prescribed regimen must contain at least one agent to which the participant's virus is known to be sensitive.

Overall Number of Baseline Participants 40
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 40 participants
50.5  (10.99)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 40 participants
Female
6
  15.0%
Male
34
  85.0%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 40 participants
Hispanic or Latino
11
  27.5%
Not Hispanic or Latino
27
  67.5%
Unknown or Not Reported
2
   5.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 40 participants
American Indian or Alaska Native
0
   0.0%
Asian
4
  10.0%
Native Hawaiian or Other Pacific Islander
0
   0.0%
Black or African American
13
  32.5%
White
22
  55.0%
More than one race
0
   0.0%
Unknown or Not Reported
1
   2.5%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 40 participants
Puerto Rico 2
United States 34
Taiwan 4
1.Primary Outcome
Title Efficacy: Proportion of Participants Achieving a Viral Load Reduction of at Least 0.5 Log 10: ITT-MEF
Hide Description Proportion of participants (%) achieving a viral load reduction of at least 0.5 log from baseline (Day 7)
Time Frame Day 14
Hide Outcome Measure Data
Hide Analysis Population Description
Intent to Treat (ITT) Population (all participants enrolled) with missing values set to zero change
Arm/Group Title Open-Label Ibalizumab Plus OBR
Hide Arm/Group Description:

2000 mg intravenous ibalizumab (loading dose) on Day 7 followed in 14 days (on Day 21) by 800 mg intravenous ibalizumab administered once every two weeks, plus an Optimized Background Regimen (OBR) beginning on Day 14.

ibalizumab: 2000mg intravenous ibalizumab (loading dose), followed 14 days later by 800mg intravenous ibalizumab every 2 weeks

Optimized Background Regimen (OBR): All participants will be prescribed an Optimized Background Regimen of antiretroviral medications selected on the basis of treatment history and the results of Screening viral resistance and tropism testing. The prescribed regimen must contain at least one agent to which the participant's virus is known to be sensitive.

Overall Number of Participants Analyzed 40
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: proportion of participants
0.825
(0.6772 to 0.9266)
2.Primary Outcome
Title Efficacy: Proportion of Subjects With a Viral Load Decrease of at Least 0.5 Log 10 - Protocol Correct
Hide Description Proportion of patients (%) with a viral load decrease of at least 0.5 log 10 from baseline (day 7)
Time Frame Day 14
Hide Outcome Measure Data
Hide Analysis Population Description
Protocol Correct (PC) Population (all participants with non-missing viral load assessments at Day 7, Day 14 and Week 25/End of Study)
Arm/Group Title Open-Label Ibalizumab Plus OBR
Hide Arm/Group Description:

2000 mg intravenous ibalizumab (loading dose) on Day 7 followed in 14 days (on Day 21) by 800 mg intravenous ibalizumab administered once every two weeks, plus an Optimized Background Regimen (OBR) beginning on Day 14.

ibalizumab: 2000mg intravenous ibalizumab (loading dose), followed 14 days later by 800mg intravenous ibalizumab every 2 weeks

Optimized Background Regimen (OBR): All participants will be prescribed an Optimized Background Regimen of antiretroviral medications selected on the basis of treatment history and the results of Screening viral resistance and tropism testing. The prescribed regimen must contain at least one agent to which the participant's virus is known to be sensitive.

Overall Number of Participants Analyzed 26
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: proportion of participants
0.846
(0.6513 to 0.9564)
3.Secondary Outcome
Title Efficacy: Proportion of Patients With Undetectable Viral Load: ITT-MEF
Hide Description Proportion of patients with undetectable Viral Load (<50 copies/mL, and <400 copies/mL)
Time Frame Week 25 /end of study
Hide Outcome Measure Data
Hide Analysis Population Description
Intent to Treat (ITT) Population (all participants enrolled) with missing values set to failure
Arm/Group Title Open-Label Ibalizumab Plus OBR
Hide Arm/Group Description:

2000 mg intravenous ibalizumab (loading dose) on Day 7 followed in 14 days (on Day 21) by 800 mg intravenous ibalizumab administered once every two weeks, plus an Optimized Background Regimen (OBR) beginning on Day 14.

ibalizumab: 2000mg intravenous ibalizumab (loading dose), followed 14 days later by 800mg intravenous ibalizumab every 2 weeks

Optimized Background Regimen (OBR): All participants will be prescribed an Optimized Background Regimen of antiretroviral medications selected on the basis of treatment history and the results of Screening viral resistance and tropism testing. The prescribed regimen must contain at least one agent to which the participant's virus is known to be sensitive.

Overall Number of Participants Analyzed 40
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: proportion of participants
<50 copies/mL
.425
(0.2704 to 0.5911)
<400 copies/mL
.525
(0.3613 to 0.6849)
4.Secondary Outcome
Title Efficacy: Proportion of Patients With Undetectable HIV-RNA Levels: Protocol Correct
Hide Description Proportion of patients (%) with HIV-RNA levels < 50 copies/mL and < 400 copies/mL at Week 25/End of Study
Time Frame Week 25/End of Study
Hide Outcome Measure Data
Hide Analysis Population Description
Protocol Correct (PC) Population (all participants with non-missing viral load assessments at Day 7, Day 14 and Week 25/End of Study)
Arm/Group Title Open-Label Ibalizumab Plus OBR
Hide Arm/Group Description:

2000 mg intravenous ibalizumab (loading dose) on Day 7 followed in 14 days (on Day 21) by 800 mg intravenous ibalizumab administered once every two weeks, plus an Optimized Background Regimen (OBR) beginning on Day 14.

ibalizumab: 2000mg intravenous ibalizumab (loading dose), followed 14 days later by 800mg intravenous ibalizumab every 2 weeks

Optimized Background Regimen (OBR): All participants will be prescribed an Optimized Background Regimen of antiretroviral medications selected on the basis of treatment history and the results of Screening viral resistance and tropism testing. The prescribed regimen must contain at least one agent to which the participant's virus is known to be sensitive.

Overall Number of Participants Analyzed 26
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: proportion of participants
<50 copies/mL
.654
(0.4433 to 0.8279)
<400 copies/mL
.808
(0.6065 to 0.9345)
5.Secondary Outcome
Title Mean Change in Viral Load as a Measure of Efficacy - ITT-MEF
Hide Description Mean change from Day 7/Baseline in log 10 vial load measured at Day 14
Time Frame Day 7 and Day 14
Hide Outcome Measure Data
Hide Analysis Population Description
Intent to Treat (ITT) Population (all participants enrolled) with missing values set to zero change
Arm/Group Title Open-Label Ibalizumab Plus OBR
Hide Arm/Group Description:

2000 mg intravenous ibalizumab (loading dose) on Day 7 followed in 14 days (on Day 21) by 800 mg intravenous ibalizumab administered once every two weeks, plus an Optimized Background Regimen (OBR) beginning on Day 14.

ibalizumab: 2000mg intravenous ibalizumab (loading dose), followed 14 days later by 800mg intravenous ibalizumab every 2 weeks

Optimized Background Regimen (OBR): All participants will be prescribed an Optimized Background Regimen of antiretroviral medications selected on the basis of treatment history and the results of Screening viral resistance and tropism testing. The prescribed regimen must contain at least one agent to which the participant's virus is known to be sensitive.

Overall Number of Participants Analyzed 40
Mean (Standard Deviation)
Unit of Measure: Log10 copies/mL
-1.07  (0.618)
6.Secondary Outcome
Title Mean Change in Viral Load as a Measure of Efficacy - Protocol Correct
Hide Description Mean change from Day 7/Baseline in Log 10 viral load measured at Day 14
Time Frame Day 7 and Day 14
Hide Outcome Measure Data
Hide Analysis Population Description
Protocol Correct (PC) Population (all participants with non-missing viral load assessments at Day 14
Arm/Group Title Open-Label Ibalizumab Plus OBR
Hide Arm/Group Description:

2000 mg intravenous ibalizumab (loading dose) on Day 7 followed in 14 days (on Day 21) by 800 mg intravenous ibalizumab administered once every two weeks, plus an Optimized Background Regimen (OBR) beginning on Day 14.

ibalizumab: 2000mg intravenous ibalizumab (loading dose), followed 14 days later by 800mg intravenous ibalizumab every 2 weeks

Optimized Background Regimen (OBR): All participants will be prescribed an Optimized Background Regimen of antiretroviral medications selected on the basis of treatment history and the results of Screening viral resistance and tropism testing. The prescribed regimen must contain at least one agent to which the participant's virus is known to be sensitive.

Overall Number of Participants Analyzed 26
Mean (Standard Deviation)
Unit of Measure: Log10 copies/mL
-1.11  (0.641)
7.Secondary Outcome
Title End of Study Viral Load Reductions as a Measure of Efficacy - Intent to Treat Analysis
Hide Description Proportion of patients achieving a >/= 0.5 log10 and >/= 1.0 log10 decrease from Day 7/Baseline in viral load at Week 25/End of Study
Time Frame at Week 25/End of Study
Hide Outcome Measure Data
Hide Analysis Population Description
Intent to Treat (ITT) Population (all participants enrolled) with missing values set to zero change
Arm/Group Title Open-Label Ibalizumab Plus OBR
Hide Arm/Group Description:

2000 mg intravenous ibalizumab (loading dose) on Day 7 followed in 14 days (on Day 21) by 800 mg intravenous ibalizumab administered once every two weeks, plus an Optimized Background Regimen (OBR) beginning on Day 14.

ibalizumab: 2000mg intravenous ibalizumab (loading dose), followed 14 days later by 800mg intravenous ibalizumab every 2 weeks

Optimized Background Regimen (OBR): All participants will be prescribed an Optimized Background Regimen of antiretroviral medications selected on the basis of treatment history and the results of Screening viral resistance and tropism testing. The prescribed regimen must contain at least one agent to which the participant's virus is known to be sensitive.

Overall Number of Participants Analyzed 40
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: proportion of participants
>/= 0.5 log10 reduction
.625
(0.4580 to 0.7727)
>/= 1.0 log10 reduction
.550
(0.3849 to 0.7074)
8.Secondary Outcome
Title End of Study Viral Load Reductions as a Measure of Efficacy - Protocol Correct Analysis
Hide Description Proportion of patients achieving a >/= 0.5 log10 and >/= 1.0 log10 decrease from Day 7/Baseline in viral load at Week 25/End of Study
Time Frame at Week 25/End of Study
Hide Outcome Measure Data
Hide Analysis Population Description
Protocol Correct (PC) Population (all participants with non-missing viral load assessments at Day 7, Day 14 and Week 25/End of Study)
Arm/Group Title Open-Label Ibalizumab Plus OBR
Hide Arm/Group Description:

2000 mg intravenous ibalizumab (loading dose) on Day 7 followed in 14 days (on Day 21) by 800 mg intravenous ibalizumab administered once every two weeks, plus an Optimized Background Regimen (OBR) beginning on Day 14.

ibalizumab: 2000mg intravenous ibalizumab (loading dose), followed 14 days later by 800mg intravenous ibalizumab every 2 weeks

Optimized Background Regimen (OBR): All participants will be prescribed an Optimized Background Regimen of antiretroviral medications selected on the basis of treatment history and the results of Screening viral resistance and tropism testing. The prescribed regimen must contain at least one agent to which the participant's virus is known to be sensitive.

Overall Number of Participants Analyzed 26
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: proportion of participants
>/= 0.5 log10 reduction
.962
(0.8036 to 0.9990)
>/= 1.0 log10 reduction
.846
(0.6513 to 0.9564)
9.Secondary Outcome
Title Mean Change in CD4+ Cell Count as a Measure of Efficacy and Safety - ITT
Hide Description Mean change from Day 7/Baseline in CD4+ cell count at Week 25/End of Study
Time Frame Day 7 and Week 25/End of Study
Hide Outcome Measure Data
Hide Analysis Population Description
Intent to Treat (ITT) Population (all participants enrolled). Only obtained values were included in analysis - missing values were not imputed.
Arm/Group Title Open-Label Ibalizumab Plus OBR
Hide Arm/Group Description:

2000 mg intravenous ibalizumab (loading dose) on Day 7 followed in 14 days (on Day 21) by 800 mg intravenous ibalizumab administered once every two weeks, plus an Optimized Background Regimen (OBR) beginning on Day 14.

ibalizumab: 2000mg intravenous ibalizumab (loading dose), followed 14 days later by 800mg intravenous ibalizumab every 2 weeks

Optimized Background Regimen (OBR): All participants will be prescribed an Optimized Background Regimen of antiretroviral medications selected on the basis of treatment history and the results of Screening viral resistance and tropism testing. The prescribed regimen must contain at least one agent to which the participant's virus is known to be sensitive.

Overall Number of Participants Analyzed 27
Mean (Standard Deviation)
Unit of Measure: cells/mm^3
62.4  (105.75)
10.Secondary Outcome
Title Mean Change in CD4+ Cell Count as a Measure of Efficacy and Safety - Protocol Correct
Hide Description Mean change from Day 7/Baseline in CD4+ cell count at Week 25/End of Study
Time Frame Day 7 and Week 25/End of Study
Hide Outcome Measure Data
Hide Analysis Population Description
Protocol Correct (PC) Population (all participants with non-missing viral load assessments at Day 7, Day 14 and Week 25/End of Study) with non-missing CD4+ cell count measurements
Arm/Group Title Open-Label Ibalizumab Plus OBR
Hide Arm/Group Description:

2000 mg intravenous ibalizumab (loading dose) on Day 7 followed in 14 days (on Day 21) by 800 mg intravenous ibalizumab administered once every two weeks, plus an Optimized Background Regimen (OBR) beginning on Day 14.

ibalizumab: 2000mg intravenous ibalizumab (loading dose), followed 14 days later by 800mg intravenous ibalizumab every 2 weeks

Optimized Background Regimen (OBR): All participants will be prescribed an Optimized Background Regimen of antiretroviral medications selected on the basis of treatment history and the results of Screening viral resistance and tropism testing. The prescribed regimen must contain at least one agent to which the participant's virus is known to be sensitive.

Overall Number of Participants Analyzed 22
Mean (Standard Deviation)
Unit of Measure: cells/mm^3
67.0  (114.35)
11.Secondary Outcome
Title Safety: Proportion of Participants Experiencing Adverse Events
Hide Description Proportion of participants experiencing at least one treatment emergent adverse event to week 25/End of Study
Time Frame Through Week 25/End of Study
Hide Outcome Measure Data
Hide Analysis Population Description
All participants receiving at least one partial dose of study drug
Arm/Group Title Open-Label Ibalizumab Plus OBR
Hide Arm/Group Description:

2000 mg intravenous ibalizumab (loading dose) on Day 7 followed in 14 days (on Day 21) by 800 mg intravenous ibalizumab administered once every two weeks, plus an Optimized Background Regimen (OBR) beginning on Day 14.

ibalizumab: 2000mg intravenous ibalizumab (loading dose), followed 14 days later by 800mg intravenous ibalizumab every 2 weeks

Optimized Background Regimen (OBR): All participants will be prescribed an Optimized Background Regimen of antiretroviral medications selected on the basis of treatment history and the results of Screening viral resistance and tropism testing. The prescribed regimen must contain at least one agent to which the participant's virus is known to be sensitive.

Overall Number of Participants Analyzed 40
Measure Type: Count of Participants
Unit of Measure: Participants
32
  80.0%
12.Secondary Outcome
Title Proportion of Participants Experiencing Adverse Event Related to Study Drug as a Measure of Safety and Tolerability
Hide Description Proportion of participants experiencing a treatment emergent adverse event determined by the investigator to be related to study drug
Time Frame Through Week 25/End of Study
Hide Outcome Measure Data
Hide Analysis Population Description
All participants receiving at least one partial dose of study drug
Arm/Group Title Open-Label Ibalizumab Plus OBR
Hide Arm/Group Description:

2000 mg intravenous ibalizumab (loading dose) on Day 7 followed in 14 days (on Day 21) by 800 mg intravenous ibalizumab administered once every two weeks, plus an Optimized Background Regimen (OBR) beginning on Day 14.

ibalizumab: 2000mg intravenous ibalizumab (loading dose), followed 14 days later by 800mg intravenous ibalizumab every 2 weeks

Optimized Background Regimen (OBR): All participants will be prescribed an Optimized Background Regimen of antiretroviral medications selected on the basis of treatment history and the results of Screening viral resistance and tropism testing. The prescribed regimen must contain at least one agent to which the participant's virus is known to be sensitive.

Overall Number of Participants Analyzed 40
Measure Type: Count of Participants
Unit of Measure: Participants
7
  17.5%
13.Secondary Outcome
Title Proportion of Participants Experiencing Serious Adverse Event as a Measure of Safety and Tolerability
Hide Description Proportion of participants experiencing at least one serious treatment emergent adverse event, excluding death
Time Frame Through Week 25/End of Study
Hide Outcome Measure Data
Hide Analysis Population Description
All participants receiving at least one partial dose of study drug
Arm/Group Title Open-Label Ibalizumab Plus OBR
Hide Arm/Group Description:

2000 mg intravenous ibalizumab (loading dose) on Day 7 followed in 14 days (on Day 21) by 800 mg intravenous ibalizumab administered once every two weeks, plus an Optimized Background Regimen (OBR) beginning on Day 14.

ibalizumab: 2000mg intravenous ibalizumab (loading dose), followed 14 days later by 800mg intravenous ibalizumab every 2 weeks

Optimized Background Regimen (OBR): All participants will be prescribed an Optimized Background Regimen of antiretroviral medications selected on the basis of treatment history and the results of Screening viral resistance and tropism testing. The prescribed regimen must contain at least one agent to which the participant's virus is known to be sensitive.

Overall Number of Participants Analyzed 40
Measure Type: Count of Participants
Unit of Measure: Participants
9
  22.5%
14.Secondary Outcome
Title Proportion of Participants Discontinuing Study Drug Due to Adverse Event
Hide Description Proportion of participants discontinuing study drug due to occurrence of treatment emergent adverse event
Time Frame Through Week 25/End of Study
Hide Outcome Measure Data
Hide Analysis Population Description
All participants receiving at least one partial dose of study drug
Arm/Group Title Open-Label Ibalizumab Plus OBR
Hide Arm/Group Description:

2000 mg intravenous ibalizumab (loading dose) on Day 7 followed in 14 days (on Day 21) by 800 mg intravenous ibalizumab administered once every two weeks, plus an Optimized Background Regimen (OBR) beginning on Day 14.

ibalizumab: 2000mg intravenous ibalizumab (loading dose), followed 14 days later by 800mg intravenous ibalizumab every 2 weeks

Optimized Background Regimen (OBR): All participants will be prescribed an Optimized Background Regimen of antiretroviral medications selected on the basis of treatment history and the results of Screening viral resistance and tropism testing. The prescribed regimen must contain at least one agent to which the participant's virus is known to be sensitive.

Overall Number of Participants Analyzed 40
Measure Type: Count of Participants
Unit of Measure: Participants
5
  12.5%
15.Secondary Outcome
Title Proportion of Participants Experiencing Adverse Event Grade 3 and Higher as a Measure of Safety and Tolerability
Hide Description Proportion of participants experiencing treatment emergent adverse event Grade 3 and higher
Time Frame Through Week 25/End of Study
Hide Outcome Measure Data
Hide Analysis Population Description
All participants receiving at least one partial dose of study drug
Arm/Group Title Open-Label Ibalizumab Plus OBR
Hide Arm/Group Description:

2000 mg intravenous ibalizumab (loading dose) on Day 7 followed in 14 days (on Day 21) by 800 mg intravenous ibalizumab administered once every two weeks, plus an Optimized Background Regimen (OBR) beginning on Day 14.

ibalizumab: 2000mg intravenous ibalizumab (loading dose), followed 14 days later by 800mg intravenous ibalizumab every 2 weeks

Optimized Background Regimen (OBR): All participants will be prescribed an Optimized Background Regimen of antiretroviral medications selected on the basis of treatment history and the results of Screening viral resistance and tropism testing. The prescribed regimen must contain at least one agent to which the participant's virus is known to be sensitive.

Overall Number of Participants Analyzed 40
Measure Type: Count of Participants
Unit of Measure: Participants
11
  27.5%
16.Secondary Outcome
Title Proportion of Participants Experiencing Adverse Event With Death as Outcome as a Measure of Safety and Tolerability
Hide Description Proportion of participants experiencing treatment emergent adverse event with death as the outcome, regardless of relationship to study drug
Time Frame Through Week 25/End of Study
Hide Outcome Measure Data
Hide Analysis Population Description
All participants receiving at least one partial dose of study drug
Arm/Group Title Open-Label Ibalizumab Plus OBR
Hide Arm/Group Description:

2000 mg intravenous ibalizumab (loading dose) on Day 7 followed in 14 days (on Day 21) by 800 mg intravenous ibalizumab administered once every two weeks, plus an Optimized Background Regimen (OBR) beginning on Day 14.

ibalizumab: 2000mg intravenous ibalizumab (loading dose), followed 14 days later by 800mg intravenous ibalizumab every 2 weeks

Optimized Background Regimen (OBR): All participants will be prescribed an Optimized Background Regimen of antiretroviral medications selected on the basis of treatment history and the results of Screening viral resistance and tropism testing. The prescribed regimen must contain at least one agent to which the participant's virus is known to be sensitive.

Overall Number of Participants Analyzed 40
Measure Type: Count of Participants
Unit of Measure: Participants
4
  10.0%
17.Secondary Outcome
Title Proportion of Participants Experiencing New AIDS-defining Adverse Event According to CDC Criteria as a Measure of Safety and Tolerability
Hide Description Proportion of participants experiencing treatment emergent adverse event that is AIDS-defining by the CDC adverse event classification criteria for HIV infection
Time Frame Through Week 25/End of Study
Hide Outcome Measure Data
Hide Analysis Population Description
All participants receiving at least one partial dose of study drug
Arm/Group Title Open-Label Ibalizumab Plus OBR
Hide Arm/Group Description:

2000 mg intravenous ibalizumab (loading dose) on Day 7 followed in 14 days (on Day 21) by 800 mg intravenous ibalizumab administered once every two weeks, plus an Optimized Background Regimen (OBR) beginning on Day 14.

ibalizumab: 2000mg intravenous ibalizumab (loading dose), followed 14 days later by 800mg intravenous ibalizumab every 2 weeks

Optimized Background Regimen (OBR): All participants will be prescribed an Optimized Background Regimen of antiretroviral medications selected on the basis of treatment history and the results of Screening viral resistance and tropism testing. The prescribed regimen must contain at least one agent to which the participant's virus is known to be sensitive.

Overall Number of Participants Analyzed 40
Measure Type: Count of Participants
Unit of Measure: Participants
4
  10.0%
18.Other Pre-specified Outcome
Title Pharmacodynamics: CD4 Receptor Occupancy
Hide Description % of CD receptors occupied by ibalizumab on CD4+ T-cells
Time Frame At Week 25/End of Study
Hide Outcome Measure Data
Hide Analysis Population Description
Intent to Treat (ITT) Population (all participants enrolled) with non-missing receptor occupancy assessments
Arm/Group Title Open-Label Ibalizumab Plus OBR
Hide Arm/Group Description:

2000 mg intravenous ibalizumab (loading dose) on Day 7 followed in 14 days (on Day 21) by 800 mg intravenous ibalizumab administered once every two weeks, plus an Optimized Background Regimen (OBR) beginning on Day 14.

ibalizumab: 2000mg intravenous ibalizumab (loading dose), followed 14 days later by 800mg intravenous ibalizumab every 2 weeks

Optimized Background Regimen (OBR): All participants will be prescribed an Optimized Background Regimen of antiretroviral medications selected on the basis of treatment history and the results of Screening viral resistance and tropism testing. The prescribed regimen must contain at least one agent to which the participant's virus is known to be sensitive.

Overall Number of Participants Analyzed 27
Mean (Standard Deviation)
Unit of Measure: percentage of receptors
90.40  (32.909)
Time Frame Through Week 29
Adverse Event Reporting Description At every participants were asked a nondirective question to elicit any medically related changes, including whether they had been hospitalized, had any accidents, used any new medications, or changed concomitant medication. AEs also were documented from clinically significant findings resulting from abnormal laboratory test values, physical examination findings, ECG abnormalities, or from other documents relevant to safety.
 
Arm/Group Title Open-Label Ibalizumab Plus OBR
Hide Arm/Group Description

2000 mg intravenous ibalizumab (loading dose) on Day 7 followed in 14 days (on Day 21) by 800 mg intravenous ibalizumab administered once every two weeks, plus an Optimized Background Regimen (OBR) beginning on Day 14.

ibalizumab: 2000mg intravenous ibalizumab (loading dose), followed 14 days later by 800mg intravenous ibalizumab every 2 weeks

Optimized Background Regimen (OBR): All participants will be prescribed an Optimized Background Regimen of antiretroviral medications selected on the basis of treatment history and the results of Screening viral resistance and tropism testing. The prescribed regimen must contain at least one agent to which the participant's virus is known to be sensitive.

All-Cause Mortality
Open-Label Ibalizumab Plus OBR
Affected / at Risk (%)
Total   4/40 (10.00%)    
Hide Serious Adverse Events
Open-Label Ibalizumab Plus OBR
Affected / at Risk (%) # Events
Total   9/40 (22.50%)    
Eye disorders   
Diplopia  1  1/40 (2.50%)  1
Gastrointestinal disorders   
Rectal haemorrhage  1  1/40 (2.50%)  1
General disorders   
Pyrexia * 1  2/40 (5.00%)  3
Asthenia  1  1/40 (2.50%)  2
Hepatobiliary disorders   
Hepatic failure  1  1/40 (2.50%)  1
Hepatic mass  1  1/40 (2.50%)  1
Immune system disorders   
Immune reconstitution inflammatory disorder  1  1/40 (2.50%)  1
Infections and infestations   
Cytomegalovirus viraemia  1  1/40 (2.50%)  1
Progressive multifocal leukoencephalopathy  1  1/40 (2.50%)  1
Septic shock  1  1/40 (2.50%)  1
Urinary tract infection  1  1/40 (2.50%)  1
Neoplasms benign, malignant and unspecified (incl cysts and polyps)   
Anal squamous cell carcinoma  1  1/40 (2.50%)  1
Kaposi's sarcoma  1  1/40 (2.50%)  2
Lymphoma  1  1/40 (2.50%)  2
Rectal cancer  1  1/40 (2.50%)  1
Psychiatric disorders   
Mental disorder  1  1/40 (2.50%)  1
Respiratory, thoracic and mediastinal disorders   
Pulmonary hypertension  1  1/40 (2.50%)  1
1
Term from vocabulary, MedDRA (17.0)
Indicates events were collected by systematic assessment
*
Indicates events were collected by non-systematic assessment
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Open-Label Ibalizumab Plus OBR
Affected / at Risk (%) # Events
Total   32/40 (80.00%)    
Blood and lymphatic system disorders   
Lymphadenopathy  1  4/40 (10.00%)  4
Gastrointestinal disorders   
Diarrhoea  1  8/40 (20.00%)  15
Nausea  1  5/40 (12.50%)  6
Vomiting  1  4/40 (10.00%)  4
Abdominal pain  1  2/40 (5.00%)  3
General disorders   
Fatigue  1  5/40 (12.50%)  6
Pyrexia  1  3/40 (7.50%)  4
Oedema peripheral  1  2/40 (5.00%)  3
Infections and infestations   
Nasopharyngitis  1  4/40 (10.00%)  4
Upper respiratory tract infection  1  3/40 (7.50%)  3
Bronchitis  1  2/40 (5.00%)  2
Folliculitis  1  2/40 (5.00%)  2
Gastroenteritis  1  2/40 (5.00%)  2
Herpes zoster  1  2/40 (5.00%)  2
Oral candidiasis  1  2/40 (5.00%)  3
Pneumonia  1  2/40 (5.00%)  2
Injury, poisoning and procedural complications   
Excoriation  1  3/40 (7.50%)  3
Metabolism and nutrition disorders   
Decreased appetite  1  3/40 (7.50%)  3
Musculoskeletal and connective tissue disorders   
Back pain  1  2/40 (5.00%)  2
Nervous system disorders   
Dizziness  1  5/40 (12.50%)  6
Headache  1  3/40 (7.50%)  3
Respiratory, thoracic and mediastinal disorders   
Cough  1  2/40 (5.00%)  2
Dyspnoea  1  2/40 (5.00%)  2
Skin and subcutaneous tissue disorders   
Rash  1 [1]  5/40 (12.50%)  12
Night sweats  1  2/40 (5.00%)  2
Papule  1  2/40 (5.00%)  2
Skin lesion  1  2/40 (5.00%)  2
1
Term from vocabulary, MedDRA (17.0)
Indicates events were collected by systematic assessment
[1]
Rash is a combined count of all types of rashes reported, including rash, rash erythematous, rash generalised,rash macular, rash maculo-papular, rash papular, rash pruritic. No rash type occurred at a rate >/= 5%.
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT 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
Layout table for Results Point of Contact information
Name/Title: Manager - Clinical Services
Organization: TaiMed Biologics USA Corp.
Phone: (949) 331-3225
EMail: bbell@taimedbio.com
Layout table for additonal information
Responsible Party: TaiMed Biologics Inc.
ClinicalTrials.gov Identifier: NCT02475629    
Other Study ID Numbers: TMB-301
First Submitted: June 11, 2015
First Posted: June 19, 2015
Results First Submitted: February 7, 2020
Results First Posted: March 19, 2020
Last Update Posted: March 19, 2020