Trial Outcomes & Findings for Study of the Safety of Trogarzo™ Administered as an Undiluted "IV Push" or an Intramuscular Injection (NCT NCT03913195)
NCT ID: NCT03913195
Last Updated: 2025-10-20
Results Overview
Number of subjects who complete 100% of all Trogarzo administrations given as infusion/bolus/push as per protocol
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
43 participants
Primary outcome timeframe
12 weeks
Results posted on
2025-10-20
Participant Flow
Participant milestones
| Measure |
Sentinel Group
Five (5) participants will receive two successive doses of 800mg ibalizumab administered in accordance with the prescribing information followed by five (5) successive 800mg doses on a schedule gradually increasing drug concentration and decreasing administration time.
ibalizumab-uiyk: Ibalizumab-uiyk is an Immunoglobulin G4 (IgG4) monoclonal antibody targeting domain 2 of the extracellular portion of the Cluster of Differentiation 4 (CD4) protein. Ibalizumab-uiyk is FDA approved for the treatment of multi-drug resistant HIV in treatment experienced patients.
|
Core Group-HIV+
HIV-infected Core Group participants will receive two successive doses of 800mg ibalizumab (Trogarzo) administered in accordance with the prescribing information followed by four (4) successive 800mg doses via undiluted IV Push over 30 seconds. Healthy Volunteer Core Group participants will receive a single 2000mg loading dose followed by three successive doses of 800mg in accordance with the prescribing information in order to reach steady state. T
ibalizumab-uiyk: Ibalizumab-uiyk is an IgG4 monoclonal antibody targeting domain 2 of the extracellular portion of the CD4 protein. Ibalizumab-uiyk is FDA approved for the treatment of multi-drug resistant HIV in treatment experienced patients.
|
Core Group-HIV Uninfected
Healthy Volunteer Core Group participants will receive a single 2000mg loading dose followed by three successive doses of 800mg in accordance with the prescribing information in order to reach steady state. Thereafter, Healthy Volunteers will receive two successive doses of 800mg ibalizumab (Trogarzo) administered in accordance with the prescribing information followed by four (4) successive 800mg doses via undiluted IV Push over 30 seconds.
ibalizumab-uiyk: Ibalizumab-uiyk is an IgG4 monoclonal antibody targeting domain 2 of the extracellular portion of the CD4 protein. Ibalizumab-uiyk is FDA approved for the treatment of multi-drug resistant HIV in treatment experienced patients.
|
Intramuscular Injection Group-HIV+
HIV-infected Intramuscular Injection Group participants will receive two successive doses of 800mg ibalizumab (Trogarzo) administered in accordance with the prescribing information followed by four (4) successive 800mg doses via Intramuscular Injection. Healthy Volunteer Intramuscular Injection Group participants will receive a single 2000mg loading dose followed by three successive doses of 800mg in accordance with the prescribing information in order to reach steady state. Thereafter, Healthy Volunteers will receive two successive doses of 800mg ibalizumab (Trogarzo) administered in accordance with the prescribing information followed by four (4) successive 800mg doses via intramuscular injection.
ibalizumab-uiyk: Ibalizumab-uiyk is an IgG4 monoclonal antibody targeting domain 2 of the extracellular portion of the CD4 protein. Ibalizumab-uiyk is FDA approved for the treatment of multi-drug resistant HIV in treatment experienced patients.
|
Intramuscular Injection Group- HIV Uninfected
HIV-uninfected Intramuscular Injection Group participants will receive 2000 mg of Trogarzo followed by four (4) successive 800mg doses via IV infusion to establish a steady state which will then be followed by four doses of 800 mg of Trogarzo given by IM injection every 2 weeks.
|
|---|---|---|---|---|---|
|
Overall Study
STARTED
|
5
|
4
|
13
|
7
|
14
|
|
Overall Study
COMPLETED
|
5
|
4
|
10
|
6
|
13
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
3
|
1
|
1
|
Reasons for withdrawal
| Measure |
Sentinel Group
Five (5) participants will receive two successive doses of 800mg ibalizumab administered in accordance with the prescribing information followed by five (5) successive 800mg doses on a schedule gradually increasing drug concentration and decreasing administration time.
ibalizumab-uiyk: Ibalizumab-uiyk is an Immunoglobulin G4 (IgG4) monoclonal antibody targeting domain 2 of the extracellular portion of the Cluster of Differentiation 4 (CD4) protein. Ibalizumab-uiyk is FDA approved for the treatment of multi-drug resistant HIV in treatment experienced patients.
|
Core Group-HIV+
HIV-infected Core Group participants will receive two successive doses of 800mg ibalizumab (Trogarzo) administered in accordance with the prescribing information followed by four (4) successive 800mg doses via undiluted IV Push over 30 seconds. Healthy Volunteer Core Group participants will receive a single 2000mg loading dose followed by three successive doses of 800mg in accordance with the prescribing information in order to reach steady state. T
ibalizumab-uiyk: Ibalizumab-uiyk is an IgG4 monoclonal antibody targeting domain 2 of the extracellular portion of the CD4 protein. Ibalizumab-uiyk is FDA approved for the treatment of multi-drug resistant HIV in treatment experienced patients.
|
Core Group-HIV Uninfected
Healthy Volunteer Core Group participants will receive a single 2000mg loading dose followed by three successive doses of 800mg in accordance with the prescribing information in order to reach steady state. Thereafter, Healthy Volunteers will receive two successive doses of 800mg ibalizumab (Trogarzo) administered in accordance with the prescribing information followed by four (4) successive 800mg doses via undiluted IV Push over 30 seconds.
ibalizumab-uiyk: Ibalizumab-uiyk is an IgG4 monoclonal antibody targeting domain 2 of the extracellular portion of the CD4 protein. Ibalizumab-uiyk is FDA approved for the treatment of multi-drug resistant HIV in treatment experienced patients.
|
Intramuscular Injection Group-HIV+
HIV-infected Intramuscular Injection Group participants will receive two successive doses of 800mg ibalizumab (Trogarzo) administered in accordance with the prescribing information followed by four (4) successive 800mg doses via Intramuscular Injection. Healthy Volunteer Intramuscular Injection Group participants will receive a single 2000mg loading dose followed by three successive doses of 800mg in accordance with the prescribing information in order to reach steady state. Thereafter, Healthy Volunteers will receive two successive doses of 800mg ibalizumab (Trogarzo) administered in accordance with the prescribing information followed by four (4) successive 800mg doses via intramuscular injection.
ibalizumab-uiyk: Ibalizumab-uiyk is an IgG4 monoclonal antibody targeting domain 2 of the extracellular portion of the CD4 protein. Ibalizumab-uiyk is FDA approved for the treatment of multi-drug resistant HIV in treatment experienced patients.
|
Intramuscular Injection Group- HIV Uninfected
HIV-uninfected Intramuscular Injection Group participants will receive 2000 mg of Trogarzo followed by four (4) successive 800mg doses via IV infusion to establish a steady state which will then be followed by four doses of 800 mg of Trogarzo given by IM injection every 2 weeks.
|
|---|---|---|---|---|---|
|
Overall Study
Adverse Event
|
0
|
0
|
1
|
1
|
0
|
|
Overall Study
Withdrawal by Subject
|
0
|
0
|
1
|
0
|
1
|
|
Overall Study
non adherence to study
|
0
|
0
|
1
|
0
|
0
|
Baseline Characteristics
Study of the Safety of Trogarzo™ Administered as an Undiluted "IV Push" or an Intramuscular Injection
Baseline characteristics by cohort
| Measure |
Sentinel Group
n=5 Participants
Five (5) participants will receive two successive doses of 800mg ibalizumab administered in accordance with the prescribing information followed by five (5) successive 800mg doses on a schedule gradually increasing drug concentration and decreasing administration time.
ibalizumab-uiyk: Ibalizumab-uiyk is an IgG4 monoclonal antibody targeting domain 2 of the extracellular portion of the CD4 protein. Ibalizumab-uiyk is FDA approved for the treatment of multi-drug resistant HIV in treatment experienced patients.
|
Core Group-HIV+
n=4 Participants
HIV-infected Core Group participants will receive two successive doses of 800mg ibalizumab (Trogarzo) administered in accordance with the prescribing information followed by four (4) successive 800mg doses via undiluted IV Push over 30 seconds. Healthy Volunteer Core Group participants will receive a single 2000mg loading dose followed by three successive doses of 800mg in accordance with the prescribing information in order to reach steady state. Thereafter, Healthy Volunteers will receive two successive doses of 800mg ibalizumab (Trogarzo) administered in accordance with the prescribing information followed by four (4) successive 800mg doses via undiluted IV Push over 30 seconds.
ibalizumab-uiyk: Ibalizumab-uiyk is an IgG4 monoclonal antibody targeting domain 2 of the extracellular portion of the CD4 protein. Ibalizumab-uiyk is FDA approved for the treatment of multi-drug resistant HIV in treatment experienced patients.
|
Core Group-HIV-uninfected
n=13 Participants
Healthy Volunteer Core Group participants will receive a single 2000mg loading dose followed by three successive doses of 800mg in accordance with the prescribing information in order to reach steady state. Thereafter, Healthy Volunteers will receive two successive doses of 800mg ibalizumab (Trogarzo) administered in accordance with the prescribing information followed by four (4) successive 800mg doses via undiluted IV Push over 30 seconds.
ibalizumab-uiyk: Ibalizumab-uiyk is an IgG4 monoclonal antibody targeting domain 2 of the extracellular portion of the CD4 protein. Ibalizumab-uiyk is FDA approved for the treatment of multi-drug resistant HIV in treatment experienced patients.
|
Intramuscular Injection Group-HIV+
n=7 Participants
HIV-infected Intramuscular Injection Group participants will receive two successive doses of 800mg ibalizumab (Trogarzo) administered in accordance with the prescribing information followed by four (4) successive 800mg doses via Intramuscular Injection. Healthy Volunteer Intramuscular Injection Group participants will receive a single 2000mg loading dose followed by three successive doses of 800mg in accordance with the prescribing information in order to reach steady state. Thereafter, Healthy Volunteers will receive two successive doses of 800mg ibalizumab (Trogarzo) administered in accordance with the prescribing information followed by four (4) successive 800mg doses via intramuscular injection.
ibalizumab-uiyk: Ibalizumab-uiyk is an IgG4 monoclonal antibody targeting domain 2 of the extracellular portion of the CD4 protein. Ibalizumab-uiyk is FDA approved for the treatment of multi-drug resistant HIV in treatment experienced patients.
|
Intramuscular Injection Group-uninfected
n=14 Participants
Healthy Volunteer Core Group participants will receive a single 2000mg loading dose followed by three successive doses of 800mg in accordance with the prescribing information in order to reach steady state. Thereafter, Healthy Volunteers will receive two successive doses of 800mg ibalizumab (Trogarzo) administered in accordance with the prescribing information followed by four (4) successive 800mg doses via IM injection.
ibalizumab-uiyk: Ibalizumab-uiyk is an IgG4 monoclonal antibody targeting domain 2 of the extracellular portion of the CD4 protein. Ibalizumab-uiyk is FDA approved for the treatment of multi-drug resistant HIV in treatment experienced patients.
|
Total
n=43 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|
|
Age, Continuous
|
58 years
STANDARD_DEVIATION 6 • n=5 Participants
|
58 years
STANDARD_DEVIATION 6 • n=7 Participants
|
31 years
STANDARD_DEVIATION 7 • n=5 Participants
|
59 years
STANDARD_DEVIATION 6 • n=4 Participants
|
35 years
STANDARD_DEVIATION 6 • n=21 Participants
|
43 years
STANDARD_DEVIATION 6 • n=8 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
6 Participants
n=21 Participants
|
10 Participants
n=8 Participants
|
|
Sex: Female, Male
Male
|
5 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
7 Participants
n=4 Participants
|
8 Participants
n=21 Participants
|
33 Participants
n=8 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
6 Participants
n=21 Participants
|
18 Participants
n=8 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
5 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
4 Participants
n=4 Participants
|
8 Participants
n=21 Participants
|
24 Participants
n=8 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
1 Participants
n=8 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
1 Participants
n=8 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
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
2 Participants
n=21 Participants
|
4 Participants
n=8 Participants
|
|
Race (NIH/OMB)
White
|
4 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
13 Participants
n=5 Participants
|
6 Participants
n=4 Participants
|
11 Participants
n=21 Participants
|
38 Participants
n=8 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
|
Region of Enrollment
United States
|
5 participants
n=5 Participants
|
4 participants
n=7 Participants
|
13 participants
n=5 Participants
|
7 participants
n=4 Participants
|
14 participants
n=21 Participants
|
43 participants
n=8 Participants
|
PRIMARY outcome
Timeframe: 12 weeksNumber of subjects who complete 100% of all Trogarzo administrations given as infusion/bolus/push as per protocol
Outcome measures
| Measure |
Sentinel Group
n=5 Participants
Five (5) participants will receive two successive doses of 800mg ibalizumab administered in accordance with the prescribing information followed by five (5) successive 800mg doses on a schedule gradually increasing drug concentration and decreasing administration time.
ibalizumab-uiyk: Ibalizumab-uiyk is an IgG4 monoclonal antibody targeting domain 2 of the extracellular portion of the CD4 protein. Ibalizumab-uiyk is FDA approved for the treatment of multi-drug resistant HIV in treatment experienced patients.
|
Core Group-HIV+
n=4 Participants
HIV infected individuals will receive four (4) successive 800mg doses via undiluted IV Push over 30 seconds.
ibalizumab-uiyk: Ibalizumab-uiyk is an IgG4 monoclonal antibody targeting domain 2 of the extracellular portion of the CD4 protein. Ibalizumab-uiyk is FDA approved for the treatment of multi-drug resistant HIV in treatment experienced patients.
|
Core Group-HIV Uninfected
n=13 Participants
Healthy Volunteer Core Group participants will receive a single 2000mg loading dose followed by three successive doses of 800mg in accordance with the prescribing information in order to reach steady state. Thereafter, Healthy Volunteers will receive two successive doses of 800mg ibalizumab (Trogarzo) administered in accordance with the prescribing information followed by four (4) successive 800mg doses via undiluted IV Push over 30 seconds.
ibalizumab-uiyk: Ibalizumab-uiyk is an IgG4 monoclonal antibody targeting domain 2 of the extracellular portion of the CD4 protein. Ibalizumab-uiyk is FDA approved for the treatment of multi-drug resistant HIV in treatment experienced patients.
|
|---|---|---|---|
|
Safety of Trogarzo Given as IV Push Over 30 Seconds
|
5 Participants
|
4 Participants
|
10 Participants
|
PRIMARY outcome
Timeframe: Day 1 infusion versus Day 85 IV PushPopulation: Intent to Treat (ITT) population (Sentinel and Core participants pooled). Each participant in both the Sentinel and Core groups received IV infusion and IV push. Since the comparison between the two routes was conducted within the same participant (intra-individual comparison), data from both groups were pooled for the pharmacokinetic (PK) bridging statistical analysis. Three Core Group HIV uninfected participants discontinued prematurely and did not have IVI or IVP data.
Ratio of proportion of subjects with trough concentration (Ctrough) ≥ the threshold of 300 ng/mL given by 15 minute infusion (IVI) versus IV push (IVP) over 30 seconds
Outcome measures
| Measure |
Sentinel Group
n=5 Participants
Five (5) participants will receive two successive doses of 800mg ibalizumab administered in accordance with the prescribing information followed by five (5) successive 800mg doses on a schedule gradually increasing drug concentration and decreasing administration time.
ibalizumab-uiyk: Ibalizumab-uiyk is an IgG4 monoclonal antibody targeting domain 2 of the extracellular portion of the CD4 protein. Ibalizumab-uiyk is FDA approved for the treatment of multi-drug resistant HIV in treatment experienced patients.
|
Core Group-HIV+
n=4 Participants
HIV infected individuals will receive four (4) successive 800mg doses via undiluted IV Push over 30 seconds.
ibalizumab-uiyk: Ibalizumab-uiyk is an IgG4 monoclonal antibody targeting domain 2 of the extracellular portion of the CD4 protein. Ibalizumab-uiyk is FDA approved for the treatment of multi-drug resistant HIV in treatment experienced patients.
|
Core Group-HIV Uninfected
n=10 Participants
Healthy Volunteer Core Group participants will receive a single 2000mg loading dose followed by three successive doses of 800mg in accordance with the prescribing information in order to reach steady state. Thereafter, Healthy Volunteers will receive two successive doses of 800mg ibalizumab (Trogarzo) administered in accordance with the prescribing information followed by four (4) successive 800mg doses via undiluted IV Push over 30 seconds.
ibalizumab-uiyk: Ibalizumab-uiyk is an IgG4 monoclonal antibody targeting domain 2 of the extracellular portion of the CD4 protein. Ibalizumab-uiyk is FDA approved for the treatment of multi-drug resistant HIV in treatment experienced patients.
|
|---|---|---|---|
|
Pharmacokinetics Bridge for IV Push and IV Infusion (Ctrough)
Participants with Ctrough ≥ 300 ng/mL (IVI)
|
5 Participants
|
3 Participants
|
10 Participants
|
|
Pharmacokinetics Bridge for IV Push and IV Infusion (Ctrough)
Participants with Ctrough ≥ 300 ng/mL (IVP)
|
5 Participants
|
3 Participants
|
10 Participants
|
PRIMARY outcome
Timeframe: Day 1 infusion versus Day 85 IV PushPopulation: Intent to Treat (ITT) population (Sentinel and Core participants pooled). Each participant in both the Sentinel and Core groups received IV infusion and IV push. Since the comparison between the two routes was conducted within the same participant (intra-individual comparison), data from both groups were pooled for the pharmacokinetic (PK) bridging statistical analysis. Three Core Group HIV uninfected participants discontinued prematurely and did not have IVI or IVP data.
Ratio of Area Under the Curve of Serum levels of Trogarzo given by 15 minute infusion versus Area Under the Curve of Serum levels of Trogarzo given by IV Push over 30 seconds
Outcome measures
| Measure |
Sentinel Group
n=5 Participants
Five (5) participants will receive two successive doses of 800mg ibalizumab administered in accordance with the prescribing information followed by five (5) successive 800mg doses on a schedule gradually increasing drug concentration and decreasing administration time.
ibalizumab-uiyk: Ibalizumab-uiyk is an IgG4 monoclonal antibody targeting domain 2 of the extracellular portion of the CD4 protein. Ibalizumab-uiyk is FDA approved for the treatment of multi-drug resistant HIV in treatment experienced patients.
|
Core Group-HIV+
n=4 Participants
HIV infected individuals will receive four (4) successive 800mg doses via undiluted IV Push over 30 seconds.
ibalizumab-uiyk: Ibalizumab-uiyk is an IgG4 monoclonal antibody targeting domain 2 of the extracellular portion of the CD4 protein. Ibalizumab-uiyk is FDA approved for the treatment of multi-drug resistant HIV in treatment experienced patients.
|
Core Group-HIV Uninfected
n=10 Participants
Healthy Volunteer Core Group participants will receive a single 2000mg loading dose followed by three successive doses of 800mg in accordance with the prescribing information in order to reach steady state. Thereafter, Healthy Volunteers will receive two successive doses of 800mg ibalizumab (Trogarzo) administered in accordance with the prescribing information followed by four (4) successive 800mg doses via undiluted IV Push over 30 seconds.
ibalizumab-uiyk: Ibalizumab-uiyk is an IgG4 monoclonal antibody targeting domain 2 of the extracellular portion of the CD4 protein. Ibalizumab-uiyk is FDA approved for the treatment of multi-drug resistant HIV in treatment experienced patients.
|
|---|---|---|---|
|
Pharmacokinetics Bridge for IV Push and IV Infusion (AUC)
AUC (IVI)
|
1232.86 day*mcg/mL
Standard Deviation 442.32
|
1143.51 day*mcg/mL
Standard Deviation 629.16
|
2772.35 day*mcg/mL
Standard Deviation 983.45
|
|
Pharmacokinetics Bridge for IV Push and IV Infusion (AUC)
AUC (IVP)
|
1172.95 day*mcg/mL
Standard Deviation 442.73
|
1207.62 day*mcg/mL
Standard Deviation 515.46
|
2812.55 day*mcg/mL
Standard Deviation 863.39
|
PRIMARY outcome
Timeframe: 10 weeksNumber of subjects in Intramuscular Injection Group who complete 100% of all Trogarzo administrations given as infusion/bolus/push as per protocol
Outcome measures
| Measure |
Sentinel Group
n=7 Participants
Five (5) participants will receive two successive doses of 800mg ibalizumab administered in accordance with the prescribing information followed by five (5) successive 800mg doses on a schedule gradually increasing drug concentration and decreasing administration time.
ibalizumab-uiyk: Ibalizumab-uiyk is an IgG4 monoclonal antibody targeting domain 2 of the extracellular portion of the CD4 protein. Ibalizumab-uiyk is FDA approved for the treatment of multi-drug resistant HIV in treatment experienced patients.
|
Core Group-HIV+
n=14 Participants
HIV infected individuals will receive four (4) successive 800mg doses via undiluted IV Push over 30 seconds.
ibalizumab-uiyk: Ibalizumab-uiyk is an IgG4 monoclonal antibody targeting domain 2 of the extracellular portion of the CD4 protein. Ibalizumab-uiyk is FDA approved for the treatment of multi-drug resistant HIV in treatment experienced patients.
|
Core Group-HIV Uninfected
Healthy Volunteer Core Group participants will receive a single 2000mg loading dose followed by three successive doses of 800mg in accordance with the prescribing information in order to reach steady state. Thereafter, Healthy Volunteers will receive two successive doses of 800mg ibalizumab (Trogarzo) administered in accordance with the prescribing information followed by four (4) successive 800mg doses via undiluted IV Push over 30 seconds.
ibalizumab-uiyk: Ibalizumab-uiyk is an IgG4 monoclonal antibody targeting domain 2 of the extracellular portion of the CD4 protein. Ibalizumab-uiyk is FDA approved for the treatment of multi-drug resistant HIV in treatment experienced patients.
|
|---|---|---|---|
|
Safety of Trogarzo Given as an Intramuscular Injection in the Intramuscular Injection Group
|
6 Participants
|
13 Participants
|
—
|
PRIMARY outcome
Timeframe: Day 1 infusion versus Day 71 intramuscular injectionPopulation: ITT population (HIV+ and HIV- participants pooled). Each HIV+ and HIV- participant received IV infusion and IM. Since the comparison between the two routes was conducted within the same participant (intra-individual comparison), data from both groups were pooled for the PK bridging statistical analysis. One HIV+ participant received only the IV infusion and discontinued prematurely without receiving the IM injection.
Ratio of proportion of subjects with trough concentration (Ctrough) ≥ the threshold of 300 ng/mL given by 15 minute infusion (IVI) versus intramuscular (IM) injection
Outcome measures
| Measure |
Sentinel Group
n=6 Participants
Five (5) participants will receive two successive doses of 800mg ibalizumab administered in accordance with the prescribing information followed by five (5) successive 800mg doses on a schedule gradually increasing drug concentration and decreasing administration time.
ibalizumab-uiyk: Ibalizumab-uiyk is an IgG4 monoclonal antibody targeting domain 2 of the extracellular portion of the CD4 protein. Ibalizumab-uiyk is FDA approved for the treatment of multi-drug resistant HIV in treatment experienced patients.
|
Core Group-HIV+
n=14 Participants
HIV infected individuals will receive four (4) successive 800mg doses via undiluted IV Push over 30 seconds.
ibalizumab-uiyk: Ibalizumab-uiyk is an IgG4 monoclonal antibody targeting domain 2 of the extracellular portion of the CD4 protein. Ibalizumab-uiyk is FDA approved for the treatment of multi-drug resistant HIV in treatment experienced patients.
|
Core Group-HIV Uninfected
Healthy Volunteer Core Group participants will receive a single 2000mg loading dose followed by three successive doses of 800mg in accordance with the prescribing information in order to reach steady state. Thereafter, Healthy Volunteers will receive two successive doses of 800mg ibalizumab (Trogarzo) administered in accordance with the prescribing information followed by four (4) successive 800mg doses via undiluted IV Push over 30 seconds.
ibalizumab-uiyk: Ibalizumab-uiyk is an IgG4 monoclonal antibody targeting domain 2 of the extracellular portion of the CD4 protein. Ibalizumab-uiyk is FDA approved for the treatment of multi-drug resistant HIV in treatment experienced patients.
|
|---|---|---|---|
|
Pharmacokinetics Bridge Demonstrated for Intramuscular Injection of Trogarzo and IV Infusion
Participants with Ctrough ≥ 300 ng/mL (IVI)
|
5 Participants
|
14 Participants
|
—
|
|
Pharmacokinetics Bridge Demonstrated for Intramuscular Injection of Trogarzo and IV Infusion
Participants with Ctrough ≥ 300 ng/mL (IM)
|
4 Participants
|
12 Participants
|
—
|
Adverse Events
Sentinel Group-HIV +
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Core Group- HIV+
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Core Group-HIV Uninfected
Serious events: 0 serious events
Other events: 8 other events
Deaths: 0 deaths
Intramuscular Injection Group-HIV+
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
Intramuscular Injection Group-HIV Uninfected
Serious events: 0 serious events
Other events: 10 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Sentinel Group-HIV +
n=5 participants at risk
Five (5) participants will receive two successive doses of 800mg ibalizumab administered in accordance with the prescribing information followed by five (5) successive 800mg doses on a schedule gradually increasing drug concentration and decreasing administration time.
ibalizumab-uiyk: Ibalizumab-uiyk is an IgG4 monoclonal antibody targeting domain 2 of the extracellular portion of the CD4 protein. Ibalizumab-uiyk is FDA approved for the treatment of multi-drug resistant HIV in treatment experienced patients.
|
Core Group- HIV+
n=4 participants at risk
HIV-infected Core Group participants will receive two successive doses of 800mg ibalizumab (Trogarzo) administered in accordance with the prescribing information followed by four (4) successive 800mg doses via undiluted IV Push over 30 seconds.
ibalizumab-uiyk: Ibalizumab-uiyk is an IgG4 monoclonal antibody targeting domain 2 of the extracellular portion of the CD4 protein. Ibalizumab-uiyk is FDA approved for the treatment of multi-drug resistant HIV in treatment experienced patients.
|
Core Group-HIV Uninfected
n=13 participants at risk
Healthy Volunteer Core Group participants will receive a single 2000mg loading dose followed by three successive doses of 800mg in accordance with the prescribing information in order to reach steady state. Thereafter, Healthy Volunteers will receive two successive doses of 800mg ibalizumab (Trogarzo) administered in accordance with the prescribing information followed by four (4) successive 800mg doses via undiluted IV Push over 30 seconds.
ibalizumab-uiyk: Ibalizumab-uiyk is an IgG4 monoclonal antibody targeting domain 2 of the extracellular portion of the CD4 protein. Ibalizumab-uiyk is FDA approved for the treatment of multi-drug resistant HIV in treatment experienced patients.
|
Intramuscular Injection Group-HIV+
n=7 participants at risk
HIV+ participants in this group will receive two successive doses of 800mg ibalizumab (Trogarzo) administered in accordance with the prescribing information followed by four (4) successive 800mg doses via intramuscular injection.
ibalizumab-uiyk: Ibalizumab-uiyk is an IgG4 monoclonal antibody targeting domain 2 of the extracellular portion of the CD4 protein. Ibalizumab-uiyk is FDA approved for the treatment of multi-drug resistant HIV in treatment experienced patients.
|
Intramuscular Injection Group-HIV Uninfected
n=14 participants at risk
Healthy Volunteer Intramuscular Injection Group participants will receive a single 2000mg loading dose followed by three successive doses of 800mg in accordance with the prescribing information in order to reach steady state. Thereafter, Healthy Volunteers will receive two successive doses of 800mg ibalizumab (Trogarzo) administered in accordance with the prescribing information followed by four (4) successive 800mg doses via intramuscular injection.
ibalizumab-uiyk: Ibalizumab-uiyk is an IgG4 monoclonal antibody targeting domain 2 of the extracellular portion of the CD4 protein. Ibalizumab-uiyk is FDA approved for the treatment of multi-drug resistant HIV in treatment experienced patients.
|
|---|---|---|---|---|---|
|
Ear and labyrinth disorders
otitis media
|
0.00%
0/5 • Adverse events were elicited from the time of signing the informed consent through completion of the study at either day 85 (HIV+ IVP, HIV+IM, HIV uninfected IVP) or day 99 (Sentinel IVP and Uninfected IM). For HIV-uninfected individuals study duration requited establishment of an ibalizumab steady state which added 55 days to period of time over which adverse event data were collected.
Adverse events were collected by subject interview, observation pre, during, and post ibalizumab infusion over 15 minute; pre, during and post ibalizumab dosing by intravenous push and pre- during, and post IM administration of ibalizumab.
|
25.0%
1/4 • Number of events 1 • Adverse events were elicited from the time of signing the informed consent through completion of the study at either day 85 (HIV+ IVP, HIV+IM, HIV uninfected IVP) or day 99 (Sentinel IVP and Uninfected IM). For HIV-uninfected individuals study duration requited establishment of an ibalizumab steady state which added 55 days to period of time over which adverse event data were collected.
Adverse events were collected by subject interview, observation pre, during, and post ibalizumab infusion over 15 minute; pre, during and post ibalizumab dosing by intravenous push and pre- during, and post IM administration of ibalizumab.
|
0.00%
0/13 • Adverse events were elicited from the time of signing the informed consent through completion of the study at either day 85 (HIV+ IVP, HIV+IM, HIV uninfected IVP) or day 99 (Sentinel IVP and Uninfected IM). For HIV-uninfected individuals study duration requited establishment of an ibalizumab steady state which added 55 days to period of time over which adverse event data were collected.
Adverse events were collected by subject interview, observation pre, during, and post ibalizumab infusion over 15 minute; pre, during and post ibalizumab dosing by intravenous push and pre- during, and post IM administration of ibalizumab.
|
0.00%
0/7 • Adverse events were elicited from the time of signing the informed consent through completion of the study at either day 85 (HIV+ IVP, HIV+IM, HIV uninfected IVP) or day 99 (Sentinel IVP and Uninfected IM). For HIV-uninfected individuals study duration requited establishment of an ibalizumab steady state which added 55 days to period of time over which adverse event data were collected.
Adverse events were collected by subject interview, observation pre, during, and post ibalizumab infusion over 15 minute; pre, during and post ibalizumab dosing by intravenous push and pre- during, and post IM administration of ibalizumab.
|
0.00%
0/14 • Adverse events were elicited from the time of signing the informed consent through completion of the study at either day 85 (HIV+ IVP, HIV+IM, HIV uninfected IVP) or day 99 (Sentinel IVP and Uninfected IM). For HIV-uninfected individuals study duration requited establishment of an ibalizumab steady state which added 55 days to period of time over which adverse event data were collected.
Adverse events were collected by subject interview, observation pre, during, and post ibalizumab infusion over 15 minute; pre, during and post ibalizumab dosing by intravenous push and pre- during, and post IM administration of ibalizumab.
|
|
Musculoskeletal and connective tissue disorders
joint swelling
|
20.0%
1/5 • Number of events 1 • Adverse events were elicited from the time of signing the informed consent through completion of the study at either day 85 (HIV+ IVP, HIV+IM, HIV uninfected IVP) or day 99 (Sentinel IVP and Uninfected IM). For HIV-uninfected individuals study duration requited establishment of an ibalizumab steady state which added 55 days to period of time over which adverse event data were collected.
Adverse events were collected by subject interview, observation pre, during, and post ibalizumab infusion over 15 minute; pre, during and post ibalizumab dosing by intravenous push and pre- during, and post IM administration of ibalizumab.
|
0.00%
0/4 • Adverse events were elicited from the time of signing the informed consent through completion of the study at either day 85 (HIV+ IVP, HIV+IM, HIV uninfected IVP) or day 99 (Sentinel IVP and Uninfected IM). For HIV-uninfected individuals study duration requited establishment of an ibalizumab steady state which added 55 days to period of time over which adverse event data were collected.
Adverse events were collected by subject interview, observation pre, during, and post ibalizumab infusion over 15 minute; pre, during and post ibalizumab dosing by intravenous push and pre- during, and post IM administration of ibalizumab.
|
0.00%
0/13 • Adverse events were elicited from the time of signing the informed consent through completion of the study at either day 85 (HIV+ IVP, HIV+IM, HIV uninfected IVP) or day 99 (Sentinel IVP and Uninfected IM). For HIV-uninfected individuals study duration requited establishment of an ibalizumab steady state which added 55 days to period of time over which adverse event data were collected.
Adverse events were collected by subject interview, observation pre, during, and post ibalizumab infusion over 15 minute; pre, during and post ibalizumab dosing by intravenous push and pre- during, and post IM administration of ibalizumab.
|
0.00%
0/7 • Adverse events were elicited from the time of signing the informed consent through completion of the study at either day 85 (HIV+ IVP, HIV+IM, HIV uninfected IVP) or day 99 (Sentinel IVP and Uninfected IM). For HIV-uninfected individuals study duration requited establishment of an ibalizumab steady state which added 55 days to period of time over which adverse event data were collected.
Adverse events were collected by subject interview, observation pre, during, and post ibalizumab infusion over 15 minute; pre, during and post ibalizumab dosing by intravenous push and pre- during, and post IM administration of ibalizumab.
|
0.00%
0/14 • Adverse events were elicited from the time of signing the informed consent through completion of the study at either day 85 (HIV+ IVP, HIV+IM, HIV uninfected IVP) or day 99 (Sentinel IVP and Uninfected IM). For HIV-uninfected individuals study duration requited establishment of an ibalizumab steady state which added 55 days to period of time over which adverse event data were collected.
Adverse events were collected by subject interview, observation pre, during, and post ibalizumab infusion over 15 minute; pre, during and post ibalizumab dosing by intravenous push and pre- during, and post IM administration of ibalizumab.
|
|
Gastrointestinal disorders
abdominal distention
|
0.00%
0/5 • Adverse events were elicited from the time of signing the informed consent through completion of the study at either day 85 (HIV+ IVP, HIV+IM, HIV uninfected IVP) or day 99 (Sentinel IVP and Uninfected IM). For HIV-uninfected individuals study duration requited establishment of an ibalizumab steady state which added 55 days to period of time over which adverse event data were collected.
Adverse events were collected by subject interview, observation pre, during, and post ibalizumab infusion over 15 minute; pre, during and post ibalizumab dosing by intravenous push and pre- during, and post IM administration of ibalizumab.
|
25.0%
1/4 • Number of events 1 • Adverse events were elicited from the time of signing the informed consent through completion of the study at either day 85 (HIV+ IVP, HIV+IM, HIV uninfected IVP) or day 99 (Sentinel IVP and Uninfected IM). For HIV-uninfected individuals study duration requited establishment of an ibalizumab steady state which added 55 days to period of time over which adverse event data were collected.
Adverse events were collected by subject interview, observation pre, during, and post ibalizumab infusion over 15 minute; pre, during and post ibalizumab dosing by intravenous push and pre- during, and post IM administration of ibalizumab.
|
0.00%
0/13 • Adverse events were elicited from the time of signing the informed consent through completion of the study at either day 85 (HIV+ IVP, HIV+IM, HIV uninfected IVP) or day 99 (Sentinel IVP and Uninfected IM). For HIV-uninfected individuals study duration requited establishment of an ibalizumab steady state which added 55 days to period of time over which adverse event data were collected.
Adverse events were collected by subject interview, observation pre, during, and post ibalizumab infusion over 15 minute; pre, during and post ibalizumab dosing by intravenous push and pre- during, and post IM administration of ibalizumab.
|
0.00%
0/7 • Adverse events were elicited from the time of signing the informed consent through completion of the study at either day 85 (HIV+ IVP, HIV+IM, HIV uninfected IVP) or day 99 (Sentinel IVP and Uninfected IM). For HIV-uninfected individuals study duration requited establishment of an ibalizumab steady state which added 55 days to period of time over which adverse event data were collected.
Adverse events were collected by subject interview, observation pre, during, and post ibalizumab infusion over 15 minute; pre, during and post ibalizumab dosing by intravenous push and pre- during, and post IM administration of ibalizumab.
|
0.00%
0/14 • Adverse events were elicited from the time of signing the informed consent through completion of the study at either day 85 (HIV+ IVP, HIV+IM, HIV uninfected IVP) or day 99 (Sentinel IVP and Uninfected IM). For HIV-uninfected individuals study duration requited establishment of an ibalizumab steady state which added 55 days to period of time over which adverse event data were collected.
Adverse events were collected by subject interview, observation pre, during, and post ibalizumab infusion over 15 minute; pre, during and post ibalizumab dosing by intravenous push and pre- during, and post IM administration of ibalizumab.
|
|
Gastrointestinal disorders
nausea
|
0.00%
0/5 • Adverse events were elicited from the time of signing the informed consent through completion of the study at either day 85 (HIV+ IVP, HIV+IM, HIV uninfected IVP) or day 99 (Sentinel IVP and Uninfected IM). For HIV-uninfected individuals study duration requited establishment of an ibalizumab steady state which added 55 days to period of time over which adverse event data were collected.
Adverse events were collected by subject interview, observation pre, during, and post ibalizumab infusion over 15 minute; pre, during and post ibalizumab dosing by intravenous push and pre- during, and post IM administration of ibalizumab.
|
0.00%
0/4 • Adverse events were elicited from the time of signing the informed consent through completion of the study at either day 85 (HIV+ IVP, HIV+IM, HIV uninfected IVP) or day 99 (Sentinel IVP and Uninfected IM). For HIV-uninfected individuals study duration requited establishment of an ibalizumab steady state which added 55 days to period of time over which adverse event data were collected.
Adverse events were collected by subject interview, observation pre, during, and post ibalizumab infusion over 15 minute; pre, during and post ibalizumab dosing by intravenous push and pre- during, and post IM administration of ibalizumab.
|
15.4%
2/13 • Number of events 2 • Adverse events were elicited from the time of signing the informed consent through completion of the study at either day 85 (HIV+ IVP, HIV+IM, HIV uninfected IVP) or day 99 (Sentinel IVP and Uninfected IM). For HIV-uninfected individuals study duration requited establishment of an ibalizumab steady state which added 55 days to period of time over which adverse event data were collected.
Adverse events were collected by subject interview, observation pre, during, and post ibalizumab infusion over 15 minute; pre, during and post ibalizumab dosing by intravenous push and pre- during, and post IM administration of ibalizumab.
|
0.00%
0/7 • Adverse events were elicited from the time of signing the informed consent through completion of the study at either day 85 (HIV+ IVP, HIV+IM, HIV uninfected IVP) or day 99 (Sentinel IVP and Uninfected IM). For HIV-uninfected individuals study duration requited establishment of an ibalizumab steady state which added 55 days to period of time over which adverse event data were collected.
Adverse events were collected by subject interview, observation pre, during, and post ibalizumab infusion over 15 minute; pre, during and post ibalizumab dosing by intravenous push and pre- during, and post IM administration of ibalizumab.
|
14.3%
2/14 • Number of events 2 • Adverse events were elicited from the time of signing the informed consent through completion of the study at either day 85 (HIV+ IVP, HIV+IM, HIV uninfected IVP) or day 99 (Sentinel IVP and Uninfected IM). For HIV-uninfected individuals study duration requited establishment of an ibalizumab steady state which added 55 days to period of time over which adverse event data were collected.
Adverse events were collected by subject interview, observation pre, during, and post ibalizumab infusion over 15 minute; pre, during and post ibalizumab dosing by intravenous push and pre- during, and post IM administration of ibalizumab.
|
|
Nervous system disorders
headache
|
0.00%
0/5 • Adverse events were elicited from the time of signing the informed consent through completion of the study at either day 85 (HIV+ IVP, HIV+IM, HIV uninfected IVP) or day 99 (Sentinel IVP and Uninfected IM). For HIV-uninfected individuals study duration requited establishment of an ibalizumab steady state which added 55 days to period of time over which adverse event data were collected.
Adverse events were collected by subject interview, observation pre, during, and post ibalizumab infusion over 15 minute; pre, during and post ibalizumab dosing by intravenous push and pre- during, and post IM administration of ibalizumab.
|
0.00%
0/4 • Adverse events were elicited from the time of signing the informed consent through completion of the study at either day 85 (HIV+ IVP, HIV+IM, HIV uninfected IVP) or day 99 (Sentinel IVP and Uninfected IM). For HIV-uninfected individuals study duration requited establishment of an ibalizumab steady state which added 55 days to period of time over which adverse event data were collected.
Adverse events were collected by subject interview, observation pre, during, and post ibalizumab infusion over 15 minute; pre, during and post ibalizumab dosing by intravenous push and pre- during, and post IM administration of ibalizumab.
|
15.4%
2/13 • Number of events 2 • Adverse events were elicited from the time of signing the informed consent through completion of the study at either day 85 (HIV+ IVP, HIV+IM, HIV uninfected IVP) or day 99 (Sentinel IVP and Uninfected IM). For HIV-uninfected individuals study duration requited establishment of an ibalizumab steady state which added 55 days to period of time over which adverse event data were collected.
Adverse events were collected by subject interview, observation pre, during, and post ibalizumab infusion over 15 minute; pre, during and post ibalizumab dosing by intravenous push and pre- during, and post IM administration of ibalizumab.
|
0.00%
0/7 • Adverse events were elicited from the time of signing the informed consent through completion of the study at either day 85 (HIV+ IVP, HIV+IM, HIV uninfected IVP) or day 99 (Sentinel IVP and Uninfected IM). For HIV-uninfected individuals study duration requited establishment of an ibalizumab steady state which added 55 days to period of time over which adverse event data were collected.
Adverse events were collected by subject interview, observation pre, during, and post ibalizumab infusion over 15 minute; pre, during and post ibalizumab dosing by intravenous push and pre- during, and post IM administration of ibalizumab.
|
50.0%
7/14 • Number of events 7 • Adverse events were elicited from the time of signing the informed consent through completion of the study at either day 85 (HIV+ IVP, HIV+IM, HIV uninfected IVP) or day 99 (Sentinel IVP and Uninfected IM). For HIV-uninfected individuals study duration requited establishment of an ibalizumab steady state which added 55 days to period of time over which adverse event data were collected.
Adverse events were collected by subject interview, observation pre, during, and post ibalizumab infusion over 15 minute; pre, during and post ibalizumab dosing by intravenous push and pre- during, and post IM administration of ibalizumab.
|
|
Gastrointestinal disorders
vomiting
|
0.00%
0/5 • Adverse events were elicited from the time of signing the informed consent through completion of the study at either day 85 (HIV+ IVP, HIV+IM, HIV uninfected IVP) or day 99 (Sentinel IVP and Uninfected IM). For HIV-uninfected individuals study duration requited establishment of an ibalizumab steady state which added 55 days to period of time over which adverse event data were collected.
Adverse events were collected by subject interview, observation pre, during, and post ibalizumab infusion over 15 minute; pre, during and post ibalizumab dosing by intravenous push and pre- during, and post IM administration of ibalizumab.
|
0.00%
0/4 • Adverse events were elicited from the time of signing the informed consent through completion of the study at either day 85 (HIV+ IVP, HIV+IM, HIV uninfected IVP) or day 99 (Sentinel IVP and Uninfected IM). For HIV-uninfected individuals study duration requited establishment of an ibalizumab steady state which added 55 days to period of time over which adverse event data were collected.
Adverse events were collected by subject interview, observation pre, during, and post ibalizumab infusion over 15 minute; pre, during and post ibalizumab dosing by intravenous push and pre- during, and post IM administration of ibalizumab.
|
0.00%
0/13 • Adverse events were elicited from the time of signing the informed consent through completion of the study at either day 85 (HIV+ IVP, HIV+IM, HIV uninfected IVP) or day 99 (Sentinel IVP and Uninfected IM). For HIV-uninfected individuals study duration requited establishment of an ibalizumab steady state which added 55 days to period of time over which adverse event data were collected.
Adverse events were collected by subject interview, observation pre, during, and post ibalizumab infusion over 15 minute; pre, during and post ibalizumab dosing by intravenous push and pre- during, and post IM administration of ibalizumab.
|
0.00%
0/7 • Adverse events were elicited from the time of signing the informed consent through completion of the study at either day 85 (HIV+ IVP, HIV+IM, HIV uninfected IVP) or day 99 (Sentinel IVP and Uninfected IM). For HIV-uninfected individuals study duration requited establishment of an ibalizumab steady state which added 55 days to period of time over which adverse event data were collected.
Adverse events were collected by subject interview, observation pre, during, and post ibalizumab infusion over 15 minute; pre, during and post ibalizumab dosing by intravenous push and pre- during, and post IM administration of ibalizumab.
|
14.3%
2/14 • Number of events 2 • Adverse events were elicited from the time of signing the informed consent through completion of the study at either day 85 (HIV+ IVP, HIV+IM, HIV uninfected IVP) or day 99 (Sentinel IVP and Uninfected IM). For HIV-uninfected individuals study duration requited establishment of an ibalizumab steady state which added 55 days to period of time over which adverse event data were collected.
Adverse events were collected by subject interview, observation pre, during, and post ibalizumab infusion over 15 minute; pre, during and post ibalizumab dosing by intravenous push and pre- during, and post IM administration of ibalizumab.
|
|
Immune system disorders
allergic rhinitis
|
0.00%
0/5 • Adverse events were elicited from the time of signing the informed consent through completion of the study at either day 85 (HIV+ IVP, HIV+IM, HIV uninfected IVP) or day 99 (Sentinel IVP and Uninfected IM). For HIV-uninfected individuals study duration requited establishment of an ibalizumab steady state which added 55 days to period of time over which adverse event data were collected.
Adverse events were collected by subject interview, observation pre, during, and post ibalizumab infusion over 15 minute; pre, during and post ibalizumab dosing by intravenous push and pre- during, and post IM administration of ibalizumab.
|
0.00%
0/4 • Adverse events were elicited from the time of signing the informed consent through completion of the study at either day 85 (HIV+ IVP, HIV+IM, HIV uninfected IVP) or day 99 (Sentinel IVP and Uninfected IM). For HIV-uninfected individuals study duration requited establishment of an ibalizumab steady state which added 55 days to period of time over which adverse event data were collected.
Adverse events were collected by subject interview, observation pre, during, and post ibalizumab infusion over 15 minute; pre, during and post ibalizumab dosing by intravenous push and pre- during, and post IM administration of ibalizumab.
|
0.00%
0/13 • Adverse events were elicited from the time of signing the informed consent through completion of the study at either day 85 (HIV+ IVP, HIV+IM, HIV uninfected IVP) or day 99 (Sentinel IVP and Uninfected IM). For HIV-uninfected individuals study duration requited establishment of an ibalizumab steady state which added 55 days to period of time over which adverse event data were collected.
Adverse events were collected by subject interview, observation pre, during, and post ibalizumab infusion over 15 minute; pre, during and post ibalizumab dosing by intravenous push and pre- during, and post IM administration of ibalizumab.
|
28.6%
2/7 • Number of events 2 • Adverse events were elicited from the time of signing the informed consent through completion of the study at either day 85 (HIV+ IVP, HIV+IM, HIV uninfected IVP) or day 99 (Sentinel IVP and Uninfected IM). For HIV-uninfected individuals study duration requited establishment of an ibalizumab steady state which added 55 days to period of time over which adverse event data were collected.
Adverse events were collected by subject interview, observation pre, during, and post ibalizumab infusion over 15 minute; pre, during and post ibalizumab dosing by intravenous push and pre- during, and post IM administration of ibalizumab.
|
0.00%
0/14 • Adverse events were elicited from the time of signing the informed consent through completion of the study at either day 85 (HIV+ IVP, HIV+IM, HIV uninfected IVP) or day 99 (Sentinel IVP and Uninfected IM). For HIV-uninfected individuals study duration requited establishment of an ibalizumab steady state which added 55 days to period of time over which adverse event data were collected.
Adverse events were collected by subject interview, observation pre, during, and post ibalizumab infusion over 15 minute; pre, during and post ibalizumab dosing by intravenous push and pre- during, and post IM administration of ibalizumab.
|
|
Skin and subcutaneous tissue disorders
injection site pruritis
|
0.00%
0/5 • Adverse events were elicited from the time of signing the informed consent through completion of the study at either day 85 (HIV+ IVP, HIV+IM, HIV uninfected IVP) or day 99 (Sentinel IVP and Uninfected IM). For HIV-uninfected individuals study duration requited establishment of an ibalizumab steady state which added 55 days to period of time over which adverse event data were collected.
Adverse events were collected by subject interview, observation pre, during, and post ibalizumab infusion over 15 minute; pre, during and post ibalizumab dosing by intravenous push and pre- during, and post IM administration of ibalizumab.
|
0.00%
0/4 • Adverse events were elicited from the time of signing the informed consent through completion of the study at either day 85 (HIV+ IVP, HIV+IM, HIV uninfected IVP) or day 99 (Sentinel IVP and Uninfected IM). For HIV-uninfected individuals study duration requited establishment of an ibalizumab steady state which added 55 days to period of time over which adverse event data were collected.
Adverse events were collected by subject interview, observation pre, during, and post ibalizumab infusion over 15 minute; pre, during and post ibalizumab dosing by intravenous push and pre- during, and post IM administration of ibalizumab.
|
0.00%
0/13 • Adverse events were elicited from the time of signing the informed consent through completion of the study at either day 85 (HIV+ IVP, HIV+IM, HIV uninfected IVP) or day 99 (Sentinel IVP and Uninfected IM). For HIV-uninfected individuals study duration requited establishment of an ibalizumab steady state which added 55 days to period of time over which adverse event data were collected.
Adverse events were collected by subject interview, observation pre, during, and post ibalizumab infusion over 15 minute; pre, during and post ibalizumab dosing by intravenous push and pre- during, and post IM administration of ibalizumab.
|
14.3%
1/7 • Number of events 1 • Adverse events were elicited from the time of signing the informed consent through completion of the study at either day 85 (HIV+ IVP, HIV+IM, HIV uninfected IVP) or day 99 (Sentinel IVP and Uninfected IM). For HIV-uninfected individuals study duration requited establishment of an ibalizumab steady state which added 55 days to period of time over which adverse event data were collected.
Adverse events were collected by subject interview, observation pre, during, and post ibalizumab infusion over 15 minute; pre, during and post ibalizumab dosing by intravenous push and pre- during, and post IM administration of ibalizumab.
|
0.00%
0/14 • Adverse events were elicited from the time of signing the informed consent through completion of the study at either day 85 (HIV+ IVP, HIV+IM, HIV uninfected IVP) or day 99 (Sentinel IVP and Uninfected IM). For HIV-uninfected individuals study duration requited establishment of an ibalizumab steady state which added 55 days to period of time over which adverse event data were collected.
Adverse events were collected by subject interview, observation pre, during, and post ibalizumab infusion over 15 minute; pre, during and post ibalizumab dosing by intravenous push and pre- during, and post IM administration of ibalizumab.
|
|
Endocrine disorders
hyperglycemia
|
0.00%
0/5 • Adverse events were elicited from the time of signing the informed consent through completion of the study at either day 85 (HIV+ IVP, HIV+IM, HIV uninfected IVP) or day 99 (Sentinel IVP and Uninfected IM). For HIV-uninfected individuals study duration requited establishment of an ibalizumab steady state which added 55 days to period of time over which adverse event data were collected.
Adverse events were collected by subject interview, observation pre, during, and post ibalizumab infusion over 15 minute; pre, during and post ibalizumab dosing by intravenous push and pre- during, and post IM administration of ibalizumab.
|
0.00%
0/4 • Adverse events were elicited from the time of signing the informed consent through completion of the study at either day 85 (HIV+ IVP, HIV+IM, HIV uninfected IVP) or day 99 (Sentinel IVP and Uninfected IM). For HIV-uninfected individuals study duration requited establishment of an ibalizumab steady state which added 55 days to period of time over which adverse event data were collected.
Adverse events were collected by subject interview, observation pre, during, and post ibalizumab infusion over 15 minute; pre, during and post ibalizumab dosing by intravenous push and pre- during, and post IM administration of ibalizumab.
|
0.00%
0/13 • Adverse events were elicited from the time of signing the informed consent through completion of the study at either day 85 (HIV+ IVP, HIV+IM, HIV uninfected IVP) or day 99 (Sentinel IVP and Uninfected IM). For HIV-uninfected individuals study duration requited establishment of an ibalizumab steady state which added 55 days to period of time over which adverse event data were collected.
Adverse events were collected by subject interview, observation pre, during, and post ibalizumab infusion over 15 minute; pre, during and post ibalizumab dosing by intravenous push and pre- during, and post IM administration of ibalizumab.
|
14.3%
1/7 • Number of events 1 • Adverse events were elicited from the time of signing the informed consent through completion of the study at either day 85 (HIV+ IVP, HIV+IM, HIV uninfected IVP) or day 99 (Sentinel IVP and Uninfected IM). For HIV-uninfected individuals study duration requited establishment of an ibalizumab steady state which added 55 days to period of time over which adverse event data were collected.
Adverse events were collected by subject interview, observation pre, during, and post ibalizumab infusion over 15 minute; pre, during and post ibalizumab dosing by intravenous push and pre- during, and post IM administration of ibalizumab.
|
0.00%
0/14 • Adverse events were elicited from the time of signing the informed consent through completion of the study at either day 85 (HIV+ IVP, HIV+IM, HIV uninfected IVP) or day 99 (Sentinel IVP and Uninfected IM). For HIV-uninfected individuals study duration requited establishment of an ibalizumab steady state which added 55 days to period of time over which adverse event data were collected.
Adverse events were collected by subject interview, observation pre, during, and post ibalizumab infusion over 15 minute; pre, during and post ibalizumab dosing by intravenous push and pre- during, and post IM administration of ibalizumab.
|
|
Skin and subcutaneous tissue disorders
hematoma at infusion site
|
0.00%
0/5 • Adverse events were elicited from the time of signing the informed consent through completion of the study at either day 85 (HIV+ IVP, HIV+IM, HIV uninfected IVP) or day 99 (Sentinel IVP and Uninfected IM). For HIV-uninfected individuals study duration requited establishment of an ibalizumab steady state which added 55 days to period of time over which adverse event data were collected.
Adverse events were collected by subject interview, observation pre, during, and post ibalizumab infusion over 15 minute; pre, during and post ibalizumab dosing by intravenous push and pre- during, and post IM administration of ibalizumab.
|
0.00%
0/4 • Adverse events were elicited from the time of signing the informed consent through completion of the study at either day 85 (HIV+ IVP, HIV+IM, HIV uninfected IVP) or day 99 (Sentinel IVP and Uninfected IM). For HIV-uninfected individuals study duration requited establishment of an ibalizumab steady state which added 55 days to period of time over which adverse event data were collected.
Adverse events were collected by subject interview, observation pre, during, and post ibalizumab infusion over 15 minute; pre, during and post ibalizumab dosing by intravenous push and pre- during, and post IM administration of ibalizumab.
|
7.7%
1/13 • Number of events 1 • Adverse events were elicited from the time of signing the informed consent through completion of the study at either day 85 (HIV+ IVP, HIV+IM, HIV uninfected IVP) or day 99 (Sentinel IVP and Uninfected IM). For HIV-uninfected individuals study duration requited establishment of an ibalizumab steady state which added 55 days to period of time over which adverse event data were collected.
Adverse events were collected by subject interview, observation pre, during, and post ibalizumab infusion over 15 minute; pre, during and post ibalizumab dosing by intravenous push and pre- during, and post IM administration of ibalizumab.
|
0.00%
0/7 • Adverse events were elicited from the time of signing the informed consent through completion of the study at either day 85 (HIV+ IVP, HIV+IM, HIV uninfected IVP) or day 99 (Sentinel IVP and Uninfected IM). For HIV-uninfected individuals study duration requited establishment of an ibalizumab steady state which added 55 days to period of time over which adverse event data were collected.
Adverse events were collected by subject interview, observation pre, during, and post ibalizumab infusion over 15 minute; pre, during and post ibalizumab dosing by intravenous push and pre- during, and post IM administration of ibalizumab.
|
0.00%
0/14 • Adverse events were elicited from the time of signing the informed consent through completion of the study at either day 85 (HIV+ IVP, HIV+IM, HIV uninfected IVP) or day 99 (Sentinel IVP and Uninfected IM). For HIV-uninfected individuals study duration requited establishment of an ibalizumab steady state which added 55 days to period of time over which adverse event data were collected.
Adverse events were collected by subject interview, observation pre, during, and post ibalizumab infusion over 15 minute; pre, during and post ibalizumab dosing by intravenous push and pre- during, and post IM administration of ibalizumab.
|
|
Blood and lymphatic system disorders
bruising
|
0.00%
0/5 • Adverse events were elicited from the time of signing the informed consent through completion of the study at either day 85 (HIV+ IVP, HIV+IM, HIV uninfected IVP) or day 99 (Sentinel IVP and Uninfected IM). For HIV-uninfected individuals study duration requited establishment of an ibalizumab steady state which added 55 days to period of time over which adverse event data were collected.
Adverse events were collected by subject interview, observation pre, during, and post ibalizumab infusion over 15 minute; pre, during and post ibalizumab dosing by intravenous push and pre- during, and post IM administration of ibalizumab.
|
0.00%
0/4 • Adverse events were elicited from the time of signing the informed consent through completion of the study at either day 85 (HIV+ IVP, HIV+IM, HIV uninfected IVP) or day 99 (Sentinel IVP and Uninfected IM). For HIV-uninfected individuals study duration requited establishment of an ibalizumab steady state which added 55 days to period of time over which adverse event data were collected.
Adverse events were collected by subject interview, observation pre, during, and post ibalizumab infusion over 15 minute; pre, during and post ibalizumab dosing by intravenous push and pre- during, and post IM administration of ibalizumab.
|
0.00%
0/13 • Adverse events were elicited from the time of signing the informed consent through completion of the study at either day 85 (HIV+ IVP, HIV+IM, HIV uninfected IVP) or day 99 (Sentinel IVP and Uninfected IM). For HIV-uninfected individuals study duration requited establishment of an ibalizumab steady state which added 55 days to period of time over which adverse event data were collected.
Adverse events were collected by subject interview, observation pre, during, and post ibalizumab infusion over 15 minute; pre, during and post ibalizumab dosing by intravenous push and pre- during, and post IM administration of ibalizumab.
|
0.00%
0/7 • Adverse events were elicited from the time of signing the informed consent through completion of the study at either day 85 (HIV+ IVP, HIV+IM, HIV uninfected IVP) or day 99 (Sentinel IVP and Uninfected IM). For HIV-uninfected individuals study duration requited establishment of an ibalizumab steady state which added 55 days to period of time over which adverse event data were collected.
Adverse events were collected by subject interview, observation pre, during, and post ibalizumab infusion over 15 minute; pre, during and post ibalizumab dosing by intravenous push and pre- during, and post IM administration of ibalizumab.
|
21.4%
3/14 • Number of events 3 • Adverse events were elicited from the time of signing the informed consent through completion of the study at either day 85 (HIV+ IVP, HIV+IM, HIV uninfected IVP) or day 99 (Sentinel IVP and Uninfected IM). For HIV-uninfected individuals study duration requited establishment of an ibalizumab steady state which added 55 days to period of time over which adverse event data were collected.
Adverse events were collected by subject interview, observation pre, during, and post ibalizumab infusion over 15 minute; pre, during and post ibalizumab dosing by intravenous push and pre- during, and post IM administration of ibalizumab.
|
|
Nervous system disorders
somnolence
|
0.00%
0/5 • Adverse events were elicited from the time of signing the informed consent through completion of the study at either day 85 (HIV+ IVP, HIV+IM, HIV uninfected IVP) or day 99 (Sentinel IVP and Uninfected IM). For HIV-uninfected individuals study duration requited establishment of an ibalizumab steady state which added 55 days to period of time over which adverse event data were collected.
Adverse events were collected by subject interview, observation pre, during, and post ibalizumab infusion over 15 minute; pre, during and post ibalizumab dosing by intravenous push and pre- during, and post IM administration of ibalizumab.
|
0.00%
0/4 • Adverse events were elicited from the time of signing the informed consent through completion of the study at either day 85 (HIV+ IVP, HIV+IM, HIV uninfected IVP) or day 99 (Sentinel IVP and Uninfected IM). For HIV-uninfected individuals study duration requited establishment of an ibalizumab steady state which added 55 days to period of time over which adverse event data were collected.
Adverse events were collected by subject interview, observation pre, during, and post ibalizumab infusion over 15 minute; pre, during and post ibalizumab dosing by intravenous push and pre- during, and post IM administration of ibalizumab.
|
7.7%
1/13 • Number of events 1 • Adverse events were elicited from the time of signing the informed consent through completion of the study at either day 85 (HIV+ IVP, HIV+IM, HIV uninfected IVP) or day 99 (Sentinel IVP and Uninfected IM). For HIV-uninfected individuals study duration requited establishment of an ibalizumab steady state which added 55 days to period of time over which adverse event data were collected.
Adverse events were collected by subject interview, observation pre, during, and post ibalizumab infusion over 15 minute; pre, during and post ibalizumab dosing by intravenous push and pre- during, and post IM administration of ibalizumab.
|
0.00%
0/7 • Adverse events were elicited from the time of signing the informed consent through completion of the study at either day 85 (HIV+ IVP, HIV+IM, HIV uninfected IVP) or day 99 (Sentinel IVP and Uninfected IM). For HIV-uninfected individuals study duration requited establishment of an ibalizumab steady state which added 55 days to period of time over which adverse event data were collected.
Adverse events were collected by subject interview, observation pre, during, and post ibalizumab infusion over 15 minute; pre, during and post ibalizumab dosing by intravenous push and pre- during, and post IM administration of ibalizumab.
|
0.00%
0/14 • Adverse events were elicited from the time of signing the informed consent through completion of the study at either day 85 (HIV+ IVP, HIV+IM, HIV uninfected IVP) or day 99 (Sentinel IVP and Uninfected IM). For HIV-uninfected individuals study duration requited establishment of an ibalizumab steady state which added 55 days to period of time over which adverse event data were collected.
Adverse events were collected by subject interview, observation pre, during, and post ibalizumab infusion over 15 minute; pre, during and post ibalizumab dosing by intravenous push and pre- during, and post IM administration of ibalizumab.
|
|
Nervous system disorders
tremor
|
0.00%
0/5 • Adverse events were elicited from the time of signing the informed consent through completion of the study at either day 85 (HIV+ IVP, HIV+IM, HIV uninfected IVP) or day 99 (Sentinel IVP and Uninfected IM). For HIV-uninfected individuals study duration requited establishment of an ibalizumab steady state which added 55 days to period of time over which adverse event data were collected.
Adverse events were collected by subject interview, observation pre, during, and post ibalizumab infusion over 15 minute; pre, during and post ibalizumab dosing by intravenous push and pre- during, and post IM administration of ibalizumab.
|
0.00%
0/4 • Adverse events were elicited from the time of signing the informed consent through completion of the study at either day 85 (HIV+ IVP, HIV+IM, HIV uninfected IVP) or day 99 (Sentinel IVP and Uninfected IM). For HIV-uninfected individuals study duration requited establishment of an ibalizumab steady state which added 55 days to period of time over which adverse event data were collected.
Adverse events were collected by subject interview, observation pre, during, and post ibalizumab infusion over 15 minute; pre, during and post ibalizumab dosing by intravenous push and pre- during, and post IM administration of ibalizumab.
|
7.7%
1/13 • Number of events 1 • Adverse events were elicited from the time of signing the informed consent through completion of the study at either day 85 (HIV+ IVP, HIV+IM, HIV uninfected IVP) or day 99 (Sentinel IVP and Uninfected IM). For HIV-uninfected individuals study duration requited establishment of an ibalizumab steady state which added 55 days to period of time over which adverse event data were collected.
Adverse events were collected by subject interview, observation pre, during, and post ibalizumab infusion over 15 minute; pre, during and post ibalizumab dosing by intravenous push and pre- during, and post IM administration of ibalizumab.
|
0.00%
0/7 • Adverse events were elicited from the time of signing the informed consent through completion of the study at either day 85 (HIV+ IVP, HIV+IM, HIV uninfected IVP) or day 99 (Sentinel IVP and Uninfected IM). For HIV-uninfected individuals study duration requited establishment of an ibalizumab steady state which added 55 days to period of time over which adverse event data were collected.
Adverse events were collected by subject interview, observation pre, during, and post ibalizumab infusion over 15 minute; pre, during and post ibalizumab dosing by intravenous push and pre- during, and post IM administration of ibalizumab.
|
0.00%
0/14 • Adverse events were elicited from the time of signing the informed consent through completion of the study at either day 85 (HIV+ IVP, HIV+IM, HIV uninfected IVP) or day 99 (Sentinel IVP and Uninfected IM). For HIV-uninfected individuals study duration requited establishment of an ibalizumab steady state which added 55 days to period of time over which adverse event data were collected.
Adverse events were collected by subject interview, observation pre, during, and post ibalizumab infusion over 15 minute; pre, during and post ibalizumab dosing by intravenous push and pre- during, and post IM administration of ibalizumab.
|
|
Musculoskeletal and connective tissue disorders
tendonitis
|
0.00%
0/5 • Adverse events were elicited from the time of signing the informed consent through completion of the study at either day 85 (HIV+ IVP, HIV+IM, HIV uninfected IVP) or day 99 (Sentinel IVP and Uninfected IM). For HIV-uninfected individuals study duration requited establishment of an ibalizumab steady state which added 55 days to period of time over which adverse event data were collected.
Adverse events were collected by subject interview, observation pre, during, and post ibalizumab infusion over 15 minute; pre, during and post ibalizumab dosing by intravenous push and pre- during, and post IM administration of ibalizumab.
|
0.00%
0/4 • Adverse events were elicited from the time of signing the informed consent through completion of the study at either day 85 (HIV+ IVP, HIV+IM, HIV uninfected IVP) or day 99 (Sentinel IVP and Uninfected IM). For HIV-uninfected individuals study duration requited establishment of an ibalizumab steady state which added 55 days to period of time over which adverse event data were collected.
Adverse events were collected by subject interview, observation pre, during, and post ibalizumab infusion over 15 minute; pre, during and post ibalizumab dosing by intravenous push and pre- during, and post IM administration of ibalizumab.
|
7.7%
1/13 • Number of events 1 • Adverse events were elicited from the time of signing the informed consent through completion of the study at either day 85 (HIV+ IVP, HIV+IM, HIV uninfected IVP) or day 99 (Sentinel IVP and Uninfected IM). For HIV-uninfected individuals study duration requited establishment of an ibalizumab steady state which added 55 days to period of time over which adverse event data were collected.
Adverse events were collected by subject interview, observation pre, during, and post ibalizumab infusion over 15 minute; pre, during and post ibalizumab dosing by intravenous push and pre- during, and post IM administration of ibalizumab.
|
0.00%
0/7 • Adverse events were elicited from the time of signing the informed consent through completion of the study at either day 85 (HIV+ IVP, HIV+IM, HIV uninfected IVP) or day 99 (Sentinel IVP and Uninfected IM). For HIV-uninfected individuals study duration requited establishment of an ibalizumab steady state which added 55 days to period of time over which adverse event data were collected.
Adverse events were collected by subject interview, observation pre, during, and post ibalizumab infusion over 15 minute; pre, during and post ibalizumab dosing by intravenous push and pre- during, and post IM administration of ibalizumab.
|
0.00%
0/14 • Adverse events were elicited from the time of signing the informed consent through completion of the study at either day 85 (HIV+ IVP, HIV+IM, HIV uninfected IVP) or day 99 (Sentinel IVP and Uninfected IM). For HIV-uninfected individuals study duration requited establishment of an ibalizumab steady state which added 55 days to period of time over which adverse event data were collected.
Adverse events were collected by subject interview, observation pre, during, and post ibalizumab infusion over 15 minute; pre, during and post ibalizumab dosing by intravenous push and pre- during, and post IM administration of ibalizumab.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee Data are considered the property of the sponsor and cannot be published without sponsor authorization. The sponsor agrees to work with the PI to determine how any manuscript is written and edited and the publication to which it is submitted. The sponsor has the authority of final determination in these matters.
- Publication restrictions are in place
Restriction type: OTHER