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| Name | Class |
|---|---|
| Amarex Clinical Research | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| PRO 140 | Experimental | PRO 140 350mg weekly SQ injection. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PRO 140 | Drug | CCR5 Antagonist |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | From initiation of PRO 140 monotherapy through week 14 or virological failure |
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of Subjects With Virologic Failure | Proportion of Participants with Virologic Failure after initiating PRO 140 monotherapy at or prior to Week 14. | From initiation of PRO 140 monotherapy through week 14 |
| Mean Change From Baseline in Viral Load |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | From initiation of PRO 140 monotherapy through week 14 |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jacob Lalezari, MD | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Quest Clinical Research | San Francisco | California | 94115 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 35358290 | Derived | Chang XL, Reed JS, Webb GM, Wu HL, Le J, Bateman KB, Greene JM, Pessoa C, Waytashek C, Weber WC, Hwang J, Fischer M, Moats C, Shiel O, Bochart RM, Crank H, Siess D, Giobbi T, Torgerson J, Agnor R, Gao L, Dhody K, Lalezari JP, Bandar IS, Carnate AM, Pang AS, Corley MJ, Kelly S, Pourhassan N, Smedley J, Bimber BN, Hansen SG, Ndhlovu LC, Sacha JB. Suppression of human and simian immunodeficiency virus replication with the CCR5-specific antibody Leronlimab in two species. PLoS Pathog. 2022 Mar 31;18(3):e1010396. doi: 10.1371/journal.ppat.1010396. eCollection 2022 Mar. |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | PRO 140 | PRO 140 350mg weekly SQ injection. PRO 140 350mg weekly SQ injection.: CCR5 Antagonist |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Per Protocol population | Posted | Mean | Standard Deviation | days | From initiation of PRO 140 monotherapy through week 14 or virological failure |
|
|
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).
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Leronlimab | Leronlimab Pro 140 | 0 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| transient ischemic attack | Nervous system disorders | MedDRA (17.0) | Systematic Assessment | TIA |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| nasopharyngitis | Infections and infestations | MedDRA (17.0) | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Joseph Meidling, Sr. Director Clinical Operations | CytoDyn Inc. | (360) 980-8524 | jmeidling@cytodyn.com |
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| ID | Term |
|---|---|
| D000163 | Acquired Immunodeficiency Syndrome |
| ID | Term |
|---|---|
| D015658 | HIV Infections |
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D007239 | Infections |
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| ID | Term |
|---|---|
| C420063 | leronlimab |
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| Historical data |
| Other |
Historical data (i.e., time to HIV-1 RNA viral load > 500 copies/mL of 29 days). |
|
Mean change in Viral Load (HIV-1 RNA levels - log 10 copies/ml)), at each visit within the 14-week treatment phase. |
| From initiation of PRO 140 monotherapy through week 14 |
| 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) | From baseline to virologic failure visit (VF). VF can occur at any time from Week 1 to Week 14. |
| Mean Change in CD4 Cell Count by Visit | Mean change in CD4 cell count, at each visit within the 14-week treatment phase | From baseline (week 2) through week 14 |
| Mean Change in CD4 Cell Count | Change from baseline in CD4 cell count, within the 14-week treatment phase | From baseline (week 2) to last visit |
| 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) | From baseline to virologic failure (VF occurring at any time from Week 1 to Week 12 or virologic failure which ever comes first) |
| 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) | From week 1 through treatment weeks 4, 8, 12 or VF visit |
| 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. | From initiation of PRO 140 monotherapy through week 14 |
| 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. | From initiation of PRO 140 monotherapy through week 14 |
| 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. | From initiation of PRO 140 monotherapy through week 14 |
| 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. | From initiation of PRO 140 monotherapy through week 14 |
| 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. | From initiation of PRO 140 monotherapy through week14 |
| 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. | From initiation of PRO 140 monotherapy through week 14 |
| 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. | From initiation of PRO 140 monotherapy through week14 |
| 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. | From initiation of PRO 140 monotherapy through week14 |
| 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. | From initiation of PRO 140 monotherapy through week 14 |
| 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. | From initiation of PRO 140 monotherapy through week 14 |
| 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. | From initiation of PRO 140 monotherapy through week 14 |
| 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. | From week 2 through week 14 |
| 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. | From week 2 through week 14 |
| 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). | At week 4, week 8, week 12 and viral failure visits |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Time since HIV Diagnosis (Years) | Mean | Standard Deviation | years |
|
|
|
| Secondary | Proportion of Subjects With Virologic Failure | Proportion of Participants with Virologic Failure after initiating PRO 140 monotherapy at or prior to Week 14. | Per Protocol | Posted | Number | poportion of subjects | From initiation of PRO 140 monotherapy through week 14 |
|
|
|
| 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. | Per Protocol population | Posted | Mean | Standard Deviation | log 10 copies/mL | From initiation of PRO 140 monotherapy through week 14 |
|
|
|
| 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) | Per Protocol | Posted | Mean | Standard Deviation | log 10 copies/ml | From baseline to virologic failure visit (VF). VF can occur at any time from Week 1 to Week 14. |
|
|
|
| Secondary | Mean Change in CD4 Cell Count by Visit | Mean change in CD4 cell count, at each visit within the 14-week treatment phase | Per protocol | Posted | Mean | Standard Deviation | cells/mm^3 | From baseline (week 2) through week 14 |
|
|
|
| Secondary | Mean Change in CD4 Cell Count | Change from baseline in CD4 cell count, within the 14-week treatment phase | Per Protocol | Posted | Mean | Standard Deviation | cells/mm^3 | From baseline (week 2) to last visit |
|
|
|
| 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) | Per Protocol | Posted | Count of Participants | Participants | From baseline to virologic failure (VF occurring at any time from Week 1 to Week 12 or virologic failure which ever comes first) |
|
|
|
| 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) | Per Protocol | Posted | Mean | Standard Deviation | score on a scale | From week 1 through treatment weeks 4, 8, 12 or VF visit |
|
|
|
| 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. | Safety | Posted | Count of Participants | Participants | From initiation of PRO 140 monotherapy through week 14 |
|
|
|
| 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. | safety population | Posted | Count of Participants | Participants | From initiation of PRO 140 monotherapy through week 14 |
|
|
|
| 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. | safety | Posted | Count of Participants | Participants | From initiation of PRO 140 monotherapy through week 14 |
|
|
|
| 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. | safety | Posted | Count of Participants | Participants | From initiation of PRO 140 monotherapy through week 14 |
|
|
|
| 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. | safety | Posted | Count of Participants | Participants | From initiation of PRO 140 monotherapy through week 14 |
|
|
|
| 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. | safety | Posted | Count of Participants | Participants | From initiation of PRO 140 monotherapy through week14 |
|
|
|
| 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. | safety | Posted | Count of Participants | Participants | From initiation of PRO 140 monotherapy through week 14 |
|
|
|
| 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. | safety | Posted | Count of Participants | Participants | From initiation of PRO 140 monotherapy through week14 |
|
|
|
| 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. | safety | Posted | Count of Participants | Participants | From initiation of PRO 140 monotherapy through week14 |
|
|
|
| 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. | safety | Posted | Count of Participants | Participants | From initiation of PRO 140 monotherapy through week 14 |
|
|
|
| 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. | Safety | Posted | Mean | Standard Deviation | score on a scale | From initiation of PRO 140 monotherapy through week 14 |
|
|
|
| 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. | Safety | Posted | Mean | Standard Deviation | score on a scale | From initiation of PRO 140 monotherapy through week 14 |
|
|
|
| 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. | Safety | Posted | Mean | Standard Deviation | score on a scale | From week 2 through week 14 |
|
|
|
| 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. | Safety | Posted | Mean | Standard Deviation | score on a scale | From week 2 through week 14 |
|
|
|
| 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). | Safety | Posted | Mean | Inter-Quartile Range | ng/ml | At week 4, week 8, week 12 and viral failure visits |
|
|
|
| 43 |
| 1 |
| 43 |
| 7 |
| 43 |
|
| Constipation | Gastrointestinal disorders | MedDRA (17.0) | Systematic Assessment |
|
| Diarrhoea | Gastrointestinal disorders | MedDRA (17.0) | Systematic Assessment |
|
| nausea | Gastrointestinal disorders | MedDRA (17.0) | Systematic Assessment |
|
| Fatigue | General disorders | MedDRA (17.0) | Systematic Assessment |
|
| Injection site pruritus | General disorders | MedDRA (17.0) | Systematic Assessment |
|
| Dizziness | Nervous system disorders | MedDRA (17.0) | Systematic Assessment |
|
Not provided
Not provided
| D015229 |
| Sexually Transmitted Diseases, Viral |
| D012749 | Sexually Transmitted Diseases |
| D016180 | Lentivirus Infections |
| D012192 | Retroviridae Infections |
| D012327 | RNA Virus Infections |
| D014777 | Virus Diseases |
| D012897 | Slow Virus Diseases |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D007153 | Immunologic Deficiency Syndromes |
| D007154 | Immune System Diseases |
| Title | Measurements |
|---|---|
|
| T4 (Week 4) |
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| T5 (Week 5) |
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| T6 (Week 6) |
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| T7 (Week 7) |
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| T8 (Week 8) |
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| T9 (Week 9) |
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| T10 (Week 10) |
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| T11 (Week 11) |
|
|
| T12 (Week 12) |
|
|
| T13 (Week 13) |
|
|
| T14 (Week 14) |
|
|
| Title | Measurements |
|---|---|
|
| T4 (Week 4) |
|
|
| T5 (Week 5) |
|
|
| T6 (Week 6) |
|
|
| T7 (Week 7) |
|
|
| T8 (Week 8) |
|
|
| T9 (Week 9) |
|
|
| T10 (Week 10) |
|
|
| T11 (Week 11) |
|
|
| T12 (Week 12) |
|
|
| T13 (Week 13) |
|
|
| T14 (Week 14) |
|
|
| VF (Viral failure) |
|
|
| Very Good |
|
| Excellent |
|
| Missing |
|
| T4 (Week 4) |
|
| T8 (Week 8) |
|
| T12 (Week 12) |
|
| VF (Virologic Failure) |
|
|
| T8 (Week 8) |
|
|
| T12 (Week 12) |
|
|
| VF (Viral Failure) |
|
|
| T2 (Week 2) |
|
|
| T3 (Week 3) |
|
|
| T4 (Week 4) |
|
|
| T5 (Week 5) |
|
|
| T6 (Week 6) |
|
|
| T7 (Week 7) |
|
|
| T8 (Week 8) |
|
|
| T9 (Week 9) |
|
|
| T10 (Week 10) |
|
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| T11 (Week 11) |
|
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| T12 (Week 12) |
|
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| T13 (Week 13) |
|
|
| T14 (Week 14) |
|
|
| T2 (Week 2) |
|
|
| T3 ( Week 3) |
|
|
| T4 (Week 4) |
|
|
| T5 (Week 5) |
|
|
| T6 (Week 6) |
|
|
| T7 (Week 7) |
|
|
| T8 (Week 8) |
|
|
| T9 (Week 9) |
|
|
| T10 (Week 10) |
|
|
| T11 (Week 11) |
|
|
| T12 (Week 12) |
|
|
| T13 (Week 13) |
|
|
| T14 ( Week 14) |
|
|
| T2 (Week 2) |
|
|
| T3 (Week 3) |
|
|
| T4 (Week 4) |
|
|
| T5 (Week 5) |
|
|
| T6 (Week 6) |
|
|
| T7 (Week 7) |
|
|
| T8 (Week 8) |
|
|
| T9 (Week 9) |
|
|
| T10 (Week 10) |
|
|
| T11 (Week 11) |
|
|
| T12 (Week 12) |
|
|
| T13 (Week 13) |
|
|
| T14 (Week 14) |
|
|
| T2 (Week 2) |
|
|
| T3 (Week 3) |
|
|
| T4 (Week 4) |
|
|
| T5 (Week 5) |
|
|
| T6 (Week 6) |
|
|
| T7 (Week 7) |
|
|
| T8 (Week 8) |
|
|
| T9 (Week 9) |
|
|
| T10 (Week 10) |
|
|
| T11 (Week 11) |
|
|
| T12 (Week 12) |
|
|
| T13 (Week 13) |
|
|
| T14 (Week 14) |
|
|
| T2 (Week 2) |
|
|
| T3 (Week 3) |
|
|
| T4 (Week 4) |
|
|
| T5 (Week 5) |
|
|
| T6 (Week 6) |
|
|
| T7 (Week 7) |
|
|
| T8 (Week 8) |
|
|
| T9 (Week 9) |
|
|
| T10 (Week 10) |
|
|
| T11 (Week 11) |
|
|
| T12 (Week 12) |
|
|
| T13 (Week 13) |
|
|
| T14 (Week 14) |
|
|
| T2 (Week 2) |
|
|
| T3 (Week 3) |
|
|
| T4 (Week 4) |
|
|
| T5 (Week 5) |
|
|
| T6 (Week 6) |
|
|
| T7 (Week 7) |
|
|
| T8 (Week 8) |
|
|
| T9 (Week 9) |
|
|
| T10 (Week 10) |
|
|
| T11 (Week 11) |
|
|
| T12 (Week 12) |
|
|
| T13 (Week 13) |
|
|
| T14 (Week 14) |
|
|
| T2 (Week 2) |
|
|
| T3 (Week 3) |
|
|
| T4 (Week 4) |
|
|
| T5 (Week 5) |
|
|
| T6 (Week 6) |
|
|
| T7 (Week 7) |
|
|
| T8 (Week 8) |
|
|
| T9 (Week 9) |
|
|
| T10 (Week 10) |
|
|
| T11 (Week 11) |
|
|
| T12 (Week 12) |
|
|
| T13 (Week 13) |
|
|
| T14 (Week 14) |
|
|
| T2 (Week 2) |
|
|
| T3 (Week 3) |
|
|
| T4 (Week 4) |
|
|
| T5 (Week 5) |
|
|
| T6 (Week 6) |
|
|
| T7 (Week 7) |
|
|
| T8 (Week 8) |
|
|
| T9 (Week 9) |
|
|
| T10 (Week 10) |
|
|
| T11 (Week 11) |
|
|
| T12 (Week 12) |
|
|
| T13 (Week 13) |
|
|
| T14 (Week 14) |
|
|
| T2 (Week 2) |
|
|
| T3 (Week 3) |
|
|
| T4 (Week 4) |
|
|
| T5 (Week 5) |
|
|
| T6 (Week 6) |
|
|
| T7 (Week 7) |
|
|
| T8 (Week 8) |
|
|
| T9 (Week 9) |
|
|
| T10 (Week 10) |
|
|
| T11 (Week 11) |
|
|
| T12 (Week 12) |
|
|
| T13 (Week 13) |
|
|
| T14 (Week 14) |
|
|
| T2 (Week 2) |
|
|
| T3 (Week 3) |
|
|
| T4 (Week 4) |
|
|
| T5 (Week 5) |
|
|
| T6 (Week 6) |
|
|
| T7 (Week 7) |
|
|
| T8 (Week 8) |
|
|
| T9 (Week 9) |
|
|
| T10 (Week 10) |
|
|
| T11 (Week 11) |
|
|
| T12 (Week 12) |
|
|
| T13 (Week 13) |
|
|
| T14 (Week 14) |
|
|
|
| T3 (Week 3) |
|
|
| T4 (Week 4) |
|
|
| T5 (Week 5) |
|
|
| T6 (Week 6) |
|
|
| T7 (Week 7) |
|
|
| T8 (Week 8) |
|
|
| T9 (Week 9) |
|
|
| T10 (Week 10) |
|
|
| T11 (Week 11) |
|
|
| T12 (Week 12) |
|
|
| T13 (Week 13) |
|
|
| T14 (Week 14) |
|
|
|
| T3 (Week 3) |
|
|
| T4 (Week 4) |
|
|
| T5 (Week 5) |
|
|
| T6 (Week 6) |
|
|
| T7 (Week 7) |
|
|
| T8 (Week 8) |
|
|
| T9 (Week 9) |
|
|
| T10 (Week 10) |
|
|
| T11 (Week 11) |
|
|
| T12 (Week 12) |
|
|
| T13 (Week 13) |
|
|
| T14 (Week 14) |
|
|
|
| T4 (Week 4) |
|
|
| T5 (Week 5) |
|
|
| T6 (Week 6) |
|
|
| T7 (Week 7) |
|
|
| T8 (Week 8) |
|
|
| T9 (Week 9) |
|
|
| T10 (Week 10) |
|
|
| T11 (Week 11) |
|
|
| T12 (Week 12) |
|
|
| T13 (Week 13) |
|
|
| T14 (Week 14) |
|
|
|
| T4 (Week 4) |
|
|
| T5 (Week 5) |
|
|
| T6 (Week 6) |
|
|
| T7 (Week 7) |
|
|
| T8 (Week 8) |
|
|
| T9 (Week 9) |
|
|
| T10 (Week 10) |
|
|
| T11 (Week 11) |
|
|
| T12 (Week 12) |
|
|
| T13 (Week 13) |
|
|
| T14 (Week 14) |
|
|
|
| T12 (Week 12) |
|
|
| VF (Viral Failure) |
|
|