Trial Outcomes & Findings for An Extension of Protocol PRO 140_CD01 Study (NCT NCT02355184)
NCT ID: NCT02355184
Last Updated: 2025-10-07
Results Overview
Virologic failure (VF) is defined as two consecutive HIV-1 RNA levels of ≥ 400 copies/ml separated by at least 3 days. The time to VF will be compared to a historical data (i.e., time to HIV-1 RNA viral load \> 500 copies/mL of 29 days). The statistical comparison will be conducted using Wilcoxon rank sum test and the median time to Virologic Failure for this study will be compared to 30 days.
Recruitment status
TERMINATED
Study phase
PHASE2
Target enrollment
20 participants
Primary outcome timeframe
From treatment extension visit 1 (TE1) until virologic failure, assessed up to 125 weeks.
Results posted on
2025-10-07
Participant Flow
Participant milestones
| Measure |
PRO 140
PRO 140 350mg weekly SC injection.
PRO 140 350mg weekly SC injection.: C-C chemokine receptor type 5 (CCR5) Antagonist
|
|---|---|
|
Overall Study
STARTED
|
20
|
|
Overall Study
COMPLETED
|
8
|
|
Overall Study
NOT COMPLETED
|
12
|
Reasons for withdrawal
| Measure |
PRO 140
PRO 140 350mg weekly SC injection.
PRO 140 350mg weekly SC injection.: C-C chemokine receptor type 5 (CCR5) Antagonist
|
|---|---|
|
Overall Study
Lost to Follow-up
|
2
|
|
Overall Study
Study Terminated
|
10
|
Baseline Characteristics
An Extension of Protocol PRO 140_CD01 Study
Baseline characteristics by cohort
| Measure |
PRO 140
n=20 Participants
PRO 140 350mg weekly SQ (subcutaneous) injection.
PRO 140 350mg weekly SQ injection.: CCR5 Antagonist
|
|---|---|
|
Age, Continuous
|
56.05 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
2 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
18 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
16 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
2 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
20 participants
n=5 Participants
|
|
Time since HIV Diagnosis
|
10 years
n=5 Participants
|
PRIMARY outcome
Timeframe: From treatment extension visit 1 (TE1) until virologic failure, assessed up to 125 weeks.Population: The efficacy population consists of all subjects who received at least one dose of leronlimab (PRO 140).
Virologic failure (VF) is defined as two consecutive HIV-1 RNA levels of ≥ 400 copies/ml separated by at least 3 days. The time to VF will be compared to a historical data (i.e., time to HIV-1 RNA viral load \> 500 copies/mL of 29 days). The statistical comparison will be conducted using Wilcoxon rank sum test and the median time to Virologic Failure for this study will be compared to 30 days.
Outcome measures
| Measure |
PRO 140
n=20 Participants
PRO 140 350mg weekly SQ injection.
|
|---|---|
|
Time to Virologic Failure After Initiating PRO 140 Monotherapy
|
228.8 days
Standard Deviation 225.6
|
SECONDARY outcome
Timeframe: From treatment extension visit 1 (TE1) until virologic failure, assessed up to 125 weeks.Population: The efficacy population consists of all subjects who received at least one dose of leronlimab (PRO 140).
Virologic failure is defined as two consecutive HIV-1 RNA levels of ≥ 400 copies/ml separated by at least 3 days.
Outcome measures
| Measure |
PRO 140
n=20 Participants
PRO 140 350mg weekly SQ injection.
|
|---|---|
|
Proportion of Participants With Virologic Failure After Initiating PRO 140 Monotherapy.
|
0.3 proportion of participants
|
SECONDARY outcome
Timeframe: From treatment extension visit TE2 (defined as baseline), until week 58 of extension treatment.Population: The efficacy population consists of all subjects who received at least one dose of leronlimab (PRO 140). Baseline was defined as TE2. Any subjects with an undefined change from baseline due to missing data were excluded. The following imputations were used in the statistical analysis: "\<40" copies/mL as 40 "Target not detected" as 20.
Mean change from baseline of HIV-1 RNA levels was assessed for each week during the treatment phase up until week 58. Weighted mean change in viral load (HIV-1 RNA levels) were calculated from baseline to week 58.
Outcome measures
| Measure |
PRO 140
n=16 Participants
PRO 140 350mg weekly SQ injection.
|
|---|---|
|
Mean Change in Viral Load (HIV-1 RNA Levels)
|
147.34 copies/mL
Standard Deviation 263.60
|
SECONDARY outcome
Timeframe: From treatment extension visit TE2 (defined as baseline), until week 58 of extension treatment.Population: The efficacy population consists of all subjects who received at least one dose of leronlimab (PRO 140). Baseline was defined as TE2. Any subjects with an undefined change from baseline due to missing data were excluded.
Mean change in CD4 cell count from baseline (TE2 visit) was assessed for each week during the treatment phase up until week 58. The average mean change was calculated from baseline to week 58.
Outcome measures
| Measure |
PRO 140
n=16 Participants
PRO 140 350mg weekly SQ injection.
|
|---|---|
|
Mean Change in CD4 Cell Count
|
22 cells/uL
Standard Deviation 111
|
SECONDARY outcome
Timeframe: From TE4 (baseline) through every fourth weekly visits to treatment visit 107 (TE107) or EOT, up to 125 weeks.Population: No QoL data was collected at screening visit (SV1) for any of the participants. For 5 participants Quality-of-life (QoL) results were either not collected or they had undefined change from baseline due to missing data.
A Quality of Life (QoL) assessment using ACTG SF-21 was planned to be performed at screening visit (SV1), once every four weeks from treatment visit 4 (TE4) through treatment visit 107 (TE107), and at end of treatment (EOT). The ACTG SF-21 has 8 QoL domains with a standard score ranging from 0 (worst) to 100 (best).
Outcome measures
| Measure |
PRO 140
n=15 Participants
PRO 140 350mg weekly SQ injection.
|
|---|---|
|
Change in Quality of Life Metrics (up to TE107)
|
1.4 score
Standard Deviation 5.9
|
OTHER_PRE_SPECIFIED outcome
Timeframe: From TE1 (first treatment administration) weekly until last treatment visit (up to 125 weeks)Population: Data on tolerability of repeated subcutaneous (SC) administration of PRO 140 was not collected.
Tolerability of repeated subcutaneous administration of PRO 140 was planned to be assessed by the study participants using a Visual Analogue Scale, and by investigator-evaluation of injection site reactions. Injection site reaction assessment was not completed when subjects performed self-administration.
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: From the first treatment visit (TE1) until final study visit, up to a 125 weeks.Population: 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).
Outcome measures
| Measure |
PRO 140
n=20 Participants
PRO 140 350mg weekly SQ injection.
|
|---|---|
|
Number of Participants With Grade 3 or 4 Adverse Events as Defined by the DAIDS Adverse Event Scale
|
7 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: From the first treatment visit (TE1) until final study visit up to 125 weeks.Population: All patients who received at least one dose of PRO 140 (leronlimab) were included in the baseline analysis population.
Treatment-related 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.
Outcome measures
| Measure |
PRO 140
n=20 Participants
PRO 140 350mg weekly SQ injection.
|
|---|---|
|
Number of Participants With at Least One Treatment-related Serious Adverse Event.
|
0 Participants
|
Adverse Events
PRO 140
Serious events: 4 serious events
Other events: 15 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
PRO 140
n=20 participants at risk
PRO 140 350mg weekly SQ injection.
PRO 140 350mg weekly SQ injection.: CCR5 Antagonist
|
|---|---|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
5.0%
1/20 • Number of events 1 • Adverse events were reported from the time of the first treatment and continued up until the final study visit to evaluate safety of PRO140 (up to a maximum of 91 months).
|
|
Gastrointestinal disorders
Intestinal Perforation
|
5.0%
1/20 • Number of events 1 • Adverse events were reported from the time of the first treatment and continued up until the final study visit to evaluate safety of PRO140 (up to a maximum of 91 months).
|
|
Psychiatric disorders
Suicide Attempt
|
5.0%
1/20 • Number of events 3 • Adverse events were reported from the time of the first treatment and continued up until the final study visit to evaluate safety of PRO140 (up to a maximum of 91 months).
|
|
Nervous system disorders
Syncope
|
5.0%
1/20 • Number of events 1 • Adverse events were reported from the time of the first treatment and continued up until the final study visit to evaluate safety of PRO140 (up to a maximum of 91 months).
|
|
Vascular disorders
Hypertension
|
5.0%
1/20 • Number of events 1 • Adverse events were reported from the time of the first treatment and continued up until the final study visit to evaluate safety of PRO140 (up to a maximum of 91 months).
|
|
General disorders
Chest Pain
|
5.0%
1/20 • Number of events 1 • Adverse events were reported from the time of the first treatment and continued up until the final study visit to evaluate safety of PRO140 (up to a maximum of 91 months).
|
|
Hepatobiliary disorders
Bile duct stone
|
5.0%
1/20 • Number of events 1 • Adverse events were reported from the time of the first treatment and continued up until the final study visit to evaluate safety of PRO140 (up to a maximum of 91 months).
|
Other adverse events
| Measure |
PRO 140
n=20 participants at risk
PRO 140 350mg weekly SQ injection.
PRO 140 350mg weekly SQ injection.: CCR5 Antagonist
|
|---|---|
|
Musculoskeletal and connective tissue disorders
Back Pain
|
5.0%
1/20 • Number of events 1 • Adverse events were reported from the time of the first treatment and continued up until the final study visit to evaluate safety of PRO140 (up to a maximum of 91 months).
|
|
Investigations
Blood pressure increased
|
5.0%
1/20 • Number of events 1 • Adverse events were reported from the time of the first treatment and continued up until the final study visit to evaluate safety of PRO140 (up to a maximum of 91 months).
|
|
Infections and infestations
Bronchitis
|
10.0%
2/20 • Number of events 3 • Adverse events were reported from the time of the first treatment and continued up until the final study visit to evaluate safety of PRO140 (up to a maximum of 91 months).
|
|
Musculoskeletal and connective tissue disorders
Bursitis
|
5.0%
1/20 • Number of events 1 • Adverse events were reported from the time of the first treatment and continued up until the final study visit to evaluate safety of PRO140 (up to a maximum of 91 months).
|
|
Gastrointestinal disorders
Colitis
|
5.0%
1/20 • Number of events 1 • Adverse events were reported from the time of the first treatment and continued up until the final study visit to evaluate safety of PRO140 (up to a maximum of 91 months).
|
|
Gastrointestinal disorders
Constipation
|
5.0%
1/20 • Number of events 1 • Adverse events were reported from the time of the first treatment and continued up until the final study visit to evaluate safety of PRO140 (up to a maximum of 91 months).
|
|
Gastrointestinal disorders
Diarrhoea
|
20.0%
4/20 • Number of events 5 • Adverse events were reported from the time of the first treatment and continued up until the final study visit to evaluate safety of PRO140 (up to a maximum of 91 months).
|
|
Infections and infestations
Epididymitis
|
5.0%
1/20 • Number of events 1 • Adverse events were reported from the time of the first treatment and continued up until the final study visit to evaluate safety of PRO140 (up to a maximum of 91 months).
|
|
Eye disorders
Eye pain
|
5.0%
1/20 • Number of events 1 • Adverse events were reported from the time of the first treatment and continued up until the final study visit to evaluate safety of PRO140 (up to a maximum of 91 months).
|
|
Infections and infestations
Fungal skin infection
|
10.0%
2/20 • Number of events 2 • Adverse events were reported from the time of the first treatment and continued up until the final study visit to evaluate safety of PRO140 (up to a maximum of 91 months).
|
|
Infections and infestations
Influenza
|
15.0%
3/20 • Number of events 3 • Adverse events were reported from the time of the first treatment and continued up until the final study visit to evaluate safety of PRO140 (up to a maximum of 91 months).
|
|
Injury, poisoning and procedural complications
Meniscus injury
|
5.0%
1/20 • Number of events 1 • Adverse events were reported from the time of the first treatment and continued up until the final study visit to evaluate safety of PRO140 (up to a maximum of 91 months).
|
|
Infections and infestations
Nasopharyngitis
|
25.0%
5/20 • Number of events 5 • Adverse events were reported from the time of the first treatment and continued up until the final study visit to evaluate safety of PRO140 (up to a maximum of 91 months).
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
10.0%
2/20 • Number of events 2 • Adverse events were reported from the time of the first treatment and continued up until the final study visit to evaluate safety of PRO140 (up to a maximum of 91 months).
|
|
Respiratory, thoracic and mediastinal disorders
Sinus congestion
|
10.0%
2/20 • Number of events 3 • Adverse events were reported from the time of the first treatment and continued up until the final study visit to evaluate safety of PRO140 (up to a maximum of 91 months).
|
|
Gastrointestinal disorders
Abdominal pain upper
|
5.0%
1/20 • Number of events 2 • Adverse events were reported from the time of the first treatment and continued up until the final study visit to evaluate safety of PRO140 (up to a maximum of 91 months).
|
|
Infections and infestations
Abscess limb
|
5.0%
1/20 • Number of events 1 • Adverse events were reported from the time of the first treatment and continued up until the final study visit to evaluate safety of PRO140 (up to a maximum of 91 months).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Basal cell carcinoma
|
5.0%
1/20 • Number of events 1 • Adverse events were reported from the time of the first treatment and continued up until the final study visit to evaluate safety of PRO140 (up to a maximum of 91 months).
|
|
Nervous system disorders
Burning sensation
|
5.0%
1/20 • Number of events 1 • Adverse events were reported from the time of the first treatment and continued up until the final study visit to evaluate safety of PRO140 (up to a maximum of 91 months).
|
|
Nervous system disorders
Carpal tunnel syndrome
|
5.0%
1/20 • Number of events 1 • Adverse events were reported from the time of the first treatment and continued up until the final study visit to evaluate safety of PRO140 (up to a maximum of 91 months).
|
|
Infections and infestations
Cellulitis
|
5.0%
1/20 • Number of events 1 • Adverse events were reported from the time of the first treatment and continued up until the final study visit to evaluate safety of PRO140 (up to a maximum of 91 months).
|
|
General disorders
Chills
|
5.0%
1/20 • Number of events 1 • Adverse events were reported from the time of the first treatment and continued up until the final study visit to evaluate safety of PRO140 (up to a maximum of 91 months).
|
|
Infections and infestations
Chlamydial infection
|
5.0%
1/20 • Number of events 1 • Adverse events were reported from the time of the first treatment and continued up until the final study visit to evaluate safety of PRO140 (up to a maximum of 91 months).
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
10.0%
2/20 • Number of events 2 • Adverse events were reported from the time of the first treatment and continued up until the final study visit to evaluate safety of PRO140 (up to a maximum of 91 months).
|
|
Injury, poisoning and procedural complications
Craniocerebral injury
|
5.0%
1/20 • Number of events 1 • Adverse events were reported from the time of the first treatment and continued up until the final study visit to evaluate safety of PRO140 (up to a maximum of 91 months).
|
|
Metabolism and nutrition disorders
Dehydration
|
5.0%
1/20 • Number of events 1 • Adverse events were reported from the time of the first treatment and continued up until the final study visit to evaluate safety of PRO140 (up to a maximum of 91 months).
|
|
Psychiatric disorders
Depression
|
5.0%
1/20 • Number of events 1 • Adverse events were reported from the time of the first treatment and continued up until the final study visit to evaluate safety of PRO140 (up to a maximum of 91 months).
|
|
Psychiatric disorders
Dissociation
|
5.0%
1/20 • Number of events 1 • Adverse events were reported from the time of the first treatment and continued up until the final study visit to evaluate safety of PRO140 (up to a maximum of 91 months).
|
|
Nervous system disorders
Dizziness
|
5.0%
1/20 • Number of events 2 • Adverse events were reported from the time of the first treatment and continued up until the final study visit to evaluate safety of PRO140 (up to a maximum of 91 months).
|
|
Psychiatric disorders
Drug Abuse
|
5.0%
1/20 • Number of events 1 • Adverse events were reported from the time of the first treatment and continued up until the final study visit to evaluate safety of PRO140 (up to a maximum of 91 months).
|
|
Infections and infestations
Ear infection
|
5.0%
1/20 • Number of events 2 • Adverse events were reported from the time of the first treatment and continued up until the final study visit to evaluate safety of PRO140 (up to a maximum of 91 months).
|
|
Reproductive system and breast disorders
Erectile dysfunction
|
5.0%
1/20 • Number of events 1 • Adverse events were reported from the time of the first treatment and continued up until the final study visit to evaluate safety of PRO140 (up to a maximum of 91 months).
|
|
Infections and infestations
Eye infection
|
5.0%
1/20 • Number of events 1 • Adverse events were reported from the time of the first treatment and continued up until the final study visit to evaluate safety of PRO140 (up to a maximum of 91 months).
|
|
Injury, poisoning and procedural complications
Fall
|
5.0%
1/20 • Number of events 1 • Adverse events were reported from the time of the first treatment and continued up until the final study visit to evaluate safety of PRO140 (up to a maximum of 91 months).
|
|
General disorders
Fatigue
|
5.0%
1/20 • Number of events 1 • Adverse events were reported from the time of the first treatment and continued up until the final study visit to evaluate safety of PRO140 (up to a maximum of 91 months).
|
|
Infections and infestations
Folliculitis
|
5.0%
1/20 • Number of events 1 • Adverse events were reported from the time of the first treatment and continued up until the final study visit to evaluate safety of PRO140 (up to a maximum of 91 months).
|
|
Injury, poisoning and procedural complications
Foot fracture
|
5.0%
1/20 • Number of events 1 • Adverse events were reported from the time of the first treatment and continued up until the final study visit to evaluate safety of PRO140 (up to a maximum of 91 months).
|
|
Infections and infestations
Gastroenteritis
|
15.0%
3/20 • Number of events 4 • Adverse events were reported from the time of the first treatment and continued up until the final study visit to evaluate safety of PRO140 (up to a maximum of 91 months).
|
|
Gastrointestinal disorders
Gastrooeophageal reflux disease
|
5.0%
1/20 • Number of events 1 • Adverse events were reported from the time of the first treatment and continued up until the final study visit to evaluate safety of PRO140 (up to a maximum of 91 months).
|
|
Infections and infestations
Giardiasis
|
10.0%
2/20 • Number of events 2 • Adverse events were reported from the time of the first treatment and continued up until the final study visit to evaluate safety of PRO140 (up to a maximum of 91 months).
|
|
Gastrointestinal disorders
Haematochezia
|
5.0%
1/20 • Number of events 1 • Adverse events were reported from the time of the first treatment and continued up until the final study visit to evaluate safety of PRO140 (up to a maximum of 91 months).
|
|
Nervous system disorders
Headache
|
5.0%
1/20 • Number of events 1 • Adverse events were reported from the time of the first treatment and continued up until the final study visit to evaluate safety of PRO140 (up to a maximum of 91 months).
|
|
General disorders
Hernia
|
5.0%
1/20 • Number of events 1 • Adverse events were reported from the time of the first treatment and continued up until the final study visit to evaluate safety of PRO140 (up to a maximum of 91 months).
|
|
Infections and infestations
Herpes simplex
|
5.0%
1/20 • Number of events 1 • Adverse events were reported from the time of the first treatment and continued up until the final study visit to evaluate safety of PRO140 (up to a maximum of 91 months).
|
|
Skin and subcutaneous tissue disorders
Hyperkeratosis
|
5.0%
1/20 • Number of events 1 • Adverse events were reported from the time of the first treatment and continued up until the final study visit to evaluate safety of PRO140 (up to a maximum of 91 months).
|
|
Vascular disorders
Hypertension
|
10.0%
2/20 • Number of events 2 • Adverse events were reported from the time of the first treatment and continued up until the final study visit to evaluate safety of PRO140 (up to a maximum of 91 months).
|
|
Nervous system disorders
Hyporeflexia
|
5.0%
1/20 • Number of events 1 • Adverse events were reported from the time of the first treatment and continued up until the final study visit to evaluate safety of PRO140 (up to a maximum of 91 months).
|
|
Vascular disorders
Hypotension
|
10.0%
2/20 • Number of events 2 • Adverse events were reported from the time of the first treatment and continued up until the final study visit to evaluate safety of PRO140 (up to a maximum of 91 months).
|
|
Endocrine disorders
Hypothyroidism
|
5.0%
1/20 • Number of events 1 • Adverse events were reported from the time of the first treatment and continued up until the final study visit to evaluate safety of PRO140 (up to a maximum of 91 months).
|
|
General disorders
Injection site haemorrhage
|
5.0%
1/20 • Number of events 1 • Adverse events were reported from the time of the first treatment and continued up until the final study visit to evaluate safety of PRO140 (up to a maximum of 91 months).
|
|
Musculoskeletal and connective tissue disorders
Intervertebral disc degeneration
|
5.0%
1/20 • Number of events 1 • Adverse events were reported from the time of the first treatment and continued up until the final study visit to evaluate safety of PRO140 (up to a maximum of 91 months).
|
|
Investigations
Intraocular pressure increased
|
5.0%
1/20 • Number of events 1 • Adverse events were reported from the time of the first treatment and continued up until the final study visit to evaluate safety of PRO140 (up to a maximum of 91 months).
|
|
Infections and infestations
Lower respiratory tract infection
|
5.0%
1/20 • Number of events 1 • Adverse events were reported from the time of the first treatment and continued up until the final study visit to evaluate safety of PRO140 (up to a maximum of 91 months).
|
|
Blood and lymphatic system disorders
Lymphadenopathy
|
15.0%
3/20 • Number of events 3 • Adverse events were reported from the time of the first treatment and continued up until the final study visit to evaluate safety of PRO140 (up to a maximum of 91 months).
|
|
General disorders
Malaise
|
5.0%
1/20 • Number of events 1 • Adverse events were reported from the time of the first treatment and continued up until the final study visit to evaluate safety of PRO140 (up to a maximum of 91 months).
|
|
Nervous system disorders
Migrane
|
5.0%
1/20 • Number of events 1 • Adverse events were reported from the time of the first treatment and continued up until the final study visit to evaluate safety of PRO140 (up to a maximum of 91 months).
|
|
Musculoskeletal and connective tissue disorders
Muscle disorder
|
5.0%
1/20 • Number of events 1 • Adverse events were reported from the time of the first treatment and continued up until the final study visit to evaluate safety of PRO140 (up to a maximum of 91 months).
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
5.0%
1/20 • Number of events 1 • Adverse events were reported from the time of the first treatment and continued up until the final study visit to evaluate safety of PRO140 (up to a maximum of 91 months).
|
|
Respiratory, thoracic and mediastinal disorders
Nasal Congestion
|
5.0%
1/20 • Number of events 1 • Adverse events were reported from the time of the first treatment and continued up until the final study visit to evaluate safety of PRO140 (up to a maximum of 91 months).
|
|
Gastrointestinal disorders
Nausea
|
10.0%
2/20 • Number of events 3 • Adverse events were reported from the time of the first treatment and continued up until the final study visit to evaluate safety of PRO140 (up to a maximum of 91 months).
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
10.0%
2/20 • Number of events 3 • Adverse events were reported from the time of the first treatment and continued up until the final study visit to evaluate safety of PRO140 (up to a maximum of 91 months).
|
|
Skin and subcutaneous tissue disorders
Night sweats
|
5.0%
1/20 • Number of events 1 • Adverse events were reported from the time of the first treatment and continued up until the final study visit to evaluate safety of PRO140 (up to a maximum of 91 months).
|
|
Infections and infestations
Onychomycosis
|
5.0%
1/20 • Number of events 1 • Adverse events were reported from the time of the first treatment and continued up until the final study visit to evaluate safety of PRO140 (up to a maximum of 91 months).
|
|
Infections and infestations
Oral Candidiasis
|
5.0%
1/20 • Number of events 1 • Adverse events were reported from the time of the first treatment and continued up until the final study visit to evaluate safety of PRO140 (up to a maximum of 91 months).
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
10.0%
2/20 • Number of events 3 • Adverse events were reported from the time of the first treatment and continued up until the final study visit to evaluate safety of PRO140 (up to a maximum of 91 months).
|
|
Gastrointestinal disorders
Pancreatitis
|
5.0%
1/20 • Number of events 1 • Adverse events were reported from the time of the first treatment and continued up until the final study visit to evaluate safety of PRO140 (up to a maximum of 91 months).
|
|
Respiratory, thoracic and mediastinal disorders
Pharyngeal erythema
|
10.0%
2/20 • Number of events 2 • Adverse events were reported from the time of the first treatment and continued up until the final study visit to evaluate safety of PRO140 (up to a maximum of 91 months).
|
|
Infections and infestations
Pharyngitis streptococcal
|
5.0%
1/20 • Number of events 1 • Adverse events were reported from the time of the first treatment and continued up until the final study visit to evaluate safety of PRO140 (up to a maximum of 91 months).
|
|
Infections and infestations
Postoperative wound infection
|
5.0%
1/20 • Number of events 1 • Adverse events were reported from the time of the first treatment and continued up until the final study visit to evaluate safety of PRO140 (up to a maximum of 91 months).
|
|
Infections and infestations
Pustule
|
5.0%
1/20 • Number of events 1 • Adverse events were reported from the time of the first treatment and continued up until the final study visit to evaluate safety of PRO140 (up to a maximum of 91 months).
|
|
General disorders
Pyrexia
|
5.0%
1/20 • Number of events 1 • Adverse events were reported from the time of the first treatment and continued up until the final study visit to evaluate safety of PRO140 (up to a maximum of 91 months).
|
|
Skin and subcutaneous tissue disorders
Rash
|
10.0%
2/20 • Number of events 2 • Adverse events were reported from the time of the first treatment and continued up until the final study visit to evaluate safety of PRO140 (up to a maximum of 91 months).
|
|
Infections and infestations
Rhinitis
|
5.0%
1/20 • Number of events 1 • Adverse events were reported from the time of the first treatment and continued up until the final study visit to evaluate safety of PRO140 (up to a maximum of 91 months).
|
|
Immune system disorders
Seasonal allergy
|
5.0%
1/20 • Number of events 1 • Adverse events were reported from the time of the first treatment and continued up until the final study visit to evaluate safety of PRO140 (up to a maximum of 91 months).
|
|
Infections and infestations
Shigella infection
|
5.0%
1/20 • Number of events 1 • Adverse events were reported from the time of the first treatment and continued up until the final study visit to evaluate safety of PRO140 (up to a maximum of 91 months).
|
|
Infections and infestations
Sinusitis
|
20.0%
4/20 • Number of events 6 • Adverse events were reported from the time of the first treatment and continued up until the final study visit to evaluate safety of PRO140 (up to a maximum of 91 months).
|
|
Psychiatric disorders
Substance abuse
|
5.0%
1/20 • Number of events 1 • Adverse events were reported from the time of the first treatment and continued up until the final study visit to evaluate safety of PRO140 (up to a maximum of 91 months).
|
|
Psychiatric disorders
Suicidal ideation
|
5.0%
1/20 • Number of events 1 • Adverse events were reported from the time of the first treatment and continued up until the final study visit to evaluate safety of PRO140 (up to a maximum of 91 months).
|
|
General disorders
Swelling face
|
5.0%
1/20 • Number of events 1 • Adverse events were reported from the time of the first treatment and continued up until the final study visit to evaluate safety of PRO140 (up to a maximum of 91 months).
|
|
Nervous system disorders
Syncope
|
5.0%
1/20 • Number of events 1 • Adverse events were reported from the time of the first treatment and continued up until the final study visit to evaluate safety of PRO140 (up to a maximum of 91 months).
|
|
Infections and infestations
Syphillis
|
5.0%
1/20 • Number of events 1 • Adverse events were reported from the time of the first treatment and continued up until the final study visit to evaluate safety of PRO140 (up to a maximum of 91 months).
|
|
Cardiac disorders
Tachycardia
|
5.0%
1/20 • Number of events 1 • Adverse events were reported from the time of the first treatment and continued up until the final study visit to evaluate safety of PRO140 (up to a maximum of 91 months).
|
|
Reproductive system and breast disorders
Testicular swelling
|
5.0%
1/20 • Number of events 1 • Adverse events were reported from the time of the first treatment and continued up until the final study visit to evaluate safety of PRO140 (up to a maximum of 91 months).
|
|
Respiratory, thoracic and mediastinal disorders
Throat irritation
|
5.0%
1/20 • Number of events 1 • Adverse events were reported from the time of the first treatment and continued up until the final study visit to evaluate safety of PRO140 (up to a maximum of 91 months).
|
|
Blood and lymphatic system disorders
Thrombotic thrombocytopenic purpura
|
5.0%
1/20 • Number of events 1 • Adverse events were reported from the time of the first treatment and continued up until the final study visit to evaluate safety of PRO140 (up to a maximum of 91 months).
|
|
Respiratory, thoracic and mediastinal disorders
Tonsillar hypertrophy
|
5.0%
1/20 • Number of events 1 • Adverse events were reported from the time of the first treatment and continued up until the final study visit to evaluate safety of PRO140 (up to a maximum of 91 months).
|
|
Infections and infestations
Tooth infection
|
5.0%
1/20 • Number of events 1 • Adverse events were reported from the time of the first treatment and continued up until the final study visit to evaluate safety of PRO140 (up to a maximum of 91 months).
|
|
Infections and infestations
Upper respiratory tract infection
|
25.0%
5/20 • Number of events 7 • Adverse events were reported from the time of the first treatment and continued up until the final study visit to evaluate safety of PRO140 (up to a maximum of 91 months).
|
|
General disorders
Vaccination site rash
|
5.0%
1/20 • Number of events 1 • Adverse events were reported from the time of the first treatment and continued up until the final study visit to evaluate safety of PRO140 (up to a maximum of 91 months).
|
|
Ear and labyrinth disorders
Vertigo
|
5.0%
1/20 • Number of events 1 • Adverse events were reported from the time of the first treatment and continued up until the final study visit to evaluate safety of PRO140 (up to a maximum of 91 months).
|
|
Infections and infestations
Viral infection
|
5.0%
1/20 • Number of events 1 • Adverse events were reported from the time of the first treatment and continued up until the final study visit to evaluate safety of PRO140 (up to a maximum of 91 months).
|
|
Gastrointestinal disorders
Vomiting
|
10.0%
2/20 • Number of events 2 • Adverse events were reported from the time of the first treatment and continued up until the final study visit to evaluate safety of PRO140 (up to a maximum of 91 months).
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place