Trial Outcomes & Findings for Treatment Substitution With PRO 140 Monotherapy in Adult Subjects With HIV-1 Infection (NCT NCT02175680)
NCT ID: NCT02175680
Last Updated: 2023-04-14
Results Overview
Time to virologic failure after initiating PRO 140 monotherapy. Virologic failure was defined as two (2) consecutive HIV-1 RNA levels of ≥ 400 copies/mL.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
43 participants
Primary outcome timeframe
From initiation of PRO 140 monotherapy through week 14 or virological failure
Results posted on
2023-04-14
Participant Flow
Participant milestones
| Measure |
PRO 140 350 mg Weekly SQ Injection
Subject enrollment was staggered in this study to facilitate adequate safety monitoring. The lead cohort included 12 subjects. Enrollment of an additional 28 subjects was initiated after approval by the independent Data Monitoring Committee (iDMC).Consenting subjects were shifted from combination antiretroviral regimen to PRO 140 monotherapy for 12 weeks. Total treatment duration with PRO 140 was up to 14 weeks, with one (1) week overlap of existing retroviral regimen and PRO 140 at the beginning end of the treatment in subjects who did not experience Virologic Failure. PRO 140 was administered as a 350 mg subcutaneous injection weekly for up to 14 weeks. Study participants were monitored for viral rebound on a weekly basis following initiation of PRO 140 monotherapy and re-initiated their previous antiretroviral regimen if plasma HIV-1 RNA levels were ≥ 400 copies/ml on two (2) consecutive blood draws at least three (3) days apart.
|
|---|---|
|
Overall Study
STARTED
|
43
|
|
Overall Study
COMPLETED
|
41
|
|
Overall Study
NOT COMPLETED
|
2
|
Reasons for withdrawal
| Measure |
PRO 140 350 mg Weekly SQ Injection
Subject enrollment was staggered in this study to facilitate adequate safety monitoring. The lead cohort included 12 subjects. Enrollment of an additional 28 subjects was initiated after approval by the independent Data Monitoring Committee (iDMC).Consenting subjects were shifted from combination antiretroviral regimen to PRO 140 monotherapy for 12 weeks. Total treatment duration with PRO 140 was up to 14 weeks, with one (1) week overlap of existing retroviral regimen and PRO 140 at the beginning end of the treatment in subjects who did not experience Virologic Failure. PRO 140 was administered as a 350 mg subcutaneous injection weekly for up to 14 weeks. Study participants were monitored for viral rebound on a weekly basis following initiation of PRO 140 monotherapy and re-initiated their previous antiretroviral regimen if plasma HIV-1 RNA levels were ≥ 400 copies/ml on two (2) consecutive blood draws at least three (3) days apart.
|
|---|---|
|
Overall Study
non-compliance
|
1
|
|
Overall Study
other non-medical reason
|
1
|
Baseline Characteristics
Treatment Substitution With PRO 140 Monotherapy in Adult Subjects With HIV-1 Infection
Baseline characteristics by cohort
| Measure |
PRO 140
n=43 Participants
PRO 140 350mg weekly SQ injection.
PRO 140 350mg weekly SQ injection.: CCR5 Antagonist
|
|---|---|
|
Age, Continuous
|
53.1 years
STANDARD_DEVIATION 10 • n=93 Participants
|
|
Sex: Female, Male
Female
|
3 Participants
n=93 Participants
|
|
Sex: Female, Male
Male
|
40 Participants
n=93 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
9 Participants
n=93 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
34 Participants
n=93 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=93 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=93 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=93 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=93 Participants
|
|
Race (NIH/OMB)
Black or African American
|
4 Participants
n=93 Participants
|
|
Race (NIH/OMB)
White
|
34 Participants
n=93 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=93 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
5 Participants
n=93 Participants
|
|
Time since HIV Diagnosis (Years)
|
18.8 years
STANDARD_DEVIATION 9.5 • n=93 Participants
|
PRIMARY outcome
Timeframe: From initiation of PRO 140 monotherapy through week 14 or virological failurePopulation: Per Protocol population
Time to virologic failure after initiating PRO 140 monotherapy. Virologic failure was defined as two (2) consecutive HIV-1 RNA levels of ≥ 400 copies/mL.
Outcome measures
| Measure |
PRO 140 350 mg
n=41 Participants
PRO 140 350 mg weekly SQ injection.
|
|---|---|
|
Time to Virologic Failure After Initiating PRO 140 Monotherapy.
|
70.71 days
Standard Deviation 23.14
|
SECONDARY outcome
Timeframe: From initiation of PRO 140 monotherapy through week 14Population: Per Protocol
Proportion of Participants with Virologic Failure after initiating PRO 140 monotherapy at or prior to Week 14.
Outcome measures
| Measure |
PRO 140 350 mg
n=41 Participants
PRO 140 350 mg weekly SQ injection.
|
|---|---|
|
Proportion of Subjects With Virologic Failure
|
0.439 poportion of subjects
|
SECONDARY outcome
Timeframe: From initiation of PRO 140 monotherapy through week 14Population: Per Protocol population
Mean change in Viral Load (HIV-1 RNA levels - log 10 copies/ml)), at each visit within the 14-week treatment phase.
Outcome measures
| Measure |
PRO 140 350 mg
n=41 Participants
PRO 140 350 mg weekly SQ injection.
|
|---|---|
|
Mean Change From Baseline in Viral Load
T2 (Week 2)
|
0.10 log 10 copies/mL
Standard Deviation 0.71
|
|
Mean Change From Baseline in Viral Load
T3 (Week 3)
|
0.01 log 10 copies/mL
Standard Deviation 0.74
|
|
Mean Change From Baseline in Viral Load
T4 (Week 4)
|
-0.13 log 10 copies/mL
Standard Deviation 0.74
|
|
Mean Change From Baseline in Viral Load
T5 (Week 5)
|
-0.25 log 10 copies/mL
Standard Deviation 1.04
|
|
Mean Change From Baseline in Viral Load
T6 (Week 6)
|
-0.76 log 10 copies/mL
Standard Deviation 1.39
|
|
Mean Change From Baseline in Viral Load
T7 (Week 7)
|
-0.88 log 10 copies/mL
Standard Deviation 1.53
|
|
Mean Change From Baseline in Viral Load
T8 (Week 8)
|
-0.72 log 10 copies/mL
Standard Deviation 1.37
|
|
Mean Change From Baseline in Viral Load
T9 (Week 9)
|
-0.84 log 10 copies/mL
Standard Deviation 1.37
|
|
Mean Change From Baseline in Viral Load
T10 (Week 10)
|
-0.71 log 10 copies/mL
Standard Deviation 1.36
|
|
Mean Change From Baseline in Viral Load
T11 (Week 11)
|
-0.81 log 10 copies/mL
Standard Deviation 1.37
|
|
Mean Change From Baseline in Viral Load
T12 (Week 12)
|
-0.91 log 10 copies/mL
Standard Deviation 1.50
|
|
Mean Change From Baseline in Viral Load
T13 (Week 13)
|
-0.44 log 10 copies/mL
Standard Deviation 1.12
|
|
Mean Change From Baseline in Viral Load
T14 (Week 14)
|
-0.37 log 10 copies/mL
Standard Deviation 1.09
|
SECONDARY outcome
Timeframe: From baseline to virologic failure visit (VF). VF can occur at any time from Week 1 to Week 14.Population: Per Protocol
Mean Change from Baseline in viral load at the last virologic failure visit from Week 1 to Week 14. VF can occur at any time during the treatment phase from week 1 to week 14. Subjects who experience Virologic Failure will be followed up every 4 weeks until the viral load suppression is achieved (i.e., plasma HIV-1 RNA levels to return back to \<50 copies/mL)
Outcome measures
| Measure |
PRO 140 350 mg
n=40 Participants
PRO 140 350 mg weekly SQ injection.
|
|---|---|
|
Change in Viral Load at the Last Virologic Failure Visit.
|
-1.78 log 10 copies/ml
Standard Deviation 1.93
|
SECONDARY outcome
Timeframe: From baseline (week 2) through week 14Population: Per protocol
Mean change in CD4 cell count, at each visit within the 14-week treatment phase
Outcome measures
| Measure |
PRO 140 350 mg
n=41 Participants
PRO 140 350 mg weekly SQ injection.
|
|---|---|
|
Mean Change in CD4 Cell Count by Visit
VF (Viral failure)
|
18.41 cells/mm^3
Standard Deviation 113.99
|
|
Mean Change in CD4 Cell Count by Visit
T2 (Week 2)
|
32.05 cells/mm^3
Standard Deviation 132.92
|
|
Mean Change in CD4 Cell Count by Visit
T3 (Week 3)
|
-33.14 cells/mm^3
Standard Deviation 137.05
|
|
Mean Change in CD4 Cell Count by Visit
T4 (Week 4)
|
-12.78 cells/mm^3
Standard Deviation 137.37
|
|
Mean Change in CD4 Cell Count by Visit
T5 (Week 5)
|
33.42 cells/mm^3
Standard Deviation 130.88
|
|
Mean Change in CD4 Cell Count by Visit
T6 (Week 6)
|
-3.26 cells/mm^3
Standard Deviation 125.78
|
|
Mean Change in CD4 Cell Count by Visit
T7 (Week 7)
|
47.50 cells/mm^3
Standard Deviation 190.10
|
|
Mean Change in CD4 Cell Count by Visit
T8 (Week 8)
|
-55.09 cells/mm^3
Standard Deviation 157.21
|
|
Mean Change in CD4 Cell Count by Visit
T9 (Week 9)
|
47.25 cells/mm^3
Standard Deviation 95.64
|
|
Mean Change in CD4 Cell Count by Visit
T10 (Week 10)
|
-6.82 cells/mm^3
Standard Deviation 140.34
|
|
Mean Change in CD4 Cell Count by Visit
T11 (Week 11)
|
-29.83 cells/mm^3
Standard Deviation 218.64
|
|
Mean Change in CD4 Cell Count by Visit
T12 (Week 12)
|
16.52 cells/mm^3
Standard Deviation 143.91
|
|
Mean Change in CD4 Cell Count by Visit
T13 (Week 13)
|
-0.44 cells/mm^3
Standard Deviation 95.54
|
|
Mean Change in CD4 Cell Count by Visit
T14 (Week 14)
|
-59.03 cells/mm^3
Standard Deviation 56.50
|
SECONDARY outcome
Timeframe: From baseline (week 2) to last visitPopulation: Per Protocol
Change from baseline in CD4 cell count, within the 14-week treatment phase
Outcome measures
| Measure |
PRO 140 350 mg
n=41 Participants
PRO 140 350 mg weekly SQ injection.
|
|---|---|
|
Mean Change in CD4 Cell Count
|
18.97 cells/mm^3
Standard Deviation 114.08
|
SECONDARY outcome
Timeframe: From baseline to virologic failure (VF occurring at any time from Week 1 to Week 12 or virologic failure which ever comes first)Population: Per Protocol
Quality of Life Q1 Current General Health Status, is collected from base line to virologic failure (VF can occur at any time from any time during the treatment phase from week 1 to week 14). Subjects who experience Virologic Failure will be followed up every 4 weeks until the viral load suppression is achieved (i.e., plasma HIV-1 RNA levels to return back to \<50 copies/mL)
Outcome measures
| Measure |
PRO 140 350 mg
n=41 Participants
PRO 140 350 mg weekly SQ injection.
|
|---|---|
|
Q1 QOL Health Status
T1 (Week 1) · Poor
|
0 Participants
|
|
Q1 QOL Health Status
T1 (Week 1) · Fair
|
1 Participants
|
|
Q1 QOL Health Status
T1 (Week 1) · Good
|
6 Participants
|
|
Q1 QOL Health Status
T1 (Week 1) · Very Good
|
10 Participants
|
|
Q1 QOL Health Status
T1 (Week 1) · Excellent
|
13 Participants
|
|
Q1 QOL Health Status
T1 (Week 1) · Missing
|
11 Participants
|
|
Q1 QOL Health Status
T4 (Week 4) · Poor
|
0 Participants
|
|
Q1 QOL Health Status
T4 (Week 4) · Fair
|
1 Participants
|
|
Q1 QOL Health Status
T4 (Week 4) · Good
|
6 Participants
|
|
Q1 QOL Health Status
T4 (Week 4) · Very Good
|
11 Participants
|
|
Q1 QOL Health Status
T4 (Week 4) · Excellent
|
12 Participants
|
|
Q1 QOL Health Status
T4 (Week 4) · Missing
|
11 Participants
|
|
Q1 QOL Health Status
T8 (Week 8) · Poor
|
1 Participants
|
|
Q1 QOL Health Status
T8 (Week 8) · Fair
|
2 Participants
|
|
Q1 QOL Health Status
T8 (Week 8) · Good
|
6 Participants
|
|
Q1 QOL Health Status
T8 (Week 8) · Very Good
|
9 Participants
|
|
Q1 QOL Health Status
T8 (Week 8) · Excellent
|
9 Participants
|
|
Q1 QOL Health Status
T8 (Week 8) · Missing
|
14 Participants
|
|
Q1 QOL Health Status
T12 (Week 12) · Poor
|
0 Participants
|
|
Q1 QOL Health Status
T12 (Week 12) · Fair
|
2 Participants
|
|
Q1 QOL Health Status
T12 (Week 12) · Good
|
2 Participants
|
|
Q1 QOL Health Status
T12 (Week 12) · Very Good
|
12 Participants
|
|
Q1 QOL Health Status
T12 (Week 12) · Excellent
|
5 Participants
|
|
Q1 QOL Health Status
T12 (Week 12) · Missing
|
20 Participants
|
|
Q1 QOL Health Status
VF (Virologic Failure) · Poor
|
0 Participants
|
|
Q1 QOL Health Status
VF (Virologic Failure) · Fair
|
0 Participants
|
|
Q1 QOL Health Status
VF (Virologic Failure) · Good
|
3 Participants
|
|
Q1 QOL Health Status
VF (Virologic Failure) · Very Good
|
3 Participants
|
|
Q1 QOL Health Status
VF (Virologic Failure) · Excellent
|
1 Participants
|
|
Q1 QOL Health Status
VF (Virologic Failure) · Missing
|
34 Participants
|
SECONDARY outcome
Timeframe: From week 1 through treatment weeks 4, 8, 12 or VF visitPopulation: Per Protocol
Subjects will rate their current state of health via Visual Analog Scale (VAS) using the line as a guide, with 0 as death or worst possible health and 100 as perfect or best possible health. A higher score indicates best outcome. Subjects may experience Virologic Failure (VF) any time during the treatment phase from week 1 to week 14. Subjects who experience VF will be followed up every 4 weeks until the viral load suppression is achieved (i.e., plasma HIV-1 RNA levels to return back to \<50 copies/mL)
Outcome measures
| Measure |
PRO 140 350 mg
n=30 Participants
PRO 140 350 mg weekly SQ injection.
|
|---|---|
|
Q2 QOL Current State of Health
T1 (Week 1)
|
82.3 score on a scale
Standard Deviation 16.4
|
|
Q2 QOL Current State of Health
T4 (Week 4)
|
83.8 score on a scale
Standard Deviation 16.2
|
|
Q2 QOL Current State of Health
T8 (Week 8)
|
80.9 score on a scale
Standard Deviation 18.0
|
|
Q2 QOL Current State of Health
T12 (Week 12)
|
84.9 score on a scale
Standard Deviation 17.3
|
|
Q2 QOL Current State of Health
VF (Viral Failure)
|
78.0 score on a scale
Standard Deviation 15.8
|
OTHER_PRE_SPECIFIED outcome
Timeframe: From initiation of PRO 140 monotherapy through week 14Population: Safety
Injection site reaction pain assessment @ injection site 1. Each subject received half the total dose of the IP into two separate injection sites. (injection site 1 and injection site 2) at each treatment visit. The information is reported under separate outcomes measures for each injection site.
Outcome measures
| Measure |
PRO 140 350 mg
n=43 Participants
PRO 140 350 mg weekly SQ injection.
|
|---|---|
|
Injection Site Reaction - Pain (Site 1)
T1 (Week 1) · absent
|
43 Participants
|
|
Injection Site Reaction - Pain (Site 1)
T1 (Week 1) · present
|
0 Participants
|
|
Injection Site Reaction - Pain (Site 1)
T2 (Week 2) · absent
|
43 Participants
|
|
Injection Site Reaction - Pain (Site 1)
T2 (Week 2) · present
|
0 Participants
|
|
Injection Site Reaction - Pain (Site 1)
T3 (Week 3) · absent
|
43 Participants
|
|
Injection Site Reaction - Pain (Site 1)
T3 (Week 3) · present
|
0 Participants
|
|
Injection Site Reaction - Pain (Site 1)
T4 (Week 4) · absent
|
43 Participants
|
|
Injection Site Reaction - Pain (Site 1)
T4 (Week 4) · present
|
0 Participants
|
|
Injection Site Reaction - Pain (Site 1)
T5 (Week 5) · absent
|
43 Participants
|
|
Injection Site Reaction - Pain (Site 1)
T5 (Week 5) · present
|
0 Participants
|
|
Injection Site Reaction - Pain (Site 1)
T6 (Week 6) · absent
|
43 Participants
|
|
Injection Site Reaction - Pain (Site 1)
T6 (Week 6) · present
|
0 Participants
|
|
Injection Site Reaction - Pain (Site 1)
T7 (Week 7) · absent
|
41 Participants
|
|
Injection Site Reaction - Pain (Site 1)
T7 (Week 7) · present
|
0 Participants
|
|
Injection Site Reaction - Pain (Site 1)
T8 (Week 8) · absent
|
36 Participants
|
|
Injection Site Reaction - Pain (Site 1)
T8 (Week 8) · present
|
0 Participants
|
|
Injection Site Reaction - Pain (Site 1)
T9 (Week 9) · absent
|
33 Participants
|
|
Injection Site Reaction - Pain (Site 1)
T9 (Week 9) · present
|
0 Participants
|
|
Injection Site Reaction - Pain (Site 1)
T10 (Week 10) · absent
|
29 Participants
|
|
Injection Site Reaction - Pain (Site 1)
T10 (Week 10) · present
|
0 Participants
|
|
Injection Site Reaction - Pain (Site 1)
T11 (Week 11) · absent
|
29 Participants
|
|
Injection Site Reaction - Pain (Site 1)
T11 (Week 11) · present
|
0 Participants
|
|
Injection Site Reaction - Pain (Site 1)
T12 (Week 12) · absent
|
27 Participants
|
|
Injection Site Reaction - Pain (Site 1)
T12 (Week 12) · present
|
0 Participants
|
|
Injection Site Reaction - Pain (Site 1)
T13 (Week 13) · absent
|
22 Participants
|
|
Injection Site Reaction - Pain (Site 1)
T13 (Week 13) · present
|
1 Participants
|
|
Injection Site Reaction - Pain (Site 1)
T14 (Week 14) · absent
|
6 Participants
|
|
Injection Site Reaction - Pain (Site 1)
T14 (Week 14) · present
|
0 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: From initiation of PRO 140 monotherapy through week 14Population: safety population
Injection site reaction pain assessment @ injection site 2. Each subject received half the total dose of the IP into two separate injection sites. (injection site 1 and injection site 2) at each treatment visit. The information is reported under separate outcomes measures for each injection site.
Outcome measures
| Measure |
PRO 140 350 mg
n=43 Participants
PRO 140 350 mg weekly SQ injection.
|
|---|---|
|
Injection Site Reaction - Pain (Site 2)
T5 (Week 5) · present
|
0 Participants
|
|
Injection Site Reaction - Pain (Site 2)
T1 (Week 1) · absent
|
43 Participants
|
|
Injection Site Reaction - Pain (Site 2)
T1 (Week 1) · present
|
0 Participants
|
|
Injection Site Reaction - Pain (Site 2)
T2 (Week 2) · absent
|
43 Participants
|
|
Injection Site Reaction - Pain (Site 2)
T2 (Week 2) · present
|
0 Participants
|
|
Injection Site Reaction - Pain (Site 2)
T3 ( Week 3) · absent
|
43 Participants
|
|
Injection Site Reaction - Pain (Site 2)
T3 ( Week 3) · present
|
0 Participants
|
|
Injection Site Reaction - Pain (Site 2)
T4 (Week 4) · absent
|
43 Participants
|
|
Injection Site Reaction - Pain (Site 2)
T4 (Week 4) · present
|
0 Participants
|
|
Injection Site Reaction - Pain (Site 2)
T5 (Week 5) · absent
|
43 Participants
|
|
Injection Site Reaction - Pain (Site 2)
T6 (Week 6) · absent
|
43 Participants
|
|
Injection Site Reaction - Pain (Site 2)
T6 (Week 6) · present
|
0 Participants
|
|
Injection Site Reaction - Pain (Site 2)
T7 (Week 7) · absent
|
41 Participants
|
|
Injection Site Reaction - Pain (Site 2)
T7 (Week 7) · present
|
0 Participants
|
|
Injection Site Reaction - Pain (Site 2)
T8 (Week 8) · absent
|
36 Participants
|
|
Injection Site Reaction - Pain (Site 2)
T8 (Week 8) · present
|
0 Participants
|
|
Injection Site Reaction - Pain (Site 2)
T9 (Week 9) · absent
|
29 Participants
|
|
Injection Site Reaction - Pain (Site 2)
T9 (Week 9) · present
|
0 Participants
|
|
Injection Site Reaction - Pain (Site 2)
T10 (Week 10) · absent
|
29 Participants
|
|
Injection Site Reaction - Pain (Site 2)
T10 (Week 10) · present
|
0 Participants
|
|
Injection Site Reaction - Pain (Site 2)
T11 (Week 11) · absent
|
29 Participants
|
|
Injection Site Reaction - Pain (Site 2)
T11 (Week 11) · present
|
0 Participants
|
|
Injection Site Reaction - Pain (Site 2)
T12 (Week 12) · absent
|
27 Participants
|
|
Injection Site Reaction - Pain (Site 2)
T12 (Week 12) · present
|
0 Participants
|
|
Injection Site Reaction - Pain (Site 2)
T13 (Week 13) · absent
|
23 Participants
|
|
Injection Site Reaction - Pain (Site 2)
T13 (Week 13) · present
|
0 Participants
|
|
Injection Site Reaction - Pain (Site 2)
T14 ( Week 14) · absent
|
6 Participants
|
|
Injection Site Reaction - Pain (Site 2)
T14 ( Week 14) · present
|
0 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: From initiation of PRO 140 monotherapy through week 14Population: safety
Summary of injection site reaction assessment - Injection site status @ injection site 1. Each subject received half the total dose of the IP into two separate injection sites. (injection site 1 and injection site 2) at each treatment visit. The information is reported under separate outcomes measures for each injection site.
Outcome measures
| Measure |
PRO 140 350 mg
n=43 Participants
PRO 140 350 mg weekly SQ injection.
|
|---|---|
|
Injection Site Reaction - Injection Site Status (Site 1)
T1 (Week 1) · Normal
|
43 Participants
|
|
Injection Site Reaction - Injection Site Status (Site 1)
T1 (Week 1) · abnormal
|
0 Participants
|
|
Injection Site Reaction - Injection Site Status (Site 1)
T2 (Week 2) · Normal
|
43 Participants
|
|
Injection Site Reaction - Injection Site Status (Site 1)
T2 (Week 2) · abnormal
|
0 Participants
|
|
Injection Site Reaction - Injection Site Status (Site 1)
T3 (Week 3) · Normal
|
43 Participants
|
|
Injection Site Reaction - Injection Site Status (Site 1)
T3 (Week 3) · abnormal
|
0 Participants
|
|
Injection Site Reaction - Injection Site Status (Site 1)
T4 (Week 4) · Normal
|
43 Participants
|
|
Injection Site Reaction - Injection Site Status (Site 1)
T4 (Week 4) · abnormal
|
0 Participants
|
|
Injection Site Reaction - Injection Site Status (Site 1)
T5 (Week 5) · Normal
|
43 Participants
|
|
Injection Site Reaction - Injection Site Status (Site 1)
T5 (Week 5) · abnormal
|
0 Participants
|
|
Injection Site Reaction - Injection Site Status (Site 1)
T6 (Week 6) · Normal
|
42 Participants
|
|
Injection Site Reaction - Injection Site Status (Site 1)
T6 (Week 6) · abnormal
|
1 Participants
|
|
Injection Site Reaction - Injection Site Status (Site 1)
T7 (Week 7) · Normal
|
41 Participants
|
|
Injection Site Reaction - Injection Site Status (Site 1)
T7 (Week 7) · abnormal
|
0 Participants
|
|
Injection Site Reaction - Injection Site Status (Site 1)
T8 (Week 8) · Normal
|
36 Participants
|
|
Injection Site Reaction - Injection Site Status (Site 1)
T8 (Week 8) · abnormal
|
0 Participants
|
|
Injection Site Reaction - Injection Site Status (Site 1)
T9 (Week 9) · Normal
|
33 Participants
|
|
Injection Site Reaction - Injection Site Status (Site 1)
T9 (Week 9) · abnormal
|
0 Participants
|
|
Injection Site Reaction - Injection Site Status (Site 1)
T10 (Week 10) · Normal
|
29 Participants
|
|
Injection Site Reaction - Injection Site Status (Site 1)
T10 (Week 10) · abnormal
|
0 Participants
|
|
Injection Site Reaction - Injection Site Status (Site 1)
T11 (Week 11) · Normal
|
29 Participants
|
|
Injection Site Reaction - Injection Site Status (Site 1)
T11 (Week 11) · abnormal
|
0 Participants
|
|
Injection Site Reaction - Injection Site Status (Site 1)
T12 (Week 12) · Normal
|
27 Participants
|
|
Injection Site Reaction - Injection Site Status (Site 1)
T12 (Week 12) · abnormal
|
0 Participants
|
|
Injection Site Reaction - Injection Site Status (Site 1)
T13 (Week 13) · Normal
|
23 Participants
|
|
Injection Site Reaction - Injection Site Status (Site 1)
T13 (Week 13) · abnormal
|
0 Participants
|
|
Injection Site Reaction - Injection Site Status (Site 1)
T14 (Week 14) · Normal
|
6 Participants
|
|
Injection Site Reaction - Injection Site Status (Site 1)
T14 (Week 14) · abnormal
|
0 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: From initiation of PRO 140 monotherapy through week 14Population: safety
Summary of injection site reaction assessment - Injection site status @ injection site 2. Each subject received half the total dose of the IP into two separate injection sites. (injection site 1 and injection site 2) at each treatment visit. The information is reported under separate outcomes measures for each injection site.
Outcome measures
| Measure |
PRO 140 350 mg
n=43 Participants
PRO 140 350 mg weekly SQ injection.
|
|---|---|
|
Injection SIte Reaction - Injection Site Status (Site 2)
T4 (Week 4) · Abnormal
|
0 Participants
|
|
Injection SIte Reaction - Injection Site Status (Site 2)
T1 (Week 1) · Normal
|
43 Participants
|
|
Injection SIte Reaction - Injection Site Status (Site 2)
T1 (Week 1) · Abnormal
|
0 Participants
|
|
Injection SIte Reaction - Injection Site Status (Site 2)
T2 (Week 2) · Normal
|
43 Participants
|
|
Injection SIte Reaction - Injection Site Status (Site 2)
T2 (Week 2) · Abnormal
|
0 Participants
|
|
Injection SIte Reaction - Injection Site Status (Site 2)
T3 (Week 3) · Normal
|
43 Participants
|
|
Injection SIte Reaction - Injection Site Status (Site 2)
T3 (Week 3) · Abnormal
|
0 Participants
|
|
Injection SIte Reaction - Injection Site Status (Site 2)
T4 (Week 4) · Normal
|
43 Participants
|
|
Injection SIte Reaction - Injection Site Status (Site 2)
T5 (Week 5) · Normal
|
43 Participants
|
|
Injection SIte Reaction - Injection Site Status (Site 2)
T5 (Week 5) · Abnormal
|
0 Participants
|
|
Injection SIte Reaction - Injection Site Status (Site 2)
T6 (Week 6) · Normal
|
42 Participants
|
|
Injection SIte Reaction - Injection Site Status (Site 2)
T6 (Week 6) · Abnormal
|
1 Participants
|
|
Injection SIte Reaction - Injection Site Status (Site 2)
T7 (Week 7) · Normal
|
41 Participants
|
|
Injection SIte Reaction - Injection Site Status (Site 2)
T7 (Week 7) · Abnormal
|
0 Participants
|
|
Injection SIte Reaction - Injection Site Status (Site 2)
T8 (Week 8) · Normal
|
36 Participants
|
|
Injection SIte Reaction - Injection Site Status (Site 2)
T8 (Week 8) · Abnormal
|
0 Participants
|
|
Injection SIte Reaction - Injection Site Status (Site 2)
T9 (Week 9) · Normal
|
33 Participants
|
|
Injection SIte Reaction - Injection Site Status (Site 2)
T9 (Week 9) · Abnormal
|
0 Participants
|
|
Injection SIte Reaction - Injection Site Status (Site 2)
T10 (Week 10) · Normal
|
29 Participants
|
|
Injection SIte Reaction - Injection Site Status (Site 2)
T10 (Week 10) · Abnormal
|
0 Participants
|
|
Injection SIte Reaction - Injection Site Status (Site 2)
T11 (Week 11) · Normal
|
29 Participants
|
|
Injection SIte Reaction - Injection Site Status (Site 2)
T11 (Week 11) · Abnormal
|
0 Participants
|
|
Injection SIte Reaction - Injection Site Status (Site 2)
T12 (Week 12) · Normal
|
27 Participants
|
|
Injection SIte Reaction - Injection Site Status (Site 2)
T12 (Week 12) · Abnormal
|
0 Participants
|
|
Injection SIte Reaction - Injection Site Status (Site 2)
T13 (Week 13) · Normal
|
23 Participants
|
|
Injection SIte Reaction - Injection Site Status (Site 2)
T13 (Week 13) · Abnormal
|
0 Participants
|
|
Injection SIte Reaction - Injection Site Status (Site 2)
T14 (Week 14) · Normal
|
6 Participants
|
|
Injection SIte Reaction - Injection Site Status (Site 2)
T14 (Week 14) · Abnormal
|
0 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: From initiation of PRO 140 monotherapy through week 14Population: safety
Summary of injection site reaction assessment - Pruritus with injection @Site 1. Each subject received half the total dose of the IP into two separate injection sites. (injection site 1 and injection site 2) at each treatment visit. The information is reported under separate outcomes measures for each injection site.
Outcome measures
| Measure |
PRO 140 350 mg
n=43 Participants
PRO 140 350 mg weekly SQ injection.
|
|---|---|
|
Injection Site Reaction - Pruritus With Injection (Site 1)
T1 (Week 1) · Absent
|
43 Participants
|
|
Injection Site Reaction - Pruritus With Injection (Site 1)
T1 (Week 1) · Present
|
0 Participants
|
|
Injection Site Reaction - Pruritus With Injection (Site 1)
T2 (Week 2) · Absent
|
42 Participants
|
|
Injection Site Reaction - Pruritus With Injection (Site 1)
T2 (Week 2) · Present
|
1 Participants
|
|
Injection Site Reaction - Pruritus With Injection (Site 1)
T3 (Week 3) · Absent
|
43 Participants
|
|
Injection Site Reaction - Pruritus With Injection (Site 1)
T3 (Week 3) · Present
|
0 Participants
|
|
Injection Site Reaction - Pruritus With Injection (Site 1)
T4 (Week 4) · Absent
|
43 Participants
|
|
Injection Site Reaction - Pruritus With Injection (Site 1)
T4 (Week 4) · Present
|
0 Participants
|
|
Injection Site Reaction - Pruritus With Injection (Site 1)
T5 (Week 5) · Absent
|
43 Participants
|
|
Injection Site Reaction - Pruritus With Injection (Site 1)
T5 (Week 5) · Present
|
0 Participants
|
|
Injection Site Reaction - Pruritus With Injection (Site 1)
T6 (Week 6) · Absent
|
43 Participants
|
|
Injection Site Reaction - Pruritus With Injection (Site 1)
T6 (Week 6) · Present
|
0 Participants
|
|
Injection Site Reaction - Pruritus With Injection (Site 1)
T7 (Week 7) · Absent
|
41 Participants
|
|
Injection Site Reaction - Pruritus With Injection (Site 1)
T7 (Week 7) · Present
|
0 Participants
|
|
Injection Site Reaction - Pruritus With Injection (Site 1)
T8 (Week 8) · Absent
|
36 Participants
|
|
Injection Site Reaction - Pruritus With Injection (Site 1)
T8 (Week 8) · Present
|
0 Participants
|
|
Injection Site Reaction - Pruritus With Injection (Site 1)
T9 (Week 9) · Absent
|
33 Participants
|
|
Injection Site Reaction - Pruritus With Injection (Site 1)
T9 (Week 9) · Present
|
0 Participants
|
|
Injection Site Reaction - Pruritus With Injection (Site 1)
T10 (Week 10) · Absent
|
29 Participants
|
|
Injection Site Reaction - Pruritus With Injection (Site 1)
T10 (Week 10) · Present
|
0 Participants
|
|
Injection Site Reaction - Pruritus With Injection (Site 1)
T11 (Week 11) · Absent
|
29 Participants
|
|
Injection Site Reaction - Pruritus With Injection (Site 1)
T11 (Week 11) · Present
|
0 Participants
|
|
Injection Site Reaction - Pruritus With Injection (Site 1)
T12 (Week 12) · Absent
|
27 Participants
|
|
Injection Site Reaction - Pruritus With Injection (Site 1)
T12 (Week 12) · Present
|
0 Participants
|
|
Injection Site Reaction - Pruritus With Injection (Site 1)
T13 (Week 13) · Absent
|
23 Participants
|
|
Injection Site Reaction - Pruritus With Injection (Site 1)
T13 (Week 13) · Present
|
0 Participants
|
|
Injection Site Reaction - Pruritus With Injection (Site 1)
T14 (Week 14) · Absent
|
6 Participants
|
|
Injection Site Reaction - Pruritus With Injection (Site 1)
T14 (Week 14) · Present
|
0 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: From initiation of PRO 140 monotherapy through week14Population: safety
Summary of injection site reaction assessment - Pruritus with injection @ Site 2. Each subject received half the total dose of the IP into two separate injection sites. (injection site 1 and injection site 2) at each treatment visit. The information is reported under separate outcomes measures for each injection site.
Outcome measures
| Measure |
PRO 140 350 mg
n=43 Participants
PRO 140 350 mg weekly SQ injection.
|
|---|---|
|
Injection Site Reaction - Pruritus With Injection (Site 2)
T7 (Week 7) · Absent
|
41 Participants
|
|
Injection Site Reaction - Pruritus With Injection (Site 2)
T1 (Week 1) · Absent
|
43 Participants
|
|
Injection Site Reaction - Pruritus With Injection (Site 2)
T1 (Week 1) · Present
|
0 Participants
|
|
Injection Site Reaction - Pruritus With Injection (Site 2)
T2 (Week 2) · Absent
|
42 Participants
|
|
Injection Site Reaction - Pruritus With Injection (Site 2)
T2 (Week 2) · Present
|
1 Participants
|
|
Injection Site Reaction - Pruritus With Injection (Site 2)
T3 (Week 3) · Absent
|
43 Participants
|
|
Injection Site Reaction - Pruritus With Injection (Site 2)
T3 (Week 3) · Present
|
0 Participants
|
|
Injection Site Reaction - Pruritus With Injection (Site 2)
T4 (Week 4) · Absent
|
43 Participants
|
|
Injection Site Reaction - Pruritus With Injection (Site 2)
T4 (Week 4) · Present
|
0 Participants
|
|
Injection Site Reaction - Pruritus With Injection (Site 2)
T5 (Week 5) · Absent
|
43 Participants
|
|
Injection Site Reaction - Pruritus With Injection (Site 2)
T5 (Week 5) · Present
|
0 Participants
|
|
Injection Site Reaction - Pruritus With Injection (Site 2)
T6 (Week 6) · Absent
|
43 Participants
|
|
Injection Site Reaction - Pruritus With Injection (Site 2)
T6 (Week 6) · Present
|
0 Participants
|
|
Injection Site Reaction - Pruritus With Injection (Site 2)
T7 (Week 7) · Present
|
2 Participants
|
|
Injection Site Reaction - Pruritus With Injection (Site 2)
T8 (Week 8) · Absent
|
36 Participants
|
|
Injection Site Reaction - Pruritus With Injection (Site 2)
T8 (Week 8) · Present
|
0 Participants
|
|
Injection Site Reaction - Pruritus With Injection (Site 2)
T9 (Week 9) · Absent
|
33 Participants
|
|
Injection Site Reaction - Pruritus With Injection (Site 2)
T9 (Week 9) · Present
|
0 Participants
|
|
Injection Site Reaction - Pruritus With Injection (Site 2)
T10 (Week 10) · Absent
|
29 Participants
|
|
Injection Site Reaction - Pruritus With Injection (Site 2)
T10 (Week 10) · Present
|
0 Participants
|
|
Injection Site Reaction - Pruritus With Injection (Site 2)
T11 (Week 11) · Absent
|
29 Participants
|
|
Injection Site Reaction - Pruritus With Injection (Site 2)
T11 (Week 11) · Present
|
0 Participants
|
|
Injection Site Reaction - Pruritus With Injection (Site 2)
T12 (Week 12) · Absent
|
27 Participants
|
|
Injection Site Reaction - Pruritus With Injection (Site 2)
T12 (Week 12) · Present
|
0 Participants
|
|
Injection Site Reaction - Pruritus With Injection (Site 2)
T13 (Week 13) · Absent
|
23 Participants
|
|
Injection Site Reaction - Pruritus With Injection (Site 2)
T13 (Week 13) · Present
|
0 Participants
|
|
Injection Site Reaction - Pruritus With Injection (Site 2)
T14 (Week 14) · Absent
|
6 Participants
|
|
Injection Site Reaction - Pruritus With Injection (Site 2)
T14 (Week 14) · Present
|
0 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: From initiation of PRO 140 monotherapy through week 14Population: safety
Summary of injection site reaction assessment - bleeding @ Site 1. Each subject received half the total dose of the IP into two separate injection sites. (injection site 1 and injection site 2) at each treatment visit. The information is reported under separate outcomes measures for each injection site.
Outcome measures
| Measure |
PRO 140 350 mg
n=43 Participants
PRO 140 350 mg weekly SQ injection.
|
|---|---|
|
Injection Site Reaction - Bleeding Site 1
T1 (Week 1) · Absent
|
43 Participants
|
|
Injection Site Reaction - Bleeding Site 1
T1 (Week 1) · Present
|
0 Participants
|
|
Injection Site Reaction - Bleeding Site 1
T2 (Week 2) · Absent
|
43 Participants
|
|
Injection Site Reaction - Bleeding Site 1
T2 (Week 2) · Present
|
0 Participants
|
|
Injection Site Reaction - Bleeding Site 1
T3 (Week 3) · Absent
|
43 Participants
|
|
Injection Site Reaction - Bleeding Site 1
T3 (Week 3) · Present
|
0 Participants
|
|
Injection Site Reaction - Bleeding Site 1
T4 (Week 4) · Absent
|
43 Participants
|
|
Injection Site Reaction - Bleeding Site 1
T4 (Week 4) · Present
|
0 Participants
|
|
Injection Site Reaction - Bleeding Site 1
T5 (Week 5) · Absent
|
43 Participants
|
|
Injection Site Reaction - Bleeding Site 1
T5 (Week 5) · Present
|
0 Participants
|
|
Injection Site Reaction - Bleeding Site 1
T6 (Week 6) · Absent
|
43 Participants
|
|
Injection Site Reaction - Bleeding Site 1
T6 (Week 6) · Present
|
0 Participants
|
|
Injection Site Reaction - Bleeding Site 1
T7 (Week 7) · Absent
|
41 Participants
|
|
Injection Site Reaction - Bleeding Site 1
T7 (Week 7) · Present
|
0 Participants
|
|
Injection Site Reaction - Bleeding Site 1
T8 (Week 8) · Absent
|
36 Participants
|
|
Injection Site Reaction - Bleeding Site 1
T8 (Week 8) · Present
|
0 Participants
|
|
Injection Site Reaction - Bleeding Site 1
T9 (Week 9) · Absent
|
33 Participants
|
|
Injection Site Reaction - Bleeding Site 1
T9 (Week 9) · Present
|
0 Participants
|
|
Injection Site Reaction - Bleeding Site 1
T10 (Week 10) · Absent
|
29 Participants
|
|
Injection Site Reaction - Bleeding Site 1
T10 (Week 10) · Present
|
0 Participants
|
|
Injection Site Reaction - Bleeding Site 1
T11 (Week 11) · Absent
|
29 Participants
|
|
Injection Site Reaction - Bleeding Site 1
T11 (Week 11) · Present
|
0 Participants
|
|
Injection Site Reaction - Bleeding Site 1
T12 (Week 12) · Absent
|
27 Participants
|
|
Injection Site Reaction - Bleeding Site 1
T12 (Week 12) · Present
|
0 Participants
|
|
Injection Site Reaction - Bleeding Site 1
T13 (Week 13) · Absent
|
23 Participants
|
|
Injection Site Reaction - Bleeding Site 1
T13 (Week 13) · Present
|
0 Participants
|
|
Injection Site Reaction - Bleeding Site 1
T14 (Week 14) · Absent
|
6 Participants
|
|
Injection Site Reaction - Bleeding Site 1
T14 (Week 14) · Present
|
0 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: From initiation of PRO 140 monotherapy through week14Population: safety
Summary of injection site reaction assessment - bleeding @ Site 2. Each subject received half the total dose of the IP into two separate injection sites. (injection site 1 and injection site 2) at each treatment visit. The information is reported under separate outcomes measures for each injection site.
Outcome measures
| Measure |
PRO 140 350 mg
n=43 Participants
PRO 140 350 mg weekly SQ injection.
|
|---|---|
|
Injection Site Reaction - Bleeding - Site 2
T1 (Week 1) · Absent
|
43 Participants
|
|
Injection Site Reaction - Bleeding - Site 2
T1 (Week 1) · Present
|
0 Participants
|
|
Injection Site Reaction - Bleeding - Site 2
T2 (Week 2) · Absent
|
43 Participants
|
|
Injection Site Reaction - Bleeding - Site 2
T2 (Week 2) · Present
|
0 Participants
|
|
Injection Site Reaction - Bleeding - Site 2
T3 (Week 3) · Absent
|
43 Participants
|
|
Injection Site Reaction - Bleeding - Site 2
T3 (Week 3) · Present
|
0 Participants
|
|
Injection Site Reaction - Bleeding - Site 2
T4 (Week 4) · Absent
|
43 Participants
|
|
Injection Site Reaction - Bleeding - Site 2
T4 (Week 4) · Present
|
0 Participants
|
|
Injection Site Reaction - Bleeding - Site 2
T5 (Week 5) · Absent
|
42 Participants
|
|
Injection Site Reaction - Bleeding - Site 2
T5 (Week 5) · Present
|
0 Participants
|
|
Injection Site Reaction - Bleeding - Site 2
T6 (Week 6) · Absent
|
42 Participants
|
|
Injection Site Reaction - Bleeding - Site 2
T6 (Week 6) · Present
|
0 Participants
|
|
Injection Site Reaction - Bleeding - Site 2
T7 (Week 7) · Absent
|
41 Participants
|
|
Injection Site Reaction - Bleeding - Site 2
T7 (Week 7) · Present
|
0 Participants
|
|
Injection Site Reaction - Bleeding - Site 2
T8 (Week 8) · Absent
|
36 Participants
|
|
Injection Site Reaction - Bleeding - Site 2
T8 (Week 8) · Present
|
0 Participants
|
|
Injection Site Reaction - Bleeding - Site 2
T9 (Week 9) · Absent
|
33 Participants
|
|
Injection Site Reaction - Bleeding - Site 2
T9 (Week 9) · Present
|
0 Participants
|
|
Injection Site Reaction - Bleeding - Site 2
T10 (Week 10) · Absent
|
29 Participants
|
|
Injection Site Reaction - Bleeding - Site 2
T10 (Week 10) · Present
|
0 Participants
|
|
Injection Site Reaction - Bleeding - Site 2
T11 (Week 11) · Absent
|
29 Participants
|
|
Injection Site Reaction - Bleeding - Site 2
T11 (Week 11) · Present
|
0 Participants
|
|
Injection Site Reaction - Bleeding - Site 2
T12 (Week 12) · Absent
|
26 Participants
|
|
Injection Site Reaction - Bleeding - Site 2
T12 (Week 12) · Present
|
1 Participants
|
|
Injection Site Reaction - Bleeding - Site 2
T13 (Week 13) · Absent
|
23 Participants
|
|
Injection Site Reaction - Bleeding - Site 2
T13 (Week 13) · Present
|
0 Participants
|
|
Injection Site Reaction - Bleeding - Site 2
T14 (Week 14) · Absent
|
6 Participants
|
|
Injection Site Reaction - Bleeding - Site 2
T14 (Week 14) · Present
|
0 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: From initiation of PRO 140 monotherapy through week14Population: safety
Summary of injection site reaction assessment - drug absorption @ Site 1. Each subject received half the total dose of the IP into two separate injection sites. (injection site 1 and injection site 2) at each treatment visit. The information is reported under separate outcomes measures for each injection site.
Outcome measures
| Measure |
PRO 140 350 mg
n=43 Participants
PRO 140 350 mg weekly SQ injection.
|
|---|---|
|
Injection Site Reaction - Drug Absorption - Site 1
T1 (Week 1) · Normal
|
43 Participants
|
|
Injection Site Reaction - Drug Absorption - Site 1
T1 (Week 1) · Abnormal
|
0 Participants
|
|
Injection Site Reaction - Drug Absorption - Site 1
T2 (Week 2) · Normal
|
43 Participants
|
|
Injection Site Reaction - Drug Absorption - Site 1
T2 (Week 2) · Abnormal
|
0 Participants
|
|
Injection Site Reaction - Drug Absorption - Site 1
T3 (Week 3) · Normal
|
43 Participants
|
|
Injection Site Reaction - Drug Absorption - Site 1
T3 (Week 3) · Abnormal
|
0 Participants
|
|
Injection Site Reaction - Drug Absorption - Site 1
T4 (Week 4) · Normal
|
43 Participants
|
|
Injection Site Reaction - Drug Absorption - Site 1
T4 (Week 4) · Abnormal
|
0 Participants
|
|
Injection Site Reaction - Drug Absorption - Site 1
T5 (Week 5) · Normal
|
43 Participants
|
|
Injection Site Reaction - Drug Absorption - Site 1
T5 (Week 5) · Abnormal
|
0 Participants
|
|
Injection Site Reaction - Drug Absorption - Site 1
T6 (Week 6) · Normal
|
43 Participants
|
|
Injection Site Reaction - Drug Absorption - Site 1
T6 (Week 6) · Abnormal
|
0 Participants
|
|
Injection Site Reaction - Drug Absorption - Site 1
T7 (Week 7) · Normal
|
41 Participants
|
|
Injection Site Reaction - Drug Absorption - Site 1
T7 (Week 7) · Abnormal
|
0 Participants
|
|
Injection Site Reaction - Drug Absorption - Site 1
T8 (Week 8) · Normal
|
36 Participants
|
|
Injection Site Reaction - Drug Absorption - Site 1
T8 (Week 8) · Abnormal
|
0 Participants
|
|
Injection Site Reaction - Drug Absorption - Site 1
T9 (Week 9) · Normal
|
33 Participants
|
|
Injection Site Reaction - Drug Absorption - Site 1
T9 (Week 9) · Abnormal
|
0 Participants
|
|
Injection Site Reaction - Drug Absorption - Site 1
T10 (Week 10) · Normal
|
29 Participants
|
|
Injection Site Reaction - Drug Absorption - Site 1
T10 (Week 10) · Abnormal
|
0 Participants
|
|
Injection Site Reaction - Drug Absorption - Site 1
T11 (Week 11) · Normal
|
29 Participants
|
|
Injection Site Reaction - Drug Absorption - Site 1
T11 (Week 11) · Abnormal
|
0 Participants
|
|
Injection Site Reaction - Drug Absorption - Site 1
T12 (Week 12) · Normal
|
27 Participants
|
|
Injection Site Reaction - Drug Absorption - Site 1
T12 (Week 12) · Abnormal
|
0 Participants
|
|
Injection Site Reaction - Drug Absorption - Site 1
T13 (Week 13) · Normal
|
23 Participants
|
|
Injection Site Reaction - Drug Absorption - Site 1
T13 (Week 13) · Abnormal
|
0 Participants
|
|
Injection Site Reaction - Drug Absorption - Site 1
T14 (Week 14) · Normal
|
6 Participants
|
|
Injection Site Reaction - Drug Absorption - Site 1
T14 (Week 14) · Abnormal
|
0 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: From initiation of PRO 140 monotherapy through week 14Population: safety
Summary of injection site reaction assessment - drug absorption @ Site 2. Each subject received half the total dose of the IP into two separate injection sites. (injection site 1 and injection site 2) at each treatment visit. The information is reported under separate outcomes measures for each injection site.
Outcome measures
| Measure |
PRO 140 350 mg
n=43 Participants
PRO 140 350 mg weekly SQ injection.
|
|---|---|
|
Injection Site Reaction - Drug Absorption - Site 2
T1 (Week 1) · Normal
|
43 Participants
|
|
Injection Site Reaction - Drug Absorption - Site 2
T1 (Week 1) · Abnormal
|
0 Participants
|
|
Injection Site Reaction - Drug Absorption - Site 2
T2 (Week 2) · Normal
|
43 Participants
|
|
Injection Site Reaction - Drug Absorption - Site 2
T2 (Week 2) · Abnormal
|
0 Participants
|
|
Injection Site Reaction - Drug Absorption - Site 2
T3 (Week 3) · Normal
|
43 Participants
|
|
Injection Site Reaction - Drug Absorption - Site 2
T3 (Week 3) · Abnormal
|
0 Participants
|
|
Injection Site Reaction - Drug Absorption - Site 2
T4 (Week 4) · Normal
|
43 Participants
|
|
Injection Site Reaction - Drug Absorption - Site 2
T4 (Week 4) · Abnormal
|
0 Participants
|
|
Injection Site Reaction - Drug Absorption - Site 2
T5 (Week 5) · Normal
|
43 Participants
|
|
Injection Site Reaction - Drug Absorption - Site 2
T5 (Week 5) · Abnormal
|
0 Participants
|
|
Injection Site Reaction - Drug Absorption - Site 2
T6 (Week 6) · Normal
|
43 Participants
|
|
Injection Site Reaction - Drug Absorption - Site 2
T6 (Week 6) · Abnormal
|
0 Participants
|
|
Injection Site Reaction - Drug Absorption - Site 2
T7 (Week 7) · Normal
|
41 Participants
|
|
Injection Site Reaction - Drug Absorption - Site 2
T7 (Week 7) · Abnormal
|
0 Participants
|
|
Injection Site Reaction - Drug Absorption - Site 2
T8 (Week 8) · Normal
|
36 Participants
|
|
Injection Site Reaction - Drug Absorption - Site 2
T8 (Week 8) · Abnormal
|
0 Participants
|
|
Injection Site Reaction - Drug Absorption - Site 2
T9 (Week 9) · Normal
|
33 Participants
|
|
Injection Site Reaction - Drug Absorption - Site 2
T9 (Week 9) · Abnormal
|
0 Participants
|
|
Injection Site Reaction - Drug Absorption - Site 2
T10 (Week 10) · Normal
|
29 Participants
|
|
Injection Site Reaction - Drug Absorption - Site 2
T10 (Week 10) · Abnormal
|
0 Participants
|
|
Injection Site Reaction - Drug Absorption - Site 2
T11 (Week 11) · Normal
|
29 Participants
|
|
Injection Site Reaction - Drug Absorption - Site 2
T11 (Week 11) · Abnormal
|
0 Participants
|
|
Injection Site Reaction - Drug Absorption - Site 2
T12 (Week 12) · Normal
|
27 Participants
|
|
Injection Site Reaction - Drug Absorption - Site 2
T12 (Week 12) · Abnormal
|
0 Participants
|
|
Injection Site Reaction - Drug Absorption - Site 2
T13 (Week 13) · Normal
|
23 Participants
|
|
Injection Site Reaction - Drug Absorption - Site 2
T13 (Week 13) · Abnormal
|
0 Participants
|
|
Injection Site Reaction - Drug Absorption - Site 2
T14 (Week 14) · Normal
|
6 Participants
|
|
Injection Site Reaction - Drug Absorption - Site 2
T14 (Week 14) · Abnormal
|
0 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: From initiation of PRO 140 monotherapy through week 14Population: Safety
Summary of injection site pain assessment (VAS) post injection mean change from baseline. Subject-perceived injection site pain was assessed using the Pain Visual Analog Scale (VAS) post study treatment administration assessing average pain. Higher score is worse outcome. Each subject received half the total dose of the IP into two separate injection sites. (injection site 1 and injection site 2) at each treatment visit. The information is reported under separate outcomes measures for each injection site.
Outcome measures
| Measure |
PRO 140 350 mg
n=43 Participants
PRO 140 350 mg weekly SQ injection.
|
|---|---|
|
Injection Site Reaction - Pain Post Injection - Site 1
T1 (Week 1)
|
18.4 score on a scale
Standard Deviation 16.1
|
|
Injection Site Reaction - Pain Post Injection - Site 1
T2 (Week 2)
|
-3.9 score on a scale
Standard Deviation 8.6
|
|
Injection Site Reaction - Pain Post Injection - Site 1
T3 (Week 3)
|
-7.9 score on a scale
Standard Deviation 11.4
|
|
Injection Site Reaction - Pain Post Injection - Site 1
T4 (Week 4)
|
-2.5 score on a scale
Standard Deviation 14.2
|
|
Injection Site Reaction - Pain Post Injection - Site 1
T5 (Week 5)
|
-12.8 score on a scale
Standard Deviation 13.9
|
|
Injection Site Reaction - Pain Post Injection - Site 1
T6 (Week 6)
|
-6.8 score on a scale
Standard Deviation 16.7
|
|
Injection Site Reaction - Pain Post Injection - Site 1
T7 (Week 7)
|
-13.5 score on a scale
Standard Deviation 13.9
|
|
Injection Site Reaction - Pain Post Injection - Site 1
T8 (Week 8)
|
-16.6 score on a scale
Standard Deviation 14.8
|
|
Injection Site Reaction - Pain Post Injection - Site 1
T9 (Week 9)
|
-15.0 score on a scale
Standard Deviation 14.2
|
|
Injection Site Reaction - Pain Post Injection - Site 1
T10 (Week 10)
|
-17.2 score on a scale
Standard Deviation 12.3
|
|
Injection Site Reaction - Pain Post Injection - Site 1
T11 (Week 11)
|
-24.0 score on a scale
Standard Deviation 18.1
|
|
Injection Site Reaction - Pain Post Injection - Site 1
T12 (Week 12)
|
-22.0 score on a scale
Standard Deviation 18.4
|
|
Injection Site Reaction - Pain Post Injection - Site 1
T13 (Week 13)
|
-17.0 score on a scale
Standard Deviation 15.6
|
|
Injection Site Reaction - Pain Post Injection - Site 1
T14 (Week 14)
|
-22.0 score on a scale
Standard Deviation 19.1
|
OTHER_PRE_SPECIFIED outcome
Timeframe: From initiation of PRO 140 monotherapy through week 14Population: Safety
Summary of injection site pain assessment (VAS) post injection @ Site 2. Subject-perceived injection site pain was assessed using the Pain Visual Analog Scale (VAS) post study treatment administration assessing average pain. A higher score is a worse outcome. Each subject received half the total dose of the IP into two separate injection sites. (injection site 1 and injection site 2) at each treatment visit. The information is reported under separate outcomes measures for each injection site.
Outcome measures
| Measure |
PRO 140 350 mg
n=43 Participants
PRO 140 350 mg weekly SQ injection.
|
|---|---|
|
Injection Site Reaction - Pain Post Injection - Site 2
T1 (Week 1)
|
17.4 score on a scale
Standard Deviation 15.2
|
|
Injection Site Reaction - Pain Post Injection - Site 2
T2 (Week 2)
|
-2.0 score on a scale
Standard Deviation 14.2
|
|
Injection Site Reaction - Pain Post Injection - Site 2
T3 (Week 3)
|
-4.8 score on a scale
Standard Deviation 11.8
|
|
Injection Site Reaction - Pain Post Injection - Site 2
T4 (Week 4)
|
-7.8 score on a scale
Standard Deviation 12.2
|
|
Injection Site Reaction - Pain Post Injection - Site 2
T5 (Week 5)
|
-8.8 score on a scale
Standard Deviation 15.7
|
|
Injection Site Reaction - Pain Post Injection - Site 2
T6 (Week 6)
|
-7.2 score on a scale
Standard Deviation 17.6
|
|
Injection Site Reaction - Pain Post Injection - Site 2
T7 (Week 7)
|
-10.4 score on a scale
Standard Deviation 14.8
|
|
Injection Site Reaction - Pain Post Injection - Site 2
T8 (Week 8)
|
-13.0 score on a scale
Standard Deviation 15.9
|
|
Injection Site Reaction - Pain Post Injection - Site 2
T9 (Week 9)
|
-14.6 score on a scale
Standard Deviation 16.0
|
|
Injection Site Reaction - Pain Post Injection - Site 2
T10 (Week 10)
|
-10.7 score on a scale
Standard Deviation 9.1
|
|
Injection Site Reaction - Pain Post Injection - Site 2
T11 (Week 11)
|
-14.7 score on a scale
Standard Deviation 13.3
|
|
Injection Site Reaction - Pain Post Injection - Site 2
T12 (Week 12)
|
-15.2 score on a scale
Standard Deviation 14.8
|
|
Injection Site Reaction - Pain Post Injection - Site 2
T13 (Week 13)
|
-10.0 score on a scale
Standard Deviation 10.3
|
|
Injection Site Reaction - Pain Post Injection - Site 2
T14 (Week 14)
|
-13.8 score on a scale
Standard Deviation 18.5
|
OTHER_PRE_SPECIFIED outcome
Timeframe: From week 2 through week 14Population: Safety
Summary of injection site pain assessment (VAS) pre injection @ Site 1 Subject-perceived injection site pain was assessed using the Pain Visual Analog Scale (VAS) prior to study treatment administration assessing average pain since last treatment. Higher score is a worse outcome. Each subject received half the total dose of the IP into two separate injection sites. (injection site 1 and injection site 2) at each treatment visit. The information is reported under separate outcomes measures for each injection site.
Outcome measures
| Measure |
PRO 140 350 mg
n=43 Participants
PRO 140 350 mg weekly SQ injection.
|
|---|---|
|
Injection Site Reaction - Pain Pre Injection - Site 1
T2 (Week 2)
|
0.0 score on a scale
Standard Deviation 0.0
|
|
Injection Site Reaction - Pain Pre Injection - Site 1
T3 (Week 3)
|
2.8 score on a scale
Standard Deviation 8.4
|
|
Injection Site Reaction - Pain Pre Injection - Site 1
T4 (Week 4)
|
1.7 score on a scale
Standard Deviation 6.6
|
|
Injection Site Reaction - Pain Pre Injection - Site 1
T5 (Week 5)
|
2.2 score on a scale
Standard Deviation 4.2
|
|
Injection Site Reaction - Pain Pre Injection - Site 1
T6 (Week 6)
|
1.6 score on a scale
Standard Deviation 4.2
|
|
Injection Site Reaction - Pain Pre Injection - Site 1
T7 (Week 7)
|
1.0 score on a scale
Standard Deviation 4.0
|
|
Injection Site Reaction - Pain Pre Injection - Site 1
T8 (Week 8)
|
0.9 score on a scale
Standard Deviation 3.6
|
|
Injection Site Reaction - Pain Pre Injection - Site 1
T9 (Week 9)
|
1.6 score on a scale
Standard Deviation 4.1
|
|
Injection Site Reaction - Pain Pre Injection - Site 1
T10 (Week 10)
|
1.5 score on a scale
Standard Deviation 5.9
|
|
Injection Site Reaction - Pain Pre Injection - Site 1
T11 (Week 11)
|
1.3 score on a scale
Standard Deviation 4.7
|
|
Injection Site Reaction - Pain Pre Injection - Site 1
T12 (Week 12)
|
0.5 score on a scale
Standard Deviation 4.1
|
|
Injection Site Reaction - Pain Pre Injection - Site 1
T13 (Week 13)
|
0.6 score on a scale
Standard Deviation 1.3
|
|
Injection Site Reaction - Pain Pre Injection - Site 1
T14 (Week 14)
|
0.0 score on a scale
Standard Deviation NA
The SD is not computed because n=1
|
OTHER_PRE_SPECIFIED outcome
Timeframe: From week 2 through week 14Population: Safety
Summary of injection site pain assessment (VAS) pre injection @ Site 2. Subject-perceived injection site pain was assessed using the Pain Visual Analog Scale (VAS) prior to study treatment administration assessing average pain since last treatment. Higher score is a worse outcome. Each subject received half the total dose of the IP into two separate injection sites. (injection site 1 and injection site 2) at each treatment visit. The information is reported under separate outcomes measures for each injection site.
Outcome measures
| Measure |
PRO 140 350 mg
n=43 Participants
PRO 140 350 mg weekly SQ injection.
|
|---|---|
|
Injection Site Reaction - Pain Pre Injection - Site 2
T2 (Week 2)
|
0.0 score on a scale
Standard Deviation 0.0
|
|
Injection Site Reaction - Pain Pre Injection - Site 2
T3 (Week 3)
|
2.4 score on a scale
Standard Deviation 9.2
|
|
Injection Site Reaction - Pain Pre Injection - Site 2
T4 (Week 4)
|
4.8 score on a scale
Standard Deviation 19.9
|
|
Injection Site Reaction - Pain Pre Injection - Site 2
T5 (Week 5)
|
2.1 score on a scale
Standard Deviation 7.1
|
|
Injection Site Reaction - Pain Pre Injection - Site 2
T6 (Week 6)
|
2.0 score on a scale
Standard Deviation 7.1
|
|
Injection Site Reaction - Pain Pre Injection - Site 2
T7 (Week 7)
|
0.8 score on a scale
Standard Deviation 6.9
|
|
Injection Site Reaction - Pain Pre Injection - Site 2
T8 (Week 8)
|
1.1 score on a scale
Standard Deviation 6.5
|
|
Injection Site Reaction - Pain Pre Injection - Site 2
T9 (Week 9)
|
1.9 score on a scale
Standard Deviation 7.2
|
|
Injection Site Reaction - Pain Pre Injection - Site 2
T10 (Week 10)
|
1.7 score on a scale
Standard Deviation 8.5
|
|
Injection Site Reaction - Pain Pre Injection - Site 2
T11 (Week 11)
|
1.4 score on a scale
Standard Deviation 7.7
|
|
Injection Site Reaction - Pain Pre Injection - Site 2
T12 (Week 12)
|
0.1 score on a scale
Standard Deviation 5.3
|
|
Injection Site Reaction - Pain Pre Injection - Site 2
T13 (Week 13)
|
0.4 score on a scale
Standard Deviation 0.8
|
|
Injection Site Reaction - Pain Pre Injection - Site 2
T14 (Week 14)
|
0.0 score on a scale
Standard Deviation NA
The SD was not computed because n=1
|
OTHER_PRE_SPECIFIED outcome
Timeframe: At week 4, week 8, week 12 and viral failure visitsPopulation: Safety
Summary of Pro 140 Concentration. Subjects may experience Virologic Failure (VF) any time during the treatment phase from week 1 to week 14. Subjects who experience VF will be followed up every 4 weeks until the viral load suppression is achieved (i.e., plasma HIV-1 RNA levels to return back to \<50 copies/mL).
Outcome measures
| Measure |
PRO 140 350 mg
n=43 Participants
PRO 140 350 mg weekly SQ injection.
|
|---|---|
|
Pro 140 Concentration
T4 (Week 4)
|
18084 ng/ml
Interval 8152.0 to 37318.0
|
|
Pro 140 Concentration
T8 (Week 8)
|
22010 ng/ml
Interval 6965.0 to 41624.0
|
|
Pro 140 Concentration
T12 (Week 12)
|
26388 ng/ml
Interval 11632.0 to 74414.0
|
|
Pro 140 Concentration
VF (Viral Failure)
|
16258 ng/ml
Interval 8133.0 to 26396.0
|
Adverse Events
Leronlimab
Serious events: 1 serious events
Other events: 7 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Leronlimab
n=43 participants at risk
Leronlimab Pro 140
|
|---|---|
|
Nervous system disorders
transient ischemic attack
|
2.3%
1/43 • Number of events 1 • Adverse events were collected for a total of 18 weeks, from treatment visit 1 (Post Rx) to treatment visit T14 (Week 14) and through the follow up period, every 2 week for total of 4 weeks. The duration of follow-up depends on the status of viral load suppression. Subjects who experience Virologic Failure will be discontinued from the treatment phase and be followed up every 4 weeks until the viral load suppression is achieved (i.e., plasma HIV-1 RNA levels to return back to <50 copies/mL).
|
Other adverse events
| Measure |
Leronlimab
n=43 participants at risk
Leronlimab Pro 140
|
|---|---|
|
Infections and infestations
nasopharyngitis
|
9.3%
4/43 • Adverse events were collected for a total of 18 weeks, from treatment visit 1 (Post Rx) to treatment visit T14 (Week 14) and through the follow up period, every 2 week for total of 4 weeks. The duration of follow-up depends on the status of viral load suppression. Subjects who experience Virologic Failure will be discontinued from the treatment phase and be followed up every 4 weeks until the viral load suppression is achieved (i.e., plasma HIV-1 RNA levels to return back to <50 copies/mL).
|
|
Gastrointestinal disorders
Constipation
|
7.0%
3/43 • Adverse events were collected for a total of 18 weeks, from treatment visit 1 (Post Rx) to treatment visit T14 (Week 14) and through the follow up period, every 2 week for total of 4 weeks. The duration of follow-up depends on the status of viral load suppression. Subjects who experience Virologic Failure will be discontinued from the treatment phase and be followed up every 4 weeks until the viral load suppression is achieved (i.e., plasma HIV-1 RNA levels to return back to <50 copies/mL).
|
|
Gastrointestinal disorders
Diarrhoea
|
9.3%
4/43 • Adverse events were collected for a total of 18 weeks, from treatment visit 1 (Post Rx) to treatment visit T14 (Week 14) and through the follow up period, every 2 week for total of 4 weeks. The duration of follow-up depends on the status of viral load suppression. Subjects who experience Virologic Failure will be discontinued from the treatment phase and be followed up every 4 weeks until the viral load suppression is achieved (i.e., plasma HIV-1 RNA levels to return back to <50 copies/mL).
|
|
Gastrointestinal disorders
nausea
|
9.3%
4/43 • Adverse events were collected for a total of 18 weeks, from treatment visit 1 (Post Rx) to treatment visit T14 (Week 14) and through the follow up period, every 2 week for total of 4 weeks. The duration of follow-up depends on the status of viral load suppression. Subjects who experience Virologic Failure will be discontinued from the treatment phase and be followed up every 4 weeks until the viral load suppression is achieved (i.e., plasma HIV-1 RNA levels to return back to <50 copies/mL).
|
|
General disorders
Fatigue
|
9.3%
4/43 • Adverse events were collected for a total of 18 weeks, from treatment visit 1 (Post Rx) to treatment visit T14 (Week 14) and through the follow up period, every 2 week for total of 4 weeks. The duration of follow-up depends on the status of viral load suppression. Subjects who experience Virologic Failure will be discontinued from the treatment phase and be followed up every 4 weeks until the viral load suppression is achieved (i.e., plasma HIV-1 RNA levels to return back to <50 copies/mL).
|
|
General disorders
Injection site pruritus
|
9.3%
4/43 • Adverse events were collected for a total of 18 weeks, from treatment visit 1 (Post Rx) to treatment visit T14 (Week 14) and through the follow up period, every 2 week for total of 4 weeks. The duration of follow-up depends on the status of viral load suppression. Subjects who experience Virologic Failure will be discontinued from the treatment phase and be followed up every 4 weeks until the viral load suppression is achieved (i.e., plasma HIV-1 RNA levels to return back to <50 copies/mL).
|
|
Nervous system disorders
Dizziness
|
7.0%
3/43 • Adverse events were collected for a total of 18 weeks, from treatment visit 1 (Post Rx) to treatment visit T14 (Week 14) and through the follow up period, every 2 week for total of 4 weeks. The duration of follow-up depends on the status of viral load suppression. Subjects who experience Virologic Failure will be discontinued from the treatment phase and be followed up every 4 weeks until the viral load suppression is achieved (i.e., plasma HIV-1 RNA levels to return back to <50 copies/mL).
|
Additional Information
Joseph Meidling, Sr. Director Clinical Operations
CytoDyn Inc.
Phone: (360) 980-8524
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place