HIV, Human Immunodeficiency Virus
Conditions
Keywords
HIV-1, HIV, Treatment Substitution, PRO 140, PRO140, CytoDyn, Amarex
Brief summary
This study is a Phase 2b study designed to evaluate the efficacy, safety, and tolerability of PRO 140 monotherapy for the maintenance of viral suppression in subjects who are stable on combination antiretroviral therapy. Consenting subjects will be shifted from their combination antiretroviral regimen to PRO 140 monotherapy for 12 weeks. Total treatment duration with PRO 140 will be 14 weeks with the one week overlap of existing retroviral regimen and PRO 140 at the beginning of the study treatment, and one week overlap at the end of the treatment in subjects who do not experience virologic failure.
Detailed description
This study is a Phase 2b, multi-center study designed to evaluate the efficacy, safety, and tolerability of PRO 140 monotherapy for the maintenance of viral suppression in patients who are stable on combination antiretroviral therapy. Patient enrollment will be staggered in this study to facilitate adequate safety monitoring. A lead cohort will include 12 subjects. Enrollment of additional 28 subjects will not be initiated until it is approved by the independent Data Monitoring Committee (DMC). Consenting patients will be shifted from combination antiretroviral regimen to PRO 140 monotherapy for 12 weeks. Total treatment duration with PRO 140 will be up to 14 weeks with the one week overlap of existing retroviral regimen and PRO 140 at the beginning of the study treatment and also one week overlap at the end of the treatment in subjects who do not experience Virologic Failure. PRO 140 will be administered as a 350 mg subcutaneous injection weekly for up to 14 weeks. Study participants will be monitored for viral rebound on a weekly basis following initiation of PRO 140 monotherapy and will re-initiate their previous antiretroviral regimen if plasma HIV-1 RNA levels rise above 400 copies/ml on two consecutive blood draws at least 3 days apart. The study will have three phases: Screening Phase, Treatment Phase and Follow-up Phase. The primary objective is to assess efficacy of PRO 140 monotherapy for the maintenance of viral suppression following substitution of antiretroviral therapy in patients who are stable on combination antiretroviral therapy. The secondary objective of the trial is to assess the clinical safety and tolerability parameters following substitution of antiretroviral therapy in patients who are stable on combination antiretroviral therapy.
Interventions
DRUGPRO 140
CCR5 Antagonist
OTHERHistorical data
Historical data (i.e., time to HIV-1 RNA viral load \> 500 copies/mL of 29 days).
Sponsors
Amarex Clinical Research
CytoDyn, Inc.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Males and females, age ≥18 years 2. Exclusive CCR5-tropic virus at Screening Visit as determined by Trofile™ DNA Assay 3. On stable antiretroviral therapy for last 12 months 4. Subject has two or more potential alternative antiretroviral regimen options to consider. 5. No documented detectable viral loads (HIV-1 RNA \<50 copies/ml) within the last 12 months prior to Screening Visit 6. Nadir CD4 cell count of \>200 cells/mm3
Exclusion criteria
1. CXCR4-tropic virus or dual/mixed tropic (R5X4) virus determined by the Trofile™ DNA Assay at the Screening Visit 2. Hepatitis B infection as manifest by the presence of Hepatitis B surface antigen (HBsAg) 3. Any acquired immune deficiency syndrome (AIDS)-defining illness according to the 1993 Centers for Disease Control and Prevention (CDC) AIDS surveillance definition 4. Prior use of any entry, attachment, CCR5 co-receptor, or fusion inhibitor, including PRO 140. 5. Any other clinical condition that, in the Investigator's judgment, would potentially compromise study compliance or the ability to evaluate safety/efficacy
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Time to Virologic Failure After Initiating PRO 140 Monotherapy. | From initiation of PRO 140 monotherapy through week 14 or virological failure | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Mean Change From Baseline in Viral Load | From initiation of PRO 140 monotherapy through week 14 | Mean change in Viral Load (HIV-1 RNA levels - log 10 copies/ml)), at each visit within the 14-week treatment phase. |
| Change in Viral Load at the Last Virologic Failure Visit. | From baseline to virologic failure visit (VF). VF can occur at any time from Week 1 to Week 14. | 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) |
| Mean Change in CD4 Cell Count by Visit | From baseline (week 2) through week 14 | Mean change in CD4 cell count, at each visit within the 14-week treatment phase |
| Proportion of Subjects With Virologic Failure | From initiation of PRO 140 monotherapy through week 14 | Proportion of Participants with Virologic Failure after initiating PRO 140 monotherapy at or prior to Week 14. |
| Q1 QOL Health Status | From baseline to virologic failure (VF occurring at any time from Week 1 to Week 12 or virologic failure which ever comes first) | 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) |
| Q2 QOL Current State of Health | From week 1 through treatment weeks 4, 8, 12 or VF visit | 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) |
| Mean Change in CD4 Cell Count | From baseline (week 2) to last visit | Change from baseline in CD4 cell count, within the 14-week treatment phase |
Other
| Measure | Time frame | Description |
|---|---|---|
| Injection Site Reaction - Drug Absorption - Site 1 | From initiation of PRO 140 monotherapy through week14 | 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. |
| Injection Site Reaction - Drug Absorption - Site 2 | From initiation of PRO 140 monotherapy through week 14 | 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. |
| Injection Site Reaction - Pain Post Injection - Site 1 | From initiation of PRO 140 monotherapy through week 14 | 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. |
| Injection Site Reaction - Pain (Site 1) | From initiation of PRO 140 monotherapy through week 14 | 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. |
| Injection Site Reaction - Pain Pre Injection - Site 1 | From week 2 through week 14 | 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. |
| Injection Site Reaction - Pain Pre Injection - Site 2 | From week 2 through week 14 | 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. |
| Pro 140 Concentration | At week 4, week 8, week 12 and viral failure visits | 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). |
| Injection Site Reaction - Pain Post Injection - Site 2 | From initiation of PRO 140 monotherapy through week 14 | 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. |
| Injection Site Reaction - Pain (Site 2) | From initiation of PRO 140 monotherapy through week 14 | 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. |
| Injection Site Reaction - Injection Site Status (Site 1) | From initiation of PRO 140 monotherapy through week 14 | 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. |
| Injection SIte Reaction - Injection Site Status (Site 2) | From initiation of PRO 140 monotherapy through week 14 | 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. |
| Injection Site Reaction - Pruritus With Injection (Site 1) | From initiation of PRO 140 monotherapy through week 14 | 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. |
| Injection Site Reaction - Pruritus With Injection (Site 2) | From initiation of PRO 140 monotherapy through week14 | 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. |
| Injection Site Reaction - Bleeding Site 1 | From initiation of PRO 140 monotherapy through week 14 | 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. |
| Injection Site Reaction - Bleeding - Site 2 | From initiation of PRO 140 monotherapy through week14 | 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| PRO 140 PRO 140 350mg weekly SQ injection.
PRO 140 350mg weekly SQ injection.: CCR5 Antagonist | 43 |
| Total | 43 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | non-compliance | 1 |
| Overall Study | other non-medical reason | 1 |
Baseline characteristics
| Characteristic | PRO 140 |
|---|---|
| Age, Continuous | 53.1 years STANDARD_DEVIATION 10 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 9 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 34 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 4 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 5 Participants |
| Race (NIH/OMB) White | 34 Participants |
| Sex: Female, Male Female | 3 Participants |
| Sex: Female, Male Male | 40 Participants |
| Time since HIV Diagnosis (Years) | 18.8 years STANDARD_DEVIATION 9.5 |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 43 |
| other Total, other adverse events | 7 / 43 |
| serious Total, serious adverse events | 1 / 43 |
Outcome results
Primary
Time to Virologic Failure After Initiating PRO 140 Monotherapy.
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.
Time frame: From initiation of PRO 140 monotherapy through week 14 or virological failure
Population: Per Protocol population
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| PRO 140 350 mg | Time to Virologic Failure After Initiating PRO 140 Monotherapy. | 70.71 days | Standard Deviation 23.14 |
p-value: <0.0001Wilcoxon Rank Sum
Secondary
Change in Viral Load at the Last Virologic Failure Visit.
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)
Time frame: From baseline to virologic failure visit (VF). VF can occur at any time from Week 1 to Week 14.
Population: Per Protocol
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| PRO 140 350 mg | Change in Viral Load at the Last Virologic Failure Visit. | -1.78 log 10 copies/ml | Standard Deviation 1.93 |
Secondary
Mean Change From Baseline in Viral Load
Mean change in Viral Load (HIV-1 RNA levels - log 10 copies/ml)), at each visit within the 14-week treatment phase.
Time frame: From initiation of PRO 140 monotherapy through week 14
Population: Per Protocol population
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| PRO 140 350 mg | Mean Change From Baseline in Viral Load | T2 (Week 2) | 0.10 log 10 copies/mL | Standard Deviation 0.71 |
| PRO 140 350 mg | Mean Change From Baseline in Viral Load | T3 (Week 3) | 0.01 log 10 copies/mL | Standard Deviation 0.74 |
| PRO 140 350 mg | Mean Change From Baseline in Viral Load | T4 (Week 4) | -0.13 log 10 copies/mL | Standard Deviation 0.74 |
| PRO 140 350 mg | Mean Change From Baseline in Viral Load | T5 (Week 5) | -0.25 log 10 copies/mL | Standard Deviation 1.04 |
| PRO 140 350 mg | Mean Change From Baseline in Viral Load | T6 (Week 6) | -0.76 log 10 copies/mL | Standard Deviation 1.39 |
| PRO 140 350 mg | Mean Change From Baseline in Viral Load | T7 (Week 7) | -0.88 log 10 copies/mL | Standard Deviation 1.53 |
| PRO 140 350 mg | Mean Change From Baseline in Viral Load | T8 (Week 8) | -0.72 log 10 copies/mL | Standard Deviation 1.37 |
| PRO 140 350 mg | Mean Change From Baseline in Viral Load | T9 (Week 9) | -0.84 log 10 copies/mL | Standard Deviation 1.37 |
| PRO 140 350 mg | Mean Change From Baseline in Viral Load | T10 (Week 10) | -0.71 log 10 copies/mL | Standard Deviation 1.36 |
| PRO 140 350 mg | Mean Change From Baseline in Viral Load | T11 (Week 11) | -0.81 log 10 copies/mL | Standard Deviation 1.37 |
| PRO 140 350 mg | Mean Change From Baseline in Viral Load | T12 (Week 12) | -0.91 log 10 copies/mL | Standard Deviation 1.5 |
| PRO 140 350 mg | Mean Change From Baseline in Viral Load | T13 (Week 13) | -0.44 log 10 copies/mL | Standard Deviation 1.12 |
| PRO 140 350 mg | Mean Change From Baseline in Viral Load | T14 (Week 14) | -0.37 log 10 copies/mL | Standard Deviation 1.09 |
Secondary
Mean Change in CD4 Cell Count
Change from baseline in CD4 cell count, within the 14-week treatment phase
Time frame: From baseline (week 2) to last visit
Population: Per Protocol
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| PRO 140 350 mg | Mean Change in CD4 Cell Count | 18.97 cells/mm^3 | Standard Deviation 114.08 |
Secondary
Mean Change in CD4 Cell Count by Visit
Mean change in CD4 cell count, at each visit within the 14-week treatment phase
Time frame: From baseline (week 2) through week 14
Population: Per protocol
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| PRO 140 350 mg | Mean Change in CD4 Cell Count by Visit | T2 (Week 2) | 32.05 cells/mm^3 | Standard Deviation 132.92 |
| PRO 140 350 mg | Mean Change in CD4 Cell Count by Visit | T3 (Week 3) | -33.14 cells/mm^3 | Standard Deviation 137.05 |
| PRO 140 350 mg | Mean Change in CD4 Cell Count by Visit | T4 (Week 4) | -12.78 cells/mm^3 | Standard Deviation 137.37 |
| PRO 140 350 mg | Mean Change in CD4 Cell Count by Visit | T5 (Week 5) | 33.42 cells/mm^3 | Standard Deviation 130.88 |
| PRO 140 350 mg | Mean Change in CD4 Cell Count by Visit | T6 (Week 6) | -3.26 cells/mm^3 | Standard Deviation 125.78 |
| PRO 140 350 mg | Mean Change in CD4 Cell Count by Visit | T7 (Week 7) | 47.50 cells/mm^3 | Standard Deviation 190.1 |
| PRO 140 350 mg | Mean Change in CD4 Cell Count by Visit | T8 (Week 8) | -55.09 cells/mm^3 | Standard Deviation 157.21 |
| PRO 140 350 mg | Mean Change in CD4 Cell Count by Visit | T9 (Week 9) | 47.25 cells/mm^3 | Standard Deviation 95.64 |
| PRO 140 350 mg | Mean Change in CD4 Cell Count by Visit | T10 (Week 10) | -6.82 cells/mm^3 | Standard Deviation 140.34 |
| PRO 140 350 mg | Mean Change in CD4 Cell Count by Visit | T12 (Week 12) | 16.52 cells/mm^3 | Standard Deviation 143.91 |
| PRO 140 350 mg | Mean Change in CD4 Cell Count by Visit | T13 (Week 13) | -0.44 cells/mm^3 | Standard Deviation 95.54 |
| PRO 140 350 mg | Mean Change in CD4 Cell Count by Visit | T14 (Week 14) | -59.03 cells/mm^3 | Standard Deviation 56.5 |
| PRO 140 350 mg | Mean Change in CD4 Cell Count by Visit | VF (Viral failure) | 18.41 cells/mm^3 | Standard Deviation 113.99 |
| PRO 140 350 mg | Mean Change in CD4 Cell Count by Visit | T11 (Week 11) | -29.83 cells/mm^3 | Standard Deviation 218.64 |
Secondary
Proportion of Subjects With Virologic Failure
Proportion of Participants with Virologic Failure after initiating PRO 140 monotherapy at or prior to Week 14.
Time frame: From initiation of PRO 140 monotherapy through week 14
Population: Per Protocol
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| PRO 140 350 mg | Proportion of Subjects With Virologic Failure | 0.439 poportion of subjects |
Secondary
Q1 QOL Health Status
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)
Time frame: 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
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| PRO 140 350 mg | Q1 QOL Health Status | T1 (Week 1) | Good | 6 Participants |
| PRO 140 350 mg | Q1 QOL Health Status | T1 (Week 1) | Very Good | 10 Participants |
| PRO 140 350 mg | Q1 QOL Health Status | T1 (Week 1) | Excellent | 13 Participants |
| PRO 140 350 mg | Q1 QOL Health Status | T1 (Week 1) | Missing | 11 Participants |
| PRO 140 350 mg | Q1 QOL Health Status | T4 (Week 4) | Poor | 0 Participants |
| PRO 140 350 mg | Q1 QOL Health Status | T4 (Week 4) | Fair | 1 Participants |
| PRO 140 350 mg | Q1 QOL Health Status | T4 (Week 4) | Good | 6 Participants |
| PRO 140 350 mg | Q1 QOL Health Status | T1 (Week 1) | Poor | 0 Participants |
| PRO 140 350 mg | Q1 QOL Health Status | T1 (Week 1) | Fair | 1 Participants |
| PRO 140 350 mg | Q1 QOL Health Status | T4 (Week 4) | Very Good | 11 Participants |
| PRO 140 350 mg | Q1 QOL Health Status | T4 (Week 4) | Excellent | 12 Participants |
| PRO 140 350 mg | Q1 QOL Health Status | T4 (Week 4) | Missing | 11 Participants |
| PRO 140 350 mg | Q1 QOL Health Status | T8 (Week 8) | Poor | 1 Participants |
| PRO 140 350 mg | Q1 QOL Health Status | T8 (Week 8) | Fair | 2 Participants |
| PRO 140 350 mg | Q1 QOL Health Status | T8 (Week 8) | Good | 6 Participants |
| PRO 140 350 mg | Q1 QOL Health Status | T8 (Week 8) | Very Good | 9 Participants |
| PRO 140 350 mg | Q1 QOL Health Status | T8 (Week 8) | Excellent | 9 Participants |
| PRO 140 350 mg | Q1 QOL Health Status | T8 (Week 8) | Missing | 14 Participants |
| PRO 140 350 mg | Q1 QOL Health Status | T12 (Week 12) | Poor | 0 Participants |
| PRO 140 350 mg | Q1 QOL Health Status | T12 (Week 12) | Fair | 2 Participants |
| PRO 140 350 mg | Q1 QOL Health Status | T12 (Week 12) | Good | 2 Participants |
| PRO 140 350 mg | Q1 QOL Health Status | T12 (Week 12) | Very Good | 12 Participants |
| PRO 140 350 mg | Q1 QOL Health Status | T12 (Week 12) | Missing | 20 Participants |
| PRO 140 350 mg | Q1 QOL Health Status | VF (Virologic Failure) | Poor | 0 Participants |
| PRO 140 350 mg | Q1 QOL Health Status | VF (Virologic Failure) | Fair | 0 Participants |
| PRO 140 350 mg | Q1 QOL Health Status | VF (Virologic Failure) | Good | 3 Participants |
| PRO 140 350 mg | Q1 QOL Health Status | VF (Virologic Failure) | Very Good | 3 Participants |
| PRO 140 350 mg | Q1 QOL Health Status | VF (Virologic Failure) | Excellent | 1 Participants |
| PRO 140 350 mg | Q1 QOL Health Status | VF (Virologic Failure) | Missing | 34 Participants |
| PRO 140 350 mg | Q1 QOL Health Status | T12 (Week 12) | Excellent | 5 Participants |
Secondary
Q2 QOL Current State of Health
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)
Time frame: From week 1 through treatment weeks 4, 8, 12 or VF visit
Population: Per Protocol
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| PRO 140 350 mg | Q2 QOL Current State of Health | T1 (Week 1) | 82.3 score on a scale | Standard Deviation 16.4 |
| PRO 140 350 mg | Q2 QOL Current State of Health | T4 (Week 4) | 83.8 score on a scale | Standard Deviation 16.2 |
| PRO 140 350 mg | Q2 QOL Current State of Health | T8 (Week 8) | 80.9 score on a scale | Standard Deviation 18 |
| PRO 140 350 mg | Q2 QOL Current State of Health | T12 (Week 12) | 84.9 score on a scale | Standard Deviation 17.3 |
| PRO 140 350 mg | Q2 QOL Current State of Health | VF (Viral Failure) | 78.0 score on a scale | Standard Deviation 15.8 |
Other Pre-specified
Injection Site Reaction - Bleeding Site 1
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.
Time frame: From initiation of PRO 140 monotherapy through week 14
Population: safety
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| PRO 140 350 mg | Injection Site Reaction - Bleeding Site 1 | T1 (Week 1) | Absent | 43 Participants |
| PRO 140 350 mg | Injection Site Reaction - Bleeding Site 1 | T1 (Week 1) | Present | 0 Participants |
| PRO 140 350 mg | Injection Site Reaction - Bleeding Site 1 | T2 (Week 2) | Absent | 43 Participants |
| PRO 140 350 mg | Injection Site Reaction - Bleeding Site 1 | T2 (Week 2) | Present | 0 Participants |
| PRO 140 350 mg | Injection Site Reaction - Bleeding Site 1 | T3 (Week 3) | Absent | 43 Participants |
| PRO 140 350 mg | Injection Site Reaction - Bleeding Site 1 | T3 (Week 3) | Present | 0 Participants |
| PRO 140 350 mg | Injection Site Reaction - Bleeding Site 1 | T4 (Week 4) | Absent | 43 Participants |
| PRO 140 350 mg | Injection Site Reaction - Bleeding Site 1 | T4 (Week 4) | Present | 0 Participants |
| PRO 140 350 mg | Injection Site Reaction - Bleeding Site 1 | T5 (Week 5) | Absent | 43 Participants |
| PRO 140 350 mg | Injection Site Reaction - Bleeding Site 1 | T5 (Week 5) | Present | 0 Participants |
| PRO 140 350 mg | Injection Site Reaction - Bleeding Site 1 | T6 (Week 6) | Absent | 43 Participants |
| PRO 140 350 mg | Injection Site Reaction - Bleeding Site 1 | T6 (Week 6) | Present | 0 Participants |
| PRO 140 350 mg | Injection Site Reaction - Bleeding Site 1 | T7 (Week 7) | Absent | 41 Participants |
| PRO 140 350 mg | Injection Site Reaction - Bleeding Site 1 | T7 (Week 7) | Present | 0 Participants |
| PRO 140 350 mg | Injection Site Reaction - Bleeding Site 1 | T8 (Week 8) | Absent | 36 Participants |
| PRO 140 350 mg | Injection Site Reaction - Bleeding Site 1 | T8 (Week 8) | Present | 0 Participants |
| PRO 140 350 mg | Injection Site Reaction - Bleeding Site 1 | T9 (Week 9) | Absent | 33 Participants |
| PRO 140 350 mg | Injection Site Reaction - Bleeding Site 1 | T9 (Week 9) | Present | 0 Participants |
| PRO 140 350 mg | Injection Site Reaction - Bleeding Site 1 | T10 (Week 10) | Absent | 29 Participants |
| PRO 140 350 mg | Injection Site Reaction - Bleeding Site 1 | T10 (Week 10) | Present | 0 Participants |
| PRO 140 350 mg | Injection Site Reaction - Bleeding Site 1 | T11 (Week 11) | Absent | 29 Participants |
| PRO 140 350 mg | Injection Site Reaction - Bleeding Site 1 | T11 (Week 11) | Present | 0 Participants |
| PRO 140 350 mg | Injection Site Reaction - Bleeding Site 1 | T12 (Week 12) | Absent | 27 Participants |
| PRO 140 350 mg | Injection Site Reaction - Bleeding Site 1 | T12 (Week 12) | Present | 0 Participants |
| PRO 140 350 mg | Injection Site Reaction - Bleeding Site 1 | T13 (Week 13) | Absent | 23 Participants |
| PRO 140 350 mg | Injection Site Reaction - Bleeding Site 1 | T13 (Week 13) | Present | 0 Participants |
| PRO 140 350 mg | Injection Site Reaction - Bleeding Site 1 | T14 (Week 14) | Absent | 6 Participants |
| PRO 140 350 mg | Injection Site Reaction - Bleeding Site 1 | T14 (Week 14) | Present | 0 Participants |
Other Pre-specified
Injection Site Reaction - Bleeding - Site 2
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.
Time frame: From initiation of PRO 140 monotherapy through week14
Population: safety
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| PRO 140 350 mg | Injection Site Reaction - Bleeding - Site 2 | T1 (Week 1) | Absent | 43 Participants |
| PRO 140 350 mg | Injection Site Reaction - Bleeding - Site 2 | T1 (Week 1) | Present | 0 Participants |
| PRO 140 350 mg | Injection Site Reaction - Bleeding - Site 2 | T2 (Week 2) | Absent | 43 Participants |
| PRO 140 350 mg | Injection Site Reaction - Bleeding - Site 2 | T2 (Week 2) | Present | 0 Participants |
| PRO 140 350 mg | Injection Site Reaction - Bleeding - Site 2 | T3 (Week 3) | Absent | 43 Participants |
| PRO 140 350 mg | Injection Site Reaction - Bleeding - Site 2 | T3 (Week 3) | Present | 0 Participants |
| PRO 140 350 mg | Injection Site Reaction - Bleeding - Site 2 | T4 (Week 4) | Absent | 43 Participants |
| PRO 140 350 mg | Injection Site Reaction - Bleeding - Site 2 | T4 (Week 4) | Present | 0 Participants |
| PRO 140 350 mg | Injection Site Reaction - Bleeding - Site 2 | T5 (Week 5) | Absent | 42 Participants |
| PRO 140 350 mg | Injection Site Reaction - Bleeding - Site 2 | T5 (Week 5) | Present | 0 Participants |
| PRO 140 350 mg | Injection Site Reaction - Bleeding - Site 2 | T6 (Week 6) | Absent | 42 Participants |
| PRO 140 350 mg | Injection Site Reaction - Bleeding - Site 2 | T6 (Week 6) | Present | 0 Participants |
| PRO 140 350 mg | Injection Site Reaction - Bleeding - Site 2 | T7 (Week 7) | Absent | 41 Participants |
| PRO 140 350 mg | Injection Site Reaction - Bleeding - Site 2 | T7 (Week 7) | Present | 0 Participants |
| PRO 140 350 mg | Injection Site Reaction - Bleeding - Site 2 | T8 (Week 8) | Absent | 36 Participants |
| PRO 140 350 mg | Injection Site Reaction - Bleeding - Site 2 | T8 (Week 8) | Present | 0 Participants |
| PRO 140 350 mg | Injection Site Reaction - Bleeding - Site 2 | T9 (Week 9) | Absent | 33 Participants |
| PRO 140 350 mg | Injection Site Reaction - Bleeding - Site 2 | T9 (Week 9) | Present | 0 Participants |
| PRO 140 350 mg | Injection Site Reaction - Bleeding - Site 2 | T10 (Week 10) | Absent | 29 Participants |
| PRO 140 350 mg | Injection Site Reaction - Bleeding - Site 2 | T10 (Week 10) | Present | 0 Participants |
| PRO 140 350 mg | Injection Site Reaction - Bleeding - Site 2 | T11 (Week 11) | Absent | 29 Participants |
| PRO 140 350 mg | Injection Site Reaction - Bleeding - Site 2 | T11 (Week 11) | Present | 0 Participants |
| PRO 140 350 mg | Injection Site Reaction - Bleeding - Site 2 | T12 (Week 12) | Absent | 26 Participants |
| PRO 140 350 mg | Injection Site Reaction - Bleeding - Site 2 | T12 (Week 12) | Present | 1 Participants |
| PRO 140 350 mg | Injection Site Reaction - Bleeding - Site 2 | T13 (Week 13) | Absent | 23 Participants |
| PRO 140 350 mg | Injection Site Reaction - Bleeding - Site 2 | T13 (Week 13) | Present | 0 Participants |
| PRO 140 350 mg | Injection Site Reaction - Bleeding - Site 2 | T14 (Week 14) | Absent | 6 Participants |
| PRO 140 350 mg | Injection Site Reaction - Bleeding - Site 2 | T14 (Week 14) | Present | 0 Participants |
Other Pre-specified
Injection Site Reaction - Drug Absorption - Site 1
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.
Time frame: From initiation of PRO 140 monotherapy through week14
Population: safety
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| PRO 140 350 mg | Injection Site Reaction - Drug Absorption - Site 1 | T1 (Week 1) | Normal | 43 Participants |
| PRO 140 350 mg | Injection Site Reaction - Drug Absorption - Site 1 | T1 (Week 1) | Abnormal | 0 Participants |
| PRO 140 350 mg | Injection Site Reaction - Drug Absorption - Site 1 | T2 (Week 2) | Normal | 43 Participants |
| PRO 140 350 mg | Injection Site Reaction - Drug Absorption - Site 1 | T2 (Week 2) | Abnormal | 0 Participants |
| PRO 140 350 mg | Injection Site Reaction - Drug Absorption - Site 1 | T3 (Week 3) | Normal | 43 Participants |
| PRO 140 350 mg | Injection Site Reaction - Drug Absorption - Site 1 | T3 (Week 3) | Abnormal | 0 Participants |
| PRO 140 350 mg | Injection Site Reaction - Drug Absorption - Site 1 | T4 (Week 4) | Normal | 43 Participants |
| PRO 140 350 mg | Injection Site Reaction - Drug Absorption - Site 1 | T4 (Week 4) | Abnormal | 0 Participants |
| PRO 140 350 mg | Injection Site Reaction - Drug Absorption - Site 1 | T5 (Week 5) | Normal | 43 Participants |
| PRO 140 350 mg | Injection Site Reaction - Drug Absorption - Site 1 | T5 (Week 5) | Abnormal | 0 Participants |
| PRO 140 350 mg | Injection Site Reaction - Drug Absorption - Site 1 | T6 (Week 6) | Normal | 43 Participants |
| PRO 140 350 mg | Injection Site Reaction - Drug Absorption - Site 1 | T6 (Week 6) | Abnormal | 0 Participants |
| PRO 140 350 mg | Injection Site Reaction - Drug Absorption - Site 1 | T7 (Week 7) | Normal | 41 Participants |
| PRO 140 350 mg | Injection Site Reaction - Drug Absorption - Site 1 | T7 (Week 7) | Abnormal | 0 Participants |
| PRO 140 350 mg | Injection Site Reaction - Drug Absorption - Site 1 | T8 (Week 8) | Normal | 36 Participants |
| PRO 140 350 mg | Injection Site Reaction - Drug Absorption - Site 1 | T8 (Week 8) | Abnormal | 0 Participants |
| PRO 140 350 mg | Injection Site Reaction - Drug Absorption - Site 1 | T9 (Week 9) | Normal | 33 Participants |
| PRO 140 350 mg | Injection Site Reaction - Drug Absorption - Site 1 | T9 (Week 9) | Abnormal | 0 Participants |
| PRO 140 350 mg | Injection Site Reaction - Drug Absorption - Site 1 | T10 (Week 10) | Normal | 29 Participants |
| PRO 140 350 mg | Injection Site Reaction - Drug Absorption - Site 1 | T10 (Week 10) | Abnormal | 0 Participants |
| PRO 140 350 mg | Injection Site Reaction - Drug Absorption - Site 1 | T11 (Week 11) | Normal | 29 Participants |
| PRO 140 350 mg | Injection Site Reaction - Drug Absorption - Site 1 | T11 (Week 11) | Abnormal | 0 Participants |
| PRO 140 350 mg | Injection Site Reaction - Drug Absorption - Site 1 | T12 (Week 12) | Normal | 27 Participants |
| PRO 140 350 mg | Injection Site Reaction - Drug Absorption - Site 1 | T12 (Week 12) | Abnormal | 0 Participants |
| PRO 140 350 mg | Injection Site Reaction - Drug Absorption - Site 1 | T13 (Week 13) | Normal | 23 Participants |
| PRO 140 350 mg | Injection Site Reaction - Drug Absorption - Site 1 | T13 (Week 13) | Abnormal | 0 Participants |
| PRO 140 350 mg | Injection Site Reaction - Drug Absorption - Site 1 | T14 (Week 14) | Normal | 6 Participants |
| PRO 140 350 mg | Injection Site Reaction - Drug Absorption - Site 1 | T14 (Week 14) | Abnormal | 0 Participants |
Other Pre-specified
Injection Site Reaction - Drug Absorption - Site 2
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.
Time frame: From initiation of PRO 140 monotherapy through week 14
Population: safety
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| PRO 140 350 mg | Injection Site Reaction - Drug Absorption - Site 2 | T1 (Week 1) | Normal | 43 Participants |
| PRO 140 350 mg | Injection Site Reaction - Drug Absorption - Site 2 | T1 (Week 1) | Abnormal | 0 Participants |
| PRO 140 350 mg | Injection Site Reaction - Drug Absorption - Site 2 | T2 (Week 2) | Normal | 43 Participants |
| PRO 140 350 mg | Injection Site Reaction - Drug Absorption - Site 2 | T2 (Week 2) | Abnormal | 0 Participants |
| PRO 140 350 mg | Injection Site Reaction - Drug Absorption - Site 2 | T3 (Week 3) | Normal | 43 Participants |
| PRO 140 350 mg | Injection Site Reaction - Drug Absorption - Site 2 | T3 (Week 3) | Abnormal | 0 Participants |
| PRO 140 350 mg | Injection Site Reaction - Drug Absorption - Site 2 | T4 (Week 4) | Normal | 43 Participants |
| PRO 140 350 mg | Injection Site Reaction - Drug Absorption - Site 2 | T4 (Week 4) | Abnormal | 0 Participants |
| PRO 140 350 mg | Injection Site Reaction - Drug Absorption - Site 2 | T5 (Week 5) | Normal | 43 Participants |
| PRO 140 350 mg | Injection Site Reaction - Drug Absorption - Site 2 | T5 (Week 5) | Abnormal | 0 Participants |
| PRO 140 350 mg | Injection Site Reaction - Drug Absorption - Site 2 | T6 (Week 6) | Normal | 43 Participants |
| PRO 140 350 mg | Injection Site Reaction - Drug Absorption - Site 2 | T6 (Week 6) | Abnormal | 0 Participants |
| PRO 140 350 mg | Injection Site Reaction - Drug Absorption - Site 2 | T7 (Week 7) | Normal | 41 Participants |
| PRO 140 350 mg | Injection Site Reaction - Drug Absorption - Site 2 | T7 (Week 7) | Abnormal | 0 Participants |
| PRO 140 350 mg | Injection Site Reaction - Drug Absorption - Site 2 | T8 (Week 8) | Normal | 36 Participants |
| PRO 140 350 mg | Injection Site Reaction - Drug Absorption - Site 2 | T8 (Week 8) | Abnormal | 0 Participants |
| PRO 140 350 mg | Injection Site Reaction - Drug Absorption - Site 2 | T9 (Week 9) | Normal | 33 Participants |
| PRO 140 350 mg | Injection Site Reaction - Drug Absorption - Site 2 | T9 (Week 9) | Abnormal | 0 Participants |
| PRO 140 350 mg | Injection Site Reaction - Drug Absorption - Site 2 | T10 (Week 10) | Normal | 29 Participants |
| PRO 140 350 mg | Injection Site Reaction - Drug Absorption - Site 2 | T10 (Week 10) | Abnormal | 0 Participants |
| PRO 140 350 mg | Injection Site Reaction - Drug Absorption - Site 2 | T11 (Week 11) | Normal | 29 Participants |
| PRO 140 350 mg | Injection Site Reaction - Drug Absorption - Site 2 | T11 (Week 11) | Abnormal | 0 Participants |
| PRO 140 350 mg | Injection Site Reaction - Drug Absorption - Site 2 | T12 (Week 12) | Normal | 27 Participants |
| PRO 140 350 mg | Injection Site Reaction - Drug Absorption - Site 2 | T12 (Week 12) | Abnormal | 0 Participants |
| PRO 140 350 mg | Injection Site Reaction - Drug Absorption - Site 2 | T13 (Week 13) | Normal | 23 Participants |
| PRO 140 350 mg | Injection Site Reaction - Drug Absorption - Site 2 | T13 (Week 13) | Abnormal | 0 Participants |
| PRO 140 350 mg | Injection Site Reaction - Drug Absorption - Site 2 | T14 (Week 14) | Normal | 6 Participants |
| PRO 140 350 mg | Injection Site Reaction - Drug Absorption - Site 2 | T14 (Week 14) | Abnormal | 0 Participants |
Other Pre-specified
Injection Site Reaction - Injection Site Status (Site 1)
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.
Time frame: From initiation of PRO 140 monotherapy through week 14
Population: safety
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| PRO 140 350 mg | Injection Site Reaction - Injection Site Status (Site 1) | T1 (Week 1) | Normal | 43 Participants |
| PRO 140 350 mg | Injection Site Reaction - Injection Site Status (Site 1) | T1 (Week 1) | abnormal | 0 Participants |
| PRO 140 350 mg | Injection Site Reaction - Injection Site Status (Site 1) | T2 (Week 2) | Normal | 43 Participants |
| PRO 140 350 mg | Injection Site Reaction - Injection Site Status (Site 1) | T2 (Week 2) | abnormal | 0 Participants |
| PRO 140 350 mg | Injection Site Reaction - Injection Site Status (Site 1) | T3 (Week 3) | Normal | 43 Participants |
| PRO 140 350 mg | Injection Site Reaction - Injection Site Status (Site 1) | T3 (Week 3) | abnormal | 0 Participants |
| PRO 140 350 mg | Injection Site Reaction - Injection Site Status (Site 1) | T4 (Week 4) | Normal | 43 Participants |
| PRO 140 350 mg | Injection Site Reaction - Injection Site Status (Site 1) | T4 (Week 4) | abnormal | 0 Participants |
| PRO 140 350 mg | Injection Site Reaction - Injection Site Status (Site 1) | T5 (Week 5) | Normal | 43 Participants |
| PRO 140 350 mg | Injection Site Reaction - Injection Site Status (Site 1) | T5 (Week 5) | abnormal | 0 Participants |
| PRO 140 350 mg | Injection Site Reaction - Injection Site Status (Site 1) | T6 (Week 6) | Normal | 42 Participants |
| PRO 140 350 mg | Injection Site Reaction - Injection Site Status (Site 1) | T6 (Week 6) | abnormal | 1 Participants |
| PRO 140 350 mg | Injection Site Reaction - Injection Site Status (Site 1) | T7 (Week 7) | Normal | 41 Participants |
| PRO 140 350 mg | Injection Site Reaction - Injection Site Status (Site 1) | T7 (Week 7) | abnormal | 0 Participants |
| PRO 140 350 mg | Injection Site Reaction - Injection Site Status (Site 1) | T8 (Week 8) | Normal | 36 Participants |
| PRO 140 350 mg | Injection Site Reaction - Injection Site Status (Site 1) | T8 (Week 8) | abnormal | 0 Participants |
| PRO 140 350 mg | Injection Site Reaction - Injection Site Status (Site 1) | T9 (Week 9) | Normal | 33 Participants |
| PRO 140 350 mg | Injection Site Reaction - Injection Site Status (Site 1) | T9 (Week 9) | abnormal | 0 Participants |
| PRO 140 350 mg | Injection Site Reaction - Injection Site Status (Site 1) | T10 (Week 10) | Normal | 29 Participants |
| PRO 140 350 mg | Injection Site Reaction - Injection Site Status (Site 1) | T10 (Week 10) | abnormal | 0 Participants |
| PRO 140 350 mg | Injection Site Reaction - Injection Site Status (Site 1) | T11 (Week 11) | Normal | 29 Participants |
| PRO 140 350 mg | Injection Site Reaction - Injection Site Status (Site 1) | T11 (Week 11) | abnormal | 0 Participants |
| PRO 140 350 mg | Injection Site Reaction - Injection Site Status (Site 1) | T12 (Week 12) | Normal | 27 Participants |
| PRO 140 350 mg | Injection Site Reaction - Injection Site Status (Site 1) | T12 (Week 12) | abnormal | 0 Participants |
| PRO 140 350 mg | Injection Site Reaction - Injection Site Status (Site 1) | T13 (Week 13) | Normal | 23 Participants |
| PRO 140 350 mg | Injection Site Reaction - Injection Site Status (Site 1) | T13 (Week 13) | abnormal | 0 Participants |
| PRO 140 350 mg | Injection Site Reaction - Injection Site Status (Site 1) | T14 (Week 14) | Normal | 6 Participants |
| PRO 140 350 mg | Injection Site Reaction - Injection Site Status (Site 1) | T14 (Week 14) | abnormal | 0 Participants |
Other Pre-specified
Injection SIte Reaction - Injection Site Status (Site 2)
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.
Time frame: From initiation of PRO 140 monotherapy through week 14
Population: safety
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| PRO 140 350 mg | Injection SIte Reaction - Injection Site Status (Site 2) | T1 (Week 1) | Normal | 43 Participants |
| PRO 140 350 mg | Injection SIte Reaction - Injection Site Status (Site 2) | T1 (Week 1) | Abnormal | 0 Participants |
| PRO 140 350 mg | Injection SIte Reaction - Injection Site Status (Site 2) | T2 (Week 2) | Normal | 43 Participants |
| PRO 140 350 mg | Injection SIte Reaction - Injection Site Status (Site 2) | T2 (Week 2) | Abnormal | 0 Participants |
| PRO 140 350 mg | Injection SIte Reaction - Injection Site Status (Site 2) | T3 (Week 3) | Normal | 43 Participants |
| PRO 140 350 mg | Injection SIte Reaction - Injection Site Status (Site 2) | T3 (Week 3) | Abnormal | 0 Participants |
| PRO 140 350 mg | Injection SIte Reaction - Injection Site Status (Site 2) | T4 (Week 4) | Normal | 43 Participants |
| PRO 140 350 mg | Injection SIte Reaction - Injection Site Status (Site 2) | T4 (Week 4) | Abnormal | 0 Participants |
| PRO 140 350 mg | Injection SIte Reaction - Injection Site Status (Site 2) | T5 (Week 5) | Normal | 43 Participants |
| PRO 140 350 mg | Injection SIte Reaction - Injection Site Status (Site 2) | T5 (Week 5) | Abnormal | 0 Participants |
| PRO 140 350 mg | Injection SIte Reaction - Injection Site Status (Site 2) | T6 (Week 6) | Normal | 42 Participants |
| PRO 140 350 mg | Injection SIte Reaction - Injection Site Status (Site 2) | T6 (Week 6) | Abnormal | 1 Participants |
| PRO 140 350 mg | Injection SIte Reaction - Injection Site Status (Site 2) | T7 (Week 7) | Normal | 41 Participants |
| PRO 140 350 mg | Injection SIte Reaction - Injection Site Status (Site 2) | T7 (Week 7) | Abnormal | 0 Participants |
| PRO 140 350 mg | Injection SIte Reaction - Injection Site Status (Site 2) | T8 (Week 8) | Normal | 36 Participants |
| PRO 140 350 mg | Injection SIte Reaction - Injection Site Status (Site 2) | T8 (Week 8) | Abnormal | 0 Participants |
| PRO 140 350 mg | Injection SIte Reaction - Injection Site Status (Site 2) | T9 (Week 9) | Normal | 33 Participants |
| PRO 140 350 mg | Injection SIte Reaction - Injection Site Status (Site 2) | T9 (Week 9) | Abnormal | 0 Participants |
| PRO 140 350 mg | Injection SIte Reaction - Injection Site Status (Site 2) | T10 (Week 10) | Normal | 29 Participants |
| PRO 140 350 mg | Injection SIte Reaction - Injection Site Status (Site 2) | T10 (Week 10) | Abnormal | 0 Participants |
| PRO 140 350 mg | Injection SIte Reaction - Injection Site Status (Site 2) | T11 (Week 11) | Normal | 29 Participants |
| PRO 140 350 mg | Injection SIte Reaction - Injection Site Status (Site 2) | T11 (Week 11) | Abnormal | 0 Participants |
| PRO 140 350 mg | Injection SIte Reaction - Injection Site Status (Site 2) | T12 (Week 12) | Normal | 27 Participants |
| PRO 140 350 mg | Injection SIte Reaction - Injection Site Status (Site 2) | T12 (Week 12) | Abnormal | 0 Participants |
| PRO 140 350 mg | Injection SIte Reaction - Injection Site Status (Site 2) | T13 (Week 13) | Normal | 23 Participants |
| PRO 140 350 mg | Injection SIte Reaction - Injection Site Status (Site 2) | T13 (Week 13) | Abnormal | 0 Participants |
| PRO 140 350 mg | Injection SIte Reaction - Injection Site Status (Site 2) | T14 (Week 14) | Normal | 6 Participants |
| PRO 140 350 mg | Injection SIte Reaction - Injection Site Status (Site 2) | T14 (Week 14) | Abnormal | 0 Participants |
Other Pre-specified
Injection Site Reaction - Pain Post Injection - Site 1
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.
Time frame: From initiation of PRO 140 monotherapy through week 14
Population: Safety
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| PRO 140 350 mg | Injection Site Reaction - Pain Post Injection - Site 1 | T1 (Week 1) | 18.4 score on a scale | Standard Deviation 16.1 |
| PRO 140 350 mg | Injection Site Reaction - Pain Post Injection - Site 1 | T2 (Week 2) | -3.9 score on a scale | Standard Deviation 8.6 |
| PRO 140 350 mg | Injection Site Reaction - Pain Post Injection - Site 1 | T3 (Week 3) | -7.9 score on a scale | Standard Deviation 11.4 |
| PRO 140 350 mg | Injection Site Reaction - Pain Post Injection - Site 1 | T4 (Week 4) | -2.5 score on a scale | Standard Deviation 14.2 |
| PRO 140 350 mg | Injection Site Reaction - Pain Post Injection - Site 1 | T5 (Week 5) | -12.8 score on a scale | Standard Deviation 13.9 |
| PRO 140 350 mg | Injection Site Reaction - Pain Post Injection - Site 1 | T6 (Week 6) | -6.8 score on a scale | Standard Deviation 16.7 |
| PRO 140 350 mg | Injection Site Reaction - Pain Post Injection - Site 1 | T7 (Week 7) | -13.5 score on a scale | Standard Deviation 13.9 |
| PRO 140 350 mg | Injection Site Reaction - Pain Post Injection - Site 1 | T8 (Week 8) | -16.6 score on a scale | Standard Deviation 14.8 |
| PRO 140 350 mg | Injection Site Reaction - Pain Post Injection - Site 1 | T9 (Week 9) | -15.0 score on a scale | Standard Deviation 14.2 |
| PRO 140 350 mg | Injection Site Reaction - Pain Post Injection - Site 1 | T10 (Week 10) | -17.2 score on a scale | Standard Deviation 12.3 |
| PRO 140 350 mg | Injection Site Reaction - Pain Post Injection - Site 1 | T11 (Week 11) | -24.0 score on a scale | Standard Deviation 18.1 |
| PRO 140 350 mg | Injection Site Reaction - Pain Post Injection - Site 1 | T12 (Week 12) | -22.0 score on a scale | Standard Deviation 18.4 |
| PRO 140 350 mg | Injection Site Reaction - Pain Post Injection - Site 1 | T13 (Week 13) | -17.0 score on a scale | Standard Deviation 15.6 |
| PRO 140 350 mg | Injection Site Reaction - Pain Post Injection - Site 1 | T14 (Week 14) | -22.0 score on a scale | Standard Deviation 19.1 |
Other Pre-specified
Injection Site Reaction - Pain Post Injection - Site 2
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.
Time frame: From initiation of PRO 140 monotherapy through week 14
Population: Safety
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| PRO 140 350 mg | Injection Site Reaction - Pain Post Injection - Site 2 | T1 (Week 1) | 17.4 score on a scale | Standard Deviation 15.2 |
| PRO 140 350 mg | Injection Site Reaction - Pain Post Injection - Site 2 | T2 (Week 2) | -2.0 score on a scale | Standard Deviation 14.2 |
| PRO 140 350 mg | Injection Site Reaction - Pain Post Injection - Site 2 | T3 (Week 3) | -4.8 score on a scale | Standard Deviation 11.8 |
| PRO 140 350 mg | Injection Site Reaction - Pain Post Injection - Site 2 | T4 (Week 4) | -7.8 score on a scale | Standard Deviation 12.2 |
| PRO 140 350 mg | Injection Site Reaction - Pain Post Injection - Site 2 | T5 (Week 5) | -8.8 score on a scale | Standard Deviation 15.7 |
| PRO 140 350 mg | Injection Site Reaction - Pain Post Injection - Site 2 | T6 (Week 6) | -7.2 score on a scale | Standard Deviation 17.6 |
| PRO 140 350 mg | Injection Site Reaction - Pain Post Injection - Site 2 | T7 (Week 7) | -10.4 score on a scale | Standard Deviation 14.8 |
| PRO 140 350 mg | Injection Site Reaction - Pain Post Injection - Site 2 | T8 (Week 8) | -13.0 score on a scale | Standard Deviation 15.9 |
| PRO 140 350 mg | Injection Site Reaction - Pain Post Injection - Site 2 | T9 (Week 9) | -14.6 score on a scale | Standard Deviation 16 |
| PRO 140 350 mg | Injection Site Reaction - Pain Post Injection - Site 2 | T10 (Week 10) | -10.7 score on a scale | Standard Deviation 9.1 |
| PRO 140 350 mg | Injection Site Reaction - Pain Post Injection - Site 2 | T11 (Week 11) | -14.7 score on a scale | Standard Deviation 13.3 |
| PRO 140 350 mg | Injection Site Reaction - Pain Post Injection - Site 2 | T12 (Week 12) | -15.2 score on a scale | Standard Deviation 14.8 |
| PRO 140 350 mg | Injection Site Reaction - Pain Post Injection - Site 2 | T13 (Week 13) | -10.0 score on a scale | Standard Deviation 10.3 |
| PRO 140 350 mg | Injection Site Reaction - Pain Post Injection - Site 2 | T14 (Week 14) | -13.8 score on a scale | Standard Deviation 18.5 |
Other Pre-specified
Injection Site Reaction - Pain Pre Injection - Site 1
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.
Time frame: From week 2 through week 14
Population: Safety
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| PRO 140 350 mg | Injection Site Reaction - Pain Pre Injection - Site 1 | T2 (Week 2) | 0.0 score on a scale | Standard Deviation 0 |
| PRO 140 350 mg | Injection Site Reaction - Pain Pre Injection - Site 1 | T3 (Week 3) | 2.8 score on a scale | Standard Deviation 8.4 |
| PRO 140 350 mg | Injection Site Reaction - Pain Pre Injection - Site 1 | T4 (Week 4) | 1.7 score on a scale | Standard Deviation 6.6 |
| PRO 140 350 mg | Injection Site Reaction - Pain Pre Injection - Site 1 | T5 (Week 5) | 2.2 score on a scale | Standard Deviation 4.2 |
| PRO 140 350 mg | Injection Site Reaction - Pain Pre Injection - Site 1 | T6 (Week 6) | 1.6 score on a scale | Standard Deviation 4.2 |
| PRO 140 350 mg | Injection Site Reaction - Pain Pre Injection - Site 1 | T7 (Week 7) | 1.0 score on a scale | Standard Deviation 4 |
| PRO 140 350 mg | Injection Site Reaction - Pain Pre Injection - Site 1 | T8 (Week 8) | 0.9 score on a scale | Standard Deviation 3.6 |
| PRO 140 350 mg | Injection Site Reaction - Pain Pre Injection - Site 1 | T9 (Week 9) | 1.6 score on a scale | Standard Deviation 4.1 |
| PRO 140 350 mg | Injection Site Reaction - Pain Pre Injection - Site 1 | T10 (Week 10) | 1.5 score on a scale | Standard Deviation 5.9 |
| PRO 140 350 mg | Injection Site Reaction - Pain Pre Injection - Site 1 | T11 (Week 11) | 1.3 score on a scale | Standard Deviation 4.7 |
| PRO 140 350 mg | Injection Site Reaction - Pain Pre Injection - Site 1 | T12 (Week 12) | 0.5 score on a scale | Standard Deviation 4.1 |
| PRO 140 350 mg | Injection Site Reaction - Pain Pre Injection - Site 1 | T13 (Week 13) | 0.6 score on a scale | Standard Deviation 1.3 |
| PRO 140 350 mg | Injection Site Reaction - Pain Pre Injection - Site 1 | T14 (Week 14) | 0.0 score on a scale | — |
Other Pre-specified
Injection Site Reaction - Pain Pre Injection - Site 2
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.
Time frame: From week 2 through week 14
Population: Safety
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| PRO 140 350 mg | Injection Site Reaction - Pain Pre Injection - Site 2 | T12 (Week 12) | 0.1 score on a scale | Standard Deviation 5.3 |
| PRO 140 350 mg | Injection Site Reaction - Pain Pre Injection - Site 2 | T2 (Week 2) | 0.0 score on a scale | Standard Deviation 0 |
| PRO 140 350 mg | Injection Site Reaction - Pain Pre Injection - Site 2 | T3 (Week 3) | 2.4 score on a scale | Standard Deviation 9.2 |
| PRO 140 350 mg | Injection Site Reaction - Pain Pre Injection - Site 2 | T4 (Week 4) | 4.8 score on a scale | Standard Deviation 19.9 |
| PRO 140 350 mg | Injection Site Reaction - Pain Pre Injection - Site 2 | T5 (Week 5) | 2.1 score on a scale | Standard Deviation 7.1 |
| PRO 140 350 mg | Injection Site Reaction - Pain Pre Injection - Site 2 | T6 (Week 6) | 2.0 score on a scale | Standard Deviation 7.1 |
| PRO 140 350 mg | Injection Site Reaction - Pain Pre Injection - Site 2 | T7 (Week 7) | 0.8 score on a scale | Standard Deviation 6.9 |
| PRO 140 350 mg | Injection Site Reaction - Pain Pre Injection - Site 2 | T8 (Week 8) | 1.1 score on a scale | Standard Deviation 6.5 |
| PRO 140 350 mg | Injection Site Reaction - Pain Pre Injection - Site 2 | T9 (Week 9) | 1.9 score on a scale | Standard Deviation 7.2 |
| PRO 140 350 mg | Injection Site Reaction - Pain Pre Injection - Site 2 | T10 (Week 10) | 1.7 score on a scale | Standard Deviation 8.5 |
| PRO 140 350 mg | Injection Site Reaction - Pain Pre Injection - Site 2 | T11 (Week 11) | 1.4 score on a scale | Standard Deviation 7.7 |
| PRO 140 350 mg | Injection Site Reaction - Pain Pre Injection - Site 2 | T13 (Week 13) | 0.4 score on a scale | Standard Deviation 0.8 |
| PRO 140 350 mg | Injection Site Reaction - Pain Pre Injection - Site 2 | T14 (Week 14) | 0.0 score on a scale | — |
Other Pre-specified
Injection Site Reaction - Pain (Site 1)
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.
Time frame: From initiation of PRO 140 monotherapy through week 14
Population: Safety
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| PRO 140 350 mg | Injection Site Reaction - Pain (Site 1) | T1 (Week 1) | absent | 43 Participants |
| PRO 140 350 mg | Injection Site Reaction - Pain (Site 1) | T1 (Week 1) | present | 0 Participants |
| PRO 140 350 mg | Injection Site Reaction - Pain (Site 1) | T2 (Week 2) | absent | 43 Participants |
| PRO 140 350 mg | Injection Site Reaction - Pain (Site 1) | T2 (Week 2) | present | 0 Participants |
| PRO 140 350 mg | Injection Site Reaction - Pain (Site 1) | T3 (Week 3) | absent | 43 Participants |
| PRO 140 350 mg | Injection Site Reaction - Pain (Site 1) | T3 (Week 3) | present | 0 Participants |
| PRO 140 350 mg | Injection Site Reaction - Pain (Site 1) | T4 (Week 4) | absent | 43 Participants |
| PRO 140 350 mg | Injection Site Reaction - Pain (Site 1) | T4 (Week 4) | present | 0 Participants |
| PRO 140 350 mg | Injection Site Reaction - Pain (Site 1) | T5 (Week 5) | absent | 43 Participants |
| PRO 140 350 mg | Injection Site Reaction - Pain (Site 1) | T5 (Week 5) | present | 0 Participants |
| PRO 140 350 mg | Injection Site Reaction - Pain (Site 1) | T6 (Week 6) | absent | 43 Participants |
| PRO 140 350 mg | Injection Site Reaction - Pain (Site 1) | T6 (Week 6) | present | 0 Participants |
| PRO 140 350 mg | Injection Site Reaction - Pain (Site 1) | T7 (Week 7) | absent | 41 Participants |
| PRO 140 350 mg | Injection Site Reaction - Pain (Site 1) | T7 (Week 7) | present | 0 Participants |
| PRO 140 350 mg | Injection Site Reaction - Pain (Site 1) | T8 (Week 8) | absent | 36 Participants |
| PRO 140 350 mg | Injection Site Reaction - Pain (Site 1) | T8 (Week 8) | present | 0 Participants |
| PRO 140 350 mg | Injection Site Reaction - Pain (Site 1) | T9 (Week 9) | absent | 33 Participants |
| PRO 140 350 mg | Injection Site Reaction - Pain (Site 1) | T9 (Week 9) | present | 0 Participants |
| PRO 140 350 mg | Injection Site Reaction - Pain (Site 1) | T10 (Week 10) | absent | 29 Participants |
| PRO 140 350 mg | Injection Site Reaction - Pain (Site 1) | T10 (Week 10) | present | 0 Participants |
| PRO 140 350 mg | Injection Site Reaction - Pain (Site 1) | T11 (Week 11) | absent | 29 Participants |
| PRO 140 350 mg | Injection Site Reaction - Pain (Site 1) | T11 (Week 11) | present | 0 Participants |
| PRO 140 350 mg | Injection Site Reaction - Pain (Site 1) | T12 (Week 12) | absent | 27 Participants |
| PRO 140 350 mg | Injection Site Reaction - Pain (Site 1) | T12 (Week 12) | present | 0 Participants |
| PRO 140 350 mg | Injection Site Reaction - Pain (Site 1) | T13 (Week 13) | absent | 22 Participants |
| PRO 140 350 mg | Injection Site Reaction - Pain (Site 1) | T13 (Week 13) | present | 1 Participants |
| PRO 140 350 mg | Injection Site Reaction - Pain (Site 1) | T14 (Week 14) | absent | 6 Participants |
| PRO 140 350 mg | Injection Site Reaction - Pain (Site 1) | T14 (Week 14) | present | 0 Participants |
Other Pre-specified
Injection Site Reaction - Pain (Site 2)
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.
Time frame: From initiation of PRO 140 monotherapy through week 14
Population: safety population
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| PRO 140 350 mg | Injection Site Reaction - Pain (Site 2) | T1 (Week 1) | absent | 43 Participants |
| PRO 140 350 mg | Injection Site Reaction - Pain (Site 2) | T1 (Week 1) | present | 0 Participants |
| PRO 140 350 mg | Injection Site Reaction - Pain (Site 2) | T2 (Week 2) | absent | 43 Participants |
| PRO 140 350 mg | Injection Site Reaction - Pain (Site 2) | T2 (Week 2) | present | 0 Participants |
| PRO 140 350 mg | Injection Site Reaction - Pain (Site 2) | T3 ( Week 3) | absent | 43 Participants |
| PRO 140 350 mg | Injection Site Reaction - Pain (Site 2) | T3 ( Week 3) | present | 0 Participants |
| PRO 140 350 mg | Injection Site Reaction - Pain (Site 2) | T4 (Week 4) | absent | 43 Participants |
| PRO 140 350 mg | Injection Site Reaction - Pain (Site 2) | T4 (Week 4) | present | 0 Participants |
| PRO 140 350 mg | Injection Site Reaction - Pain (Site 2) | T5 (Week 5) | absent | 43 Participants |
| PRO 140 350 mg | Injection Site Reaction - Pain (Site 2) | T5 (Week 5) | present | 0 Participants |
| PRO 140 350 mg | Injection Site Reaction - Pain (Site 2) | T6 (Week 6) | absent | 43 Participants |
| PRO 140 350 mg | Injection Site Reaction - Pain (Site 2) | T6 (Week 6) | present | 0 Participants |
| PRO 140 350 mg | Injection Site Reaction - Pain (Site 2) | T7 (Week 7) | absent | 41 Participants |
| PRO 140 350 mg | Injection Site Reaction - Pain (Site 2) | T7 (Week 7) | present | 0 Participants |
| PRO 140 350 mg | Injection Site Reaction - Pain (Site 2) | T8 (Week 8) | absent | 36 Participants |
| PRO 140 350 mg | Injection Site Reaction - Pain (Site 2) | T8 (Week 8) | present | 0 Participants |
| PRO 140 350 mg | Injection Site Reaction - Pain (Site 2) | T9 (Week 9) | absent | 29 Participants |
| PRO 140 350 mg | Injection Site Reaction - Pain (Site 2) | T9 (Week 9) | present | 0 Participants |
| PRO 140 350 mg | Injection Site Reaction - Pain (Site 2) | T10 (Week 10) | absent | 29 Participants |
| PRO 140 350 mg | Injection Site Reaction - Pain (Site 2) | T10 (Week 10) | present | 0 Participants |
| PRO 140 350 mg | Injection Site Reaction - Pain (Site 2) | T11 (Week 11) | absent | 29 Participants |
| PRO 140 350 mg | Injection Site Reaction - Pain (Site 2) | T11 (Week 11) | present | 0 Participants |
| PRO 140 350 mg | Injection Site Reaction - Pain (Site 2) | T12 (Week 12) | absent | 27 Participants |
| PRO 140 350 mg | Injection Site Reaction - Pain (Site 2) | T12 (Week 12) | present | 0 Participants |
| PRO 140 350 mg | Injection Site Reaction - Pain (Site 2) | T13 (Week 13) | absent | 23 Participants |
| PRO 140 350 mg | Injection Site Reaction - Pain (Site 2) | T13 (Week 13) | present | 0 Participants |
| PRO 140 350 mg | Injection Site Reaction - Pain (Site 2) | T14 ( Week 14) | absent | 6 Participants |
| PRO 140 350 mg | Injection Site Reaction - Pain (Site 2) | T14 ( Week 14) | present | 0 Participants |
Other Pre-specified
Injection Site Reaction - Pruritus With Injection (Site 1)
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.
Time frame: From initiation of PRO 140 monotherapy through week 14
Population: safety
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| PRO 140 350 mg | Injection Site Reaction - Pruritus With Injection (Site 1) | T1 (Week 1) | Absent | 43 Participants |
| PRO 140 350 mg | Injection Site Reaction - Pruritus With Injection (Site 1) | T1 (Week 1) | Present | 0 Participants |
| PRO 140 350 mg | Injection Site Reaction - Pruritus With Injection (Site 1) | T2 (Week 2) | Absent | 42 Participants |
| PRO 140 350 mg | Injection Site Reaction - Pruritus With Injection (Site 1) | T2 (Week 2) | Present | 1 Participants |
| PRO 140 350 mg | Injection Site Reaction - Pruritus With Injection (Site 1) | T3 (Week 3) | Absent | 43 Participants |
| PRO 140 350 mg | Injection Site Reaction - Pruritus With Injection (Site 1) | T3 (Week 3) | Present | 0 Participants |
| PRO 140 350 mg | Injection Site Reaction - Pruritus With Injection (Site 1) | T4 (Week 4) | Absent | 43 Participants |
| PRO 140 350 mg | Injection Site Reaction - Pruritus With Injection (Site 1) | T4 (Week 4) | Present | 0 Participants |
| PRO 140 350 mg | Injection Site Reaction - Pruritus With Injection (Site 1) | T5 (Week 5) | Absent | 43 Participants |
| PRO 140 350 mg | Injection Site Reaction - Pruritus With Injection (Site 1) | T5 (Week 5) | Present | 0 Participants |
| PRO 140 350 mg | Injection Site Reaction - Pruritus With Injection (Site 1) | T6 (Week 6) | Absent | 43 Participants |
| PRO 140 350 mg | Injection Site Reaction - Pruritus With Injection (Site 1) | T6 (Week 6) | Present | 0 Participants |
| PRO 140 350 mg | Injection Site Reaction - Pruritus With Injection (Site 1) | T7 (Week 7) | Absent | 41 Participants |
| PRO 140 350 mg | Injection Site Reaction - Pruritus With Injection (Site 1) | T7 (Week 7) | Present | 0 Participants |
| PRO 140 350 mg | Injection Site Reaction - Pruritus With Injection (Site 1) | T8 (Week 8) | Absent | 36 Participants |
| PRO 140 350 mg | Injection Site Reaction - Pruritus With Injection (Site 1) | T8 (Week 8) | Present | 0 Participants |
| PRO 140 350 mg | Injection Site Reaction - Pruritus With Injection (Site 1) | T9 (Week 9) | Absent | 33 Participants |
| PRO 140 350 mg | Injection Site Reaction - Pruritus With Injection (Site 1) | T9 (Week 9) | Present | 0 Participants |
| PRO 140 350 mg | Injection Site Reaction - Pruritus With Injection (Site 1) | T10 (Week 10) | Absent | 29 Participants |
| PRO 140 350 mg | Injection Site Reaction - Pruritus With Injection (Site 1) | T10 (Week 10) | Present | 0 Participants |
| PRO 140 350 mg | Injection Site Reaction - Pruritus With Injection (Site 1) | T11 (Week 11) | Absent | 29 Participants |
| PRO 140 350 mg | Injection Site Reaction - Pruritus With Injection (Site 1) | T11 (Week 11) | Present | 0 Participants |
| PRO 140 350 mg | Injection Site Reaction - Pruritus With Injection (Site 1) | T12 (Week 12) | Absent | 27 Participants |
| PRO 140 350 mg | Injection Site Reaction - Pruritus With Injection (Site 1) | T12 (Week 12) | Present | 0 Participants |
| PRO 140 350 mg | Injection Site Reaction - Pruritus With Injection (Site 1) | T13 (Week 13) | Absent | 23 Participants |
| PRO 140 350 mg | Injection Site Reaction - Pruritus With Injection (Site 1) | T13 (Week 13) | Present | 0 Participants |
| PRO 140 350 mg | Injection Site Reaction - Pruritus With Injection (Site 1) | T14 (Week 14) | Absent | 6 Participants |
| PRO 140 350 mg | Injection Site Reaction - Pruritus With Injection (Site 1) | T14 (Week 14) | Present | 0 Participants |
Other Pre-specified
Injection Site Reaction - Pruritus With Injection (Site 2)
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.
Time frame: From initiation of PRO 140 monotherapy through week14
Population: safety
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| PRO 140 350 mg | Injection Site Reaction - Pruritus With Injection (Site 2) | T1 (Week 1) | Absent | 43 Participants |
| PRO 140 350 mg | Injection Site Reaction - Pruritus With Injection (Site 2) | T1 (Week 1) | Present | 0 Participants |
| PRO 140 350 mg | Injection Site Reaction - Pruritus With Injection (Site 2) | T2 (Week 2) | Absent | 42 Participants |
| PRO 140 350 mg | Injection Site Reaction - Pruritus With Injection (Site 2) | T2 (Week 2) | Present | 1 Participants |
| PRO 140 350 mg | Injection Site Reaction - Pruritus With Injection (Site 2) | T3 (Week 3) | Absent | 43 Participants |
| PRO 140 350 mg | Injection Site Reaction - Pruritus With Injection (Site 2) | T3 (Week 3) | Present | 0 Participants |
| PRO 140 350 mg | Injection Site Reaction - Pruritus With Injection (Site 2) | T4 (Week 4) | Absent | 43 Participants |
| PRO 140 350 mg | Injection Site Reaction - Pruritus With Injection (Site 2) | T4 (Week 4) | Present | 0 Participants |
| PRO 140 350 mg | Injection Site Reaction - Pruritus With Injection (Site 2) | T5 (Week 5) | Absent | 43 Participants |
| PRO 140 350 mg | Injection Site Reaction - Pruritus With Injection (Site 2) | T5 (Week 5) | Present | 0 Participants |
| PRO 140 350 mg | Injection Site Reaction - Pruritus With Injection (Site 2) | T6 (Week 6) | Absent | 43 Participants |
| PRO 140 350 mg | Injection Site Reaction - Pruritus With Injection (Site 2) | T6 (Week 6) | Present | 0 Participants |
| PRO 140 350 mg | Injection Site Reaction - Pruritus With Injection (Site 2) | T7 (Week 7) | Absent | 41 Participants |
| PRO 140 350 mg | Injection Site Reaction - Pruritus With Injection (Site 2) | T7 (Week 7) | Present | 2 Participants |
| PRO 140 350 mg | Injection Site Reaction - Pruritus With Injection (Site 2) | T8 (Week 8) | Absent | 36 Participants |
| PRO 140 350 mg | Injection Site Reaction - Pruritus With Injection (Site 2) | T8 (Week 8) | Present | 0 Participants |
| PRO 140 350 mg | Injection Site Reaction - Pruritus With Injection (Site 2) | T9 (Week 9) | Absent | 33 Participants |
| PRO 140 350 mg | Injection Site Reaction - Pruritus With Injection (Site 2) | T9 (Week 9) | Present | 0 Participants |
| PRO 140 350 mg | Injection Site Reaction - Pruritus With Injection (Site 2) | T10 (Week 10) | Absent | 29 Participants |
| PRO 140 350 mg | Injection Site Reaction - Pruritus With Injection (Site 2) | T10 (Week 10) | Present | 0 Participants |
| PRO 140 350 mg | Injection Site Reaction - Pruritus With Injection (Site 2) | T11 (Week 11) | Absent | 29 Participants |
| PRO 140 350 mg | Injection Site Reaction - Pruritus With Injection (Site 2) | T11 (Week 11) | Present | 0 Participants |
| PRO 140 350 mg | Injection Site Reaction - Pruritus With Injection (Site 2) | T12 (Week 12) | Absent | 27 Participants |
| PRO 140 350 mg | Injection Site Reaction - Pruritus With Injection (Site 2) | T12 (Week 12) | Present | 0 Participants |
| PRO 140 350 mg | Injection Site Reaction - Pruritus With Injection (Site 2) | T13 (Week 13) | Absent | 23 Participants |
| PRO 140 350 mg | Injection Site Reaction - Pruritus With Injection (Site 2) | T13 (Week 13) | Present | 0 Participants |
| PRO 140 350 mg | Injection Site Reaction - Pruritus With Injection (Site 2) | T14 (Week 14) | Absent | 6 Participants |
| PRO 140 350 mg | Injection Site Reaction - Pruritus With Injection (Site 2) | T14 (Week 14) | Present | 0 Participants |
Other Pre-specified
Pro 140 Concentration
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).
Time frame: At week 4, week 8, week 12 and viral failure visits
Population: Safety
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| PRO 140 350 mg | Pro 140 Concentration | T4 (Week 4) | 18084 ng/ml |
| PRO 140 350 mg | Pro 140 Concentration | T8 (Week 8) | 22010 ng/ml |
| PRO 140 350 mg | Pro 140 Concentration | T12 (Week 12) | 26388 ng/ml |
| PRO 140 350 mg | Pro 140 Concentration | VF (Viral Failure) | 16258 ng/ml |