All patients have exclusive C-C chemokine receptor type 5 (CCR5)-tropic virus at study entry. The proportion of patients with any tropism result of dual/mixed was summarized.

At each visit during the treatment extension phase, an injection site reaction assessment was completed for the current and previous injection sites. To assess severity, subcutaneous (SC) injection related events were recorded according to the Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table).

Grade 1 indicates a mild event Grade 2 indicates a moderate event Grade 3 indicates a severe event Grade 4 indicates a potentially life-threatening event Participants who had no symptoms of injection site reactions, "0" was assigned.

Treatment-related adverse events are defined as events with an onset on or after the first treatment (TE1).

The Division of AIDS (DAIDS) grading table provides an adverse event severity grading scale ranging from grades 1 to 5 with descriptions for each adverse event based on the following general guidelines:

• Grade 1 indicates a mild event
• Grade 2 indicates a moderate event
• Grade 3 indicates a severe event
• Grade 4 indicates a potentially life-threatening event
• Grade 5 indicates death (Note: This grade is not specifically listed on each page of the grading table).

Treatment-related (as defined by the investigator) serious adverse events are defined as serious events with an onset on or after the first treatment.

A serious adverse event is defined as any adverse event that:

• Results in death
• Is life threatening (the subject is at immediate risk of dying from the AE)
• Requires subject hospitalization or prolongs existing hospitalization
• Results in persistent or significant disability/incapacity
• Is a congenital anomaly/birth defect Important medical events that may not result in death, be life-threatening, or require hospitalization may be considered a serious adverse event when, based upon appropriate medical judgment, they may jeopardize the subject and may require medical or surgical intervention to prevent one of the outcomes listed in this definition.

The change from baseline in CD4 cell count was summarized for each visit during the treatment phase. The time-weighted mean of change of the post baseline values was calculated. The time-weighted mean was adjusted AUC (area under the curve) by time.

The analysis population is defined as all subjects who enrolled in the study and received at least one dose of PRO 140. Subjects who had undefined change from baseline due to missing data were excluded from the analysis population.

All patients have exclusive C-C chemokine receptor type 5 (CCR5)-tropic virus at study entry. The proportion of patients with any tropism result of dual/mixed was summarized.

The analysis population is defined as all subjects who enrolled in the extension portion of the study and received at least one dose of PRO140. Participants who had no dual/mixed tropism data collected or had undefined change from baseline due to missing data were excluded from the analysis.

At each visit during the treatment extension phase, an injection site reaction assessment was completed for the current and previous injection sites. To assess severity, subcutaneous (SC) injection related events were recorded according to the Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table).

Grade 1 indicates a mild event Grade 2 indicates a moderate event Grade 3 indicates a severe event Grade 4 indicates a potentially life-threatening event Participants who had no symptoms of injection site reactions, "0" was assigned.

All patients who received at least one dose of PRO 140 (leronlimab) were included in the baseline analysis population. Subjects who had undefined value due to missing data were excluded from the analysis population.

Treatment-related adverse events are defined as events with an onset on or after the first treatment (TE1).

All patients who received at least one dose of PRO 140 (leronlimab) were included in the baseline analysis population.

The Division of AIDS (DAIDS) grading table provides an adverse event severity grading scale ranging from grades 1 to 5 with descriptions for each adverse event based on the following general guidelines:

• Grade 1 indicates a mild event
• Grade 2 indicates a moderate event
• Grade 3 indicates a severe event
• Grade 4 indicates a potentially life-threatening event
• Grade 5 indicates death (Note: This grade is not specifically listed on each page of the grading table).

All patients who received at least one dose of PRO 140 (leronlimab) were included in the baseline analysis population.

Treatment-related (as defined by the investigator) serious adverse events are defined as serious events with an onset on or after the first treatment.

A serious adverse event is defined as any adverse event that:

• Results in death
• Is life threatening (the subject is at immediate risk of dying from the AE)
• Requires subject hospitalization or prolongs existing hospitalization
• Results in persistent or significant disability/incapacity
• Is a congenital anomaly/birth defect Important medical events that may not result in death, be life-threatening, or require hospitalization may be considered a serious adverse event when, based upon appropriate medical judgment, they may jeopardize the subject and may require medical or surgical intervention to prevent one of the outcomes listed in this definition.

All patients who received at least one dose of PRO 140 (leronlimab) were included in the baseline analysis population.

Eligible subjects received 700 mg PRO 140 (leronlimab) administered weekly as subcutaneous injections along with Optimized Background Therapy (OBT) until virologic failure or another reason for discontinuation.