Trial Outcomes & Findings for Ibalizumab Plus Optimized Background Regimen in Patient With Multi-Drug Resistant HIV (NCT NCT02475629)
NCT ID: NCT02475629
Last Updated: 2020-03-19
Results Overview
Proportion of participants (%) achieving a viral load reduction of at least 0.5 log from baseline (Day 7)
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
40 participants
Primary outcome timeframe
Day 14
Results posted on
2020-03-19
Participant Flow
Participant milestones
| Measure |
Open-Label Ibalizumab Plus OBR
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.
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|---|---|
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Overall Study
STARTED
|
40
|
|
Overall Study
COMPLETED
|
31
|
|
Overall Study
NOT COMPLETED
|
9
|
Reasons for withdrawal
| Measure |
Open-Label Ibalizumab Plus OBR
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.
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|---|---|
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Overall Study
Adverse Event
|
1
|
|
Overall Study
Death
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4
|
|
Overall Study
Physician Decision
|
1
|
|
Overall Study
Withdrawal by Subject
|
1
|
|
Overall Study
Lost to Follow-up
|
1
|
|
Overall Study
Subject non-compliance
|
1
|
Baseline Characteristics
Ibalizumab Plus Optimized Background Regimen in Patient With Multi-Drug Resistant HIV
Baseline characteristics by cohort
| Measure |
Open-Label Ibalizumab Plus OBR
n=40 Participants
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.
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|---|---|
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Age, Continuous
|
50.5 years
STANDARD_DEVIATION 10.99 • n=5 Participants
|
|
Sex: Female, Male
Female
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6 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
34 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
11 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
27 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
4 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
13 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
22 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
|
Region of Enrollment
Puerto Rico
|
2 participants
n=5 Participants
|
|
Region of Enrollment
United States
|
34 participants
n=5 Participants
|
|
Region of Enrollment
Taiwan
|
4 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Day 14Population: Intent to Treat (ITT) Population (all participants enrolled) with missing values set to zero change
Proportion of participants (%) achieving a viral load reduction of at least 0.5 log from baseline (Day 7)
Outcome measures
| Measure |
Open-Label Ibalizumab Plus OBR
n=40 Participants
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.
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|---|---|
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Efficacy: Proportion of Participants Achieving a Viral Load Reduction of at Least 0.5 Log 10: ITT-MEF
|
0.825 proportion of participants
Interval 0.6772 to 0.9266
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PRIMARY outcome
Timeframe: Day 14Population: Protocol Correct (PC) Population (all participants with non-missing viral load assessments at Day 7, Day 14 and Week 25/End of Study)
Proportion of patients (%) with a viral load decrease of at least 0.5 log 10 from baseline (day 7)
Outcome measures
| Measure |
Open-Label Ibalizumab Plus OBR
n=26 Participants
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.
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|---|---|
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Efficacy: Proportion of Subjects With a Viral Load Decrease of at Least 0.5 Log 10 - Protocol Correct
|
0.846 proportion of participants
Interval 0.6513 to 0.9564
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SECONDARY outcome
Timeframe: Week 25 /end of studyPopulation: Intent to Treat (ITT) Population (all participants enrolled) with missing values set to failure
Proportion of patients with undetectable Viral Load (\<50 copies/mL, and \<400 copies/mL)
Outcome measures
| Measure |
Open-Label Ibalizumab Plus OBR
n=40 Participants
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.
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|---|---|
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Efficacy: Proportion of Patients With Undetectable Viral Load: ITT-MEF
<50 copies/mL
|
.425 proportion of participants
Interval 0.2704 to 0.5911
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|
Efficacy: Proportion of Patients With Undetectable Viral Load: ITT-MEF
<400 copies/mL
|
.525 proportion of participants
Interval 0.3613 to 0.6849
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SECONDARY outcome
Timeframe: Week 25/End of StudyPopulation: Protocol Correct (PC) Population (all participants with non-missing viral load assessments at Day 7, Day 14 and Week 25/End of Study)
Proportion of patients (%) with HIV-RNA levels \< 50 copies/mL and \< 400 copies/mL at Week 25/End of Study
Outcome measures
| Measure |
Open-Label Ibalizumab Plus OBR
n=26 Participants
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.
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|---|---|
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Efficacy: Proportion of Patients With Undetectable HIV-RNA Levels: Protocol Correct
<50 copies/mL
|
.654 proportion of participants
Interval 0.4433 to 0.8279
|
|
Efficacy: Proportion of Patients With Undetectable HIV-RNA Levels: Protocol Correct
<400 copies/mL
|
.808 proportion of participants
Interval 0.6065 to 0.9345
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SECONDARY outcome
Timeframe: Day 7 and Day 14Population: Intent to Treat (ITT) Population (all participants enrolled) with missing values set to zero change
Mean change from Day 7/Baseline in log 10 vial load measured at Day 14
Outcome measures
| Measure |
Open-Label Ibalizumab Plus OBR
n=40 Participants
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.
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|---|---|
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Mean Change in Viral Load as a Measure of Efficacy - ITT-MEF
|
-1.07 Log10 copies/mL
Standard Deviation 0.618
|
SECONDARY outcome
Timeframe: Day 7 and Day 14Population: Protocol Correct (PC) Population (all participants with non-missing viral load assessments at Day 14
Mean change from Day 7/Baseline in Log 10 viral load measured at Day 14
Outcome measures
| Measure |
Open-Label Ibalizumab Plus OBR
n=26 Participants
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.
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|---|---|
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Mean Change in Viral Load as a Measure of Efficacy - Protocol Correct
|
-1.11 Log10 copies/mL
Standard Deviation 0.641
|
SECONDARY outcome
Timeframe: at Week 25/End of StudyPopulation: Intent to Treat (ITT) Population (all participants enrolled) with missing values set to zero change
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
Outcome measures
| Measure |
Open-Label Ibalizumab Plus OBR
n=40 Participants
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.
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|---|---|
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End of Study Viral Load Reductions as a Measure of Efficacy - Intent to Treat Analysis
>/= 0.5 log10 reduction
|
.625 proportion of participants
Interval 0.458 to 0.7727
|
|
End of Study Viral Load Reductions as a Measure of Efficacy - Intent to Treat Analysis
>/= 1.0 log10 reduction
|
.550 proportion of participants
Interval 0.3849 to 0.7074
|
SECONDARY outcome
Timeframe: at Week 25/End of StudyPopulation: Protocol Correct (PC) Population (all participants with non-missing viral load assessments at Day 7, Day 14 and Week 25/End of Study)
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
Outcome measures
| Measure |
Open-Label Ibalizumab Plus OBR
n=26 Participants
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.
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|---|---|
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End of Study Viral Load Reductions as a Measure of Efficacy - Protocol Correct Analysis
>/= 0.5 log10 reduction
|
.962 proportion of participants
Interval 0.8036 to 0.999
|
|
End of Study Viral Load Reductions as a Measure of Efficacy - Protocol Correct Analysis
>/= 1.0 log10 reduction
|
.846 proportion of participants
Interval 0.6513 to 0.9564
|
SECONDARY outcome
Timeframe: Day 7 and Week 25/End of StudyPopulation: Intent to Treat (ITT) Population (all participants enrolled). Only obtained values were included in analysis - missing values were not imputed.
Mean change from Day 7/Baseline in CD4+ cell count at Week 25/End of Study
Outcome measures
| Measure |
Open-Label Ibalizumab Plus OBR
n=27 Participants
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.
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|---|---|
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Mean Change in CD4+ Cell Count as a Measure of Efficacy and Safety - ITT
|
62.4 cells/mm^3
Standard Deviation 105.75
|
SECONDARY outcome
Timeframe: Day 7 and Week 25/End of StudyPopulation: 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
Mean change from Day 7/Baseline in CD4+ cell count at Week 25/End of Study
Outcome measures
| Measure |
Open-Label Ibalizumab Plus OBR
n=22 Participants
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.
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|---|---|
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Mean Change in CD4+ Cell Count as a Measure of Efficacy and Safety - Protocol Correct
|
67.0 cells/mm^3
Standard Deviation 114.35
|
SECONDARY outcome
Timeframe: Through Week 25/End of StudyPopulation: All participants receiving at least one partial dose of study drug
Proportion of participants experiencing at least one treatment emergent adverse event to week 25/End of Study
Outcome measures
| Measure |
Open-Label Ibalizumab Plus OBR
n=40 Participants
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.
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|---|---|
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Safety: Proportion of Participants Experiencing Adverse Events
|
32 Participants
|
SECONDARY outcome
Timeframe: Through Week 25/End of StudyPopulation: All participants receiving at least one partial dose of study drug
Proportion of participants experiencing a treatment emergent adverse event determined by the investigator to be related to study drug
Outcome measures
| Measure |
Open-Label Ibalizumab Plus OBR
n=40 Participants
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.
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|---|---|
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Proportion of Participants Experiencing Adverse Event Related to Study Drug as a Measure of Safety and Tolerability
|
7 Participants
|
SECONDARY outcome
Timeframe: Through Week 25/End of StudyPopulation: All participants receiving at least one partial dose of study drug
Proportion of participants experiencing at least one serious treatment emergent adverse event, excluding death
Outcome measures
| Measure |
Open-Label Ibalizumab Plus OBR
n=40 Participants
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.
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|---|---|
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Proportion of Participants Experiencing Serious Adverse Event as a Measure of Safety and Tolerability
|
9 Participants
|
SECONDARY outcome
Timeframe: Through Week 25/End of StudyPopulation: All participants receiving at least one partial dose of study drug
Proportion of participants discontinuing study drug due to occurrence of treatment emergent adverse event
Outcome measures
| Measure |
Open-Label Ibalizumab Plus OBR
n=40 Participants
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.
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|---|---|
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Proportion of Participants Discontinuing Study Drug Due to Adverse Event
|
5 Participants
|
SECONDARY outcome
Timeframe: Through Week 25/End of StudyPopulation: All participants receiving at least one partial dose of study drug
Proportion of participants experiencing treatment emergent adverse event Grade 3 and higher
Outcome measures
| Measure |
Open-Label Ibalizumab Plus OBR
n=40 Participants
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.
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|---|---|
|
Proportion of Participants Experiencing Adverse Event Grade 3 and Higher as a Measure of Safety and Tolerability
|
11 Participants
|
SECONDARY outcome
Timeframe: Through Week 25/End of StudyPopulation: All participants receiving at least one partial dose of study drug
Proportion of participants experiencing treatment emergent adverse event with death as the outcome, regardless of relationship to study drug
Outcome measures
| Measure |
Open-Label Ibalizumab Plus OBR
n=40 Participants
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.
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|---|---|
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Proportion of Participants Experiencing Adverse Event With Death as Outcome as a Measure of Safety and Tolerability
|
4 Participants
|
SECONDARY outcome
Timeframe: Through Week 25/End of StudyPopulation: All participants receiving at least one partial dose of study drug
Proportion of participants experiencing treatment emergent adverse event that is AIDS-defining by the CDC adverse event classification criteria for HIV infection
Outcome measures
| Measure |
Open-Label Ibalizumab Plus OBR
n=40 Participants
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.
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|---|---|
|
Proportion of Participants Experiencing New AIDS-defining Adverse Event According to CDC Criteria as a Measure of Safety and Tolerability
|
4 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: At Week 25/End of StudyPopulation: Intent to Treat (ITT) Population (all participants enrolled) with non-missing receptor occupancy assessments
% of CD receptors occupied by ibalizumab on CD4+ T-cells
Outcome measures
| Measure |
Open-Label Ibalizumab Plus OBR
n=27 Participants
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.
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|---|---|
|
Pharmacodynamics: CD4 Receptor Occupancy
|
90.40 percentage of receptors
Standard Deviation 32.909
|
Adverse Events
Open-Label Ibalizumab Plus OBR
Serious events: 9 serious events
Other events: 32 other events
Deaths: 4 deaths
Serious adverse events
| Measure |
Open-Label Ibalizumab Plus OBR
n=40 participants at risk
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.
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|---|---|
|
General disorders
Pyrexia
|
5.0%
2/40 • Number of events 3 • Through Week 29
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.
|
|
General disorders
Asthenia
|
2.5%
1/40 • Number of events 2 • Through Week 29
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.
|
|
Infections and infestations
Cytomegalovirus viraemia
|
2.5%
1/40 • Number of events 1 • Through Week 29
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.
|
|
Infections and infestations
Progressive multifocal leukoencephalopathy
|
2.5%
1/40 • Number of events 1 • Through Week 29
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.
|
|
Infections and infestations
Septic shock
|
2.5%
1/40 • Number of events 1 • Through Week 29
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.
|
|
Infections and infestations
Urinary tract infection
|
2.5%
1/40 • Number of events 1 • Through Week 29
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.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Anal squamous cell carcinoma
|
2.5%
1/40 • Number of events 1 • Through Week 29
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.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Kaposi's sarcoma
|
2.5%
1/40 • Number of events 2 • Through Week 29
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.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lymphoma
|
2.5%
1/40 • Number of events 2 • Through Week 29
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.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Rectal cancer
|
2.5%
1/40 • Number of events 1 • Through Week 29
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.
|
|
Eye disorders
Diplopia
|
2.5%
1/40 • Number of events 1 • Through Week 29
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.
|
|
Gastrointestinal disorders
Rectal haemorrhage
|
2.5%
1/40 • Number of events 1 • Through Week 29
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.
|
|
Hepatobiliary disorders
Hepatic failure
|
2.5%
1/40 • Number of events 1 • Through Week 29
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.
|
|
Hepatobiliary disorders
Hepatic mass
|
2.5%
1/40 • Number of events 1 • Through Week 29
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.
|
|
Immune system disorders
Immune reconstitution inflammatory disorder
|
2.5%
1/40 • Number of events 1 • Through Week 29
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.
|
|
Psychiatric disorders
Mental disorder
|
2.5%
1/40 • Number of events 1 • Through Week 29
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.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary hypertension
|
2.5%
1/40 • Number of events 1 • Through Week 29
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.
|
Other adverse events
| Measure |
Open-Label Ibalizumab Plus OBR
n=40 participants at risk
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.
|
|---|---|
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Infections and infestations
Nasopharyngitis
|
10.0%
4/40 • Number of events 4 • Through Week 29
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.
|
|
Infections and infestations
Upper respiratory tract infection
|
7.5%
3/40 • Number of events 3 • Through Week 29
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.
|
|
Infections and infestations
Bronchitis
|
5.0%
2/40 • Number of events 2 • Through Week 29
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.
|
|
Infections and infestations
Folliculitis
|
5.0%
2/40 • Number of events 2 • Through Week 29
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.
|
|
Infections and infestations
Gastroenteritis
|
5.0%
2/40 • Number of events 2 • Through Week 29
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.
|
|
Infections and infestations
Herpes zoster
|
5.0%
2/40 • Number of events 2 • Through Week 29
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.
|
|
Infections and infestations
Oral candidiasis
|
5.0%
2/40 • Number of events 3 • Through Week 29
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.
|
|
Infections and infestations
Pneumonia
|
5.0%
2/40 • Number of events 2 • Through Week 29
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.
|
|
Gastrointestinal disorders
Diarrhoea
|
20.0%
8/40 • Number of events 15 • Through Week 29
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.
|
|
Gastrointestinal disorders
Nausea
|
12.5%
5/40 • Number of events 6 • Through Week 29
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.
|
|
Gastrointestinal disorders
Vomiting
|
10.0%
4/40 • Number of events 4 • Through Week 29
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.
|
|
Gastrointestinal disorders
Abdominal pain
|
5.0%
2/40 • Number of events 3 • Through Week 29
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.
|
|
General disorders
Fatigue
|
12.5%
5/40 • Number of events 6 • Through Week 29
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.
|
|
General disorders
Pyrexia
|
7.5%
3/40 • Number of events 4 • Through Week 29
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.
|
|
General disorders
Oedema peripheral
|
5.0%
2/40 • Number of events 3 • Through Week 29
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.
|
|
Skin and subcutaneous tissue disorders
Rash
|
12.5%
5/40 • Number of events 12 • Through Week 29
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.
|
|
Skin and subcutaneous tissue disorders
Night sweats
|
5.0%
2/40 • Number of events 2 • Through Week 29
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.
|
|
Skin and subcutaneous tissue disorders
Papule
|
5.0%
2/40 • Number of events 2 • Through Week 29
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.
|
|
Skin and subcutaneous tissue disorders
Skin lesion
|
5.0%
2/40 • Number of events 2 • Through Week 29
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.
|
|
Nervous system disorders
Dizziness
|
12.5%
5/40 • Number of events 6 • Through Week 29
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.
|
|
Nervous system disorders
Headache
|
7.5%
3/40 • Number of events 3 • Through Week 29
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.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
5.0%
2/40 • Number of events 2 • Through Week 29
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.
|
|
Blood and lymphatic system disorders
Lymphadenopathy
|
10.0%
4/40 • Number of events 4 • Through Week 29
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.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
7.5%
3/40 • Number of events 3 • Through Week 29
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.
|
|
Injury, poisoning and procedural complications
Excoriation
|
7.5%
3/40 • Number of events 3 • Through Week 29
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.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
5.0%
2/40 • Number of events 2 • Through Week 29
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.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
5.0%
2/40 • Number of events 2 • Through Week 29
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.
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Additional Information
Manager - Clinical Services
TaiMed Biologics USA Corp.
Phone: (949) 331-3225
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place