Ibalizumab Plus Optimized Background Regimen in Patient W... | NCT02475629

NCT02475629

Status Module

Sponsor/Collaborators Module

Oversight Module

Description Module

Conditions Module

Design Module

Interventional Study Design

Biospecimen

No data available

No data is available for this block.

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Open-Label Ibalizumab plus OBR	Experimental	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.	Biological: ibalizumab Drug: Optimized Background Regimen (OBR)

Interventions

Name	Type	Description	Arm Group Labels	Other Names
ibalizumab	Biological	2000mg intravenous ibalizumab (loading dose), followed 14 days later by 800mg intravenous ibalizumab every 2 weeks	Open-Label Ibalizumab plus OBR

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Efficacy: Proportion of Participants Achieving a Viral Load Reduction of at Least 0.5 Log 10: ITT-MEF	Proportion of participants (%) achieving a viral load reduction of at least 0.5 log from baseline (Day 7)	Day 14
Efficacy: Proportion of Subjects With a Viral Load Decrease of at Least 0.5 Log 10 - Protocol Correct	Proportion of patients (%) with a viral load decrease of at least 0.5 log 10 from baseline (day 7)	Day 14

Secondary Outcomes

Measure	Description	Time Frame
Efficacy: Proportion of Patients With Undetectable Viral Load: ITT-MEF	Proportion of patients with undetectable Viral Load (<50 copies/mL, and <400 copies/mL)	Week 25 /end of study
Efficacy: Proportion of Patients With Undetectable HIV-RNA Levels: Protocol Correct

Measure	Description	Time Frame
Pharmacodynamics: CD4 Receptor Occupancy	% of CD receptors occupied by ibalizumab on CD4+ T-cells	At Week 25/End of Study

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Are capable of understanding and have voluntarily signed the informed consent document
Have documented HIV-1 infection by official, signed, written history (e.g., laboratory report), otherwise an HIV-antibody test will be performed
Have no acquired immunodeficiency syndrome (AIDS)-defining events in the 3 months before Screening, other than cutaneous Kaposi's sarcoma or wasting syndrome due to HIV
Are able and willing to comply with all protocol requirements and procedures
Have a life expectancy that is >6 months.
Have a viral load >1,000 copies/mL and documented resistance to at least one antiretroviral medication from each of three classes of antiretroviral medications as measured by resistance testing
Have a history of at least 6 months on antiretroviral treatment
Are receiving a stable highly active antiretroviral regimen for at least 8 weeks before Screening and are willing to continue that regimen until Day 14, OR (in the past 8 weeks) have failed and are off therapy and are willing to stay off therapy until Day 14
Have full viral sensitivity/susceptibility to at least one antiretroviral agent, other than ibalizumab, as determined by the screening resistance tests and be willing and able to be treated with at least one agent to which the patient's viral isolate is fully sensitive/susceptible according to the screening resistance tests as a component of OBR
If sexually active, are willing to use an effective method of contraception during the study and for 30 days after the last administration of the study drug

Exclusion Criteria:

Any active AIDS-defining illness per Category C conditions according to the Centers for Disease Control and Prevention (CDC) Classification System for HIV Infection, with the following exceptions: cutaneous Kaposi's sarcoma and wasting syndrome due to HIV
Any significant diseases (other than HIV-1 infection) or clinically significant findings, including psychiatric and behavioral problems, determined from screening, medical history and/or physical examination that, in the investigator's opinion, would preclude the patient from participating in this study
Any significant acute illness within 1 week before the initial administration of study drug
Any active infection secondary to HIV requiring acute therapy; however, patients that require maintenance therapy (i.e., secondary prophylaxis for opportunistic infections) will be eligible for the study.
Any immunomodulating therapy (including interferon), systemic steroids, or systemic chemotherapy within 12 weeks before Enrollment
Any prior exposure to ibalizumab (formerly TNX-355 and Hu5A8)
Any vaccination within 7 days before Enrollment
Any female patient who either is pregnant, intends to become pregnant, or is currently breastfeeding
Any current alcohol or illicit drug use that, in the investigator's opinion, will interfere with the patient's ability to comply with the study schedule and protocol evaluations
Any previous clinically significant allergy or hypersensitivity to any excipient in the ibalizumab formulation
Any radiation therapy during the 28 days before first administration of investigational medication
Any Grade 3 or 4 laboratory abnormality according to the Division of AIDS grading scale, except for the following asymptomatic Grade 3 events triglyceride elevation total cholesterol elevation

Contacts/Locations Module

Facility	Status	City	State	ZIP	Country	Contacts
Long Beach Education and Research Consultants		Long Beach	California	90813	United States
W King Health Care Group

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
30110589	Derived	Emu B, Fessel J, Schrader S, Kumar P, Richmond G, Win S, Weinheimer S, Marsolais C, Lewis S. Phase 3 Study of Ibalizumab for Multidrug-Resistant HIV-1. N Engl J Med. 2018 Aug 16;379(7):645-654. doi: 10.1056/NEJMoa1711460.

IPD Sharing Statement Module

No data available

No data is available for this block.

Results Section

Participant Flow Module

Arm/Group Information

ID	Title	Description
FG000	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.

Baseline Characteristics Module

Outcome Measures Module

Adverse Events Module

More Info Module

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Submission Tracking

No data available

No data is available for this block.

Condition Browse Module

No data available

No data is available for this block.

Intervention Browse Module

Masking Info

Type of Units Analyzed

Arm/Group Information

ID	Title	Description
BG000	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.

Baseline Measures

Title

Description

Population Description

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Denominator Units Selected

Denominators

Classes

Age, Continuous

Mean

Standard Deviation

years

Title

Denominators

Categories

Title	Measurements
	BG00050.5± 10.99

Sex: Female, Male

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
Female	BG0006
Male	BG00034

Ethnicity (NIH/OMB)

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
Hispanic or Latino	BG00011
Not Hispanic or Latino	BG00027

Race (NIH/OMB)

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
American Indian or Alaska Native	BG0000
Asian	BG0004

Region of Enrollment

Number

participants

Title

Denominators

Categories

Puerto Rico

Title	Measurements
	BG0002

United States

Title	Measurements
	BG000

Type

Title

Description

Population Description

Reporting Status

Anticipated Posting Date

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Time Frame

Units Analyzed

Denominator Units Selected

Arm/Group Information

Denominators

Classes

Analyses

Primary

Efficacy: Proportion of Participants Achieving a Viral Load Reduction of at Least 0.5 Log 10: ITT-MEF

Proportion of participants (%) achieving a viral load reduction of at least 0.5 log from baseline (Day 7)

Intent to Treat (ITT) Population (all participants enrolled) with missing values set to zero change

Posted

Number

95% Confidence Interval

proportion of participants

Day 14

ID	Title	Description
OG000	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.

Units	Counts
Participants	OG00040

Title

Denominators

Categories

Title	Measurements
	OG0000.825(0.6772 to 0.9266)

Primary

Efficacy: Proportion of Subjects With a Viral Load Decrease of at Least 0.5 Log 10 - Protocol Correct

Proportion of patients (%) with a viral load decrease of at least 0.5 log 10 from baseline (day 7)

Protocol Correct (PC) Population (all participants with non-missing viral load assessments at Day 7, Day 14 and Week 25/End of Study)

Posted

Number

95% Confidence Interval

proportion of participants

Day 14

ID	Title	Description
OG000	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.

Units	Counts
Participants

Secondary

Efficacy: Proportion of Patients With Undetectable Viral Load: ITT-MEF

Proportion of patients with undetectable Viral Load (<50 copies/mL, and <400 copies/mL)

Intent to Treat (ITT) Population (all participants enrolled) with missing values set to failure

Posted

Number

95% Confidence Interval

proportion of participants

Week 25 /end of study

ID	Title	Description
OG000	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.

Units	Counts
Participants	OG000

Secondary

Efficacy: Proportion of Patients With Undetectable HIV-RNA Levels: Protocol Correct

Proportion of patients (%) with HIV-RNA levels < 50 copies/mL and < 400 copies/mL at Week 25/End of Study

Protocol Correct (PC) Population (all participants with non-missing viral load assessments at Day 7, Day 14 and Week 25/End of Study)

Posted

Number

95% Confidence Interval

proportion of participants

Week 25/End of Study

ID	Title	Description
OG000	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.

Units	Counts
Participants

Secondary

Mean Change in Viral Load as a Measure of Efficacy - ITT-MEF

Mean change from Day 7/Baseline in log 10 vial load measured at Day 14

Intent to Treat (ITT) Population (all participants enrolled) with missing values set to zero change

Posted

Mean

Standard Deviation

Log10 copies/mL

Day 7 and Day 14

ID	Title	Description
OG000	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.

Units	Counts
Participants	OG000

Secondary

Mean Change in Viral Load as a Measure of Efficacy - Protocol Correct

Mean change from Day 7/Baseline in Log 10 viral load measured at Day 14

Protocol Correct (PC) Population (all participants with non-missing viral load assessments at Day 14

Posted

Mean

Standard Deviation

Log10 copies/mL

Day 7 and Day 14

ID	Title	Description
OG000	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.

Units	Counts
Participants	OG000

Secondary

End of Study Viral Load Reductions as a Measure of Efficacy - Intent to Treat Analysis

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

Intent to Treat (ITT) Population (all participants enrolled) with missing values set to zero change

Posted

Number

95% Confidence Interval

proportion of participants

at Week 25/End of Study

ID	Title	Description
OG000	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.

Units	Counts
Participants

Secondary

End of Study Viral Load Reductions as a Measure of Efficacy - Protocol Correct Analysis

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

Protocol Correct (PC) Population (all participants with non-missing viral load assessments at Day 7, Day 14 and Week 25/End of Study)

Posted

Number

95% Confidence Interval

proportion of participants

at Week 25/End of Study

ID	Title	Description
OG000	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.

Units	Counts
Participants

Secondary

Mean Change in CD4+ Cell Count as a Measure of Efficacy and Safety - ITT

Mean change from Day 7/Baseline in CD4+ cell count at Week 25/End of Study

Intent to Treat (ITT) Population (all participants enrolled). Only obtained values were included in analysis - missing values were not imputed.

Posted

Mean

Standard Deviation

cells/mm^3

Day 7 and Week 25/End of Study

ID	Title	Description
OG000	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.

Units	Counts
Participants	OG000

Secondary

Mean Change in CD4+ Cell Count as a Measure of Efficacy and Safety - Protocol Correct

Mean change from Day 7/Baseline in CD4+ cell count at Week 25/End of Study

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

Posted

Mean

Standard Deviation

cells/mm^3

Day 7 and Week 25/End of Study

ID	Title	Description
OG000	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.

Units	Counts
Participants

Secondary

Safety: Proportion of Participants Experiencing Adverse Events

Proportion of participants experiencing at least one treatment emergent adverse event to week 25/End of Study

All participants receiving at least one partial dose of study drug

Posted

Count of Participants

Participants

Through Week 25/End of Study

ID	Title	Description
OG000	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.

Units	Counts
Participants	OG000

Secondary

Proportion of Participants Experiencing Adverse Event Related to Study Drug as a Measure of Safety and Tolerability

Proportion of participants experiencing a treatment emergent adverse event determined by the investigator to be related to study drug

All participants receiving at least one partial dose of study drug

Posted

Count of Participants

Participants

Through Week 25/End of Study

ID	Title	Description
OG000	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.

Units	Counts
Participants

Secondary

Proportion of Participants Experiencing Serious Adverse Event as a Measure of Safety and Tolerability

Proportion of participants experiencing at least one serious treatment emergent adverse event, excluding death

All participants receiving at least one partial dose of study drug

Posted

Count of Participants

Participants

Through Week 25/End of Study

ID	Title	Description
OG000	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.

Units	Counts
Participants	OG000

Secondary

Proportion of Participants Discontinuing Study Drug Due to Adverse Event

Proportion of participants discontinuing study drug due to occurrence of treatment emergent adverse event

All participants receiving at least one partial dose of study drug

Posted

Count of Participants

Participants

Through Week 25/End of Study

ID	Title	Description
OG000	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.

Units	Counts
Participants	OG000

Secondary

Proportion of Participants Experiencing Adverse Event Grade 3 and Higher as a Measure of Safety and Tolerability

Proportion of participants experiencing treatment emergent adverse event Grade 3 and higher

All participants receiving at least one partial dose of study drug

Posted

Count of Participants

Participants

Through Week 25/End of Study

ID	Title	Description
OG000	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.

Units	Counts
Participants	OG000

Secondary

Proportion of Participants Experiencing Adverse Event With Death as Outcome as a Measure of Safety and Tolerability

Proportion of participants experiencing treatment emergent adverse event with death as the outcome, regardless of relationship to study drug

All participants receiving at least one partial dose of study drug

Posted

Count of Participants

Participants

Through Week 25/End of Study

ID	Title	Description
OG000	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.

Units	Counts
Participants

Secondary

Proportion of Participants Experiencing New AIDS-defining Adverse Event According to CDC Criteria as a Measure of Safety and Tolerability

Proportion of participants experiencing treatment emergent adverse event that is AIDS-defining by the CDC adverse event classification criteria for HIV infection

All participants receiving at least one partial dose of study drug

Posted

Count of Participants

Participants

Through Week 25/End of Study

ID	Title	Description
OG000	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.

Units	Counts
Participants

Other Pre-specified

Pharmacodynamics: CD4 Receptor Occupancy

% of CD receptors occupied by ibalizumab on CD4+ T-cells

Intent to Treat (ITT) Population (all participants enrolled) with non-missing receptor occupancy assessments

Posted

Mean

Standard Deviation

percentage of receptors

At Week 25/End of Study

ID	Title	Description
OG000	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.

Units	Counts
Participants	OG000

Arm/Groups

ID	Title	Description	Deaths (Affected)	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	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.	4	40	9	40	32	40

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Pyrexia	General disorders	MedDRA (17.0)	Non-systematic Assessment	EG0003 events2 affected40 at risk
Asthenia	General disorders	MedDRA (17.0)	Systematic Assessment	EG0002 events1 affected40 at risk
Cytomegalovirus viraemia	Infections and infestations	MedDRA (17.0)	Systematic Assessment	EG0001 events1 affected40 at risk
Progressive multifocal leukoencephalopathy	Infections and infestations	MedDRA (17.0)	Systematic Assessment	EG0001 events1 affected40 at risk
Septic shock	Infections and infestations	MedDRA (17.0)	Systematic Assessment	EG0001 events1 affected40 at risk
Urinary tract infection	Infections and infestations	MedDRA (17.0)	Systematic Assessment	EG0001 events1 affected40 at risk
Anal squamous cell carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (17.0)	Systematic Assessment	EG0001 events1 affected40 at risk
Kaposi's sarcoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (17.0)	Systematic Assessment	EG0002 events1 affected40 at risk
Lymphoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (17.0)	Systematic Assessment	EG0002 events1 affected40 at risk
Rectal cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (17.0)	Systematic Assessment	EG0001 events1 affected40 at risk
Diplopia	Eye disorders	MedDRA (17.0)	Systematic Assessment	EG0001 events1 affected40 at risk
Rectal haemorrhage	Gastrointestinal disorders	MedDRA (17.0)	Systematic Assessment	EG0001 events1 affected40 at risk
Hepatic failure	Hepatobiliary disorders	MedDRA (17.0)	Systematic Assessment	EG0001 events1 affected40 at risk
Hepatic mass	Hepatobiliary disorders	MedDRA (17.0)	Systematic Assessment	EG0001 events1 affected40 at risk
Immune reconstitution inflammatory disorder	Immune system disorders	MedDRA (17.0)	Systematic Assessment	EG0001 events1 affected40 at risk
Mental disorder	Psychiatric disorders	MedDRA (17.0)	Systematic Assessment	EG0001 events1 affected40 at risk
Pulmonary hypertension	Respiratory, thoracic and mediastinal disorders	MedDRA (17.0)	Systematic Assessment	EG0001 events1 affected40 at risk

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Notes	Statistical Information
Nasopharyngitis	Infections and infestations	MedDRA (17.0)	Systematic Assessment		EG0004 events4 affected40 at risk
Upper respiratory tract infection	Infections and infestations	MedDRA (17.0)	Systematic Assessment		EG0003 events3 affected40 at risk
Bronchitis	Infections and infestations	MedDRA (17.0)	Systematic Assessment		EG0002 events2 affected40 at risk
Folliculitis	Infections and infestations	MedDRA (17.0)	Systematic Assessment		EG0002 events2 affected40 at risk
Gastroenteritis	Infections and infestations	MedDRA (17.0)	Systematic Assessment		EG0002 events2 affected40 at risk
Herpes zoster	Infections and infestations	MedDRA (17.0)	Systematic Assessment		EG0002 events2 affected40 at risk
Oral candidiasis	Infections and infestations	MedDRA (17.0)	Systematic Assessment		EG0003 events2 affected40 at risk
Pneumonia	Infections and infestations	MedDRA (17.0)	Systematic Assessment		EG0002 events2 affected40 at risk
Diarrhoea	Gastrointestinal disorders	MedDRA (17.0)	Systematic Assessment		EG00015 events8 affected40 at risk
Nausea	Gastrointestinal disorders	MedDRA (17.0)	Systematic Assessment		EG0006 events5 affected40 at risk
Vomiting	Gastrointestinal disorders	MedDRA (17.0)	Systematic Assessment		EG0004 events4 affected40 at risk
Abdominal pain	Gastrointestinal disorders	MedDRA (17.0)	Systematic Assessment		EG0003 events2 affected40 at risk
Fatigue	General disorders	MedDRA (17.0)	Systematic Assessment		EG0006 events5 affected40 at risk
Pyrexia	General disorders	MedDRA (17.0)	Systematic Assessment		EG0004 events3 affected40 at risk
Oedema peripheral	General disorders	MedDRA (17.0)	Systematic Assessment		EG0003 events2 affected40 at risk
Rash	Skin and subcutaneous tissue disorders	MedDRA (17.0)	Systematic Assessment	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%.	EG00012 events5 affected40 at risk
Night sweats	Skin and subcutaneous tissue disorders	MedDRA (17.0)	Systematic Assessment		EG0002 events2 affected40 at risk
Papule	Skin and subcutaneous tissue disorders	MedDRA (17.0)	Systematic Assessment		EG0002 events2 affected40 at risk
Skin lesion	Skin and subcutaneous tissue disorders	MedDRA (17.0)	Systematic Assessment		EG0002 events2 affected40 at risk
Dizziness	Nervous system disorders	MedDRA (17.0)	Systematic Assessment		EG0006 events5 affected40 at risk
Headache	Nervous system disorders	MedDRA (17.0)	Systematic Assessment		EG0003 events3 affected40 at risk
Back pain	Musculoskeletal and connective tissue disorders	MedDRA (17.0)	Systematic Assessment		EG0002 events2 affected40 at risk
Lymphadenopathy	Blood and lymphatic system disorders	MedDRA (17.0)	Systematic Assessment		EG0004 events4 affected40 at risk
Decreased appetite	Metabolism and nutrition disorders	MedDRA (17.0)	Systematic Assessment		EG0003 events3 affected40 at risk
Excoriation	Injury, poisoning and procedural complications	MedDRA (17.0)	Systematic Assessment		EG0003 events3 affected40 at risk
Cough	Respiratory, thoracic and mediastinal disorders	MedDRA (17.0)	Systematic Assessment		EG0002 events2 affected40 at risk
Dyspnoea	Respiratory, thoracic and mediastinal disorders	MedDRA (17.0)	Systematic Assessment		EG0002 events2 affected40 at risk

ID	Term
C481504	ibalizumab