Trial Outcomes & Findings for Ibalizumab Plus Optimized Background Regimen in Treatment-Experienced Patients With Multi-Drug Resistant HIV-1 (NCT NCT02707861)

NCT ID: NCT02707861

Last Updated: 2021-03-11

Results Overview

Number of participants with Grade 3/4 adverse events possibly, probably, or definitely due to ibalizumab

• Recruitment status: COMPLETED
• Study phase: PHASE3
• Target enrollment: 79 participants
• Primary outcome timeframe: Through 48 weeks
• Results posted on: 2021-03-11

Participant Flow

Participant milestones

Measure	Cohort 1 IV ibalizumab (combined with optimized background regimen): 800 mg once every two weeks for patients receiving that dosage on prior, successfully completed ibalizumab clinical trial OR 2000 mg once every four weeks for patients receiving that dosage on prior, successfully completed ibalizumab clinical trial Administered for 48 weeks, or until ibalizumab becomes commercially available ibalizumab: Intravenous infusion of humanized monoclonal antibody binding with a region of Domain 2 of CD4 receptor, blocking post-attachment conformational changes necessary for HIV cell entry Optimized Background Regimen: An investigator-selected, standard-of-care combination regimen of antiretroviral agents for treating HIV-1 infection, selected based upon patient treatment history and the results of previous viral resistance testing. The combination must contain at least one agent other than ibalizumab to which the patient's virus is sensitive (susceptible).	Cohort 2 IV ibalizumab (combined with optimized background regimen): 800 mg once every two weeks for qualifying patients who have never received ibalizumab Administered for 48 weeks, or until ibalizumab becomes commercially available ibalizumab: Intravenous infusion of humanized monoclonal antibody binding with a region of Domain 2 of CD4 receptor, blocking post-attachment conformational changes necessary for HIV cell entry Optimized Background Regimen: An investigator-selected, standard-of-care combination regimen of antiretroviral agents for treating HIV-1 infection, selected based upon patient treatment history and the results of previous viral resistance testing. The combination must contain at least one agent other than ibalizumab to which the patient's virus is sensitive (susceptible).
Overall Study STARTED	41	38
Overall Study COMPLETED	0	0
Overall Study NOT COMPLETED	41	38

Reasons for withdrawal

Measure	Cohort 1 IV ibalizumab (combined with optimized background regimen): 800 mg once every two weeks for patients receiving that dosage on prior, successfully completed ibalizumab clinical trial OR 2000 mg once every four weeks for patients receiving that dosage on prior, successfully completed ibalizumab clinical trial Administered for 48 weeks, or until ibalizumab becomes commercially available ibalizumab: Intravenous infusion of humanized monoclonal antibody binding with a region of Domain 2 of CD4 receptor, blocking post-attachment conformational changes necessary for HIV cell entry Optimized Background Regimen: An investigator-selected, standard-of-care combination regimen of antiretroviral agents for treating HIV-1 infection, selected based upon patient treatment history and the results of previous viral resistance testing. The combination must contain at least one agent other than ibalizumab to which the patient's virus is sensitive (susceptible).	Cohort 2 IV ibalizumab (combined with optimized background regimen): 800 mg once every two weeks for qualifying patients who have never received ibalizumab Administered for 48 weeks, or until ibalizumab becomes commercially available ibalizumab: Intravenous infusion of humanized monoclonal antibody binding with a region of Domain 2 of CD4 receptor, blocking post-attachment conformational changes necessary for HIV cell entry Optimized Background Regimen: An investigator-selected, standard-of-care combination regimen of antiretroviral agents for treating HIV-1 infection, selected based upon patient treatment history and the results of previous viral resistance testing. The combination must contain at least one agent other than ibalizumab to which the patient's virus is sensitive (susceptible).
Overall Study Went onto commercial drug	30	23
Overall Study Adverse Event	2	3
Overall Study Death	5	2
Overall Study Lack of Efficacy	0	2
Overall Study Physician Decision	1	4
Overall Study Withdrawal by Subject	2	1
Overall Study Lost to Follow-up	1	3

Baseline Characteristics

Ibalizumab Plus Optimized Background Regimen in Treatment-Experienced Patients With Multi-Drug Resistant HIV-1

Baseline characteristics by cohort

Measure	Cohort 1 n=41 Participants IV ibalizumab (combined with optimized background regimen): 800 mg once every two weeks for patients receiving that dosage on prior, successfully completed ibalizumab clinical trial OR 2000 mg once every four weeks for patients receiving that dosage on prior, successfully completed ibalizumab clinical trial Administered for 48 weeks, or until ibalizumab becomes commercially available ibalizumab: Intravenous infusion of humanized monoclonal antibody binding with a region of Domain 2 of CD4 receptor, blocking post-attachment conformational changes necessary for HIV cell entry Optimized Background Regimen: An investigator-selected, standard-of-care combination regimen of antiretroviral agents for treating HIV-1 infection, selected based upon patient treatment history and the results of previous viral resistance testing. The combination must contain at least one agent other than ibalizumab to which the patient's virus is sensitive (susceptible).	Cohort 2 n=38 Participants IV ibalizumab (combined with optimized background regimen): 800 mg once every two weeks for qualifying patients who have never received ibalizumab Administered for 48 weeks, or until ibalizumab becomes commercially available ibalizumab: Intravenous infusion of humanized monoclonal antibody binding with a region of Domain 2 of CD4 receptor, blocking post-attachment conformational changes necessary for HIV cell entry Optimized Background Regimen: An investigator-selected, standard-of-care combination regimen of antiretroviral agents for treating HIV-1 infection, selected based upon patient treatment history and the results of previous viral resistance testing. The combination must contain at least one agent other than ibalizumab to which the patient's virus is sensitive (susceptible).	Total n=79 Participants Total of all reporting groups
Age, Continuous	52.8 years STANDARD_DEVIATION 9.07 • n=5 Participants	49.9 years STANDARD_DEVIATION 11.7 • n=7 Participants	51.9 years STANDARD_DEVIATION 10.4 • n=5 Participants
Sex: Female, Male Female	4 Participants n=5 Participants	4 Participants n=7 Participants	8 Participants n=5 Participants
Sex: Female, Male Male	37 Participants n=5 Participants	34 Participants n=7 Participants	71 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	12 Participants n=5 Participants	8 Participants n=7 Participants	20 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	29 Participants n=5 Participants	30 Participants n=7 Participants	59 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	12 Participants n=5 Participants	16 Participants n=7 Participants	28 Participants n=5 Participants
Race (NIH/OMB) White	27 Participants n=5 Participants	20 Participants n=7 Participants	47 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	2 Participants n=5 Participants	2 Participants n=7 Participants	4 Participants n=5 Participants
Region of Enrollment Puerto Rico	2 participants n=5 Participants	4 participants n=7 Participants	6 participants n=5 Participants
Region of Enrollment United States	39 participants n=5 Participants	34 participants n=7 Participants	73 participants n=5 Participants
Number of Study Participants Enrolled	41 Participants n=5 Participants	38 Participants n=7 Participants	79 Participants n=5 Participants

PRIMARY outcome

Timeframe: Through 48 weeks

Population: intent-to-treat

Number of participants with Grade 3/4 adverse events possibly, probably, or definitely due to ibalizumab

Outcome measures

Measure	Cohort 1 n=41 Participants IV ibalizumab (combined with optimized background regimen): 800 mg once every two weeks for patients receiving that dosage on prior, successfully completed ibalizumab clinical trial OR 2000 mg once every four weeks for patients receiving that dosage on prior, successfully completed ibalizumab clinical trial Administered for 48 weeks, or until ibalizumab becomes commercially available ibalizumab: Intravenous infusion of humanized monoclonal antibody binding with a region of Domain 2 of CD4 receptor, blocking post-attachment conformational changes necessary for HIV cell entry Optimized Background Regimen: An investigator-selected, standard-of-care combination regimen of antiretroviral agents for treating HIV-1 infection, selected based upon patient treatment history and the results of previous viral resistance testing. The combination must contain at least one agent other than ibalizumab to which the patient's virus is sensitive (susceptible).	Cohort 2 n=38 Participants IV ibalizumab (combined with optimized background regimen): 800 mg once every two weeks for qualifying patients who have never received ibalizumab Administered for 48 weeks, or until ibalizumab becomes commercially available ibalizumab: Intravenous infusion of humanized monoclonal antibody binding with a region of Domain 2 of CD4 receptor, blocking post-attachment conformational changes necessary for HIV cell entry Optimized Background Regimen: An investigator-selected, standard-of-care combination regimen of antiretroviral agents for treating HIV-1 infection, selected based upon patient treatment history and the results of previous viral resistance testing. The combination must contain at least one agent other than ibalizumab to which the patient's virus is sensitive (susceptible).
Safety and Tolerability of Ibalizumab + OBR	8 participants	9 participants

PRIMARY outcome

Timeframe: 48 weeks

Population: intent-to -treat

number of participants discontinuing ibalizumab treatment due to adverse events probably, possibly, or definitely related to ibalizumab

Outcome measures

Measure	Cohort 1 n=41 Participants IV ibalizumab (combined with optimized background regimen): 800 mg once every two weeks for patients receiving that dosage on prior, successfully completed ibalizumab clinical trial OR 2000 mg once every four weeks for patients receiving that dosage on prior, successfully completed ibalizumab clinical trial Administered for 48 weeks, or until ibalizumab becomes commercially available ibalizumab: Intravenous infusion of humanized monoclonal antibody binding with a region of Domain 2 of CD4 receptor, blocking post-attachment conformational changes necessary for HIV cell entry Optimized Background Regimen: An investigator-selected, standard-of-care combination regimen of antiretroviral agents for treating HIV-1 infection, selected based upon patient treatment history and the results of previous viral resistance testing. The combination must contain at least one agent other than ibalizumab to which the patient's virus is sensitive (susceptible).	Cohort 2 n=38 Participants IV ibalizumab (combined with optimized background regimen): 800 mg once every two weeks for qualifying patients who have never received ibalizumab Administered for 48 weeks, or until ibalizumab becomes commercially available ibalizumab: Intravenous infusion of humanized monoclonal antibody binding with a region of Domain 2 of CD4 receptor, blocking post-attachment conformational changes necessary for HIV cell entry Optimized Background Regimen: An investigator-selected, standard-of-care combination regimen of antiretroviral agents for treating HIV-1 infection, selected based upon patient treatment history and the results of previous viral resistance testing. The combination must contain at least one agent other than ibalizumab to which the patient's virus is sensitive (susceptible).
Discontinuations Due to Adverse Events Related to Ibalizumab	0 Participants	3 Participants

PRIMARY outcome

Timeframe: 7 days

Population: As treated analysis

Number of patients in Cohort 2 achieving at least a 0.5 log change from Baseline in viral load at Day 7 of the study

Outcome measures

Measure	Cohort 1 IV ibalizumab (combined with optimized background regimen): 800 mg once every two weeks for patients receiving that dosage on prior, successfully completed ibalizumab clinical trial OR 2000 mg once every four weeks for patients receiving that dosage on prior, successfully completed ibalizumab clinical trial Administered for 48 weeks, or until ibalizumab becomes commercially available ibalizumab: Intravenous infusion of humanized monoclonal antibody binding with a region of Domain 2 of CD4 receptor, blocking post-attachment conformational changes necessary for HIV cell entry Optimized Background Regimen: An investigator-selected, standard-of-care combination regimen of antiretroviral agents for treating HIV-1 infection, selected based upon patient treatment history and the results of previous viral resistance testing. The combination must contain at least one agent other than ibalizumab to which the patient's virus is sensitive (susceptible).	Cohort 2 n=38 Participants IV ibalizumab (combined with optimized background regimen): 800 mg once every two weeks for qualifying patients who have never received ibalizumab Administered for 48 weeks, or until ibalizumab becomes commercially available ibalizumab: Intravenous infusion of humanized monoclonal antibody binding with a region of Domain 2 of CD4 receptor, blocking post-attachment conformational changes necessary for HIV cell entry Optimized Background Regimen: An investigator-selected, standard-of-care combination regimen of antiretroviral agents for treating HIV-1 infection, selected based upon patient treatment history and the results of previous viral resistance testing. The combination must contain at least one agent other than ibalizumab to which the patient's virus is sensitive (susceptible).
Effectiveness of Ibalizumab + OBR (Cohort 2 Only)	—	28 participants

SECONDARY outcome

Timeframe: 48 weeks

Population: as-treated-population

Number of patients in Cohort 2 with HIV-1 RNA levels <50 copies/mL at week 48

Outcome measures

Measure	Cohort 1 IV ibalizumab (combined with optimized background regimen): 800 mg once every two weeks for patients receiving that dosage on prior, successfully completed ibalizumab clinical trial OR 2000 mg once every four weeks for patients receiving that dosage on prior, successfully completed ibalizumab clinical trial Administered for 48 weeks, or until ibalizumab becomes commercially available ibalizumab: Intravenous infusion of humanized monoclonal antibody binding with a region of Domain 2 of CD4 receptor, blocking post-attachment conformational changes necessary for HIV cell entry Optimized Background Regimen: An investigator-selected, standard-of-care combination regimen of antiretroviral agents for treating HIV-1 infection, selected based upon patient treatment history and the results of previous viral resistance testing. The combination must contain at least one agent other than ibalizumab to which the patient's virus is sensitive (susceptible).	Cohort 2 n=17 Participants IV ibalizumab (combined with optimized background regimen): 800 mg once every two weeks for qualifying patients who have never received ibalizumab Administered for 48 weeks, or until ibalizumab becomes commercially available ibalizumab: Intravenous infusion of humanized monoclonal antibody binding with a region of Domain 2 of CD4 receptor, blocking post-attachment conformational changes necessary for HIV cell entry Optimized Background Regimen: An investigator-selected, standard-of-care combination regimen of antiretroviral agents for treating HIV-1 infection, selected based upon patient treatment history and the results of previous viral resistance testing. The combination must contain at least one agent other than ibalizumab to which the patient's virus is sensitive (susceptible).
Suppression to <50 Copies With Ibalizumab + OBR (Cohort 2 Only)	—	11 Participants

SECONDARY outcome

Timeframe: 48 weeks

Population: as-treated-analysis

Number of patients in Cohort 2 with HIV-1 RNA levels <400 copies/mL at week 48

Outcome measures

Measure	Cohort 1 IV ibalizumab (combined with optimized background regimen): 800 mg once every two weeks for patients receiving that dosage on prior, successfully completed ibalizumab clinical trial OR 2000 mg once every four weeks for patients receiving that dosage on prior, successfully completed ibalizumab clinical trial Administered for 48 weeks, or until ibalizumab becomes commercially available ibalizumab: Intravenous infusion of humanized monoclonal antibody binding with a region of Domain 2 of CD4 receptor, blocking post-attachment conformational changes necessary for HIV cell entry Optimized Background Regimen: An investigator-selected, standard-of-care combination regimen of antiretroviral agents for treating HIV-1 infection, selected based upon patient treatment history and the results of previous viral resistance testing. The combination must contain at least one agent other than ibalizumab to which the patient's virus is sensitive (susceptible).	Cohort 2 n=17 Participants IV ibalizumab (combined with optimized background regimen): 800 mg once every two weeks for qualifying patients who have never received ibalizumab Administered for 48 weeks, or until ibalizumab becomes commercially available ibalizumab: Intravenous infusion of humanized monoclonal antibody binding with a region of Domain 2 of CD4 receptor, blocking post-attachment conformational changes necessary for HIV cell entry Optimized Background Regimen: An investigator-selected, standard-of-care combination regimen of antiretroviral agents for treating HIV-1 infection, selected based upon patient treatment history and the results of previous viral resistance testing. The combination must contain at least one agent other than ibalizumab to which the patient's virus is sensitive (susceptible).
Suppression to <400 Copies by Ibalizumab + OBR (Cohort 2 Only)	—	10 Participants

SECONDARY outcome

Timeframe: 48 weeks

Population: as treated analysis

Number of patients in Cohort 2 achieving at least a 1.0 log10 decrease in viral load from Baseline measurement at all assessment time points

Outcome measures

Measure	Cohort 1 IV ibalizumab (combined with optimized background regimen): 800 mg once every two weeks for patients receiving that dosage on prior, successfully completed ibalizumab clinical trial OR 2000 mg once every four weeks for patients receiving that dosage on prior, successfully completed ibalizumab clinical trial Administered for 48 weeks, or until ibalizumab becomes commercially available ibalizumab: Intravenous infusion of humanized monoclonal antibody binding with a region of Domain 2 of CD4 receptor, blocking post-attachment conformational changes necessary for HIV cell entry Optimized Background Regimen: An investigator-selected, standard-of-care combination regimen of antiretroviral agents for treating HIV-1 infection, selected based upon patient treatment history and the results of previous viral resistance testing. The combination must contain at least one agent other than ibalizumab to which the patient's virus is sensitive (susceptible).	Cohort 2 n=17 Participants IV ibalizumab (combined with optimized background regimen): 800 mg once every two weeks for qualifying patients who have never received ibalizumab Administered for 48 weeks, or until ibalizumab becomes commercially available ibalizumab: Intravenous infusion of humanized monoclonal antibody binding with a region of Domain 2 of CD4 receptor, blocking post-attachment conformational changes necessary for HIV cell entry Optimized Background Regimen: An investigator-selected, standard-of-care combination regimen of antiretroviral agents for treating HIV-1 infection, selected based upon patient treatment history and the results of previous viral resistance testing. The combination must contain at least one agent other than ibalizumab to which the patient's virus is sensitive (susceptible).
Effectiveness of Ibalizumab + OBR by 1.0 Log10 Decrease in Viral Load From Baseline (Cohort 2 Only)	0 Participants	11 Participants

Adverse Events

Cohort 1

Serious events: 16 serious events

Other events: 39 other events

Deaths: 5 deaths

Cohort 2

Serious events: 15 serious events

Other events: 37 other events

Deaths: 2 deaths

Serious adverse events

Measure	Cohort 1 n=41 participants at risk IV ibalizumab (combined with optimized background regimen): 800 mg once every two weeks for patients receiving that dosage on prior, successfully completed ibalizumab clinical trial OR 2000 mg once every four weeks for patients receiving that dosage on prior, successfully completed ibalizumab clinical trial Administered for 48 weeks, or until ibalizumab becomes commercially available ibalizumab: Intravenous infusion of humanized monoclonal antibody binding with a region of Domain 2 of CD4 receptor, blocking post-attachment conformational changes necessary for HIV cell entry Optimized Background Regimen: An investigator-selected, standard-of-care combination regimen of antiretroviral agents for treating HIV-1 infection, selected based upon patient treatment history and the results of previous viral resistance testing. The combination must contain at least one agent other than ibalizumab to which the patient's virus is sensitive (susceptible).	Cohort 2 n=38 participants at risk IV ibalizumab (combined with optimized background regimen): 800 mg once every two weeks for qualifying patients who have never received ibalizumab Administered for 48 weeks, or until ibalizumab becomes commercially available ibalizumab: Intravenous infusion of humanized monoclonal antibody binding with a region of Domain 2 of CD4 receptor, blocking post-attachment conformational changes necessary for HIV cell entry Optimized Background Regimen: An investigator-selected, standard-of-care combination regimen of antiretroviral agents for treating HIV-1 infection, selected based upon patient treatment history and the results of previous viral resistance testing. The combination must contain at least one agent other than ibalizumab to which the patient's virus is sensitive (susceptible).
Infections and infestations sepsis	9.8% 4/41 • Number of events 4 • Adverse event data is reported is reported for all subjects who received at least one dose of ibalizumab. The time period of observation ranges from day 1 to day 869 for study participants depending on the duration of ibalizumab therapy. The definitions of adverse events and methods of collection do not differ from clinical trials.gov definitions and methods.	10.5% 4/38 • Number of events 4 • Adverse event data is reported is reported for all subjects who received at least one dose of ibalizumab. The time period of observation ranges from day 1 to day 869 for study participants depending on the duration of ibalizumab therapy. The definitions of adverse events and methods of collection do not differ from clinical trials.gov definitions and methods.
Cardiac disorders cardiovascular disorder	2.4% 1/41 • Number of events 1 • Adverse event data is reported is reported for all subjects who received at least one dose of ibalizumab. The time period of observation ranges from day 1 to day 869 for study participants depending on the duration of ibalizumab therapy. The definitions of adverse events and methods of collection do not differ from clinical trials.gov definitions and methods.	2.6% 1/38 • Number of events 1 • Adverse event data is reported is reported for all subjects who received at least one dose of ibalizumab. The time period of observation ranges from day 1 to day 869 for study participants depending on the duration of ibalizumab therapy. The definitions of adverse events and methods of collection do not differ from clinical trials.gov definitions and methods.
Vascular disorders DVT	7.3% 3/41 • Number of events 3 • Adverse event data is reported is reported for all subjects who received at least one dose of ibalizumab. The time period of observation ranges from day 1 to day 869 for study participants depending on the duration of ibalizumab therapy. The definitions of adverse events and methods of collection do not differ from clinical trials.gov definitions and methods.	5.3% 2/38 • Number of events 2 • Adverse event data is reported is reported for all subjects who received at least one dose of ibalizumab. The time period of observation ranges from day 1 to day 869 for study participants depending on the duration of ibalizumab therapy. The definitions of adverse events and methods of collection do not differ from clinical trials.gov definitions and methods.
Infections and infestations pneumonia	9.8% 4/41 • Number of events 4 • Adverse event data is reported is reported for all subjects who received at least one dose of ibalizumab. The time period of observation ranges from day 1 to day 869 for study participants depending on the duration of ibalizumab therapy. The definitions of adverse events and methods of collection do not differ from clinical trials.gov definitions and methods.	10.5% 4/38 • Number of events 4 • Adverse event data is reported is reported for all subjects who received at least one dose of ibalizumab. The time period of observation ranges from day 1 to day 869 for study participants depending on the duration of ibalizumab therapy. The definitions of adverse events and methods of collection do not differ from clinical trials.gov definitions and methods.
Renal and urinary disorders acute renal failure	4.9% 2/41 • Number of events 2 • Adverse event data is reported is reported for all subjects who received at least one dose of ibalizumab. The time period of observation ranges from day 1 to day 869 for study participants depending on the duration of ibalizumab therapy. The definitions of adverse events and methods of collection do not differ from clinical trials.gov definitions and methods.	7.9% 3/38 • Number of events 3 • Adverse event data is reported is reported for all subjects who received at least one dose of ibalizumab. The time period of observation ranges from day 1 to day 869 for study participants depending on the duration of ibalizumab therapy. The definitions of adverse events and methods of collection do not differ from clinical trials.gov definitions and methods.
Infections and infestations opportunistic infection	4.9% 2/41 • Number of events 2 • Adverse event data is reported is reported for all subjects who received at least one dose of ibalizumab. The time period of observation ranges from day 1 to day 869 for study participants depending on the duration of ibalizumab therapy. The definitions of adverse events and methods of collection do not differ from clinical trials.gov definitions and methods.	5.3% 2/38 • Number of events 2 • Adverse event data is reported is reported for all subjects who received at least one dose of ibalizumab. The time period of observation ranges from day 1 to day 869 for study participants depending on the duration of ibalizumab therapy. The definitions of adverse events and methods of collection do not differ from clinical trials.gov definitions and methods.

Other adverse events

Measure	Cohort 1 n=41 participants at risk IV ibalizumab (combined with optimized background regimen): 800 mg once every two weeks for patients receiving that dosage on prior, successfully completed ibalizumab clinical trial OR 2000 mg once every four weeks for patients receiving that dosage on prior, successfully completed ibalizumab clinical trial Administered for 48 weeks, or until ibalizumab becomes commercially available ibalizumab: Intravenous infusion of humanized monoclonal antibody binding with a region of Domain 2 of CD4 receptor, blocking post-attachment conformational changes necessary for HIV cell entry Optimized Background Regimen: An investigator-selected, standard-of-care combination regimen of antiretroviral agents for treating HIV-1 infection, selected based upon patient treatment history and the results of previous viral resistance testing. The combination must contain at least one agent other than ibalizumab to which the patient's virus is sensitive (susceptible).	Cohort 2 n=38 participants at risk IV ibalizumab (combined with optimized background regimen): 800 mg once every two weeks for qualifying patients who have never received ibalizumab Administered for 48 weeks, or until ibalizumab becomes commercially available ibalizumab: Intravenous infusion of humanized monoclonal antibody binding with a region of Domain 2 of CD4 receptor, blocking post-attachment conformational changes necessary for HIV cell entry Optimized Background Regimen: An investigator-selected, standard-of-care combination regimen of antiretroviral agents for treating HIV-1 infection, selected based upon patient treatment history and the results of previous viral resistance testing. The combination must contain at least one agent other than ibalizumab to which the patient's virus is sensitive (susceptible).
Gastrointestinal disorders diarrhea	41.5% 17/41 • Number of events 17 • Adverse event data is reported is reported for all subjects who received at least one dose of ibalizumab. The time period of observation ranges from day 1 to day 869 for study participants depending on the duration of ibalizumab therapy. The definitions of adverse events and methods of collection do not differ from clinical trials.gov definitions and methods.	26.3% 10/38 • Number of events 10 • Adverse event data is reported is reported for all subjects who received at least one dose of ibalizumab. The time period of observation ranges from day 1 to day 869 for study participants depending on the duration of ibalizumab therapy. The definitions of adverse events and methods of collection do not differ from clinical trials.gov definitions and methods.
Nervous system disorders headache	19.5% 8/41 • Number of events 8 • Adverse event data is reported is reported for all subjects who received at least one dose of ibalizumab. The time period of observation ranges from day 1 to day 869 for study participants depending on the duration of ibalizumab therapy. The definitions of adverse events and methods of collection do not differ from clinical trials.gov definitions and methods.	26.3% 10/38 • Number of events 10 • Adverse event data is reported is reported for all subjects who received at least one dose of ibalizumab. The time period of observation ranges from day 1 to day 869 for study participants depending on the duration of ibalizumab therapy. The definitions of adverse events and methods of collection do not differ from clinical trials.gov definitions and methods.
Gastrointestinal disorders nausea	19.5% 8/41 • Number of events 8 • Adverse event data is reported is reported for all subjects who received at least one dose of ibalizumab. The time period of observation ranges from day 1 to day 869 for study participants depending on the duration of ibalizumab therapy. The definitions of adverse events and methods of collection do not differ from clinical trials.gov definitions and methods.	23.7% 9/38 • Number of events 9 • Adverse event data is reported is reported for all subjects who received at least one dose of ibalizumab. The time period of observation ranges from day 1 to day 869 for study participants depending on the duration of ibalizumab therapy. The definitions of adverse events and methods of collection do not differ from clinical trials.gov definitions and methods.
Skin and subcutaneous tissue disorders rash	41.5% 17/41 • Number of events 17 • Adverse event data is reported is reported for all subjects who received at least one dose of ibalizumab. The time period of observation ranges from day 1 to day 869 for study participants depending on the duration of ibalizumab therapy. The definitions of adverse events and methods of collection do not differ from clinical trials.gov definitions and methods.	21.1% 8/38 • Number of events 8 • Adverse event data is reported is reported for all subjects who received at least one dose of ibalizumab. The time period of observation ranges from day 1 to day 869 for study participants depending on the duration of ibalizumab therapy. The definitions of adverse events and methods of collection do not differ from clinical trials.gov definitions and methods.

Additional Information

Manager - Clinical Operations

TaiMed Biologics USA Corp.

Phone: 713-478-2927

Email: bbell@taimedbio.com

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place

Restriction type: LTE60