Trial Outcomes & Findings for Randomized, Double-Blind, Placebo-Controlled Trial, Followed by Single-Arm Treatment of PRO 140 (NCT NCT02483078)

Last Updated: 2022-11-03

Results Overview

The primary efficacy endpoint will be proportion of participants with a 0.5 log10 or greater reduction in HIV-1 RNA viral load from baseline at the end of the one week double-blind treatment period (Part 1).

Recruitment status

COMPLETED

Study phase

PHASE2/PHASE3

Target enrollment

52 participants

Primary outcome timeframe

From baseline visit to week 1 visit

Results posted on

2022-11-03

Participant Flow

Participants were enrolled from U.S. sites only. The first participant was enrolled on 21 October 2015 and the last subject completed the study on 25 July 2018.

365 participants were screened.

Participant milestones

Participant milestones
Measure	PRO 140 PRO140 350mg weekly SC Inj. + existing ART for one week. After one week, all subjects will enter the 24-week single-arm, open-label treatment period. During this period, all subjects will receive PRO 140 SC injection and Optimized Background Therapy. PRO 140: PRO 140 is a humanized IgG4,κ monoclonal antibody (mAb) to the chemokine receptor CCR5. Optimized Background Regimen: Optimized background therapy (OBT) is chosen on the basis of a subject's resistance test results and treatment history.	Placebo Placebo weekly SC Inj. + existing ART for one week. After one week, all subjects will enter the 24-week single-arm, open-label treatment period. During this period, all subjects will receive PRO 140 SC injection and Optimized Background Therapy. Placebo Optimized Background Regimen: Optimized background therapy (OBT) is chosen on the basis of a subject's resistance test results and treatment history.
Part 1 One-week Randomized STARTED	25	27
Part 1 One-week Randomized COMPLETED	25	26
Part 1 One-week Randomized NOT COMPLETED	0	1
Part 2 Open Label Treatment Period STARTED	25	26
Part 2 Open Label Treatment Period COMPLETED	25	21
Part 2 Open Label Treatment Period NOT COMPLETED	0	5

Reasons for withdrawal

Reasons for withdrawal
Measure	PRO 140 PRO140 350mg weekly SC Inj. + existing ART for one week. After one week, all subjects will enter the 24-week single-arm, open-label treatment period. During this period, all subjects will receive PRO 140 SC injection and Optimized Background Therapy. PRO 140: PRO 140 is a humanized IgG4,κ monoclonal antibody (mAb) to the chemokine receptor CCR5. Optimized Background Regimen: Optimized background therapy (OBT) is chosen on the basis of a subject's resistance test results and treatment history.	Placebo Placebo weekly SC Inj. + existing ART for one week. After one week, all subjects will enter the 24-week single-arm, open-label treatment period. During this period, all subjects will receive PRO 140 SC injection and Optimized Background Therapy. Placebo Optimized Background Regimen: Optimized background therapy (OBT) is chosen on the basis of a subject's resistance test results and treatment history.
Part 1 One-week Randomized Lost to Follow-up	0	1
Part 2 Open Label Treatment Period Non-medical	0	1
Part 2 Open Label Treatment Period Withdrawal by Subject	0	1
Part 2 Open Label Treatment Period Subject non compliant	0	1
Part 2 Open Label Treatment Period Lost to Follow-up	0	1
Part 2 Open Label Treatment Period Adverse Event	0	1

Baseline Characteristics

Randomized, Double-Blind, Placebo-Controlled Trial, Followed by Single-Arm Treatment of PRO 140

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	PRO 140 n=25 Participants PRO140 350mg weekly SC Inj. + existing ART for one week. After one week, all subjects will enter the 24-week single-arm, open-label treatment period. During this period, all subjects will receive PRO 140 SC injection and Optimized Background Therapy. PRO 140: PRO 140 is a humanized IgG4,κ monoclonal antibody (mAb) to the chemokine receptor CCR5. Optimized Background Regimen: Optimized background therapy (OBT) is chosen on the basis of a subject's resistance test results and treatment history.	Placebo n=27 Participants Placebo weekly SC Inj. + existing ART for one week. After one week, all subjects will enter the 24-week single-arm, open-label treatment period. During this period, all subjects will receive PRO 140 SC injection and Optimized Background Therapy. Placebo Optimized Background Regimen: Optimized background therapy (OBT) is chosen on the basis of a subject's resistance test results and treatment history.	Total n=52 Participants Total of all reporting groups
Age, Continuous	52.4 years STANDARD_DEVIATION 8.6 • n=5 Participants	52.4 years STANDARD_DEVIATION 6.7 • n=7 Participants	52.4 years STANDARD_DEVIATION 7.6 • n=5 Participants
Sex: Female, Male Female	8 Participants n=5 Participants	6 Participants n=7 Participants	14 Participants n=5 Participants
Sex: Female, Male Male	17 Participants n=5 Participants	21 Participants n=7 Participants	38 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	11 Participants n=5 Participants	13 Participants n=7 Participants	24 Participants n=5 Participants
Race (NIH/OMB) White	14 Participants n=5 Participants	13 Participants n=7 Participants	27 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Region of Enrollment United States	25 participants n=5 Participants	27 participants n=7 Participants	52 participants n=5 Participants
Time since HIV Diagnosis	20.0 years STANDARD_DEVIATION 9.5 • n=5 Participants	20.8 years STANDARD_DEVIATION 9.4 • n=7 Participants	20.4 years STANDARD_DEVIATION 9.4 • n=5 Participants
Lowest CD4+ Cell Count <200 cells/mm^3	10 Participants n=5 Participants	12 Participants n=7 Participants	22 Participants n=5 Participants
Lowest CD4+ Cell Count 200-500 cells/mm^3	13 Participants n=5 Participants	14 Participants n=7 Participants	27 Participants n=5 Participants
Lowest CD4+ Cell Count >500 cells/mm^3	2 Participants n=5 Participants	1 Participants n=7 Participants	3 Participants n=5 Participants
Number of ART Drug Exposure Prior to Enrollment	11.8 Number of ART Drugs prior to enrolment STANDARD_DEVIATION 4.8 • n=5 Participants	9.6 Number of ART Drugs prior to enrolment STANDARD_DEVIATION 4.2 • n=7 Participants	10.7 Number of ART Drugs prior to enrolment STANDARD_DEVIATION 4.6 • n=5 Participants
Number of ART Drug with Documented Resistance	9.4 Number of ART drugs with resistance STANDARD_DEVIATION 5.8 • n=5 Participants	8.8 Number of ART drugs with resistance STANDARD_DEVIATION 3.3 • n=7 Participants	9.1 Number of ART drugs with resistance STANDARD_DEVIATION 4.6 • n=5 Participants

PRIMARY outcome

Timeframe: From baseline visit to week 1 visit

Population: The primary population used for this analysis was the ITT population, defined as subjects who were randomized and had received at least one (1) dose of leronlimab (PRO 140) or placebo

Outcome measures

Outcome measures
Measure	PRO 140 n=25 Participants PRO140 350mg weekly SC Inj. + existing ART for one week. After one week, all subjects will enter the 24-week single-arm, open-label treatment period. During this period, all subjects will receive PRO 140 SC injection and Optimized Background Therapy. PRO 140: PRO 140 is a humanized IgG4,κ monoclonal antibody (mAb) to the chemokine receptor CCR5. Optimized Background Regimen: Optimized background therapy (OBT) is chosen on the basis of a subject's resistance test results and treatment history.	Placebo n=27 Participants Placebo weekly SC Inj. + existing ART for one week. After one week, all subjects will enter the 24-week single-arm, open-label treatment period. During this period, all subjects will receive PRO 140 SC injection and Optimized Background Therapy. Placebo Optimized Background Regimen: Optimized background therapy (OBT) is chosen on the basis of a subject's resistance test results and treatment history.
Proportion of Participants With ≥ 0.5 log10 Reduction in HIV-1 RNA Viral Load From Baseline at the End of the 1-week Double-blind Treatment Period With >= 0.5 LOG10 IN HIV-1 RNA VIRAL Load Change from Baseline	.64 Proportion of subjects	.23 Proportion of subjects
Proportion of Participants With ≥ 0.5 log10 Reduction in HIV-1 RNA Viral Load From Baseline at the End of the 1-week Double-blind Treatment Period Without >= 0.5 LOG10 IN HIV-1 RNA VIRAL Load Change from Baseline	.36 Proportion of subjects	.77 Proportion of subjects

SECONDARY outcome

Timeframe: From baseline visit to week 1 visit

Population: The total number of participants in the study ITT population, 52, is further stratified into two subgroups as follows: 1. Participants with Resistance to ART Drugs Within Two Drug Class With Limited Treatment Option (N = 24) 2. Participants with resistance to ART Drugs Within Three Drug Classes (N = 28) This measure includes only the 24 participants with Resistance to ART Drugs Within Two Drug Class With Limited Treatment Option

Proportion of participants with ≥ 0.5 log10 reduction in HIV-1 RNA viral load from baseline at the end of the 1-week double-blind treatment period, stratified to each group: a. resistance to ART drugs within two drug class with limited treatment option (N = 24). This outcome measures the proportion of participants that are classified as having a resistance to ART drugs within two drug classes and with limited treatment options with ≥ 0.5 log10 reduction in HIV-1 RNA viral load from baseline at the end of the 1-week double-blind treatment period . The total number of participants in the study ITT population, 52, is further stratified into two subgroups: 1. Participants with resistance to ART Drugs Within Two Drug Class With Limited Treatment Option (N = 24) 2. Participants with resistance to ART Drugs Within Three Drug Classes (N = 28) This measure includes only the 24 participants with Resistance to ART Drugs Within Two Drug Class With Limited Treatment Options

Outcome measures

Outcome measures
Measure	PRO 140 n=11 Participants PRO140 350mg weekly SC Inj. + existing ART for one week. After one week, all subjects will enter the 24-week single-arm, open-label treatment period. During this period, all subjects will receive PRO 140 SC injection and Optimized Background Therapy. PRO 140: PRO 140 is a humanized IgG4,κ monoclonal antibody (mAb) to the chemokine receptor CCR5. Optimized Background Regimen: Optimized background therapy (OBT) is chosen on the basis of a subject's resistance test results and treatment history.	Placebo n=13 Participants Placebo weekly SC Inj. + existing ART for one week. After one week, all subjects will enter the 24-week single-arm, open-label treatment period. During this period, all subjects will receive PRO 140 SC injection and Optimized Background Therapy. Placebo Optimized Background Regimen: Optimized background therapy (OBT) is chosen on the basis of a subject's resistance test results and treatment history.
Proportion of Participants With ≥ 0.5 log10 Reduction in HIV-1 RNA Viral Load From Baseline at the End of the 1-week Double-blind Treatment Period, Stratified to Each Group: Resistance to ART Drugs Within Two Drug Class With Limited Treatment Option.	.7273 Proportion of participants	.2308 Proportion of participants

SECONDARY outcome

Timeframe: From baseline visit to week 1 visit

Population: The total number of participants in the study ITT population, 52, is further stratified into two subgroups as follows: 1. Participants with resistance to ART Drugs Within Two Drug Class With Limited Treatment Options (N = 24) 2. Participants with resistance to ART Drugs Within Three Drug Classes (N = 28) This measure includes only the 28 participants with resistance to ART drugs within three drug classes

Proportion of participants with ≥ 0.5 log10 reduction in HIV-1 RNA viral load from baseline at the end of the 1-week double-blind treatment period, stratified to each group: a. Resistance to ART drugs within three drug classes (N = 28) This outcome measures the proportion of participants that are classified as having a resistance to ART drugs within two drug classes and with limited treatment options with ≥ 0.5 log10 reduction in HIV-1 RNA viral load from baseline at the end of the 1-week double-blind treatment period . The total number of participants in the study ITT population, 52, is further stratified into two subgroups as follows: 1. Participants with Resistance to ART Drugs Within Two Drug Class With Limited Treatment Option (N = 24) 2. Participants with resistance to ART Drugs Within Three Drug Classes (N = 28) This measure includes only the 28 participants with resistance to ART drugs within three drug classes

Outcome measures

Outcome measures
Measure	PRO 140 n=14 Participants PRO140 350mg weekly SC Inj. + existing ART for one week. After one week, all subjects will enter the 24-week single-arm, open-label treatment period. During this period, all subjects will receive PRO 140 SC injection and Optimized Background Therapy. PRO 140: PRO 140 is a humanized IgG4,κ monoclonal antibody (mAb) to the chemokine receptor CCR5. Optimized Background Regimen: Optimized background therapy (OBT) is chosen on the basis of a subject's resistance test results and treatment history.	Placebo n=14 Participants Placebo weekly SC Inj. + existing ART for one week. After one week, all subjects will enter the 24-week single-arm, open-label treatment period. During this period, all subjects will receive PRO 140 SC injection and Optimized Background Therapy. Placebo Optimized Background Regimen: Optimized background therapy (OBT) is chosen on the basis of a subject's resistance test results and treatment history.
Proportion of Participants With ≥ 0.5 log10 Reduction in HIV-1 RNA Viral Load From Baseline at the End of the 1-week Double-blind Treatment Period, Stratified to Each Group: Resistance to ART Drugs Within Three Drug Classes	.5714 Proportion of participants	.2308 Proportion of participants

SECONDARY outcome

Timeframe: From baseline visit to week 1 visit

Population: Intent-to-Treat: The Intent-to-Treat (ITT) population was defined as the set of subjects who were randomized and had received at least one (1) dose of leronlimab (PRO 140) or placebo. This population was to be used as the primary analysis population for the primary and secondary endpoints.

The raw and change from baseline in HIV-1 RNA levels (log10 copies/mL) at the end of the 1-week double-blind treatment period was to be summarized by treatment group for the first week during the double-blind treatment phase. For change from baseline summaries, subjects with an undefined change from baseline, because of missing data, were to be excluded. The change from baseline in HIV-1 RNA levels was to be compared between the two (2) groups using Analysis of covariance (ANCOVA) with the stratification factor (i.e., Resistance to ART drugs at the time of randomization) included in the model.

Outcome measures

Outcome measures
Measure	PRO 140 n=25 Participants PRO140 350mg weekly SC Inj. + existing ART for one week. After one week, all subjects will enter the 24-week single-arm, open-label treatment period. During this period, all subjects will receive PRO 140 SC injection and Optimized Background Therapy. PRO 140: PRO 140 is a humanized IgG4,κ monoclonal antibody (mAb) to the chemokine receptor CCR5. Optimized Background Regimen: Optimized background therapy (OBT) is chosen on the basis of a subject's resistance test results and treatment history.	Placebo n=27 Participants Placebo weekly SC Inj. + existing ART for one week. After one week, all subjects will enter the 24-week single-arm, open-label treatment period. During this period, all subjects will receive PRO 140 SC injection and Optimized Background Therapy. Placebo Optimized Background Regimen: Optimized background therapy (OBT) is chosen on the basis of a subject's resistance test results and treatment history.
Mean Change From Baseline in HIV-1 RNA Levels (log10 Copies/mL) at the End of the 1-week Double-blind Treatment Period for All Patients and Within Each Stratum	0.6 Log10 Copies/mL Standard Deviation 0.45	0.1 Log10 Copies/mL Standard Deviation 0.51

SECONDARY outcome

Timeframe: 25 weeks

Population: The Intent-to-Treat (ITT) population was defined as the set of subjects who were randomized and received at least one (1) dose of leronlimab (PRO 140) or placebo

The number and percentages of subjects achieving HIV-1 RNA \< 400 copies/mL at Week 25, from the open label portion of the study, are presented

Outcome measures

Outcome measures
Measure	PRO 140 n=52 Participants PRO140 350mg weekly SC Inj. + existing ART for one week. After one week, all subjects will enter the 24-week single-arm, open-label treatment period. During this period, all subjects will receive PRO 140 SC injection and Optimized Background Therapy. PRO 140: PRO 140 is a humanized IgG4,κ monoclonal antibody (mAb) to the chemokine receptor CCR5. Optimized Background Regimen: Optimized background therapy (OBT) is chosen on the basis of a subject's resistance test results and treatment history.	Placebo Placebo weekly SC Inj. + existing ART for one week. After one week, all subjects will enter the 24-week single-arm, open-label treatment period. During this period, all subjects will receive PRO 140 SC injection and Optimized Background Therapy. Placebo Optimized Background Regimen: Optimized background therapy (OBT) is chosen on the basis of a subject's resistance test results and treatment history.
Percentage of Participants Achieving HIV-1 RNA < 400 Copies/mL at Week 25 for All Patients and Within Each Stratum With HIV-1 RNA < 400 Copies/mL at Week 25	37 Participants	—
Percentage of Participants Achieving HIV-1 RNA < 400 Copies/mL at Week 25 for All Patients and Within Each Stratum Without HIV-1 RNA < 400 Copies/mL at Week 25	3 Participants	—
Percentage of Participants Achieving HIV-1 RNA < 400 Copies/mL at Week 25 for All Patients and Within Each Stratum Missing	12 Participants	—

SECONDARY outcome

Timeframe: 25 weeks

Population: The Intent-to-Treat (ITT) population was defined as the set of subjects who were randomized and received at least one (1) dose of leronlimab (PRO 140) or placebo

The number and percentages of subjects achieving HIV-1 RNA \< 50 copies/mL at Week 25 are presented. This is from the 24 week open label portion of the of the trial.

Outcome measures

Outcome measures
Measure	PRO 140 n=52 Participants PRO140 350mg weekly SC Inj. + existing ART for one week. After one week, all subjects will enter the 24-week single-arm, open-label treatment period. During this period, all subjects will receive PRO 140 SC injection and Optimized Background Therapy. PRO 140: PRO 140 is a humanized IgG4,κ monoclonal antibody (mAb) to the chemokine receptor CCR5. Optimized Background Regimen: Optimized background therapy (OBT) is chosen on the basis of a subject's resistance test results and treatment history.	Placebo Placebo weekly SC Inj. + existing ART for one week. After one week, all subjects will enter the 24-week single-arm, open-label treatment period. During this period, all subjects will receive PRO 140 SC injection and Optimized Background Therapy. Placebo Optimized Background Regimen: Optimized background therapy (OBT) is chosen on the basis of a subject's resistance test results and treatment history.
Percentage and Number of Participants Achieving HIV-1 RNA < 50 Copies/mL at Week 25 for All Patients and Within Each Stratum With HIV-1 RNA < 50 Copies/mL at Week 25	32 Participants	—
Percentage and Number of Participants Achieving HIV-1 RNA < 50 Copies/mL at Week 25 for All Patients and Within Each Stratum Without HIV-1 RNA < 50 Copies/mL at Week 25	8 Participants	—
Percentage and Number of Participants Achieving HIV-1 RNA < 50 Copies/mL at Week 25 for All Patients and Within Each Stratum Missing	12 Participants	—

SECONDARY outcome

Timeframe: 25 weeks

Population: The Intent-to-Treat (ITT) population was defined as the set of subjects who were randomized and received at least one (1) dose of leronlimab (PRO 140) or placebo

The raw and change from baseline in HIV-1 RNA levels (log10 copies/mL) at Week 25 was to be summarized for each week during the treatment phase. For change from baseline summaries, subjects with an undefined change from baseline, because of missing data, were to be excluded.

Outcome measures

Outcome measures
Measure	PRO 140 n=52 Participants PRO140 350mg weekly SC Inj. + existing ART for one week. After one week, all subjects will enter the 24-week single-arm, open-label treatment period. During this period, all subjects will receive PRO 140 SC injection and Optimized Background Therapy. PRO 140: PRO 140 is a humanized IgG4,κ monoclonal antibody (mAb) to the chemokine receptor CCR5. Optimized Background Regimen: Optimized background therapy (OBT) is chosen on the basis of a subject's resistance test results and treatment history.	Placebo Placebo weekly SC Inj. + existing ART for one week. After one week, all subjects will enter the 24-week single-arm, open-label treatment period. During this period, all subjects will receive PRO 140 SC injection and Optimized Background Therapy. Placebo Optimized Background Regimen: Optimized background therapy (OBT) is chosen on the basis of a subject's resistance test results and treatment history.
Mean Change From Baseline in HIV-1 RNA Levels (log10 Copies/mL) at Week 25 for All Patients and Within Each Stratum	2.4 Log10 copies/mL Standard Deviation 1.42	—

SECONDARY outcome

Timeframe: From baseline visit to week 1 visit

Population: The Intent-to-Treat (ITT) population was defined as the set of subjects who were randomized and received at least one (1) dose of leronlimab (PRO 140) or placebo

The raw and change from baseline in CD4 cell count at the end of the 1-week double blind treatment period was to be summarized by treatment group for the first week during the double-blind treatment phase. For change from baseline summaries, subjects with an undefined change from baseline, because of missing data, were to be excluded.

Outcome measures

Outcome measures
Measure	PRO 140 n=25 Participants PRO140 350mg weekly SC Inj. + existing ART for one week. After one week, all subjects will enter the 24-week single-arm, open-label treatment period. During this period, all subjects will receive PRO 140 SC injection and Optimized Background Therapy. PRO 140: PRO 140 is a humanized IgG4,κ monoclonal antibody (mAb) to the chemokine receptor CCR5. Optimized Background Regimen: Optimized background therapy (OBT) is chosen on the basis of a subject's resistance test results and treatment history.	Placebo n=27 Participants Placebo weekly SC Inj. + existing ART for one week. After one week, all subjects will enter the 24-week single-arm, open-label treatment period. During this period, all subjects will receive PRO 140 SC injection and Optimized Background Therapy. Placebo Optimized Background Regimen: Optimized background therapy (OBT) is chosen on the basis of a subject's resistance test results and treatment history.
Mean Change From Baseline in CD4 Cell Count at the End of the 1-week Double-blind Treatment Period for All Patients and Within Each Stratum	41.1 CD4 Cell Count Standard Deviation 154	25 CD4 Cell Count Standard Deviation 131

SECONDARY outcome

Timeframe: 25 weeks

Population: The Intent-to-Treat (ITT) population was defined as the set of subjects who were randomized and received at least one (1) dose of leronlimab (PRO 140) or placebo.

The raw and change from baseline in CD4 cell count at Week 25 was to be summarized for each week during the treatment phase. For change from baseline summaries, subjects with an undefined change from baseline, because of missing data, were to be excluded.

Outcome measures

Outcome measures
Measure	PRO 140 n=52 Participants PRO140 350mg weekly SC Inj. + existing ART for one week. After one week, all subjects will enter the 24-week single-arm, open-label treatment period. During this period, all subjects will receive PRO 140 SC injection and Optimized Background Therapy. PRO 140: PRO 140 is a humanized IgG4,κ monoclonal antibody (mAb) to the chemokine receptor CCR5. Optimized Background Regimen: Optimized background therapy (OBT) is chosen on the basis of a subject's resistance test results and treatment history.	Placebo Placebo weekly SC Inj. + existing ART for one week. After one week, all subjects will enter the 24-week single-arm, open-label treatment period. During this period, all subjects will receive PRO 140 SC injection and Optimized Background Therapy. Placebo Optimized Background Regimen: Optimized background therapy (OBT) is chosen on the basis of a subject's resistance test results and treatment history.
Mean Change From Baseline in CD4 Cell Count at Week 25 for All Patients and Within Each Stratum	85.9 CD4 Cell Count Standard Deviation 175.2	—

SECONDARY outcome

Timeframe: From baseline visit to week 1 visit

Population: The Intent-to-Treat (ITT) population was defined as the set of subjects who were randomized and received at least one (1) dose of leronlimab (PRO 140) or placebo

The number and percentage of subjects with a ≥ 1log10 or greater reduction in HIV-1 RNA viral load from baseline was to be presented for the two (2) treatment groups. The analysis of change in viral load was done for subjects with ≥ 1.0 log10 reduction in HIV-1 RNA after the first week of treatment. The analysis is presented for the ITT population

Outcome measures

Outcome measures
Measure	PRO 140 n=25 Participants PRO140 350mg weekly SC Inj. + existing ART for one week. After one week, all subjects will enter the 24-week single-arm, open-label treatment period. During this period, all subjects will receive PRO 140 SC injection and Optimized Background Therapy. PRO 140: PRO 140 is a humanized IgG4,κ monoclonal antibody (mAb) to the chemokine receptor CCR5. Optimized Background Regimen: Optimized background therapy (OBT) is chosen on the basis of a subject's resistance test results and treatment history.	Placebo n=27 Participants Placebo weekly SC Inj. + existing ART for one week. After one week, all subjects will enter the 24-week single-arm, open-label treatment period. During this period, all subjects will receive PRO 140 SC injection and Optimized Background Therapy. Placebo Optimized Background Regimen: Optimized background therapy (OBT) is chosen on the basis of a subject's resistance test results and treatment history.
Proportion of Participants With ≥ 1 log10 Reduction in HIV-1 RNA Viral Load From Baseline at the End of the 1-week Double-blind Treatment Period for All Patients and Within Each Stratum	.2 Proportion of participants	.0385 Proportion of participants

OTHER_PRE_SPECIFIED outcome

Timeframe: 25 weeks

Population: Assessments of subject-perceived injection site pain using the Pain Visual Analog Scale (VAS) was performed during each visit to the clinic for a study visit. The number of study participant visits varied each week and N = the number that visited the clinic and were assessed each week.

Assessments of subject-perceived injection site pain using the Pain Visual Analog Scale (VAS) were performed during each visit to the clinic for a study visit. Beginning at Treatment Visit 2 (T2), subjects were asked to mark the point that best represents the average pain intensity over the past week at the injection site on a horizontal line (100 mm in length) anchored by the following word descriptors at each end, "no pain" on the left side and "pain as bad as it could possibly be" on the right side of the line. The subject marks on the line or by pointing to a position on the line the point that they feel represents their perception of their pain state. The VAS score is determined by measuring in millimeters from the left-hand end of the line to the point that the patient marks The scale range is 0mm to 100 mm, with 0 mm = No Pain and 100 mm = Pain as bad as it could possibly be. In this measurement, a lower number corresponds to less perceived pain. T# = Visit Week#

Outcome measures

Outcome measures
Measure	PRO 140 n=50 Participants PRO140 350mg weekly SC Inj. + existing ART for one week. After one week, all subjects will enter the 24-week single-arm, open-label treatment period. During this period, all subjects will receive PRO 140 SC injection and Optimized Background Therapy. PRO 140: PRO 140 is a humanized IgG4,κ monoclonal antibody (mAb) to the chemokine receptor CCR5. Optimized Background Regimen: Optimized background therapy (OBT) is chosen on the basis of a subject's resistance test results and treatment history.	Placebo Placebo weekly SC Inj. + existing ART for one week. After one week, all subjects will enter the 24-week single-arm, open-label treatment period. During this period, all subjects will receive PRO 140 SC injection and Optimized Background Therapy. Placebo Optimized Background Regimen: Optimized background therapy (OBT) is chosen on the basis of a subject's resistance test results and treatment history.
Tolerability of Repeated Subcutaneous Administration of PRO 140 as Assessed by Study Participants (Using Visual Analogue Scale) and by Investigator-evaluation of Injection Site Reactions T6 (Week 6) Left Side Injection Site	.8 Units on a scale Standard Deviation 4.8	—
Tolerability of Repeated Subcutaneous Administration of PRO 140 as Assessed by Study Participants (Using Visual Analogue Scale) and by Investigator-evaluation of Injection Site Reactions T6 (Week 6) Right Side Injection Site	.3 Units on a scale Standard Deviation 1.7	—
Tolerability of Repeated Subcutaneous Administration of PRO 140 as Assessed by Study Participants (Using Visual Analogue Scale) and by Investigator-evaluation of Injection Site Reactions T7 (Week 7) Left Side Injection Site	.2 Units on a scale Standard Deviation .9	—
Tolerability of Repeated Subcutaneous Administration of PRO 140 as Assessed by Study Participants (Using Visual Analogue Scale) and by Investigator-evaluation of Injection Site Reactions T7 (Week 7) Right Side Injection Site	.3 Units on a scale Standard Deviation 1.7	—
Tolerability of Repeated Subcutaneous Administration of PRO 140 as Assessed by Study Participants (Using Visual Analogue Scale) and by Investigator-evaluation of Injection Site Reactions T8 (Week 8) Left Side Injection Site	.3 Units on a scale Standard Deviation 1.3	—
Tolerability of Repeated Subcutaneous Administration of PRO 140 as Assessed by Study Participants (Using Visual Analogue Scale) and by Investigator-evaluation of Injection Site Reactions T8 (Week 8) Right Side Injection Site	.4 Units on a scale Standard Deviation 1.5	—
Tolerability of Repeated Subcutaneous Administration of PRO 140 as Assessed by Study Participants (Using Visual Analogue Scale) and by Investigator-evaluation of Injection Site Reactions T9 (Week 9) Left Side Injection Site	.2 Units on a scale Standard Deviation .8	—
Tolerability of Repeated Subcutaneous Administration of PRO 140 as Assessed by Study Participants (Using Visual Analogue Scale) and by Investigator-evaluation of Injection Site Reactions T9 (Week 9) Right Side Injection Site	.2 Units on a scale Standard Deviation .9	—
Tolerability of Repeated Subcutaneous Administration of PRO 140 as Assessed by Study Participants (Using Visual Analogue Scale) and by Investigator-evaluation of Injection Site Reactions T10 (Week 10) Left Side Injection Site	.3 Units on a scale Standard Deviation 1.1	—
Tolerability of Repeated Subcutaneous Administration of PRO 140 as Assessed by Study Participants (Using Visual Analogue Scale) and by Investigator-evaluation of Injection Site Reactions T10 (Week 10) Right Side Injection Site	.3 Units on a scale Standard Deviation 1.1	—
Tolerability of Repeated Subcutaneous Administration of PRO 140 as Assessed by Study Participants (Using Visual Analogue Scale) and by Investigator-evaluation of Injection Site Reactions T11 (Week 11) Left Side Injection Site	.3 Units on a scale Standard Deviation 1.1	—
Tolerability of Repeated Subcutaneous Administration of PRO 140 as Assessed by Study Participants (Using Visual Analogue Scale) and by Investigator-evaluation of Injection Site Reactions T11 (Week 11) Right Side Injection Site	.2 Units on a scale Standard Deviation 1	—
Tolerability of Repeated Subcutaneous Administration of PRO 140 as Assessed by Study Participants (Using Visual Analogue Scale) and by Investigator-evaluation of Injection Site Reactions T12 (Week 12) Left Side Injection Site	.9 Units on a scale Standard Deviation 3	—
Tolerability of Repeated Subcutaneous Administration of PRO 140 as Assessed by Study Participants (Using Visual Analogue Scale) and by Investigator-evaluation of Injection Site Reactions T12 (Week 12) Right Side Injection Site	.8 Units on a scale Standard Deviation 2.7	—
Tolerability of Repeated Subcutaneous Administration of PRO 140 as Assessed by Study Participants (Using Visual Analogue Scale) and by Investigator-evaluation of Injection Site Reactions T13 (Week 13) Left Side Injection Site	.1 Units on a scale Standard Deviation .9	—
Tolerability of Repeated Subcutaneous Administration of PRO 140 as Assessed by Study Participants (Using Visual Analogue Scale) and by Investigator-evaluation of Injection Site Reactions T13 (Week 13) Right Side Injection Site	.1 Units on a scale Standard Deviation .9	—
Tolerability of Repeated Subcutaneous Administration of PRO 140 as Assessed by Study Participants (Using Visual Analogue Scale) and by Investigator-evaluation of Injection Site Reactions T14 (Week 14) Left Side Injection Site	.4 Units on a scale Standard Deviation 1.7	—
Tolerability of Repeated Subcutaneous Administration of PRO 140 as Assessed by Study Participants (Using Visual Analogue Scale) and by Investigator-evaluation of Injection Site Reactions T14 (Week 14) Right Side Injection Site	.4 Units on a scale Standard Deviation 1.8	—
Tolerability of Repeated Subcutaneous Administration of PRO 140 as Assessed by Study Participants (Using Visual Analogue Scale) and by Investigator-evaluation of Injection Site Reactions T15 (Week 15) Left Side Injection Site	.1 Units on a scale Standard Deviation .6	—
Tolerability of Repeated Subcutaneous Administration of PRO 140 as Assessed by Study Participants (Using Visual Analogue Scale) and by Investigator-evaluation of Injection Site Reactions T15 (Week 15) Right Side Injection Site	.2 Units on a scale Standard Deviation .9	—
Tolerability of Repeated Subcutaneous Administration of PRO 140 as Assessed by Study Participants (Using Visual Analogue Scale) and by Investigator-evaluation of Injection Site Reactions T16 (Week 16) Left Side Injection Site	.4 Units on a scale Standard Deviation 1.6	—
Tolerability of Repeated Subcutaneous Administration of PRO 140 as Assessed by Study Participants (Using Visual Analogue Scale) and by Investigator-evaluation of Injection Site Reactions T16 (Week 16) Right Side Injection Site	.2 Units on a scale Standard Deviation .8	—
Tolerability of Repeated Subcutaneous Administration of PRO 140 as Assessed by Study Participants (Using Visual Analogue Scale) and by Investigator-evaluation of Injection Site Reactions T17 (Week 17) Left Side Injection Site	.1 Units on a scale Standard Deviation .4	—
Tolerability of Repeated Subcutaneous Administration of PRO 140 as Assessed by Study Participants (Using Visual Analogue Scale) and by Investigator-evaluation of Injection Site Reactions T17 (Week 17) Right Side Injection Site	.1 Units on a scale Standard Deviation .4	—
Tolerability of Repeated Subcutaneous Administration of PRO 140 as Assessed by Study Participants (Using Visual Analogue Scale) and by Investigator-evaluation of Injection Site Reactions T18 (Week 18) Left Side Injection Site	.2 Units on a scale Standard Deviation 1.2	—
Tolerability of Repeated Subcutaneous Administration of PRO 140 as Assessed by Study Participants (Using Visual Analogue Scale) and by Investigator-evaluation of Injection Site Reactions T18 (Week 18) Right Side Injection Site	.3 Units on a scale Standard Deviation 1.5	—
Tolerability of Repeated Subcutaneous Administration of PRO 140 as Assessed by Study Participants (Using Visual Analogue Scale) and by Investigator-evaluation of Injection Site Reactions T19 (Week 19) Left Side Injection Site	.3 Units on a scale Standard Deviation 1.3	—
Tolerability of Repeated Subcutaneous Administration of PRO 140 as Assessed by Study Participants (Using Visual Analogue Scale) and by Investigator-evaluation of Injection Site Reactions T19 (Week 19) Right Side Injection Site	.2 Units on a scale Standard Deviation 1.3	—
Tolerability of Repeated Subcutaneous Administration of PRO 140 as Assessed by Study Participants (Using Visual Analogue Scale) and by Investigator-evaluation of Injection Site Reactions T20 (Week 20) Left Side Injection Site	1.5 Units on a scale Standard Deviation 8.9	—
Tolerability of Repeated Subcutaneous Administration of PRO 140 as Assessed by Study Participants (Using Visual Analogue Scale) and by Investigator-evaluation of Injection Site Reactions T20 (Week 20) Right Side Injection Site	1.1 Units on a scale Standard Deviation 6	—
Tolerability of Repeated Subcutaneous Administration of PRO 140 as Assessed by Study Participants (Using Visual Analogue Scale) and by Investigator-evaluation of Injection Site Reactions T21 (Week 21) Left Side Injection Site	.8 Units on a scale Standard Deviation 4.5	—
Tolerability of Repeated Subcutaneous Administration of PRO 140 as Assessed by Study Participants (Using Visual Analogue Scale) and by Investigator-evaluation of Injection Site Reactions T21 (Week 21) Right Side Injection Site	.4 Units on a scale Standard Deviation 1.8	—
Tolerability of Repeated Subcutaneous Administration of PRO 140 as Assessed by Study Participants (Using Visual Analogue Scale) and by Investigator-evaluation of Injection Site Reactions T22 (Week 22) Left Side Injection Site	.2 Units on a scale Standard Deviation .9	—
Tolerability of Repeated Subcutaneous Administration of PRO 140 as Assessed by Study Participants (Using Visual Analogue Scale) and by Investigator-evaluation of Injection Site Reactions T22 (Week 22) Right Side Injection Site	.2 Units on a scale Standard Deviation .8	—
Tolerability of Repeated Subcutaneous Administration of PRO 140 as Assessed by Study Participants (Using Visual Analogue Scale) and by Investigator-evaluation of Injection Site Reactions T23 (Week 23) Left Side Injection Site	.3 Units on a scale Standard Deviation 1.7	—
Tolerability of Repeated Subcutaneous Administration of PRO 140 as Assessed by Study Participants (Using Visual Analogue Scale) and by Investigator-evaluation of Injection Site Reactions T23 (Week 23) Right Side Injection Site	.2 Units on a scale Standard Deviation .9	—
Tolerability of Repeated Subcutaneous Administration of PRO 140 as Assessed by Study Participants (Using Visual Analogue Scale) and by Investigator-evaluation of Injection Site Reactions T24 (Week 24) Left Side Injection Site	.2 Units on a scale Standard Deviation 1.4	—
Tolerability of Repeated Subcutaneous Administration of PRO 140 as Assessed by Study Participants (Using Visual Analogue Scale) and by Investigator-evaluation of Injection Site Reactions T24 (Week 24) Right Side Injection Site	0 Units on a scale Standard Deviation .2	—
Tolerability of Repeated Subcutaneous Administration of PRO 140 as Assessed by Study Participants (Using Visual Analogue Scale) and by Investigator-evaluation of Injection Site Reactions T25 (Week 25) Left Side Injection Site	.1 Units on a scale Standard Deviation .6	—
Tolerability of Repeated Subcutaneous Administration of PRO 140 as Assessed by Study Participants (Using Visual Analogue Scale) and by Investigator-evaluation of Injection Site Reactions T25 (Week 25) Right Side Injection Site	0 Units on a scale Standard Deviation .3	—
Tolerability of Repeated Subcutaneous Administration of PRO 140 as Assessed by Study Participants (Using Visual Analogue Scale) and by Investigator-evaluation of Injection Site Reactions T2 (Week 2) Left Side Injection Site	1.3 Units on a scale Standard Deviation 8.5	—
Tolerability of Repeated Subcutaneous Administration of PRO 140 as Assessed by Study Participants (Using Visual Analogue Scale) and by Investigator-evaluation of Injection Site Reactions T2 (Week 2) Right Side Injection Site	1.0 Units on a scale Standard Deviation 7.1	—
Tolerability of Repeated Subcutaneous Administration of PRO 140 as Assessed by Study Participants (Using Visual Analogue Scale) and by Investigator-evaluation of Injection Site Reactions T3 (Week 3) Left Side Injection Site	0.3 Units on a scale Standard Deviation 1.5	—
Tolerability of Repeated Subcutaneous Administration of PRO 140 as Assessed by Study Participants (Using Visual Analogue Scale) and by Investigator-evaluation of Injection Site Reactions T3 (Week 3) Right Side Injection Site	0.2 Units on a scale Standard Deviation 0.7	—
Tolerability of Repeated Subcutaneous Administration of PRO 140 as Assessed by Study Participants (Using Visual Analogue Scale) and by Investigator-evaluation of Injection Site Reactions T4 (Week 4) Left Side Injection Site	0.4 Units on a scale Standard Deviation 1.7	—
Tolerability of Repeated Subcutaneous Administration of PRO 140 as Assessed by Study Participants (Using Visual Analogue Scale) and by Investigator-evaluation of Injection Site Reactions T4 (Week 4) Right Side Injection Site	0.3 Units on a scale Standard Deviation 1.1	—
Tolerability of Repeated Subcutaneous Administration of PRO 140 as Assessed by Study Participants (Using Visual Analogue Scale) and by Investigator-evaluation of Injection Site Reactions T5 (Week 5) Left Side Injection Site	.7 Units on a scale Standard Deviation 4	—
Tolerability of Repeated Subcutaneous Administration of PRO 140 as Assessed by Study Participants (Using Visual Analogue Scale) and by Investigator-evaluation of Injection Site Reactions T5 (Week 5) Right Side Injection Site	.1 Units on a scale Standard Deviation .6	—

OTHER_PRE_SPECIFIED outcome

Timeframe: 25 weeks

Population: The Safety population was defined as all subjects who received at least one (1) dose of leronlimab (PRO 140) or placebo after randomization. This population was used for the analysis of safety parameters.

The investigator was to carefully evaluate the comments of each subject and the response to treatment in order to judge the true nature and severity of the AE. The question of the relationship of AEs to study drug should have been determined by the investigator after thorough consideration of all available facts. To assess severity, the investigator was to use the DAIDS AE grading table for adverse events as well as any injection site reactions.

Outcome measures

Outcome measures
Measure	PRO 140 n=52 Participants PRO140 350mg weekly SC Inj. + existing ART for one week. After one week, all subjects will enter the 24-week single-arm, open-label treatment period. During this period, all subjects will receive PRO 140 SC injection and Optimized Background Therapy. PRO 140: PRO 140 is a humanized IgG4,κ monoclonal antibody (mAb) to the chemokine receptor CCR5. Optimized Background Regimen: Optimized background therapy (OBT) is chosen on the basis of a subject's resistance test results and treatment history.	Placebo Placebo weekly SC Inj. + existing ART for one week. After one week, all subjects will enter the 24-week single-arm, open-label treatment period. During this period, all subjects will receive PRO 140 SC injection and Optimized Background Therapy. Placebo Optimized Background Regimen: Optimized background therapy (OBT) is chosen on the basis of a subject's resistance test results and treatment history.
Frequency of Grade 3 or 4 Adverse Events as Defined by the DAIDS Adverse Event Scale Moderate AEs	40 Number of Adverse Events	—
Frequency of Grade 3 or 4 Adverse Events as Defined by the DAIDS Adverse Event Scale Severe AEs	15 Number of Adverse Events	—

OTHER_PRE_SPECIFIED outcome

Timeframe: 25 weeks

The incidence of serious adverse events (SAEs) by relationship to the study treatment. In total, there were 16 SAEs reported for eight (8) subjects (15.4%, 8/52). Thirteen of the SAEs were determined to be Unrelated, three were determined to be Unlikely Related to study treatment.

Outcome measures

Outcome measures
Measure	PRO 140 n=52 Participants PRO140 350mg weekly SC Inj. + existing ART for one week. After one week, all subjects will enter the 24-week single-arm, open-label treatment period. During this period, all subjects will receive PRO 140 SC injection and Optimized Background Therapy. PRO 140: PRO 140 is a humanized IgG4,κ monoclonal antibody (mAb) to the chemokine receptor CCR5. Optimized Background Regimen: Optimized background therapy (OBT) is chosen on the basis of a subject's resistance test results and treatment history.	Placebo Placebo weekly SC Inj. + existing ART for one week. After one week, all subjects will enter the 24-week single-arm, open-label treatment period. During this period, all subjects will receive PRO 140 SC injection and Optimized Background Therapy. Placebo Optimized Background Regimen: Optimized background therapy (OBT) is chosen on the basis of a subject's resistance test results and treatment history.
Frequency of Treatment-Emergent Serious Adverse Events Unrelated	13 Number of Serious Adverse Events	—
Frequency of Treatment-Emergent Serious Adverse Events Unlikely Related	3 Number of Serious Adverse Events	—

OTHER_PRE_SPECIFIED outcome

Timeframe: 25 weeks

The number of study participants who had exclusive CCR5-tropic virus at study entry and subsequently developed Dual/Mixed (D/M)- and CXCR4-tropic virus at any time during study treatment while receiving PRO 140.

Outcome measures

Outcome measures
Measure	PRO 140 n=52 Participants PRO140 350mg weekly SC Inj. + existing ART for one week. After one week, all subjects will enter the 24-week single-arm, open-label treatment period. During this period, all subjects will receive PRO 140 SC injection and Optimized Background Therapy. PRO 140: PRO 140 is a humanized IgG4,κ monoclonal antibody (mAb) to the chemokine receptor CCR5. Optimized Background Regimen: Optimized background therapy (OBT) is chosen on the basis of a subject's resistance test results and treatment history.	Placebo Placebo weekly SC Inj. + existing ART for one week. After one week, all subjects will enter the 24-week single-arm, open-label treatment period. During this period, all subjects will receive PRO 140 SC injection and Optimized Background Therapy. Placebo Optimized Background Regimen: Optimized background therapy (OBT) is chosen on the basis of a subject's resistance test results and treatment history.
Emergence of Dual/Mixed (D/M)- and CXCR4-tropic Virus in Patients Who Had Exclusive CCR5-tropic Virus at Study Entry.	2 Participants	—

Adverse Events

Pro 140 Weekly for 1 Week

Serious events: 0 serious events

Other events: 2 other events

Deaths: 0 deaths

Placebo Weekly for 1 Week

Serious events: 0 serious events

Other events: 2 other events

Deaths: 0 deaths

Part 2 PRO 140 Open Label for 24 Weeks

Serious events: 8 serious events

Other events: 34 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Pro 140 Weekly for 1 Week n=25 participants at risk PRO140 350mg weekly SC Inj. + existing ART for one week. After one week, all subjects will enter the 24-week single-arm, open-label treatment period. During this period, all subjects will receive PRO 140 SC injection and Optimized Background Therapy. PRO 140: PRO 140 is a humanized IgG4,κ monoclonal antibody (mAb) to the chemokine receptor CCR5. Optimized Background Regimen: Optimized background therapy (OBT) is chosen on the basis of a subject's resistance test results and treatment history.	Placebo Weekly for 1 Week n=27 participants at risk PRO140 350mg weekly SC Inj. + existing ART for one week. After one week, all subjects will enter the 24-week single-arm, open-label treatment period. During this period, all subjects will receive PRO 140 SC injection and Optimized Background Therapy. Placebo Optimized Background Regimen: Optimized background therapy (OBT) is chosen on the basis of a subject's resistance test results and treatment history.	Part 2 PRO 140 Open Label for 24 Weeks n=52 participants at risk PRO140 350mg weekly SC Inj. + existing ART for one week. After one week, all subjects will enter the 24-week single-arm, open-label treatment period. During this period, all subjects will receive PRO 140 SC injection and Optimized Background Therapy. PRO 140: PRO 140 is a humanized IgG4,κ monoclonal antibody (mAb) to the chemokine receptor CCR5. Optimized Background Regimen: Optimized background therapy (OBT) is chosen on the basis of a subject's resistance test results and treatment history.
Infections and infestations Pneumonia	0.00% 0/25 • 25 weeks Adverse events were systematically assessed through documented symptom-directed physical examinations, vital sign evaluation and injection site reaction evaluations performed at treatment and follow-up visits. All information is collected on case report forms.	0.00% 0/27 • 25 weeks Adverse events were systematically assessed through documented symptom-directed physical examinations, vital sign evaluation and injection site reaction evaluations performed at treatment and follow-up visits. All information is collected on case report forms.	5.8% 3/52 • 25 weeks Adverse events were systematically assessed through documented symptom-directed physical examinations, vital sign evaluation and injection site reaction evaluations performed at treatment and follow-up visits. All information is collected on case report forms.
Blood and lymphatic system disorders Lymphadenopathy	0.00% 0/25 • 25 weeks Adverse events were systematically assessed through documented symptom-directed physical examinations, vital sign evaluation and injection site reaction evaluations performed at treatment and follow-up visits. All information is collected on case report forms.	0.00% 0/27 • 25 weeks Adverse events were systematically assessed through documented symptom-directed physical examinations, vital sign evaluation and injection site reaction evaluations performed at treatment and follow-up visits. All information is collected on case report forms.	1.9% 1/52 • 25 weeks Adverse events were systematically assessed through documented symptom-directed physical examinations, vital sign evaluation and injection site reaction evaluations performed at treatment and follow-up visits. All information is collected on case report forms.
Gastrointestinal disorders Diarrhoea	0.00% 0/25 • 25 weeks Adverse events were systematically assessed through documented symptom-directed physical examinations, vital sign evaluation and injection site reaction evaluations performed at treatment and follow-up visits. All information is collected on case report forms.	0.00% 0/27 • 25 weeks Adverse events were systematically assessed through documented symptom-directed physical examinations, vital sign evaluation and injection site reaction evaluations performed at treatment and follow-up visits. All information is collected on case report forms.	1.9% 1/52 • 25 weeks Adverse events were systematically assessed through documented symptom-directed physical examinations, vital sign evaluation and injection site reaction evaluations performed at treatment and follow-up visits. All information is collected on case report forms.
Gastrointestinal disorders Pancreatitis	0.00% 0/25 • 25 weeks Adverse events were systematically assessed through documented symptom-directed physical examinations, vital sign evaluation and injection site reaction evaluations performed at treatment and follow-up visits. All information is collected on case report forms.	0.00% 0/27 • 25 weeks Adverse events were systematically assessed through documented symptom-directed physical examinations, vital sign evaluation and injection site reaction evaluations performed at treatment and follow-up visits. All information is collected on case report forms.	1.9% 1/52 • 25 weeks Adverse events were systematically assessed through documented symptom-directed physical examinations, vital sign evaluation and injection site reaction evaluations performed at treatment and follow-up visits. All information is collected on case report forms.
Infections and infestations Mycobacterium avium complex infection	0.00% 0/25 • 25 weeks Adverse events were systematically assessed through documented symptom-directed physical examinations, vital sign evaluation and injection site reaction evaluations performed at treatment and follow-up visits. All information is collected on case report forms.	0.00% 0/27 • 25 weeks Adverse events were systematically assessed through documented symptom-directed physical examinations, vital sign evaluation and injection site reaction evaluations performed at treatment and follow-up visits. All information is collected on case report forms.	1.9% 1/52 • 25 weeks Adverse events were systematically assessed through documented symptom-directed physical examinations, vital sign evaluation and injection site reaction evaluations performed at treatment and follow-up visits. All information is collected on case report forms.
Infections and infestations Septic shock	0.00% 0/25 • 25 weeks Adverse events were systematically assessed through documented symptom-directed physical examinations, vital sign evaluation and injection site reaction evaluations performed at treatment and follow-up visits. All information is collected on case report forms.	0.00% 0/27 • 25 weeks Adverse events were systematically assessed through documented symptom-directed physical examinations, vital sign evaluation and injection site reaction evaluations performed at treatment and follow-up visits. All information is collected on case report forms.	1.9% 1/52 • 25 weeks Adverse events were systematically assessed through documented symptom-directed physical examinations, vital sign evaluation and injection site reaction evaluations performed at treatment and follow-up visits. All information is collected on case report forms.
Metabolism and nutrition disorders Dehydration	0.00% 0/25 • 25 weeks Adverse events were systematically assessed through documented symptom-directed physical examinations, vital sign evaluation and injection site reaction evaluations performed at treatment and follow-up visits. All information is collected on case report forms.	0.00% 0/27 • 25 weeks Adverse events were systematically assessed through documented symptom-directed physical examinations, vital sign evaluation and injection site reaction evaluations performed at treatment and follow-up visits. All information is collected on case report forms.	1.9% 1/52 • 25 weeks Adverse events were systematically assessed through documented symptom-directed physical examinations, vital sign evaluation and injection site reaction evaluations performed at treatment and follow-up visits. All information is collected on case report forms.
Metabolism and nutrition disorders Malnutrition	0.00% 0/25 • 25 weeks Adverse events were systematically assessed through documented symptom-directed physical examinations, vital sign evaluation and injection site reaction evaluations performed at treatment and follow-up visits. All information is collected on case report forms.	0.00% 0/27 • 25 weeks Adverse events were systematically assessed through documented symptom-directed physical examinations, vital sign evaluation and injection site reaction evaluations performed at treatment and follow-up visits. All information is collected on case report forms.	1.9% 1/52 • 25 weeks Adverse events were systematically assessed through documented symptom-directed physical examinations, vital sign evaluation and injection site reaction evaluations performed at treatment and follow-up visits. All information is collected on case report forms.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Rectal cancer	0.00% 0/25 • 25 weeks Adverse events were systematically assessed through documented symptom-directed physical examinations, vital sign evaluation and injection site reaction evaluations performed at treatment and follow-up visits. All information is collected on case report forms.	0.00% 0/27 • 25 weeks Adverse events were systematically assessed through documented symptom-directed physical examinations, vital sign evaluation and injection site reaction evaluations performed at treatment and follow-up visits. All information is collected on case report forms.	1.9% 1/52 • 25 weeks Adverse events were systematically assessed through documented symptom-directed physical examinations, vital sign evaluation and injection site reaction evaluations performed at treatment and follow-up visits. All information is collected on case report forms.
Nervous system disorders Convulsion	0.00% 0/25 • 25 weeks Adverse events were systematically assessed through documented symptom-directed physical examinations, vital sign evaluation and injection site reaction evaluations performed at treatment and follow-up visits. All information is collected on case report forms.	0.00% 0/27 • 25 weeks Adverse events were systematically assessed through documented symptom-directed physical examinations, vital sign evaluation and injection site reaction evaluations performed at treatment and follow-up visits. All information is collected on case report forms.	1.9% 1/52 • 25 weeks Adverse events were systematically assessed through documented symptom-directed physical examinations, vital sign evaluation and injection site reaction evaluations performed at treatment and follow-up visits. All information is collected on case report forms.
Nervous system disorders Grand mal convulsion	0.00% 0/25 • 25 weeks Adverse events were systematically assessed through documented symptom-directed physical examinations, vital sign evaluation and injection site reaction evaluations performed at treatment and follow-up visits. All information is collected on case report forms.	0.00% 0/27 • 25 weeks Adverse events were systematically assessed through documented symptom-directed physical examinations, vital sign evaluation and injection site reaction evaluations performed at treatment and follow-up visits. All information is collected on case report forms.	1.9% 1/52 • 25 weeks Adverse events were systematically assessed through documented symptom-directed physical examinations, vital sign evaluation and injection site reaction evaluations performed at treatment and follow-up visits. All information is collected on case report forms.
Psychiatric disorders Schizoaffective disorder	0.00% 0/25 • 25 weeks Adverse events were systematically assessed through documented symptom-directed physical examinations, vital sign evaluation and injection site reaction evaluations performed at treatment and follow-up visits. All information is collected on case report forms.	0.00% 0/27 • 25 weeks Adverse events were systematically assessed through documented symptom-directed physical examinations, vital sign evaluation and injection site reaction evaluations performed at treatment and follow-up visits. All information is collected on case report forms.	1.9% 1/52 • 25 weeks Adverse events were systematically assessed through documented symptom-directed physical examinations, vital sign evaluation and injection site reaction evaluations performed at treatment and follow-up visits. All information is collected on case report forms.
Psychiatric disorders Suicidal ideation	0.00% 0/25 • 25 weeks Adverse events were systematically assessed through documented symptom-directed physical examinations, vital sign evaluation and injection site reaction evaluations performed at treatment and follow-up visits. All information is collected on case report forms.	0.00% 0/27 • 25 weeks Adverse events were systematically assessed through documented symptom-directed physical examinations, vital sign evaluation and injection site reaction evaluations performed at treatment and follow-up visits. All information is collected on case report forms.	1.9% 1/52 • 25 weeks Adverse events were systematically assessed through documented symptom-directed physical examinations, vital sign evaluation and injection site reaction evaluations performed at treatment and follow-up visits. All information is collected on case report forms.

Other adverse events

Additional Information

Joseph Meidling Senior Director Clinical Operations

CytoDyn

Phone: (360) 980-8524

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place