Trial Outcomes & Findings for An Extension Protocol for Subjects Who Successfully Completed PRO140_CD02 or PRO140_CD02_Open Label Study (NCT NCT02990858)
NCT ID: NCT02990858
Last Updated: 2025-11-12
Results Overview
The change from baseline in HIV-1 RNA levels (log 10 copies/mL) was summarized at least once every four weeks during the treatment extension 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.
Recruitment status
TERMINATED
Study phase
PHASE2/PHASE3
Target enrollment
43 participants
Primary outcome timeframe
From TE1 (first treatment administration) to once every four weeks until last treatment visit (up to 56 months).
Results posted on
2025-11-12
Participant Flow
This trial was conducted in 43 participants in the United States.
Participant milestones
| Measure |
PRO 140
Eligible subjects received 350 mg or 700 mg PRO 140 (leronlimab) administered weekly as subcutaneous injections along with Optimized Background Therapy (OBT) until virologic failure or another reason for discontinuation.
|
|---|---|
|
Overall Study
STARTED
|
43
|
|
Overall Study
COMPLETED
|
23
|
|
Overall Study
NOT COMPLETED
|
20
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
An Extension Protocol for Subjects Who Successfully Completed PRO140_CD02 or PRO140_CD02_Open Label Study
Baseline characteristics by cohort
| Measure |
PRO 140
n=43 Participants
Eligible subjects received 350 mg or 700 mg PRO 140 (leronlimab) administered weekly as subcutaneous injections along with Optimized Background Therapy (OBT) until virologic failure or another reason for discontinuation.
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=10 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
43 Participants
n=10 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=10 Participants
|
|
Age, Continuous
|
53.07 years
STANDARD_DEVIATION 7.31 • n=10 Participants
|
|
Sex: Female, Male
Female
|
10 Participants
n=10 Participants
|
|
Sex: Female, Male
Male
|
33 Participants
n=10 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
9 Participants
n=10 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
34 Participants
n=10 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=10 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=10 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=10 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=10 Participants
|
|
Race (NIH/OMB)
Black or African American
|
18 Participants
n=10 Participants
|
|
Race (NIH/OMB)
White
|
23 Participants
n=10 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=10 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=10 Participants
|
|
Region of Enrollment
United States
|
43 participants
n=10 Participants
|
PRIMARY outcome
Timeframe: From TE1 (first treatment administration) to once every four weeks until last treatment visit (up to 56 months).Population: 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.
The change from baseline in HIV-1 RNA levels (log 10 copies/mL) was summarized at least once every four weeks during the treatment extension 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.
Outcome measures
| Measure |
PRO 140
n=43 Participants
Eligible subjects received 350 mg or 700 mg PRO 140 (leronlimab) administered weekly as subcutaneous injections along with Optimized Background Therapy (OBT) until virologic failure or another reason for discontinuation.
|
|---|---|
|
Mean Change in Viral Load (HIV-1 RNA Levels) at the Conclusion of Treatment Period
|
0.13 log10 copies/mL
Standard Deviation 1.11
|
SECONDARY outcome
Timeframe: From first treatment administration to each weekly visit until the last treatment visit (up to 56 months)Population: 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.
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.
Outcome measures
| Measure |
PRO 140
n=43 Participants
Eligible subjects received 350 mg or 700 mg PRO 140 (leronlimab) administered weekly as subcutaneous injections along with Optimized Background Therapy (OBT) until virologic failure or another reason for discontinuation.
|
|---|---|
|
Mean Change in CD4 Cell Count at the Conclusion of Treatment Period
|
46 cells/uL
Standard Deviation 122
|
SECONDARY outcome
Timeframe: From TE1 (first treatment administration) to last treatment visit, up to 56 months.Population: 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.
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.
Outcome measures
| Measure |
PRO 140
n=37 Participants
Eligible subjects received 350 mg or 700 mg PRO 140 (leronlimab) administered weekly as subcutaneous injections along with Optimized Background Therapy (OBT) until virologic failure or another reason for discontinuation.
|
|---|---|
|
Proportion of Participants Experiencing Emergence of Dual/Mixed (D/M)- and CXCR4-tropic Virus in Patients Who Had Exclusive CCR5-tropic Virus at Study Entry.
|
0.093 proportion of participants
|
SECONDARY outcome
Timeframe: From TE1 (first treatment administration) weekly until last treatment visit (up to 56 months).Population: 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.
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.
Outcome measures
| Measure |
PRO 140
n=39 Participants
Eligible subjects received 350 mg or 700 mg PRO 140 (leronlimab) administered weekly as subcutaneous injections along with Optimized Background Therapy (OBT) until virologic failure or another reason for discontinuation.
|
|---|---|
|
Tolerability of Repeated Subcutaneous Administration of PRO 140 as Assessed by Investigator Evaluation of Injection Site Reactions (ISR)
Participants with no ISR symptoms
|
20 participants
|
|
Tolerability of Repeated Subcutaneous Administration of PRO 140 as Assessed by Investigator Evaluation of Injection Site Reactions (ISR)
Participants with Grade 1 ISR
|
19 participants
|
|
Tolerability of Repeated Subcutaneous Administration of PRO 140 as Assessed by Investigator Evaluation of Injection Site Reactions (ISR)
Participants with Grade 2 or higher ISR
|
0 participants
|
SECONDARY outcome
Timeframe: From TE1 (first treatment administration) to last treatment visit, up to 56 months.Population: All patients who received at least one dose of PRO 140 (leronlimab) were included in the baseline analysis population.
Treatment-related adverse events are defined as events with an onset on or after the first treatment (TE1).
Outcome measures
| Measure |
PRO 140
n=43 Participants
Eligible subjects received 350 mg or 700 mg PRO 140 (leronlimab) administered weekly as subcutaneous injections along with Optimized Background Therapy (OBT) until virologic failure or another reason for discontinuation.
|
|---|---|
|
Number of Participants With Treatment-related Adverse Events Resulting in Study Drug Discontinuation
|
1 participants
|
SECONDARY outcome
Timeframe: From TE1 (first treatment administration) to last treatment visit, up to 56 months.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=43 Participants
Eligible subjects received 350 mg or 700 mg PRO 140 (leronlimab) administered weekly as subcutaneous injections along with Optimized Background Therapy (OBT) until virologic failure or another reason for discontinuation.
|
|---|---|
|
Number of Participants With Grade 3 or 4 Adverse Events as Defined by the DAIDS Adverse Event Scale
|
12 participants
|
SECONDARY outcome
Timeframe: From TE1 (first treatment administration) to last treatment visit, up to 56 months.Population: 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.
Outcome measures
| Measure |
PRO 140
n=43 Participants
Eligible subjects received 350 mg or 700 mg PRO 140 (leronlimab) administered weekly as subcutaneous injections along with Optimized Background Therapy (OBT) until virologic failure or another reason for discontinuation.
|
|---|---|
|
Number of Participants With at Least One Treatment-related Serious Adverse Event.
|
15 Participants
|
Adverse Events
PRO 140 350 mg
Serious events: 11 serious events
Other events: 27 other events
Deaths: 3 deaths
PRO 140 700 mg
Serious events: 4 serious events
Other events: 13 other events
Deaths: 1 deaths
Serious adverse events
| Measure |
PRO 140 350 mg
n=29 participants at risk
Eligible subjects received 350 mg PRO 140 (leronlimab) administered weekly as subcutaneous injections along with Optimized Background Therapy (OBT) until virologic failure or another reason for discontinuation.
|
PRO 140 700 mg
n=14 participants at risk
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.
|
|---|---|---|
|
Cardiac disorders
Coronary artery occlusion
|
3.4%
1/29 • Number of events 1 • Adverse events were reported from the time of the first treatment extension visit and continue up until the final study visit, up to 56 months.
Adverse events were elicited through direct questioning and subject reports. Any abnormalities in visit evaluations, physical examination findings or laboratory results that the Investigator believed were clinically significant to the research subject and that occurred after initiation of the first study treatment was reported as an adverse event.
|
0.00%
0/14 • Adverse events were reported from the time of the first treatment extension visit and continue up until the final study visit, up to 56 months.
Adverse events were elicited through direct questioning and subject reports. Any abnormalities in visit evaluations, physical examination findings or laboratory results that the Investigator believed were clinically significant to the research subject and that occurred after initiation of the first study treatment was reported as an adverse event.
|
|
Blood and lymphatic system disorders
Aplastic anaemia
|
3.4%
1/29 • Number of events 1 • Adverse events were reported from the time of the first treatment extension visit and continue up until the final study visit, up to 56 months.
Adverse events were elicited through direct questioning and subject reports. Any abnormalities in visit evaluations, physical examination findings or laboratory results that the Investigator believed were clinically significant to the research subject and that occurred after initiation of the first study treatment was reported as an adverse event.
|
0.00%
0/14 • Adverse events were reported from the time of the first treatment extension visit and continue up until the final study visit, up to 56 months.
Adverse events were elicited through direct questioning and subject reports. Any abnormalities in visit evaluations, physical examination findings or laboratory results that the Investigator believed were clinically significant to the research subject and that occurred after initiation of the first study treatment was reported as an adverse event.
|
|
Cardiac disorders
Acute myocardial infarction
|
6.9%
2/29 • Number of events 2 • Adverse events were reported from the time of the first treatment extension visit and continue up until the final study visit, up to 56 months.
Adverse events were elicited through direct questioning and subject reports. Any abnormalities in visit evaluations, physical examination findings or laboratory results that the Investigator believed were clinically significant to the research subject and that occurred after initiation of the first study treatment was reported as an adverse event.
|
0.00%
0/14 • Adverse events were reported from the time of the first treatment extension visit and continue up until the final study visit, up to 56 months.
Adverse events were elicited through direct questioning and subject reports. Any abnormalities in visit evaluations, physical examination findings or laboratory results that the Investigator believed were clinically significant to the research subject and that occurred after initiation of the first study treatment was reported as an adverse event.
|
|
Gastrointestinal disorders
Haematochezia
|
3.4%
1/29 • Number of events 1 • Adverse events were reported from the time of the first treatment extension visit and continue up until the final study visit, up to 56 months.
Adverse events were elicited through direct questioning and subject reports. Any abnormalities in visit evaluations, physical examination findings or laboratory results that the Investigator believed were clinically significant to the research subject and that occurred after initiation of the first study treatment was reported as an adverse event.
|
0.00%
0/14 • Adverse events were reported from the time of the first treatment extension visit and continue up until the final study visit, up to 56 months.
Adverse events were elicited through direct questioning and subject reports. Any abnormalities in visit evaluations, physical examination findings or laboratory results that the Investigator believed were clinically significant to the research subject and that occurred after initiation of the first study treatment was reported as an adverse event.
|
|
Gastrointestinal disorders
Vomiting
|
3.4%
1/29 • Number of events 1 • Adverse events were reported from the time of the first treatment extension visit and continue up until the final study visit, up to 56 months.
Adverse events were elicited through direct questioning and subject reports. Any abnormalities in visit evaluations, physical examination findings or laboratory results that the Investigator believed were clinically significant to the research subject and that occurred after initiation of the first study treatment was reported as an adverse event.
|
0.00%
0/14 • Adverse events were reported from the time of the first treatment extension visit and continue up until the final study visit, up to 56 months.
Adverse events were elicited through direct questioning and subject reports. Any abnormalities in visit evaluations, physical examination findings or laboratory results that the Investigator believed were clinically significant to the research subject and that occurred after initiation of the first study treatment was reported as an adverse event.
|
|
Gastrointestinal disorders
Abdominal pain
|
3.4%
1/29 • Number of events 1 • Adverse events were reported from the time of the first treatment extension visit and continue up until the final study visit, up to 56 months.
Adverse events were elicited through direct questioning and subject reports. Any abnormalities in visit evaluations, physical examination findings or laboratory results that the Investigator believed were clinically significant to the research subject and that occurred after initiation of the first study treatment was reported as an adverse event.
|
0.00%
0/14 • Adverse events were reported from the time of the first treatment extension visit and continue up until the final study visit, up to 56 months.
Adverse events were elicited through direct questioning and subject reports. Any abnormalities in visit evaluations, physical examination findings or laboratory results that the Investigator believed were clinically significant to the research subject and that occurred after initiation of the first study treatment was reported as an adverse event.
|
|
General disorders
Chest pain
|
3.4%
1/29 • Number of events 1 • Adverse events were reported from the time of the first treatment extension visit and continue up until the final study visit, up to 56 months.
Adverse events were elicited through direct questioning and subject reports. Any abnormalities in visit evaluations, physical examination findings or laboratory results that the Investigator believed were clinically significant to the research subject and that occurred after initiation of the first study treatment was reported as an adverse event.
|
7.1%
1/14 • Number of events 1 • Adverse events were reported from the time of the first treatment extension visit and continue up until the final study visit, up to 56 months.
Adverse events were elicited through direct questioning and subject reports. Any abnormalities in visit evaluations, physical examination findings or laboratory results that the Investigator believed were clinically significant to the research subject and that occurred after initiation of the first study treatment was reported as an adverse event.
|
|
General disorders
Pyrexia
|
0.00%
0/29 • Adverse events were reported from the time of the first treatment extension visit and continue up until the final study visit, up to 56 months.
Adverse events were elicited through direct questioning and subject reports. Any abnormalities in visit evaluations, physical examination findings or laboratory results that the Investigator believed were clinically significant to the research subject and that occurred after initiation of the first study treatment was reported as an adverse event.
|
7.1%
1/14 • Number of events 1 • Adverse events were reported from the time of the first treatment extension visit and continue up until the final study visit, up to 56 months.
Adverse events were elicited through direct questioning and subject reports. Any abnormalities in visit evaluations, physical examination findings or laboratory results that the Investigator believed were clinically significant to the research subject and that occurred after initiation of the first study treatment was reported as an adverse event.
|
|
General disorders
Death
|
0.00%
0/29 • Adverse events were reported from the time of the first treatment extension visit and continue up until the final study visit, up to 56 months.
Adverse events were elicited through direct questioning and subject reports. Any abnormalities in visit evaluations, physical examination findings or laboratory results that the Investigator believed were clinically significant to the research subject and that occurred after initiation of the first study treatment was reported as an adverse event.
|
7.1%
1/14 • Number of events 1 • Adverse events were reported from the time of the first treatment extension visit and continue up until the final study visit, up to 56 months.
Adverse events were elicited through direct questioning and subject reports. Any abnormalities in visit evaluations, physical examination findings or laboratory results that the Investigator believed were clinically significant to the research subject and that occurred after initiation of the first study treatment was reported as an adverse event.
|
|
General disorders
Multiple organ dysfunction syndrome
|
3.4%
1/29 • Number of events 1 • Adverse events were reported from the time of the first treatment extension visit and continue up until the final study visit, up to 56 months.
Adverse events were elicited through direct questioning and subject reports. Any abnormalities in visit evaluations, physical examination findings or laboratory results that the Investigator believed were clinically significant to the research subject and that occurred after initiation of the first study treatment was reported as an adverse event.
|
0.00%
0/14 • Adverse events were reported from the time of the first treatment extension visit and continue up until the final study visit, up to 56 months.
Adverse events were elicited through direct questioning and subject reports. Any abnormalities in visit evaluations, physical examination findings or laboratory results that the Investigator believed were clinically significant to the research subject and that occurred after initiation of the first study treatment was reported as an adverse event.
|
|
Infections and infestations
Epstein-Barr virus infection
|
3.4%
1/29 • Number of events 1 • Adverse events were reported from the time of the first treatment extension visit and continue up until the final study visit, up to 56 months.
Adverse events were elicited through direct questioning and subject reports. Any abnormalities in visit evaluations, physical examination findings or laboratory results that the Investigator believed were clinically significant to the research subject and that occurred after initiation of the first study treatment was reported as an adverse event.
|
0.00%
0/14 • Adverse events were reported from the time of the first treatment extension visit and continue up until the final study visit, up to 56 months.
Adverse events were elicited through direct questioning and subject reports. Any abnormalities in visit evaluations, physical examination findings or laboratory results that the Investigator believed were clinically significant to the research subject and that occurred after initiation of the first study treatment was reported as an adverse event.
|
|
Infections and infestations
Septic shock
|
3.4%
1/29 • Number of events 1 • Adverse events were reported from the time of the first treatment extension visit and continue up until the final study visit, up to 56 months.
Adverse events were elicited through direct questioning and subject reports. Any abnormalities in visit evaluations, physical examination findings or laboratory results that the Investigator believed were clinically significant to the research subject and that occurred after initiation of the first study treatment was reported as an adverse event.
|
0.00%
0/14 • Adverse events were reported from the time of the first treatment extension visit and continue up until the final study visit, up to 56 months.
Adverse events were elicited through direct questioning and subject reports. Any abnormalities in visit evaluations, physical examination findings or laboratory results that the Investigator believed were clinically significant to the research subject and that occurred after initiation of the first study treatment was reported as an adverse event.
|
|
Infections and infestations
Cellulitis
|
3.4%
1/29 • Number of events 1 • Adverse events were reported from the time of the first treatment extension visit and continue up until the final study visit, up to 56 months.
Adverse events were elicited through direct questioning and subject reports. Any abnormalities in visit evaluations, physical examination findings or laboratory results that the Investigator believed were clinically significant to the research subject and that occurred after initiation of the first study treatment was reported as an adverse event.
|
0.00%
0/14 • Adverse events were reported from the time of the first treatment extension visit and continue up until the final study visit, up to 56 months.
Adverse events were elicited through direct questioning and subject reports. Any abnormalities in visit evaluations, physical examination findings or laboratory results that the Investigator believed were clinically significant to the research subject and that occurred after initiation of the first study treatment was reported as an adverse event.
|
|
Infections and infestations
Bronchitis
|
6.9%
2/29 • Number of events 2 • Adverse events were reported from the time of the first treatment extension visit and continue up until the final study visit, up to 56 months.
Adverse events were elicited through direct questioning and subject reports. Any abnormalities in visit evaluations, physical examination findings or laboratory results that the Investigator believed were clinically significant to the research subject and that occurred after initiation of the first study treatment was reported as an adverse event.
|
0.00%
0/14 • Adverse events were reported from the time of the first treatment extension visit and continue up until the final study visit, up to 56 months.
Adverse events were elicited through direct questioning and subject reports. Any abnormalities in visit evaluations, physical examination findings or laboratory results that the Investigator believed were clinically significant to the research subject and that occurred after initiation of the first study treatment was reported as an adverse event.
|
|
Infections and infestations
Mycobacterium avium complex infection
|
3.4%
1/29 • Number of events 1 • Adverse events were reported from the time of the first treatment extension visit and continue up until the final study visit, up to 56 months.
Adverse events were elicited through direct questioning and subject reports. Any abnormalities in visit evaluations, physical examination findings or laboratory results that the Investigator believed were clinically significant to the research subject and that occurred after initiation of the first study treatment was reported as an adverse event.
|
0.00%
0/14 • Adverse events were reported from the time of the first treatment extension visit and continue up until the final study visit, up to 56 months.
Adverse events were elicited through direct questioning and subject reports. Any abnormalities in visit evaluations, physical examination findings or laboratory results that the Investigator believed were clinically significant to the research subject and that occurred after initiation of the first study treatment was reported as an adverse event.
|
|
Infections and infestations
Pyelonephritis
|
3.4%
1/29 • Number of events 1 • Adverse events were reported from the time of the first treatment extension visit and continue up until the final study visit, up to 56 months.
Adverse events were elicited through direct questioning and subject reports. Any abnormalities in visit evaluations, physical examination findings or laboratory results that the Investigator believed were clinically significant to the research subject and that occurred after initiation of the first study treatment was reported as an adverse event.
|
0.00%
0/14 • Adverse events were reported from the time of the first treatment extension visit and continue up until the final study visit, up to 56 months.
Adverse events were elicited through direct questioning and subject reports. Any abnormalities in visit evaluations, physical examination findings or laboratory results that the Investigator believed were clinically significant to the research subject and that occurred after initiation of the first study treatment was reported as an adverse event.
|
|
Infections and infestations
Medical device site joint infection
|
3.4%
1/29 • Number of events 1 • Adverse events were reported from the time of the first treatment extension visit and continue up until the final study visit, up to 56 months.
Adverse events were elicited through direct questioning and subject reports. Any abnormalities in visit evaluations, physical examination findings or laboratory results that the Investigator believed were clinically significant to the research subject and that occurred after initiation of the first study treatment was reported as an adverse event.
|
0.00%
0/14 • Adverse events were reported from the time of the first treatment extension visit and continue up until the final study visit, up to 56 months.
Adverse events were elicited through direct questioning and subject reports. Any abnormalities in visit evaluations, physical examination findings or laboratory results that the Investigator believed were clinically significant to the research subject and that occurred after initiation of the first study treatment was reported as an adverse event.
|
|
Infections and infestations
Staphylococcal bacteraemia
|
3.4%
1/29 • Number of events 1 • Adverse events were reported from the time of the first treatment extension visit and continue up until the final study visit, up to 56 months.
Adverse events were elicited through direct questioning and subject reports. Any abnormalities in visit evaluations, physical examination findings or laboratory results that the Investigator believed were clinically significant to the research subject and that occurred after initiation of the first study treatment was reported as an adverse event.
|
0.00%
0/14 • Adverse events were reported from the time of the first treatment extension visit and continue up until the final study visit, up to 56 months.
Adverse events were elicited through direct questioning and subject reports. Any abnormalities in visit evaluations, physical examination findings or laboratory results that the Investigator believed were clinically significant to the research subject and that occurred after initiation of the first study treatment was reported as an adverse event.
|
|
Infections and infestations
Abscess limb
|
0.00%
0/29 • Adverse events were reported from the time of the first treatment extension visit and continue up until the final study visit, up to 56 months.
Adverse events were elicited through direct questioning and subject reports. Any abnormalities in visit evaluations, physical examination findings or laboratory results that the Investigator believed were clinically significant to the research subject and that occurred after initiation of the first study treatment was reported as an adverse event.
|
7.1%
1/14 • Number of events 1 • Adverse events were reported from the time of the first treatment extension visit and continue up until the final study visit, up to 56 months.
Adverse events were elicited through direct questioning and subject reports. Any abnormalities in visit evaluations, physical examination findings or laboratory results that the Investigator believed were clinically significant to the research subject and that occurred after initiation of the first study treatment was reported as an adverse event.
|
|
Injury, poisoning and procedural complications
Head Injury
|
0.00%
0/29 • Adverse events were reported from the time of the first treatment extension visit and continue up until the final study visit, up to 56 months.
Adverse events were elicited through direct questioning and subject reports. Any abnormalities in visit evaluations, physical examination findings or laboratory results that the Investigator believed were clinically significant to the research subject and that occurred after initiation of the first study treatment was reported as an adverse event.
|
7.1%
1/14 • Number of events 1 • Adverse events were reported from the time of the first treatment extension visit and continue up until the final study visit, up to 56 months.
Adverse events were elicited through direct questioning and subject reports. Any abnormalities in visit evaluations, physical examination findings or laboratory results that the Investigator believed were clinically significant to the research subject and that occurred after initiation of the first study treatment was reported as an adverse event.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Myelodysplastic syndrome
|
3.4%
1/29 • Number of events 1 • Adverse events were reported from the time of the first treatment extension visit and continue up until the final study visit, up to 56 months.
Adverse events were elicited through direct questioning and subject reports. Any abnormalities in visit evaluations, physical examination findings or laboratory results that the Investigator believed were clinically significant to the research subject and that occurred after initiation of the first study treatment was reported as an adverse event.
|
0.00%
0/14 • Adverse events were reported from the time of the first treatment extension visit and continue up until the final study visit, up to 56 months.
Adverse events were elicited through direct questioning and subject reports. Any abnormalities in visit evaluations, physical examination findings or laboratory results that the Investigator believed were clinically significant to the research subject and that occurred after initiation of the first study treatment was reported as an adverse event.
|
|
Vascular disorders
Arterial thrombosis
|
3.4%
1/29 • Number of events 1 • Adverse events were reported from the time of the first treatment extension visit and continue up until the final study visit, up to 56 months.
Adverse events were elicited through direct questioning and subject reports. Any abnormalities in visit evaluations, physical examination findings or laboratory results that the Investigator believed were clinically significant to the research subject and that occurred after initiation of the first study treatment was reported as an adverse event.
|
0.00%
0/14 • Adverse events were reported from the time of the first treatment extension visit and continue up until the final study visit, up to 56 months.
Adverse events were elicited through direct questioning and subject reports. Any abnormalities in visit evaluations, physical examination findings or laboratory results that the Investigator believed were clinically significant to the research subject and that occurred after initiation of the first study treatment was reported as an adverse event.
|
|
Infections and infestations
Pneumonia
|
0.00%
0/29 • Adverse events were reported from the time of the first treatment extension visit and continue up until the final study visit, up to 56 months.
Adverse events were elicited through direct questioning and subject reports. Any abnormalities in visit evaluations, physical examination findings or laboratory results that the Investigator believed were clinically significant to the research subject and that occurred after initiation of the first study treatment was reported as an adverse event.
|
7.1%
1/14 • Number of events 1 • Adverse events were reported from the time of the first treatment extension visit and continue up until the final study visit, up to 56 months.
Adverse events were elicited through direct questioning and subject reports. Any abnormalities in visit evaluations, physical examination findings or laboratory results that the Investigator believed were clinically significant to the research subject and that occurred after initiation of the first study treatment was reported as an adverse event.
|
Other adverse events
| Measure |
PRO 140 350 mg
n=29 participants at risk
Eligible subjects received 350 mg PRO 140 (leronlimab) administered weekly as subcutaneous injections along with Optimized Background Therapy (OBT) until virologic failure or another reason for discontinuation.
|
PRO 140 700 mg
n=14 participants at risk
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.
|
|---|---|---|
|
Gastrointestinal disorders
Constipation
|
10.3%
3/29 • Number of events 4 • Adverse events were reported from the time of the first treatment extension visit and continue up until the final study visit, up to 56 months.
Adverse events were elicited through direct questioning and subject reports. Any abnormalities in visit evaluations, physical examination findings or laboratory results that the Investigator believed were clinically significant to the research subject and that occurred after initiation of the first study treatment was reported as an adverse event.
|
0.00%
0/14 • Adverse events were reported from the time of the first treatment extension visit and continue up until the final study visit, up to 56 months.
Adverse events were elicited through direct questioning and subject reports. Any abnormalities in visit evaluations, physical examination findings or laboratory results that the Investigator believed were clinically significant to the research subject and that occurred after initiation of the first study treatment was reported as an adverse event.
|
|
Gastrointestinal disorders
Diarrhoea
|
20.7%
6/29 • Number of events 10 • Adverse events were reported from the time of the first treatment extension visit and continue up until the final study visit, up to 56 months.
Adverse events were elicited through direct questioning and subject reports. Any abnormalities in visit evaluations, physical examination findings or laboratory results that the Investigator believed were clinically significant to the research subject and that occurred after initiation of the first study treatment was reported as an adverse event.
|
0.00%
0/14 • Adverse events were reported from the time of the first treatment extension visit and continue up until the final study visit, up to 56 months.
Adverse events were elicited through direct questioning and subject reports. Any abnormalities in visit evaluations, physical examination findings or laboratory results that the Investigator believed were clinically significant to the research subject and that occurred after initiation of the first study treatment was reported as an adverse event.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
10.3%
3/29 • Number of events 3 • Adverse events were reported from the time of the first treatment extension visit and continue up until the final study visit, up to 56 months.
Adverse events were elicited through direct questioning and subject reports. Any abnormalities in visit evaluations, physical examination findings or laboratory results that the Investigator believed were clinically significant to the research subject and that occurred after initiation of the first study treatment was reported as an adverse event.
|
0.00%
0/14 • Adverse events were reported from the time of the first treatment extension visit and continue up until the final study visit, up to 56 months.
Adverse events were elicited through direct questioning and subject reports. Any abnormalities in visit evaluations, physical examination findings or laboratory results that the Investigator believed were clinically significant to the research subject and that occurred after initiation of the first study treatment was reported as an adverse event.
|
|
Gastrointestinal disorders
abdominal pain
|
10.3%
3/29 • Number of events 3 • Adverse events were reported from the time of the first treatment extension visit and continue up until the final study visit, up to 56 months.
Adverse events were elicited through direct questioning and subject reports. Any abnormalities in visit evaluations, physical examination findings or laboratory results that the Investigator believed were clinically significant to the research subject and that occurred after initiation of the first study treatment was reported as an adverse event.
|
7.1%
1/14 • Number of events 1 • Adverse events were reported from the time of the first treatment extension visit and continue up until the final study visit, up to 56 months.
Adverse events were elicited through direct questioning and subject reports. Any abnormalities in visit evaluations, physical examination findings or laboratory results that the Investigator believed were clinically significant to the research subject and that occurred after initiation of the first study treatment was reported as an adverse event.
|
|
General disorders
Injection site pain
|
6.9%
2/29 • Number of events 2 • Adverse events were reported from the time of the first treatment extension visit and continue up until the final study visit, up to 56 months.
Adverse events were elicited through direct questioning and subject reports. Any abnormalities in visit evaluations, physical examination findings or laboratory results that the Investigator believed were clinically significant to the research subject and that occurred after initiation of the first study treatment was reported as an adverse event.
|
14.3%
2/14 • Number of events 6 • Adverse events were reported from the time of the first treatment extension visit and continue up until the final study visit, up to 56 months.
Adverse events were elicited through direct questioning and subject reports. Any abnormalities in visit evaluations, physical examination findings or laboratory results that the Investigator believed were clinically significant to the research subject and that occurred after initiation of the first study treatment was reported as an adverse event.
|
|
General disorders
Pyrexia
|
13.8%
4/29 • Number of events 4 • Adverse events were reported from the time of the first treatment extension visit and continue up until the final study visit, up to 56 months.
Adverse events were elicited through direct questioning and subject reports. Any abnormalities in visit evaluations, physical examination findings or laboratory results that the Investigator believed were clinically significant to the research subject and that occurred after initiation of the first study treatment was reported as an adverse event.
|
0.00%
0/14 • Adverse events were reported from the time of the first treatment extension visit and continue up until the final study visit, up to 56 months.
Adverse events were elicited through direct questioning and subject reports. Any abnormalities in visit evaluations, physical examination findings or laboratory results that the Investigator believed were clinically significant to the research subject and that occurred after initiation of the first study treatment was reported as an adverse event.
|
|
General disorders
Oedema peripheral
|
10.3%
3/29 • Number of events 4 • Adverse events were reported from the time of the first treatment extension visit and continue up until the final study visit, up to 56 months.
Adverse events were elicited through direct questioning and subject reports. Any abnormalities in visit evaluations, physical examination findings or laboratory results that the Investigator believed were clinically significant to the research subject and that occurred after initiation of the first study treatment was reported as an adverse event.
|
0.00%
0/14 • Adverse events were reported from the time of the first treatment extension visit and continue up until the final study visit, up to 56 months.
Adverse events were elicited through direct questioning and subject reports. Any abnormalities in visit evaluations, physical examination findings or laboratory results that the Investigator believed were clinically significant to the research subject and that occurred after initiation of the first study treatment was reported as an adverse event.
|
|
General disorders
Fatigue
|
10.3%
3/29 • Number of events 3 • Adverse events were reported from the time of the first treatment extension visit and continue up until the final study visit, up to 56 months.
Adverse events were elicited through direct questioning and subject reports. Any abnormalities in visit evaluations, physical examination findings or laboratory results that the Investigator believed were clinically significant to the research subject and that occurred after initiation of the first study treatment was reported as an adverse event.
|
0.00%
0/14 • Adverse events were reported from the time of the first treatment extension visit and continue up until the final study visit, up to 56 months.
Adverse events were elicited through direct questioning and subject reports. Any abnormalities in visit evaluations, physical examination findings or laboratory results that the Investigator believed were clinically significant to the research subject and that occurred after initiation of the first study treatment was reported as an adverse event.
|
|
General disorders
Injection site haemorrhage
|
17.2%
5/29 • Number of events 10 • Adverse events were reported from the time of the first treatment extension visit and continue up until the final study visit, up to 56 months.
Adverse events were elicited through direct questioning and subject reports. Any abnormalities in visit evaluations, physical examination findings or laboratory results that the Investigator believed were clinically significant to the research subject and that occurred after initiation of the first study treatment was reported as an adverse event.
|
7.1%
1/14 • Number of events 1 • Adverse events were reported from the time of the first treatment extension visit and continue up until the final study visit, up to 56 months.
Adverse events were elicited through direct questioning and subject reports. Any abnormalities in visit evaluations, physical examination findings or laboratory results that the Investigator believed were clinically significant to the research subject and that occurred after initiation of the first study treatment was reported as an adverse event.
|
|
General disorders
Chest pain
|
13.8%
4/29 • Number of events 4 • Adverse events were reported from the time of the first treatment extension visit and continue up until the final study visit, up to 56 months.
Adverse events were elicited through direct questioning and subject reports. Any abnormalities in visit evaluations, physical examination findings or laboratory results that the Investigator believed were clinically significant to the research subject and that occurred after initiation of the first study treatment was reported as an adverse event.
|
7.1%
1/14 • Number of events 1 • Adverse events were reported from the time of the first treatment extension visit and continue up until the final study visit, up to 56 months.
Adverse events were elicited through direct questioning and subject reports. Any abnormalities in visit evaluations, physical examination findings or laboratory results that the Investigator believed were clinically significant to the research subject and that occurred after initiation of the first study treatment was reported as an adverse event.
|
|
Infections and infestations
Influenza
|
6.9%
2/29 • Number of events 2 • Adverse events were reported from the time of the first treatment extension visit and continue up until the final study visit, up to 56 months.
Adverse events were elicited through direct questioning and subject reports. Any abnormalities in visit evaluations, physical examination findings or laboratory results that the Investigator believed were clinically significant to the research subject and that occurred after initiation of the first study treatment was reported as an adverse event.
|
7.1%
1/14 • Number of events 1 • Adverse events were reported from the time of the first treatment extension visit and continue up until the final study visit, up to 56 months.
Adverse events were elicited through direct questioning and subject reports. Any abnormalities in visit evaluations, physical examination findings or laboratory results that the Investigator believed were clinically significant to the research subject and that occurred after initiation of the first study treatment was reported as an adverse event.
|
|
Infections and infestations
Pharyngitis
|
10.3%
3/29 • Number of events 3 • Adverse events were reported from the time of the first treatment extension visit and continue up until the final study visit, up to 56 months.
Adverse events were elicited through direct questioning and subject reports. Any abnormalities in visit evaluations, physical examination findings or laboratory results that the Investigator believed were clinically significant to the research subject and that occurred after initiation of the first study treatment was reported as an adverse event.
|
0.00%
0/14 • Adverse events were reported from the time of the first treatment extension visit and continue up until the final study visit, up to 56 months.
Adverse events were elicited through direct questioning and subject reports. Any abnormalities in visit evaluations, physical examination findings or laboratory results that the Investigator believed were clinically significant to the research subject and that occurred after initiation of the first study treatment was reported as an adverse event.
|
|
Infections and infestations
Nasopharyngitis
|
17.2%
5/29 • Number of events 8 • Adverse events were reported from the time of the first treatment extension visit and continue up until the final study visit, up to 56 months.
Adverse events were elicited through direct questioning and subject reports. Any abnormalities in visit evaluations, physical examination findings or laboratory results that the Investigator believed were clinically significant to the research subject and that occurred after initiation of the first study treatment was reported as an adverse event.
|
21.4%
3/14 • Number of events 3 • Adverse events were reported from the time of the first treatment extension visit and continue up until the final study visit, up to 56 months.
Adverse events were elicited through direct questioning and subject reports. Any abnormalities in visit evaluations, physical examination findings or laboratory results that the Investigator believed were clinically significant to the research subject and that occurred after initiation of the first study treatment was reported as an adverse event.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
13.8%
4/29 • Number of events 6 • Adverse events were reported from the time of the first treatment extension visit and continue up until the final study visit, up to 56 months.
Adverse events were elicited through direct questioning and subject reports. Any abnormalities in visit evaluations, physical examination findings or laboratory results that the Investigator believed were clinically significant to the research subject and that occurred after initiation of the first study treatment was reported as an adverse event.
|
7.1%
1/14 • Number of events 1 • Adverse events were reported from the time of the first treatment extension visit and continue up until the final study visit, up to 56 months.
Adverse events were elicited through direct questioning and subject reports. Any abnormalities in visit evaluations, physical examination findings or laboratory results that the Investigator believed were clinically significant to the research subject and that occurred after initiation of the first study treatment was reported as an adverse event.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
10.3%
3/29 • Number of events 3 • Adverse events were reported from the time of the first treatment extension visit and continue up until the final study visit, up to 56 months.
Adverse events were elicited through direct questioning and subject reports. Any abnormalities in visit evaluations, physical examination findings or laboratory results that the Investigator believed were clinically significant to the research subject and that occurred after initiation of the first study treatment was reported as an adverse event.
|
7.1%
1/14 • Number of events 3 • Adverse events were reported from the time of the first treatment extension visit and continue up until the final study visit, up to 56 months.
Adverse events were elicited through direct questioning and subject reports. Any abnormalities in visit evaluations, physical examination findings or laboratory results that the Investigator believed were clinically significant to the research subject and that occurred after initiation of the first study treatment was reported as an adverse event.
|
|
Infections and infestations
Bronchitis
|
10.3%
3/29 • Number of events 3 • Adverse events were reported from the time of the first treatment extension visit and continue up until the final study visit, up to 56 months.
Adverse events were elicited through direct questioning and subject reports. Any abnormalities in visit evaluations, physical examination findings or laboratory results that the Investigator believed were clinically significant to the research subject and that occurred after initiation of the first study treatment was reported as an adverse event.
|
0.00%
0/14 • Adverse events were reported from the time of the first treatment extension visit and continue up until the final study visit, up to 56 months.
Adverse events were elicited through direct questioning and subject reports. Any abnormalities in visit evaluations, physical examination findings or laboratory results that the Investigator believed were clinically significant to the research subject and that occurred after initiation of the first study treatment was reported as an adverse event.
|
|
Injury, poisoning and procedural complications
Contusion
|
6.9%
2/29 • Number of events 7 • Adverse events were reported from the time of the first treatment extension visit and continue up until the final study visit, up to 56 months.
Adverse events were elicited through direct questioning and subject reports. Any abnormalities in visit evaluations, physical examination findings or laboratory results that the Investigator believed were clinically significant to the research subject and that occurred after initiation of the first study treatment was reported as an adverse event.
|
7.1%
1/14 • Number of events 1 • Adverse events were reported from the time of the first treatment extension visit and continue up until the final study visit, up to 56 months.
Adverse events were elicited through direct questioning and subject reports. Any abnormalities in visit evaluations, physical examination findings or laboratory results that the Investigator believed were clinically significant to the research subject and that occurred after initiation of the first study treatment was reported as an adverse event.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
17.2%
5/29 • Number of events 5 • Adverse events were reported from the time of the first treatment extension visit and continue up until the final study visit, up to 56 months.
Adverse events were elicited through direct questioning and subject reports. Any abnormalities in visit evaluations, physical examination findings or laboratory results that the Investigator believed were clinically significant to the research subject and that occurred after initiation of the first study treatment was reported as an adverse event.
|
0.00%
0/14 • Adverse events were reported from the time of the first treatment extension visit and continue up until the final study visit, up to 56 months.
Adverse events were elicited through direct questioning and subject reports. Any abnormalities in visit evaluations, physical examination findings or laboratory results that the Investigator believed were clinically significant to the research subject and that occurred after initiation of the first study treatment was reported as an adverse event.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
10.3%
3/29 • Number of events 3 • Adverse events were reported from the time of the first treatment extension visit and continue up until the final study visit, up to 56 months.
Adverse events were elicited through direct questioning and subject reports. Any abnormalities in visit evaluations, physical examination findings or laboratory results that the Investigator believed were clinically significant to the research subject and that occurred after initiation of the first study treatment was reported as an adverse event.
|
0.00%
0/14 • Adverse events were reported from the time of the first treatment extension visit and continue up until the final study visit, up to 56 months.
Adverse events were elicited through direct questioning and subject reports. Any abnormalities in visit evaluations, physical examination findings or laboratory results that the Investigator believed were clinically significant to the research subject and that occurred after initiation of the first study treatment was reported as an adverse event.
|
|
Skin and subcutaneous tissue disorders
Ecchymosis
|
10.3%
3/29 • Number of events 4 • Adverse events were reported from the time of the first treatment extension visit and continue up until the final study visit, up to 56 months.
Adverse events were elicited through direct questioning and subject reports. Any abnormalities in visit evaluations, physical examination findings or laboratory results that the Investigator believed were clinically significant to the research subject and that occurred after initiation of the first study treatment was reported as an adverse event.
|
14.3%
2/14 • Number of events 2 • Adverse events were reported from the time of the first treatment extension visit and continue up until the final study visit, up to 56 months.
Adverse events were elicited through direct questioning and subject reports. Any abnormalities in visit evaluations, physical examination findings or laboratory results that the Investigator believed were clinically significant to the research subject and that occurred after initiation of the first study treatment was reported as an adverse event.
|
|
Nervous system disorders
Headache
|
13.8%
4/29 • Number of events 5 • Adverse events were reported from the time of the first treatment extension visit and continue up until the final study visit, up to 56 months.
Adverse events were elicited through direct questioning and subject reports. Any abnormalities in visit evaluations, physical examination findings or laboratory results that the Investigator believed were clinically significant to the research subject and that occurred after initiation of the first study treatment was reported as an adverse event.
|
7.1%
1/14 • Number of events 1 • Adverse events were reported from the time of the first treatment extension visit and continue up until the final study visit, up to 56 months.
Adverse events were elicited through direct questioning and subject reports. Any abnormalities in visit evaluations, physical examination findings or laboratory results that the Investigator believed were clinically significant to the research subject and that occurred after initiation of the first study treatment was reported as an adverse event.
|
|
Vascular disorders
Hypertension
|
10.3%
3/29 • Number of events 3 • Adverse events were reported from the time of the first treatment extension visit and continue up until the final study visit, up to 56 months.
Adverse events were elicited through direct questioning and subject reports. Any abnormalities in visit evaluations, physical examination findings or laboratory results that the Investigator believed were clinically significant to the research subject and that occurred after initiation of the first study treatment was reported as an adverse event.
|
7.1%
1/14 • Number of events 2 • Adverse events were reported from the time of the first treatment extension visit and continue up until the final study visit, up to 56 months.
Adverse events were elicited through direct questioning and subject reports. Any abnormalities in visit evaluations, physical examination findings or laboratory results that the Investigator believed were clinically significant to the research subject and that occurred after initiation of the first study treatment was reported as an adverse event.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
10.3%
3/29 • Number of events 4 • Adverse events were reported from the time of the first treatment extension visit and continue up until the final study visit, up to 56 months.
Adverse events were elicited through direct questioning and subject reports. Any abnormalities in visit evaluations, physical examination findings or laboratory results that the Investigator believed were clinically significant to the research subject and that occurred after initiation of the first study treatment was reported as an adverse event.
|
0.00%
0/14 • Adverse events were reported from the time of the first treatment extension visit and continue up until the final study visit, up to 56 months.
Adverse events were elicited through direct questioning and subject reports. Any abnormalities in visit evaluations, physical examination findings or laboratory results that the Investigator believed were clinically significant to the research subject and that occurred after initiation of the first study treatment was reported as an adverse event.
|
|
Skin and subcutaneous tissue disorders
Rash
|
13.8%
4/29 • Number of events 5 • Adverse events were reported from the time of the first treatment extension visit and continue up until the final study visit, up to 56 months.
Adverse events were elicited through direct questioning and subject reports. Any abnormalities in visit evaluations, physical examination findings or laboratory results that the Investigator believed were clinically significant to the research subject and that occurred after initiation of the first study treatment was reported as an adverse event.
|
0.00%
0/14 • Adverse events were reported from the time of the first treatment extension visit and continue up until the final study visit, up to 56 months.
Adverse events were elicited through direct questioning and subject reports. Any abnormalities in visit evaluations, physical examination findings or laboratory results that the Investigator believed were clinically significant to the research subject and that occurred after initiation of the first study treatment was reported as an adverse event.
|
|
Infections and infestations
Sinusitis
|
13.8%
4/29 • Number of events 6 • Adverse events were reported from the time of the first treatment extension visit and continue up until the final study visit, up to 56 months.
Adverse events were elicited through direct questioning and subject reports. Any abnormalities in visit evaluations, physical examination findings or laboratory results that the Investigator believed were clinically significant to the research subject and that occurred after initiation of the first study treatment was reported as an adverse event.
|
0.00%
0/14 • Adverse events were reported from the time of the first treatment extension visit and continue up until the final study visit, up to 56 months.
Adverse events were elicited through direct questioning and subject reports. Any abnormalities in visit evaluations, physical examination findings or laboratory results that the Investigator believed were clinically significant to the research subject and that occurred after initiation of the first study treatment was reported as an adverse event.
|
|
Infections and infestations
upper respiratory tract infection
|
6.9%
2/29 • Number of events 4 • Adverse events were reported from the time of the first treatment extension visit and continue up until the final study visit, up to 56 months.
Adverse events were elicited through direct questioning and subject reports. Any abnormalities in visit evaluations, physical examination findings or laboratory results that the Investigator believed were clinically significant to the research subject and that occurred after initiation of the first study treatment was reported as an adverse event.
|
7.1%
1/14 • Number of events 1 • Adverse events were reported from the time of the first treatment extension visit and continue up until the final study visit, up to 56 months.
Adverse events were elicited through direct questioning and subject reports. Any abnormalities in visit evaluations, physical examination findings or laboratory results that the Investigator believed were clinically significant to the research subject and that occurred after initiation of the first study treatment was reported as an adverse event.
|
|
Infections and infestations
Urinary tract infection
|
13.8%
4/29 • Number of events 4 • Adverse events were reported from the time of the first treatment extension visit and continue up until the final study visit, up to 56 months.
Adverse events were elicited through direct questioning and subject reports. Any abnormalities in visit evaluations, physical examination findings or laboratory results that the Investigator believed were clinically significant to the research subject and that occurred after initiation of the first study treatment was reported as an adverse event.
|
28.6%
4/14 • Number of events 7 • Adverse events were reported from the time of the first treatment extension visit and continue up until the final study visit, up to 56 months.
Adverse events were elicited through direct questioning and subject reports. Any abnormalities in visit evaluations, physical examination findings or laboratory results that the Investigator believed were clinically significant to the research subject and that occurred after initiation of the first study treatment was reported as an adverse event.
|
|
Gastrointestinal disorders
Abdominal rebound tenderness
|
0.00%
0/29 • Adverse events were reported from the time of the first treatment extension visit and continue up until the final study visit, up to 56 months.
Adverse events were elicited through direct questioning and subject reports. Any abnormalities in visit evaluations, physical examination findings or laboratory results that the Investigator believed were clinically significant to the research subject and that occurred after initiation of the first study treatment was reported as an adverse event.
|
7.1%
1/14 • Number of events 1 • Adverse events were reported from the time of the first treatment extension visit and continue up until the final study visit, up to 56 months.
Adverse events were elicited through direct questioning and subject reports. Any abnormalities in visit evaluations, physical examination findings or laboratory results that the Investigator believed were clinically significant to the research subject and that occurred after initiation of the first study treatment was reported as an adverse event.
|
|
Injury, poisoning and procedural complications
Arthropod bite
|
0.00%
0/29 • Adverse events were reported from the time of the first treatment extension visit and continue up until the final study visit, up to 56 months.
Adverse events were elicited through direct questioning and subject reports. Any abnormalities in visit evaluations, physical examination findings or laboratory results that the Investigator believed were clinically significant to the research subject and that occurred after initiation of the first study treatment was reported as an adverse event.
|
7.1%
1/14 • Number of events 1 • Adverse events were reported from the time of the first treatment extension visit and continue up until the final study visit, up to 56 months.
Adverse events were elicited through direct questioning and subject reports. Any abnormalities in visit evaluations, physical examination findings or laboratory results that the Investigator believed were clinically significant to the research subject and that occurred after initiation of the first study treatment was reported as an adverse event.
|
|
Investigations
Blood HIV RNA increased
|
0.00%
0/29 • Adverse events were reported from the time of the first treatment extension visit and continue up until the final study visit, up to 56 months.
Adverse events were elicited through direct questioning and subject reports. Any abnormalities in visit evaluations, physical examination findings or laboratory results that the Investigator believed were clinically significant to the research subject and that occurred after initiation of the first study treatment was reported as an adverse event.
|
7.1%
1/14 • Number of events 6 • Adverse events were reported from the time of the first treatment extension visit and continue up until the final study visit, up to 56 months.
Adverse events were elicited through direct questioning and subject reports. Any abnormalities in visit evaluations, physical examination findings or laboratory results that the Investigator believed were clinically significant to the research subject and that occurred after initiation of the first study treatment was reported as an adverse event.
|
|
Infections and infestations
Cellulitis
|
6.9%
2/29 • Number of events 2 • Adverse events were reported from the time of the first treatment extension visit and continue up until the final study visit, up to 56 months.
Adverse events were elicited through direct questioning and subject reports. Any abnormalities in visit evaluations, physical examination findings or laboratory results that the Investigator believed were clinically significant to the research subject and that occurred after initiation of the first study treatment was reported as an adverse event.
|
0.00%
0/14 • Adverse events were reported from the time of the first treatment extension visit and continue up until the final study visit, up to 56 months.
Adverse events were elicited through direct questioning and subject reports. Any abnormalities in visit evaluations, physical examination findings or laboratory results that the Investigator believed were clinically significant to the research subject and that occurred after initiation of the first study treatment was reported as an adverse event.
|
|
Renal and urinary disorders
Chronic kidney disease
|
0.00%
0/29 • Adverse events were reported from the time of the first treatment extension visit and continue up until the final study visit, up to 56 months.
Adverse events were elicited through direct questioning and subject reports. Any abnormalities in visit evaluations, physical examination findings or laboratory results that the Investigator believed were clinically significant to the research subject and that occurred after initiation of the first study treatment was reported as an adverse event.
|
7.1%
1/14 • Number of events 1 • Adverse events were reported from the time of the first treatment extension visit and continue up until the final study visit, up to 56 months.
Adverse events were elicited through direct questioning and subject reports. Any abnormalities in visit evaluations, physical examination findings or laboratory results that the Investigator believed were clinically significant to the research subject and that occurred after initiation of the first study treatment was reported as an adverse event.
|
|
Infections and infestations
Covid-19
|
3.4%
1/29 • Number of events 1 • Adverse events were reported from the time of the first treatment extension visit and continue up until the final study visit, up to 56 months.
Adverse events were elicited through direct questioning and subject reports. Any abnormalities in visit evaluations, physical examination findings or laboratory results that the Investigator believed were clinically significant to the research subject and that occurred after initiation of the first study treatment was reported as an adverse event.
|
7.1%
1/14 • Number of events 1 • Adverse events were reported from the time of the first treatment extension visit and continue up until the final study visit, up to 56 months.
Adverse events were elicited through direct questioning and subject reports. Any abnormalities in visit evaluations, physical examination findings or laboratory results that the Investigator believed were clinically significant to the research subject and that occurred after initiation of the first study treatment was reported as an adverse event.
|
|
Infections and infestations
Gastrointestinal viral infection
|
0.00%
0/29 • Adverse events were reported from the time of the first treatment extension visit and continue up until the final study visit, up to 56 months.
Adverse events were elicited through direct questioning and subject reports. Any abnormalities in visit evaluations, physical examination findings or laboratory results that the Investigator believed were clinically significant to the research subject and that occurred after initiation of the first study treatment was reported as an adverse event.
|
7.1%
1/14 • Number of events 1 • Adverse events were reported from the time of the first treatment extension visit and continue up until the final study visit, up to 56 months.
Adverse events were elicited through direct questioning and subject reports. Any abnormalities in visit evaluations, physical examination findings or laboratory results that the Investigator believed were clinically significant to the research subject and that occurred after initiation of the first study treatment was reported as an adverse event.
|
|
Gastrointestinal disorders
Gastritis
|
0.00%
0/29 • Adverse events were reported from the time of the first treatment extension visit and continue up until the final study visit, up to 56 months.
Adverse events were elicited through direct questioning and subject reports. Any abnormalities in visit evaluations, physical examination findings or laboratory results that the Investigator believed were clinically significant to the research subject and that occurred after initiation of the first study treatment was reported as an adverse event.
|
7.1%
1/14 • Number of events 1 • Adverse events were reported from the time of the first treatment extension visit and continue up until the final study visit, up to 56 months.
Adverse events were elicited through direct questioning and subject reports. Any abnormalities in visit evaluations, physical examination findings or laboratory results that the Investigator believed were clinically significant to the research subject and that occurred after initiation of the first study treatment was reported as an adverse event.
|
|
Infections and infestations
Herpes zoster
|
3.4%
1/29 • Number of events 1 • Adverse events were reported from the time of the first treatment extension visit and continue up until the final study visit, up to 56 months.
Adverse events were elicited through direct questioning and subject reports. Any abnormalities in visit evaluations, physical examination findings or laboratory results that the Investigator believed were clinically significant to the research subject and that occurred after initiation of the first study treatment was reported as an adverse event.
|
7.1%
1/14 • Number of events 1 • Adverse events were reported from the time of the first treatment extension visit and continue up until the final study visit, up to 56 months.
Adverse events were elicited through direct questioning and subject reports. Any abnormalities in visit evaluations, physical examination findings or laboratory results that the Investigator believed were clinically significant to the research subject and that occurred after initiation of the first study treatment was reported as an adverse event.
|
|
Congenital, familial and genetic disorders
Hydrocele
|
0.00%
0/29 • Adverse events were reported from the time of the first treatment extension visit and continue up until the final study visit, up to 56 months.
Adverse events were elicited through direct questioning and subject reports. Any abnormalities in visit evaluations, physical examination findings or laboratory results that the Investigator believed were clinically significant to the research subject and that occurred after initiation of the first study treatment was reported as an adverse event.
|
7.1%
1/14 • Number of events 1 • Adverse events were reported from the time of the first treatment extension visit and continue up until the final study visit, up to 56 months.
Adverse events were elicited through direct questioning and subject reports. Any abnormalities in visit evaluations, physical examination findings or laboratory results that the Investigator believed were clinically significant to the research subject and that occurred after initiation of the first study treatment was reported as an adverse event.
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
0.00%
0/29 • Adverse events were reported from the time of the first treatment extension visit and continue up until the final study visit, up to 56 months.
Adverse events were elicited through direct questioning and subject reports. Any abnormalities in visit evaluations, physical examination findings or laboratory results that the Investigator believed were clinically significant to the research subject and that occurred after initiation of the first study treatment was reported as an adverse event.
|
7.1%
1/14 • Number of events 1 • Adverse events were reported from the time of the first treatment extension visit and continue up until the final study visit, up to 56 months.
Adverse events were elicited through direct questioning and subject reports. Any abnormalities in visit evaluations, physical examination findings or laboratory results that the Investigator believed were clinically significant to the research subject and that occurred after initiation of the first study treatment was reported as an adverse event.
|
|
Psychiatric disorders
Insomnia
|
0.00%
0/29 • Adverse events were reported from the time of the first treatment extension visit and continue up until the final study visit, up to 56 months.
Adverse events were elicited through direct questioning and subject reports. Any abnormalities in visit evaluations, physical examination findings or laboratory results that the Investigator believed were clinically significant to the research subject and that occurred after initiation of the first study treatment was reported as an adverse event.
|
7.1%
1/14 • Number of events 1 • Adverse events were reported from the time of the first treatment extension visit and continue up until the final study visit, up to 56 months.
Adverse events were elicited through direct questioning and subject reports. Any abnormalities in visit evaluations, physical examination findings or laboratory results that the Investigator believed were clinically significant to the research subject and that occurred after initiation of the first study treatment was reported as an adverse event.
|
|
Investigations
Lip Injury
|
0.00%
0/29 • Adverse events were reported from the time of the first treatment extension visit and continue up until the final study visit, up to 56 months.
Adverse events were elicited through direct questioning and subject reports. Any abnormalities in visit evaluations, physical examination findings or laboratory results that the Investigator believed were clinically significant to the research subject and that occurred after initiation of the first study treatment was reported as an adverse event.
|
7.1%
1/14 • Number of events 1 • Adverse events were reported from the time of the first treatment extension visit and continue up until the final study visit, up to 56 months.
Adverse events were elicited through direct questioning and subject reports. Any abnormalities in visit evaluations, physical examination findings or laboratory results that the Investigator believed were clinically significant to the research subject and that occurred after initiation of the first study treatment was reported as an adverse event.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal Congestion
|
0.00%
0/29 • Adverse events were reported from the time of the first treatment extension visit and continue up until the final study visit, up to 56 months.
Adverse events were elicited through direct questioning and subject reports. Any abnormalities in visit evaluations, physical examination findings or laboratory results that the Investigator believed were clinically significant to the research subject and that occurred after initiation of the first study treatment was reported as an adverse event.
|
7.1%
1/14 • Number of events 1 • Adverse events were reported from the time of the first treatment extension visit and continue up until the final study visit, up to 56 months.
Adverse events were elicited through direct questioning and subject reports. Any abnormalities in visit evaluations, physical examination findings or laboratory results that the Investigator believed were clinically significant to the research subject and that occurred after initiation of the first study treatment was reported as an adverse event.
|
|
Infections and infestations
Oral candidiasis
|
3.4%
1/29 • Number of events 1 • Adverse events were reported from the time of the first treatment extension visit and continue up until the final study visit, up to 56 months.
Adverse events were elicited through direct questioning and subject reports. Any abnormalities in visit evaluations, physical examination findings or laboratory results that the Investigator believed were clinically significant to the research subject and that occurred after initiation of the first study treatment was reported as an adverse event.
|
7.1%
1/14 • Number of events 1 • Adverse events were reported from the time of the first treatment extension visit and continue up until the final study visit, up to 56 months.
Adverse events were elicited through direct questioning and subject reports. Any abnormalities in visit evaluations, physical examination findings or laboratory results that the Investigator believed were clinically significant to the research subject and that occurred after initiation of the first study treatment was reported as an adverse event.
|
|
Infections and infestations
Orchitis
|
0.00%
0/29 • Adverse events were reported from the time of the first treatment extension visit and continue up until the final study visit, up to 56 months.
Adverse events were elicited through direct questioning and subject reports. Any abnormalities in visit evaluations, physical examination findings or laboratory results that the Investigator believed were clinically significant to the research subject and that occurred after initiation of the first study treatment was reported as an adverse event.
|
7.1%
1/14 • Number of events 1 • Adverse events were reported from the time of the first treatment extension visit and continue up until the final study visit, up to 56 months.
Adverse events were elicited through direct questioning and subject reports. Any abnormalities in visit evaluations, physical examination findings or laboratory results that the Investigator believed were clinically significant to the research subject and that occurred after initiation of the first study treatment was reported as an adverse event.
|
|
Renal and urinary disorders
Pharyngitis
|
10.3%
3/29 • Number of events 3 • Adverse events were reported from the time of the first treatment extension visit and continue up until the final study visit, up to 56 months.
Adverse events were elicited through direct questioning and subject reports. Any abnormalities in visit evaluations, physical examination findings or laboratory results that the Investigator believed were clinically significant to the research subject and that occurred after initiation of the first study treatment was reported as an adverse event.
|
0.00%
0/14 • Adverse events were reported from the time of the first treatment extension visit and continue up until the final study visit, up to 56 months.
Adverse events were elicited through direct questioning and subject reports. Any abnormalities in visit evaluations, physical examination findings or laboratory results that the Investigator believed were clinically significant to the research subject and that occurred after initiation of the first study treatment was reported as an adverse event.
|
|
Investigations
Red blood cells urine
|
0.00%
0/29 • Adverse events were reported from the time of the first treatment extension visit and continue up until the final study visit, up to 56 months.
Adverse events were elicited through direct questioning and subject reports. Any abnormalities in visit evaluations, physical examination findings or laboratory results that the Investigator believed were clinically significant to the research subject and that occurred after initiation of the first study treatment was reported as an adverse event.
|
7.1%
1/14 • Number of events 1 • Adverse events were reported from the time of the first treatment extension visit and continue up until the final study visit, up to 56 months.
Adverse events were elicited through direct questioning and subject reports. Any abnormalities in visit evaluations, physical examination findings or laboratory results that the Investigator believed were clinically significant to the research subject and that occurred after initiation of the first study treatment was reported as an adverse event.
|
|
Infections and infestations
Tooth infection
|
6.9%
2/29 • Number of events 2 • Adverse events were reported from the time of the first treatment extension visit and continue up until the final study visit, up to 56 months.
Adverse events were elicited through direct questioning and subject reports. Any abnormalities in visit evaluations, physical examination findings or laboratory results that the Investigator believed were clinically significant to the research subject and that occurred after initiation of the first study treatment was reported as an adverse event.
|
7.1%
1/14 • Number of events 1 • Adverse events were reported from the time of the first treatment extension visit and continue up until the final study visit, up to 56 months.
Adverse events were elicited through direct questioning and subject reports. Any abnormalities in visit evaluations, physical examination findings or laboratory results that the Investigator believed were clinically significant to the research subject and that occurred after initiation of the first study treatment was reported as an adverse event.
|
|
Eye disorders
Uveitis
|
0.00%
0/29 • Adverse events were reported from the time of the first treatment extension visit and continue up until the final study visit, up to 56 months.
Adverse events were elicited through direct questioning and subject reports. Any abnormalities in visit evaluations, physical examination findings or laboratory results that the Investigator believed were clinically significant to the research subject and that occurred after initiation of the first study treatment was reported as an adverse event.
|
7.1%
1/14 • Number of events 1 • Adverse events were reported from the time of the first treatment extension visit and continue up until the final study visit, up to 56 months.
Adverse events were elicited through direct questioning and subject reports. Any abnormalities in visit evaluations, physical examination findings or laboratory results that the Investigator believed were clinically significant to the research subject and that occurred after initiation of the first study treatment was reported as an adverse event.
|
|
Gastrointestinal disorders
Vomiting
|
3.4%
1/29 • Number of events 1 • Adverse events were reported from the time of the first treatment extension visit and continue up until the final study visit, up to 56 months.
Adverse events were elicited through direct questioning and subject reports. Any abnormalities in visit evaluations, physical examination findings or laboratory results that the Investigator believed were clinically significant to the research subject and that occurred after initiation of the first study treatment was reported as an adverse event.
|
7.1%
1/14 • Number of events 1 • Adverse events were reported from the time of the first treatment extension visit and continue up until the final study visit, up to 56 months.
Adverse events were elicited through direct questioning and subject reports. Any abnormalities in visit evaluations, physical examination findings or laboratory results that the Investigator believed were clinically significant to the research subject and that occurred after initiation of the first study treatment was reported as an adverse event.
|
|
Infections and infestations
Wound infection
|
0.00%
0/29 • Adverse events were reported from the time of the first treatment extension visit and continue up until the final study visit, up to 56 months.
Adverse events were elicited through direct questioning and subject reports. Any abnormalities in visit evaluations, physical examination findings or laboratory results that the Investigator believed were clinically significant to the research subject and that occurred after initiation of the first study treatment was reported as an adverse event.
|
7.1%
1/14 • Number of events 1 • Adverse events were reported from the time of the first treatment extension visit and continue up until the final study visit, up to 56 months.
Adverse events were elicited through direct questioning and subject reports. Any abnormalities in visit evaluations, physical examination findings or laboratory results that the Investigator believed were clinically significant to the research subject and that occurred after initiation of the first study treatment was reported as an adverse event.
|
|
Nervous system disorders
Sciatica
|
0.00%
0/29 • Adverse events were reported from the time of the first treatment extension visit and continue up until the final study visit, up to 56 months.
Adverse events were elicited through direct questioning and subject reports. Any abnormalities in visit evaluations, physical examination findings or laboratory results that the Investigator believed were clinically significant to the research subject and that occurred after initiation of the first study treatment was reported as an adverse event.
|
7.1%
1/14 • Number of events 1 • Adverse events were reported from the time of the first treatment extension visit and continue up until the final study visit, up to 56 months.
Adverse events were elicited through direct questioning and subject reports. Any abnormalities in visit evaluations, physical examination findings or laboratory results that the Investigator believed were clinically significant to the research subject and that occurred after initiation of the first study treatment was reported as an adverse event.
|
|
Gastrointestinal disorders
Anal fissure
|
0.00%
0/29 • Adverse events were reported from the time of the first treatment extension visit and continue up until the final study visit, up to 56 months.
Adverse events were elicited through direct questioning and subject reports. Any abnormalities in visit evaluations, physical examination findings or laboratory results that the Investigator believed were clinically significant to the research subject and that occurred after initiation of the first study treatment was reported as an adverse event.
|
7.1%
1/14 • Number of events 1 • Adverse events were reported from the time of the first treatment extension visit and continue up until the final study visit, up to 56 months.
Adverse events were elicited through direct questioning and subject reports. Any abnormalities in visit evaluations, physical examination findings or laboratory results that the Investigator believed were clinically significant to the research subject and that occurred after initiation of the first study treatment was reported as an adverse event.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Anal dysplasia
|
0.00%
0/29 • Adverse events were reported from the time of the first treatment extension visit and continue up until the final study visit, up to 56 months.
Adverse events were elicited through direct questioning and subject reports. Any abnormalities in visit evaluations, physical examination findings or laboratory results that the Investigator believed were clinically significant to the research subject and that occurred after initiation of the first study treatment was reported as an adverse event.
|
7.1%
1/14 • Number of events 1 • Adverse events were reported from the time of the first treatment extension visit and continue up until the final study visit, up to 56 months.
Adverse events were elicited through direct questioning and subject reports. Any abnormalities in visit evaluations, physical examination findings or laboratory results that the Investigator believed were clinically significant to the research subject and that occurred after initiation of the first study treatment was reported as an adverse event.
|
|
Musculoskeletal and connective tissue disorders
Scapula pain
|
0.00%
0/29 • Adverse events were reported from the time of the first treatment extension visit and continue up until the final study visit, up to 56 months.
Adverse events were elicited through direct questioning and subject reports. Any abnormalities in visit evaluations, physical examination findings or laboratory results that the Investigator believed were clinically significant to the research subject and that occurred after initiation of the first study treatment was reported as an adverse event.
|
7.1%
1/14 • Number of events 1 • Adverse events were reported from the time of the first treatment extension visit and continue up until the final study visit, up to 56 months.
Adverse events were elicited through direct questioning and subject reports. Any abnormalities in visit evaluations, physical examination findings or laboratory results that the Investigator believed were clinically significant to the research subject and that occurred after initiation of the first study treatment was reported as an adverse event.
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/29 • Adverse events were reported from the time of the first treatment extension visit and continue up until the final study visit, up to 56 months.
Adverse events were elicited through direct questioning and subject reports. Any abnormalities in visit evaluations, physical examination findings or laboratory results that the Investigator believed were clinically significant to the research subject and that occurred after initiation of the first study treatment was reported as an adverse event.
|
7.1%
1/14 • Number of events 1 • Adverse events were reported from the time of the first treatment extension visit and continue up until the final study visit, up to 56 months.
Adverse events were elicited through direct questioning and subject reports. Any abnormalities in visit evaluations, physical examination findings or laboratory results that the Investigator believed were clinically significant to the research subject and that occurred after initiation of the first study treatment was reported as an adverse event.
|
|
Ear and labyrinth disorders
Hearing loss
|
0.00%
0/29 • Adverse events were reported from the time of the first treatment extension visit and continue up until the final study visit, up to 56 months.
Adverse events were elicited through direct questioning and subject reports. Any abnormalities in visit evaluations, physical examination findings or laboratory results that the Investigator believed were clinically significant to the research subject and that occurred after initiation of the first study treatment was reported as an adverse event.
|
7.1%
1/14 • Number of events 1 • Adverse events were reported from the time of the first treatment extension visit and continue up until the final study visit, up to 56 months.
Adverse events were elicited through direct questioning and subject reports. Any abnormalities in visit evaluations, physical examination findings or laboratory results that the Investigator believed were clinically significant to the research subject and that occurred after initiation of the first study treatment was reported as an adverse event.
|
|
Musculoskeletal and connective tissue disorders
Olecranon bursitis
|
0.00%
0/29 • Adverse events were reported from the time of the first treatment extension visit and continue up until the final study visit, up to 56 months.
Adverse events were elicited through direct questioning and subject reports. Any abnormalities in visit evaluations, physical examination findings or laboratory results that the Investigator believed were clinically significant to the research subject and that occurred after initiation of the first study treatment was reported as an adverse event.
|
7.1%
1/14 • Number of events 1 • Adverse events were reported from the time of the first treatment extension visit and continue up until the final study visit, up to 56 months.
Adverse events were elicited through direct questioning and subject reports. Any abnormalities in visit evaluations, physical examination findings or laboratory results that the Investigator believed were clinically significant to the research subject and that occurred after initiation of the first study treatment was reported as an adverse event.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place