Trial Outcomes & Findings for Safety Study of a Dual Anti-HIV Gene Transfer Construct to Treat HIV-1 Infection (NCT NCT01734850)
NCT ID: NCT01734850
Last Updated: 2020-08-06
Results Overview
Recruitment status
COMPLETED
Study phase
PHASE1/PHASE2
Target enrollment
13 participants
Primary outcome timeframe
Up to 48 weeks
Results posted on
2020-08-06
Participant Flow
Participant milestones
| Measure |
Cohort 1 (CSL202 With No Busulfan)
Cal-1 modified Hematopoietic stem/progenitor cells (HSPC) and Cal-1 modified CD4+ T lymphocytes (CSL202) without busulfan preconditioning
|
Cohort 2 (CSL202 With 1 Busulfan Dose)
Cal-1 modified HSPC and Cal-1 modified CD4+ T lymphocytes (CSL202), with single 4mg/kg busulfan dose administered as pre-conditioning for transplant
Busulfan: Intravenous busulfan
|
Cohort 3 (CSL202 With 2 Busulfan Doses)
Cal-1 modified HSPC and Cal-1 modified CD4+ T lymphocytes (CSL202), first busulfan dose = 3mg/kg and second busulfan dose adjusted (total target exposure of 8,000 μmolar/min AUC) administered as pre-conditioning for transplant
Busulfan: Intravenous busulfan
|
|---|---|---|---|
|
Overall Study
STARTED
|
4
|
4
|
5
|
|
Overall Study
COMPLETED
|
1
|
2
|
1
|
|
Overall Study
NOT COMPLETED
|
3
|
2
|
4
|
Reasons for withdrawal
| Measure |
Cohort 1 (CSL202 With No Busulfan)
Cal-1 modified Hematopoietic stem/progenitor cells (HSPC) and Cal-1 modified CD4+ T lymphocytes (CSL202) without busulfan preconditioning
|
Cohort 2 (CSL202 With 1 Busulfan Dose)
Cal-1 modified HSPC and Cal-1 modified CD4+ T lymphocytes (CSL202), with single 4mg/kg busulfan dose administered as pre-conditioning for transplant
Busulfan: Intravenous busulfan
|
Cohort 3 (CSL202 With 2 Busulfan Doses)
Cal-1 modified HSPC and Cal-1 modified CD4+ T lymphocytes (CSL202), first busulfan dose = 3mg/kg and second busulfan dose adjusted (total target exposure of 8,000 μmolar/min AUC) administered as pre-conditioning for transplant
Busulfan: Intravenous busulfan
|
|---|---|---|---|
|
Overall Study
Continued to Week 48 but recommenced ART
|
3
|
2
|
3
|
|
Overall Study
Not infused due to manufacturing failure
|
0
|
0
|
1
|
Baseline Characteristics
Safety Study of a Dual Anti-HIV Gene Transfer Construct to Treat HIV-1 Infection
Baseline characteristics by cohort
| Measure |
Cohort 1 (CSL202 With No Busulfan)
n=4 Participants
Cal-1 modified HSPC and Cal-1 modified CD4+ T lymphocytes (CSL202) without busulfan preconditioning
|
Cohort 2 (CSL202 With 1 Busulfan Dose)
n=4 Participants
Cal-1 modified HSPC and Cal-1 modified CD4+ T lymphocytes (CSL202), with single 4mg/kg busulfan dose administered as pre-conditioning for transplant
Busulfan: Intravenous busulfan
|
Cohort 3 (CSL202 With 2 Busulfan Doses)
n=5 Participants
Cal-1 modified HSPC and Cal-1 modified CD4+ T lymphocytes (CSL202), first busulfan dose = 3mg/kg and second busulfan dose adjusted (total target exposure of 8,000 μmolar/min AUC)administered as pre-conditioning for transplant
Busulfan: Intravenous busulfan
|
Total
n=13 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
4 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
13 Participants
n=4 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Age, Continuous
|
43.0 years
STANDARD_DEVIATION 11.7 • n=5 Participants
|
48.5 years
STANDARD_DEVIATION 12.8 • n=7 Participants
|
46.8 years
STANDARD_DEVIATION 3.1 • n=5 Participants
|
46.2 years
STANDARD_DEVIATION 9.2 • n=4 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
4 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
13 Participants
n=4 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
White
|
4 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
12 Participants
n=4 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Region of Enrollment
United States
|
4 participants
n=5 Participants
|
4 participants
n=7 Participants
|
5 participants
n=5 Participants
|
13 participants
n=4 Participants
|
PRIMARY outcome
Timeframe: Up to 48 weeksPopulation: Safety Population (SP): The safety population includes all enrolled subjects signing informed consent who started the interventional phase of the trial (i.e. CD4+ Apheresis and discontinued subjects who re-commenced ART)
Outcome measures
| Measure |
Cohort 1 (CSL202 With No Busulfan)
n=4 Participants
Cal-1 modified HSPC and Cal-1 modified CD4+ T lymphocytes (CSL202) without busulfan preconditioning
|
Cohort 2 (CSL202 With 1 Busulfan Dose)
n=4 Participants
Cal-1 modified HSPC and Cal-1 modified CD4+ T lymphocytes (CSL202), with single 4mg/kg busulfan dose administered as pre-conditioning for transplant
Busulfan: Intravenous busulfan
|
Cohort 3 (CSL202 With 2 Busulfan Doses)
n=5 Participants
Cal-1 modified HSPC and Cal-1 modified CD4+ T lymphocytes (CSL202), first busulfan dose = 3mg/kg and second busulfan dose adjusted (total target exposure of 8,000 μmolar/min AUC) administered as pre-conditioning for transplant
Busulfan: Intravenous busulfan
|
|---|---|---|---|
|
Number of Participants With Severe and Life-threatening Adverse Events (AEs)
Severe
|
0 Participants
|
4 Participants
|
4 Participants
|
|
Number of Participants With Severe and Life-threatening Adverse Events (AEs)
Life-threatening
|
0 Participants
|
3 Participants
|
4 Participants
|
PRIMARY outcome
Timeframe: Up to 48 weeksPopulation: SP
Outcome measures
| Measure |
Cohort 1 (CSL202 With No Busulfan)
n=4 Participants
Cal-1 modified HSPC and Cal-1 modified CD4+ T lymphocytes (CSL202) without busulfan preconditioning
|
Cohort 2 (CSL202 With 1 Busulfan Dose)
n=4 Participants
Cal-1 modified HSPC and Cal-1 modified CD4+ T lymphocytes (CSL202), with single 4mg/kg busulfan dose administered as pre-conditioning for transplant
Busulfan: Intravenous busulfan
|
Cohort 3 (CSL202 With 2 Busulfan Doses)
n=5 Participants
Cal-1 modified HSPC and Cal-1 modified CD4+ T lymphocytes (CSL202), first busulfan dose = 3mg/kg and second busulfan dose adjusted (total target exposure of 8,000 μmolar/min AUC) administered as pre-conditioning for transplant
Busulfan: Intravenous busulfan
|
|---|---|---|---|
|
Number of Participants With Severe or Life-threatening AEs Related to CSL202
|
0 Participants
|
0 Participants
|
1 Participants
|
PRIMARY outcome
Timeframe: Up to 48 weeksPopulation: SP
Outcome measures
| Measure |
Cohort 1 (CSL202 With No Busulfan)
n=4 Participants
Cal-1 modified HSPC and Cal-1 modified CD4+ T lymphocytes (CSL202) without busulfan preconditioning
|
Cohort 2 (CSL202 With 1 Busulfan Dose)
n=4 Participants
Cal-1 modified HSPC and Cal-1 modified CD4+ T lymphocytes (CSL202), with single 4mg/kg busulfan dose administered as pre-conditioning for transplant
Busulfan: Intravenous busulfan
|
Cohort 3 (CSL202 With 2 Busulfan Doses)
n=5 Participants
Cal-1 modified HSPC and Cal-1 modified CD4+ T lymphocytes (CSL202), first busulfan dose = 3mg/kg and second busulfan dose adjusted (total target exposure of 8,000 μmolar/min AUC) administered as pre-conditioning for transplant
Busulfan: Intravenous busulfan
|
|---|---|---|---|
|
Number of Participants With the Presence of Replication-competent Retrovirus
|
0 Participants
|
0 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: Up to 48 weeksPopulation: SP (1 participant in Cohort 3 withdrew consent and did not receive busulfan or Ttn and HSPCtn)
Vector Integration Site Analysis performed only when Cal-1 Marking is \>= 1%.
Outcome measures
| Measure |
Cohort 1 (CSL202 With No Busulfan)
n=4 Participants
Cal-1 modified HSPC and Cal-1 modified CD4+ T lymphocytes (CSL202) without busulfan preconditioning
|
Cohort 2 (CSL202 With 1 Busulfan Dose)
n=4 Participants
Cal-1 modified HSPC and Cal-1 modified CD4+ T lymphocytes (CSL202), with single 4mg/kg busulfan dose administered as pre-conditioning for transplant
Busulfan: Intravenous busulfan
|
Cohort 3 (CSL202 With 2 Busulfan Doses)
n=4 Participants
Cal-1 modified HSPC and Cal-1 modified CD4+ T lymphocytes (CSL202), first busulfan dose = 3mg/kg and second busulfan dose adjusted (total target exposure of 8,000 μmolar/min AUC) administered as pre-conditioning for transplant
Busulfan: Intravenous busulfan
|
|---|---|---|---|
|
Number of Participants With Predominant Integration Site Analysis
|
NA Participants
Not done because Cal-1 Marking was \<1% at the corresponding time point required
|
NA Participants
Not done because Cal-1 Marking was \<1% at the corresponding time point required
|
NA Participants
Not done because Cal-1 Marking was \<1% at the corresponding time point required
|
PRIMARY outcome
Timeframe: Up to 48 weeksPopulation: SP (1 participant in Cohort 3 withdrew consent and did not receive busulfan or Ttn and HSPCtn)
Outcome measures
| Measure |
Cohort 1 (CSL202 With No Busulfan)
n=4 Participants
Cal-1 modified HSPC and Cal-1 modified CD4+ T lymphocytes (CSL202) without busulfan preconditioning
|
Cohort 2 (CSL202 With 1 Busulfan Dose)
n=4 Participants
Cal-1 modified HSPC and Cal-1 modified CD4+ T lymphocytes (CSL202), with single 4mg/kg busulfan dose administered as pre-conditioning for transplant
Busulfan: Intravenous busulfan
|
Cohort 3 (CSL202 With 2 Busulfan Doses)
n=4 Participants
Cal-1 modified HSPC and Cal-1 modified CD4+ T lymphocytes (CSL202), first busulfan dose = 3mg/kg and second busulfan dose adjusted (total target exposure of 8,000 μmolar/min AUC) administered as pre-conditioning for transplant
Busulfan: Intravenous busulfan
|
|---|---|---|---|
|
Mean Cell Dose for CD4+ Cells (Ttn)
|
16.940 Number (10^8 cells)
Interval 14.61 to 20.62
|
81.855 Number (10^8 cells)
Interval 38.94 to 138.68
|
49.553 Number (10^8 cells)
Interval 20.7 to 79.29
|
PRIMARY outcome
Timeframe: Up to 48 weeksPopulation: SP (1 participant in Cohort 3 withdrew consent and did not receive busulfan or Ttn and HSPCtn)
Outcome measures
| Measure |
Cohort 1 (CSL202 With No Busulfan)
n=4 Participants
Cal-1 modified HSPC and Cal-1 modified CD4+ T lymphocytes (CSL202) without busulfan preconditioning
|
Cohort 2 (CSL202 With 1 Busulfan Dose)
n=4 Participants
Cal-1 modified HSPC and Cal-1 modified CD4+ T lymphocytes (CSL202), with single 4mg/kg busulfan dose administered as pre-conditioning for transplant
Busulfan: Intravenous busulfan
|
Cohort 3 (CSL202 With 2 Busulfan Doses)
n=4 Participants
Cal-1 modified HSPC and Cal-1 modified CD4+ T lymphocytes (CSL202), first busulfan dose = 3mg/kg and second busulfan dose adjusted (total target exposure of 8,000 μmolar/min AUC) administered as pre-conditioning for transplant
Busulfan: Intravenous busulfan
|
|---|---|---|---|
|
Mean Cell Dose for CD34+ Cells (HSPCtn)
|
2.1 Number (10^6 cells/kg body weight)
Interval 0.35 to 5.0
|
2.4 Number (10^6 cells/kg body weight)
Interval 1.0 to 4.0
|
10.6 Number (10^6 cells/kg body weight)
Interval 7.4 to 12.5
|
PRIMARY outcome
Timeframe: Up to 48 weeksPopulation: SP (1 participant in Cohort 3 withdrew consent and did not receive busulfan or Ttn and HSPCtn)
Outcome measures
| Measure |
Cohort 1 (CSL202 With No Busulfan)
n=4 Participants
Cal-1 modified HSPC and Cal-1 modified CD4+ T lymphocytes (CSL202) without busulfan preconditioning
|
Cohort 2 (CSL202 With 1 Busulfan Dose)
n=4 Participants
Cal-1 modified HSPC and Cal-1 modified CD4+ T lymphocytes (CSL202), with single 4mg/kg busulfan dose administered as pre-conditioning for transplant
Busulfan: Intravenous busulfan
|
Cohort 3 (CSL202 With 2 Busulfan Doses)
n=4 Participants
Cal-1 modified HSPC and Cal-1 modified CD4+ T lymphocytes (CSL202), first busulfan dose = 3mg/kg and second busulfan dose adjusted (total target exposure of 8,000 μmolar/min AUC) administered as pre-conditioning for transplant
Busulfan: Intravenous busulfan
|
|---|---|---|---|
|
Percent Transduction Efficiency of CD4+ Cells (Ttn) and CD34+ Cells (HSPCtn) of Final Cell Product
CD4+ Cells (Ttn)
|
41.0 Percent transduction efficiency
Interval 21.0 to 60.0
|
29.2 Percent transduction efficiency
Interval 13.0 to 39.0
|
66.8 Percent transduction efficiency
Interval 39.0 to 84.0
|
|
Percent Transduction Efficiency of CD4+ Cells (Ttn) and CD34+ Cells (HSPCtn) of Final Cell Product
CD34+ Cells (HSPCtn)
|
58.6 Percent transduction efficiency
Interval 51.0 to 77.0
|
26.3 Percent transduction efficiency
Interval 12.0 to 53.0
|
31.3 Percent transduction efficiency
Interval 21.0 to 49.0
|
PRIMARY outcome
Timeframe: Up to 48 weeksPopulation: SP (1 participant in Cohort 3 withdrew consent and did not receive busulfan or Ttn and HSPCtn)
Cohort 3: Total AUC = first dose AUC value + second dose AUC value
Outcome measures
| Measure |
Cohort 1 (CSL202 With No Busulfan)
n=4 Participants
Cal-1 modified HSPC and Cal-1 modified CD4+ T lymphocytes (CSL202) without busulfan preconditioning
|
Cohort 2 (CSL202 With 1 Busulfan Dose)
n=4 Participants
Cal-1 modified HSPC and Cal-1 modified CD4+ T lymphocytes (CSL202), with single 4mg/kg busulfan dose administered as pre-conditioning for transplant
Busulfan: Intravenous busulfan
|
Cohort 3 (CSL202 With 2 Busulfan Doses)
Cal-1 modified HSPC and Cal-1 modified CD4+ T lymphocytes (CSL202), first busulfan dose = 3mg/kg and second busulfan dose adjusted (total target exposure of 8,000 μmolar/min AUC) administered as pre-conditioning for transplant
Busulfan: Intravenous busulfan
|
|---|---|---|---|
|
Total Area Under the Curve (AUC) for Busulfan
|
6521.5 micromolar*min
Interval 5863.0 to 7259.0
|
8296.8 micromolar*min
Interval 7893.0 to 8601.0
|
—
|
SECONDARY outcome
Timeframe: Up to 48 weeksPopulation: SP (1 participant in Cohort 3 withdrew consent and did not receive busulfan or Ttn and HSPCtn)
Outcome measures
| Measure |
Cohort 1 (CSL202 With No Busulfan)
n=4 Participants
Cal-1 modified HSPC and Cal-1 modified CD4+ T lymphocytes (CSL202) without busulfan preconditioning
|
Cohort 2 (CSL202 With 1 Busulfan Dose)
n=4 Participants
Cal-1 modified HSPC and Cal-1 modified CD4+ T lymphocytes (CSL202), with single 4mg/kg busulfan dose administered as pre-conditioning for transplant
Busulfan: Intravenous busulfan
|
Cohort 3 (CSL202 With 2 Busulfan Doses)
n=4 Participants
Cal-1 modified HSPC and Cal-1 modified CD4+ T lymphocytes (CSL202), first busulfan dose = 3mg/kg and second busulfan dose adjusted (total target exposure of 8,000 μmolar/min AUC) administered as pre-conditioning for transplant
Busulfan: Intravenous busulfan
|
|---|---|---|---|
|
Percent Cal-1 Marking in Peripheral Blood
Peak marking
|
0.3500 percent Cal-1 marking
Interval 0.0 to 1.16
|
0.7650 percent Cal-1 marking
Interval 0.61 to 0.89
|
3.1200 percent Cal-1 marking
Interval 0.18 to 7.46
|
|
Percent Cal-1 Marking in Peripheral Blood
Week 48
|
0.0000 percent Cal-1 marking
Interval 0.0 to 0.0
|
0.1275 percent Cal-1 marking
Interval 0.0 to 0.38
|
0.1275 percent Cal-1 marking
Interval 0.0 to 0.49
|
SECONDARY outcome
Timeframe: Up to 48 weeksPopulation: SP (1 participant in Cohort 3 withdrew consent and did not receive busulfan or Ttn and HSPCtn)
Samples were collected via endoscopic biopsy from the sigmoid colon: 10-15 cm from the anal margin
Outcome measures
| Measure |
Cohort 1 (CSL202 With No Busulfan)
n=4 Participants
Cal-1 modified HSPC and Cal-1 modified CD4+ T lymphocytes (CSL202) without busulfan preconditioning
|
Cohort 2 (CSL202 With 1 Busulfan Dose)
n=4 Participants
Cal-1 modified HSPC and Cal-1 modified CD4+ T lymphocytes (CSL202), with single 4mg/kg busulfan dose administered as pre-conditioning for transplant
Busulfan: Intravenous busulfan
|
Cohort 3 (CSL202 With 2 Busulfan Doses)
n=4 Participants
Cal-1 modified HSPC and Cal-1 modified CD4+ T lymphocytes (CSL202), first busulfan dose = 3mg/kg and second busulfan dose adjusted (total target exposure of 8,000 μmolar/min AUC) administered as pre-conditioning for transplant
Busulfan: Intravenous busulfan
|
|---|---|---|---|
|
Cal-1 Marking in Gut-associated Lymphoid Tissue (GALT) (10-15 cm)
Peak marking
|
0.8121 copies/cell
Interval 0.0 to 2.7054
|
0.0007 copies/cell
Interval 0.0 to 0.0019
|
0.0022 copies/cell
Interval 0.0006 to 0.006
|
|
Cal-1 Marking in Gut-associated Lymphoid Tissue (GALT) (10-15 cm)
Week 48
|
0.8121 copies/cell
Interval 0.0 to 2.7054
|
0.0004 copies/cell
Interval 0.0 to 0.001
|
0.0001 copies/cell
Interval 0.0 to 0.0004
|
SECONDARY outcome
Timeframe: Up to 48 weeksPopulation: SP (1 participant in Cohort 3 withdrew consent and did not receive busulfan or Ttn and HSPCtn)
Samples were collected via endoscopic biopsy from the sigmoid colon: 25-35 cm from the anal margin
Outcome measures
| Measure |
Cohort 1 (CSL202 With No Busulfan)
n=4 Participants
Cal-1 modified HSPC and Cal-1 modified CD4+ T lymphocytes (CSL202) without busulfan preconditioning
|
Cohort 2 (CSL202 With 1 Busulfan Dose)
n=4 Participants
Cal-1 modified HSPC and Cal-1 modified CD4+ T lymphocytes (CSL202), with single 4mg/kg busulfan dose administered as pre-conditioning for transplant
Busulfan: Intravenous busulfan
|
Cohort 3 (CSL202 With 2 Busulfan Doses)
n=4 Participants
Cal-1 modified HSPC and Cal-1 modified CD4+ T lymphocytes (CSL202), first busulfan dose = 3mg/kg and second busulfan dose adjusted (total target exposure of 8,000 μmolar/min AUC) administered as pre-conditioning for transplant
Busulfan: Intravenous busulfan
|
|---|---|---|---|
|
Cal-1 Marking in GALT (25-35 cm)
Peak marking
|
0.0255 copies/cell
Interval 0.0 to 0.0677
|
0.0003 copies/cell
Interval 0.0 to 0.0011
|
0.0068 copies/cell
Interval 0.002 to 0.0186
|
|
Cal-1 Marking in GALT (25-35 cm)
Week 48
|
0.0255 copies/cell
Interval 0.0 to 0.0677
|
0.0003 copies/cell
Interval 0.0 to 0.0011
|
0.0055 copies/cell
Interval 0.0 to 0.0186
|
SECONDARY outcome
Timeframe: Up to 48 weeksPopulation: SP (1 participant in Cohort 3 withdrew consent and did not receive busulfan or Ttn and HSPCtn)
Outcome measures
| Measure |
Cohort 1 (CSL202 With No Busulfan)
n=4 Participants
Cal-1 modified HSPC and Cal-1 modified CD4+ T lymphocytes (CSL202) without busulfan preconditioning
|
Cohort 2 (CSL202 With 1 Busulfan Dose)
n=4 Participants
Cal-1 modified HSPC and Cal-1 modified CD4+ T lymphocytes (CSL202), with single 4mg/kg busulfan dose administered as pre-conditioning for transplant
Busulfan: Intravenous busulfan
|
Cohort 3 (CSL202 With 2 Busulfan Doses)
n=4 Participants
Cal-1 modified HSPC and Cal-1 modified CD4+ T lymphocytes (CSL202), first busulfan dose = 3mg/kg and second busulfan dose adjusted (total target exposure of 8,000 μmolar/min AUC) administered as pre-conditioning for transplant
Busulfan: Intravenous busulfan
|
|---|---|---|---|
|
Cal-1 Marking in Bone Marrow
Peak marking
|
0.0007 copies/cell
Interval 0.0 to 0.0026
|
0.0539 copies/cell
Interval 0.0005 to 0.2027
|
0.0021 copies/cell
Interval 0.0009 to 0.003
|
|
Cal-1 Marking in Bone Marrow
Week 48
|
0.0007 copies/cell
Interval 0.0 to 0.0026
|
0.0015 copies/cell
Interval 0.0005 to 0.0044
|
0.0009 copies/cell
Interval 0.0003 to 0.0025
|
SECONDARY outcome
Timeframe: Up to 48 weeksPopulation: SP (1 participant in Cohort 3 withdrew consent and did not receive busulfan or Ttn and HSPCtn)
C46 relative expression will be analyzed by reverse transcriptase-quantitative polymerase chain reaction (RT-qPCR) and normalized to the expression of β2-microglobulin (β2M) mRNA
Outcome measures
| Measure |
Cohort 1 (CSL202 With No Busulfan)
n=4 Participants
Cal-1 modified HSPC and Cal-1 modified CD4+ T lymphocytes (CSL202) without busulfan preconditioning
|
Cohort 2 (CSL202 With 1 Busulfan Dose)
n=4 Participants
Cal-1 modified HSPC and Cal-1 modified CD4+ T lymphocytes (CSL202), with single 4mg/kg busulfan dose administered as pre-conditioning for transplant
Busulfan: Intravenous busulfan
|
Cohort 3 (CSL202 With 2 Busulfan Doses)
n=4 Participants
Cal-1 modified HSPC and Cal-1 modified CD4+ T lymphocytes (CSL202), first busulfan dose = 3mg/kg and second busulfan dose adjusted (total target exposure of 8,000 μmolar/min AUC) administered as pre-conditioning for transplant
Busulfan: Intravenous busulfan
|
|---|---|---|---|
|
Cal-1 C46 Expression in Peripheral Blood
Peak marking
|
0.0000 units of relative expression
Interval 0.0 to 0.0
|
1.0496 units of relative expression
Interval 0.0 to 2.9977
|
2.1701 units of relative expression
Interval 0.0 to 6.48
|
|
Cal-1 C46 Expression in Peripheral Blood
Week 48
|
0.0000 units of relative expression
Interval 0.0 to 0.0
|
0.0000 units of relative expression
Interval 0.0 to 0.0
|
0.0000 units of relative expression
Interval 0.0 to 0.0
|
SECONDARY outcome
Timeframe: Up to 48 weeksPopulation: SP (1 participant in Cohort 3 withdrew consent and did not receive busulfan or Ttn and HSPCtn)
sh5 relative expression will be analyzed by RT-qPCR and normalized to the expression of RNU38B microRNA
Outcome measures
| Measure |
Cohort 1 (CSL202 With No Busulfan)
n=4 Participants
Cal-1 modified HSPC and Cal-1 modified CD4+ T lymphocytes (CSL202) without busulfan preconditioning
|
Cohort 2 (CSL202 With 1 Busulfan Dose)
n=4 Participants
Cal-1 modified HSPC and Cal-1 modified CD4+ T lymphocytes (CSL202), with single 4mg/kg busulfan dose administered as pre-conditioning for transplant
Busulfan: Intravenous busulfan
|
Cohort 3 (CSL202 With 2 Busulfan Doses)
n=4 Participants
Cal-1 modified HSPC and Cal-1 modified CD4+ T lymphocytes (CSL202), first busulfan dose = 3mg/kg and second busulfan dose adjusted (total target exposure of 8,000 μmolar/min AUC) administered as pre-conditioning for transplant
Busulfan: Intravenous busulfan
|
|---|---|---|---|
|
Cal-1 sh5 Expression in Peripheral Blood
Peak marking
|
0.0000 units of relative expression
Interval 0.0 to 0.0
|
0.2027 units of relative expression
Interval 0.0 to 0.6489
|
1.6933 units of relative expression
Interval 0.193 to 4.6736
|
|
Cal-1 sh5 Expression in Peripheral Blood
Week 48
|
0.0000 units of relative expression
Interval 0.0 to 0.0
|
0.0000 units of relative expression
Interval 0.0 to 0.0
|
0.0000 units of relative expression
Interval 0.0 to 0.0
|
SECONDARY outcome
Timeframe: Up to 48 weeksPopulation: SP (1 participant in Cohort 3 withdrew consent and did not receive busulfan or Ttn and HSPCtn)
Outcome measures
| Measure |
Cohort 1 (CSL202 With No Busulfan)
n=4 Participants
Cal-1 modified HSPC and Cal-1 modified CD4+ T lymphocytes (CSL202) without busulfan preconditioning
|
Cohort 2 (CSL202 With 1 Busulfan Dose)
n=4 Participants
Cal-1 modified HSPC and Cal-1 modified CD4+ T lymphocytes (CSL202), with single 4mg/kg busulfan dose administered as pre-conditioning for transplant
Busulfan: Intravenous busulfan
|
Cohort 3 (CSL202 With 2 Busulfan Doses)
n=4 Participants
Cal-1 modified HSPC and Cal-1 modified CD4+ T lymphocytes (CSL202), first busulfan dose = 3mg/kg and second busulfan dose adjusted (total target exposure of 8,000 μmolar/min AUC) administered as pre-conditioning for transplant
Busulfan: Intravenous busulfan
|
|---|---|---|---|
|
HIV Viral Load at Baseline Screening and Week 48 or at Anti-retroviral Therapy (ART) Re-commencement
Week 48 or at ART re-commencement
|
4.56 Log10 (copies/mL)
Interval 4.0 to 4.93
|
4.70 Log10 (copies/mL)
Interval 3.88 to 4.96
|
4.61 Log10 (copies/mL)
Interval 4.2 to 4.95
|
|
HIV Viral Load at Baseline Screening and Week 48 or at Anti-retroviral Therapy (ART) Re-commencement
Baseline screening
|
4.59 Log10 (copies/mL)
Interval 4.06 to 4.87
|
4.51 Log10 (copies/mL)
Interval 3.98 to 4.82
|
4.28 Log10 (copies/mL)
Interval 3.45 to 4.62
|
SECONDARY outcome
Timeframe: Up to 48 weeksPopulation: SP (1 participant in Cohort 3 withdrew consent and did not receive busulfan or Ttn and HSPCtn)
Outcome measures
| Measure |
Cohort 1 (CSL202 With No Busulfan)
n=4 Participants
Cal-1 modified HSPC and Cal-1 modified CD4+ T lymphocytes (CSL202) without busulfan preconditioning
|
Cohort 2 (CSL202 With 1 Busulfan Dose)
n=4 Participants
Cal-1 modified HSPC and Cal-1 modified CD4+ T lymphocytes (CSL202), with single 4mg/kg busulfan dose administered as pre-conditioning for transplant
Busulfan: Intravenous busulfan
|
Cohort 3 (CSL202 With 2 Busulfan Doses)
n=4 Participants
Cal-1 modified HSPC and Cal-1 modified CD4+ T lymphocytes (CSL202), first busulfan dose = 3mg/kg and second busulfan dose adjusted (total target exposure of 8,000 μmolar/min AUC) administered as pre-conditioning for transplant
Busulfan: Intravenous busulfan
|
|---|---|---|---|
|
CD4+ Count at Baseline Screening and Week 48 or at ART Re-commencement
Baseline screening
|
680.75 CD4+ cells/cubic mm
Interval 522.5 to 809.5
|
575.13 CD4+ cells/cubic mm
Interval 537.0 to 677.5
|
668.63 CD4+ cells/cubic mm
Interval 529.0 to 878.0
|
|
CD4+ Count at Baseline Screening and Week 48 or at ART Re-commencement
Week 48 or at ART re-commencement
|
553.3 CD4+ cells/cubic mm
Interval 450.0 to 759.0
|
383.5 CD4+ cells/cubic mm
Interval 274.0 to 549.0
|
245.5 CD4+ cells/cubic mm
Interval 152.0 to 385.0
|
SECONDARY outcome
Timeframe: Up to 48 weeksPopulation: SP
Shift from R5 to X4 or dual/mixed tropism
Outcome measures
| Measure |
Cohort 1 (CSL202 With No Busulfan)
n=4 Participants
Cal-1 modified HSPC and Cal-1 modified CD4+ T lymphocytes (CSL202) without busulfan preconditioning
|
Cohort 2 (CSL202 With 1 Busulfan Dose)
n=4 Participants
Cal-1 modified HSPC and Cal-1 modified CD4+ T lymphocytes (CSL202), with single 4mg/kg busulfan dose administered as pre-conditioning for transplant
Busulfan: Intravenous busulfan
|
Cohort 3 (CSL202 With 2 Busulfan Doses)
n=5 Participants
Cal-1 modified HSPC and Cal-1 modified CD4+ T lymphocytes (CSL202), first busulfan dose = 3mg/kg and second busulfan dose adjusted (total target exposure of 8,000 μmolar/min AUC) administered as pre-conditioning for transplant
Busulfan: Intravenous busulfan
|
|---|---|---|---|
|
Number of Participants With HIV-1 Tropism Shift
|
0 Participants
|
0 Participants
|
0 Participants
|
Adverse Events
Cohort 1 (CSL202 With No Busulfan)
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
Cohort 2 (CSL202 With 1 Busulfan Dose)
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
Cohort 3 (CSL202 With 2 Busulfan Doses)
Serious events: 1 serious events
Other events: 5 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Cohort 1 (CSL202 With No Busulfan)
n=4 participants at risk
Cal-1 modified HSPC and Cal-1 modified CD4+ T lymphocytes (CSL202) without busulfan preconditioning
|
Cohort 2 (CSL202 With 1 Busulfan Dose)
n=4 participants at risk
Cal-1 modified HSPC and Cal-1 modified CD4+ T lymphocytes (CSL202), with single 4mg/kg busulfan dose administered as pre-conditioning for transplant
Busulfan: Intravenous busulfan
|
Cohort 3 (CSL202 With 2 Busulfan Doses)
n=5 participants at risk
Cal-1 modified HSPC and Cal-1 modified CD4+ T lymphocytes (CSL202), first busulfan dose = 3mg/kg and second busulfan dose adjusted (total target exposure of 8,000 μmolar/min AUC) administered as pre-conditioning for transplant
Busulfan: Intravenous busulfan
|
|---|---|---|---|
|
Gastrointestinal disorders
gastroenteritis
|
0.00%
0/4 • Up to 48 weeks per participant
|
0.00%
0/4 • Up to 48 weeks per participant
|
20.0%
1/5 • Number of events 1 • Up to 48 weeks per participant
|
Other adverse events
| Measure |
Cohort 1 (CSL202 With No Busulfan)
n=4 participants at risk
Cal-1 modified HSPC and Cal-1 modified CD4+ T lymphocytes (CSL202) without busulfan preconditioning
|
Cohort 2 (CSL202 With 1 Busulfan Dose)
n=4 participants at risk
Cal-1 modified HSPC and Cal-1 modified CD4+ T lymphocytes (CSL202), with single 4mg/kg busulfan dose administered as pre-conditioning for transplant
Busulfan: Intravenous busulfan
|
Cohort 3 (CSL202 With 2 Busulfan Doses)
n=5 participants at risk
Cal-1 modified HSPC and Cal-1 modified CD4+ T lymphocytes (CSL202), first busulfan dose = 3mg/kg and second busulfan dose adjusted (total target exposure of 8,000 μmolar/min AUC) administered as pre-conditioning for transplant
Busulfan: Intravenous busulfan
|
|---|---|---|---|
|
Ear and labyrinth disorders
ear congestion
|
0.00%
0/4 • Up to 48 weeks per participant
|
0.00%
0/4 • Up to 48 weeks per participant
|
20.0%
1/5 • Number of events 1 • Up to 48 weeks per participant
|
|
Eye disorders
Eye irritation
|
0.00%
0/4 • Up to 48 weeks per participant
|
0.00%
0/4 • Up to 48 weeks per participant
|
20.0%
1/5 • Number of events 1 • Up to 48 weeks per participant
|
|
Eye disorders
Eye pruritus
|
0.00%
0/4 • Up to 48 weeks per participant
|
25.0%
1/4 • Number of events 1 • Up to 48 weeks per participant
|
0.00%
0/5 • Up to 48 weeks per participant
|
|
Eye disorders
Vision blurred
|
25.0%
1/4 • Number of events 1 • Up to 48 weeks per participant
|
0.00%
0/4 • Up to 48 weeks per participant
|
0.00%
0/5 • Up to 48 weeks per participant
|
|
Blood and lymphatic system disorders
Neutropenia
|
0.00%
0/4 • Up to 48 weeks per participant
|
100.0%
4/4 • Number of events 38 • Up to 48 weeks per participant
|
100.0%
5/5 • Number of events 21 • Up to 48 weeks per participant
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
0.00%
0/4 • Up to 48 weeks per participant
|
100.0%
4/4 • Number of events 19 • Up to 48 weeks per participant
|
80.0%
4/5 • Number of events 40 • Up to 48 weeks per participant
|
|
Blood and lymphatic system disorders
Leukopenia
|
0.00%
0/4 • Up to 48 weeks per participant
|
100.0%
4/4 • Number of events 18 • Up to 48 weeks per participant
|
60.0%
3/5 • Number of events 4 • Up to 48 weeks per participant
|
|
General disorders
Fatigue
|
50.0%
2/4 • Number of events 3 • Up to 48 weeks per participant
|
75.0%
3/4 • Number of events 5 • Up to 48 weeks per participant
|
60.0%
3/5 • Number of events 4 • Up to 48 weeks per participant
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
75.0%
3/4 • Number of events 3 • Up to 48 weeks per participant
|
75.0%
3/4 • Number of events 5 • Up to 48 weeks per participant
|
40.0%
2/5 • Number of events 2 • Up to 48 weeks per participant
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/4 • Up to 48 weeks per participant
|
50.0%
2/4 • Number of events 3 • Up to 48 weeks per participant
|
100.0%
5/5 • Number of events 5 • Up to 48 weeks per participant
|
|
Gastrointestinal disorders
Diarrhoea
|
25.0%
1/4 • Number of events 3 • Up to 48 weeks per participant
|
0.00%
0/4 • Up to 48 weeks per participant
|
80.0%
4/5 • Number of events 5 • Up to 48 weeks per participant
|
|
Infections and infestations
Upper respiratory tract infection
|
75.0%
3/4 • Number of events 5 • Up to 48 weeks per participant
|
25.0%
1/4 • Number of events 2 • Up to 48 weeks per participant
|
20.0%
1/5 • Number of events 1 • Up to 48 weeks per participant
|
|
General disorders
Chills
|
25.0%
1/4 • Number of events 1 • Up to 48 weeks per participant
|
25.0%
1/4 • Number of events 1 • Up to 48 weeks per participant
|
60.0%
3/5 • Number of events 3 • Up to 48 weeks per participant
|
|
Skin and subcutaneous tissue disorders
Skin odour abnormal
|
75.0%
3/4 • Number of events 3 • Up to 48 weeks per participant
|
50.0%
2/4 • Number of events 2 • Up to 48 weeks per participant
|
0.00%
0/5 • Up to 48 weeks per participant
|
|
General disorders
Pain
|
25.0%
1/4 • Number of events 1 • Up to 48 weeks per participant
|
25.0%
1/4 • Number of events 1 • Up to 48 weeks per participant
|
40.0%
2/5 • Number of events 2 • Up to 48 weeks per participant
|
|
General disorders
Pyrexia
|
25.0%
1/4 • Number of events 1 • Up to 48 weeks per participant
|
0.00%
0/4 • Up to 48 weeks per participant
|
60.0%
3/5 • Number of events 3 • Up to 48 weeks per participant
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
25.0%
1/4 • Number of events 1 • Up to 48 weeks per participant
|
0.00%
0/4 • Up to 48 weeks per participant
|
60.0%
3/5 • Number of events 3 • Up to 48 weeks per participant
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
25.0%
1/4 • Number of events 1 • Up to 48 weeks per participant
|
25.0%
1/4 • Number of events 1 • Up to 48 weeks per participant
|
40.0%
2/5 • Number of events 2 • Up to 48 weeks per participant
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
0.00%
0/4 • Up to 48 weeks per participant
|
75.0%
3/4 • Number of events 3 • Up to 48 weeks per participant
|
20.0%
1/5 • Number of events 1 • Up to 48 weeks per participant
|
|
Nervous system disorders
Headache
|
25.0%
1/4 • Number of events 1 • Up to 48 weeks per participant
|
25.0%
1/4 • Number of events 1 • Up to 48 weeks per participant
|
20.0%
1/5 • Number of events 2 • Up to 48 weeks per participant
|
|
Nervous system disorders
Insomnia
|
25.0%
1/4 • Number of events 1 • Up to 48 weeks per participant
|
0.00%
0/4 • Up to 48 weeks per participant
|
40.0%
2/5 • Number of events 3 • Up to 48 weeks per participant
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.00%
0/4 • Up to 48 weeks per participant
|
50.0%
2/4 • Number of events 3 • Up to 48 weeks per participant
|
20.0%
1/5 • Number of events 1 • Up to 48 weeks per participant
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
50.0%
2/4 • Number of events 4 • Up to 48 weeks per participant
|
0.00%
0/4 • Up to 48 weeks per participant
|
0.00%
0/5 • Up to 48 weeks per participant
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/4 • Up to 48 weeks per participant
|
0.00%
0/4 • Up to 48 weeks per participant
|
40.0%
2/5 • Number of events 3 • Up to 48 weeks per participant
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
25.0%
1/4 • Number of events 2 • Up to 48 weeks per participant
|
0.00%
0/4 • Up to 48 weeks per participant
|
20.0%
1/5 • Number of events 1 • Up to 48 weeks per participant
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/4 • Up to 48 weeks per participant
|
50.0%
2/4 • Number of events 2 • Up to 48 weeks per participant
|
0.00%
0/5 • Up to 48 weeks per participant
|
|
Gastrointestinal disorders
Retching
|
0.00%
0/4 • Up to 48 weeks per participant
|
0.00%
0/4 • Up to 48 weeks per participant
|
40.0%
2/5 • Number of events 2 • Up to 48 weeks per participant
|
|
Gastrointestinal disorders
Toothache
|
25.0%
1/4 • Number of events 1 • Up to 48 weeks per participant
|
25.0%
1/4 • Number of events 1 • Up to 48 weeks per participant
|
0.00%
0/5 • Up to 48 weeks per participant
|
|
General disorders
Asthenia
|
0.00%
0/4 • Up to 48 weeks per participant
|
25.0%
1/4 • Number of events 1 • Up to 48 weeks per participant
|
20.0%
1/5 • Number of events 1 • Up to 48 weeks per participant
|
|
General disorders
Malaise
|
25.0%
1/4 • Number of events 1 • Up to 48 weeks per participant
|
25.0%
1/4 • Number of events 1 • Up to 48 weeks per participant
|
0.00%
0/5 • Up to 48 weeks per participant
|
|
General disorders
Night Sweats
|
0.00%
0/4 • Up to 48 weeks per participant
|
0.00%
0/4 • Up to 48 weeks per participant
|
40.0%
2/5 • Number of events 2 • Up to 48 weeks per participant
|
|
Infections and infestations
Cellulitis
|
0.00%
0/4 • Up to 48 weeks per participant
|
0.00%
0/4 • Up to 48 weeks per participant
|
40.0%
2/5 • Number of events 2 • Up to 48 weeks per participant
|
|
Infections and infestations
Sinusitis
|
25.0%
1/4 • Number of events 1 • Up to 48 weeks per participant
|
0.00%
0/4 • Up to 48 weeks per participant
|
20.0%
1/5 • Number of events 1 • Up to 48 weeks per participant
|
|
Metabolism and nutrition disorders
Decreased appetite
|
25.0%
1/4 • Number of events 1 • Up to 48 weeks per participant
|
0.00%
0/4 • Up to 48 weeks per participant
|
20.0%
1/5 • Number of events 1 • Up to 48 weeks per participant
|
|
Nervous system disorders
Dizziness
|
25.0%
1/4 • Number of events 1 • Up to 48 weeks per participant
|
0.00%
0/4 • Up to 48 weeks per participant
|
20.0%
1/5 • Number of events 1 • Up to 48 weeks per participant
|
|
Respiratory, thoracic and mediastinal disorders
Wheezing
|
0.00%
0/4 • Up to 48 weeks per participant
|
0.00%
0/4 • Up to 48 weeks per participant
|
40.0%
2/5 • Number of events 2 • Up to 48 weeks per participant
|
|
Infections and infestations
Acarodermatitis
|
0.00%
0/4 • Up to 48 weeks per participant
|
0.00%
0/4 • Up to 48 weeks per participant
|
20.0%
1/5 • Number of events 2 • Up to 48 weeks per participant
|
|
Reproductive system and breast disorders
Haematospermia
|
0.00%
0/4 • Up to 48 weeks per participant
|
25.0%
1/4 • Number of events 2 • Up to 48 weeks per participant
|
0.00%
0/5 • Up to 48 weeks per participant
|
|
Skin and subcutaneous tissue disorders
Dermatitis allergic
|
0.00%
0/4 • Up to 48 weeks per participant
|
0.00%
0/4 • Up to 48 weeks per participant
|
20.0%
1/5 • Number of events 2 • Up to 48 weeks per participant
|
|
Skin and subcutaneous tissue disorders
Rash vesicular
|
0.00%
0/4 • Up to 48 weeks per participant
|
0.00%
0/4 • Up to 48 weeks per participant
|
20.0%
1/5 • Number of events 2 • Up to 48 weeks per participant
|
|
Blood and lymphatic system disorders
Leukocytosis
|
0.00%
0/4 • Up to 48 weeks per participant
|
0.00%
0/4 • Up to 48 weeks per participant
|
20.0%
1/5 • Number of events 1 • Up to 48 weeks per participant
|
|
Gastrointestinal disorders
Abdominal distension
|
0.00%
0/4 • Up to 48 weeks per participant
|
25.0%
1/4 • Number of events 1 • Up to 48 weeks per participant
|
0.00%
0/5 • Up to 48 weeks per participant
|
|
Gastrointestinal disorders
Dry mouth
|
0.00%
0/4 • Up to 48 weeks per participant
|
0.00%
0/4 • Up to 48 weeks per participant
|
20.0%
1/5 • Number of events 1 • Up to 48 weeks per participant
|
|
Gastrointestinal disorders
Faeces soft
|
0.00%
0/4 • Up to 48 weeks per participant
|
0.00%
0/4 • Up to 48 weeks per participant
|
20.0%
1/5 • Number of events 1 • Up to 48 weeks per participant
|
|
Gastrointestinal disorders
Food poisoning
|
0.00%
0/4 • Up to 48 weeks per participant
|
25.0%
1/4 • Number of events 1 • Up to 48 weeks per participant
|
0.00%
0/5 • Up to 48 weeks per participant
|
|
Gastrointestinal disorders
Haematochezia
|
0.00%
0/4 • Up to 48 weeks per participant
|
25.0%
1/4 • Number of events 1 • Up to 48 weeks per participant
|
0.00%
0/5 • Up to 48 weeks per participant
|
|
Gastrointestinal disorders
Stomatitis
|
0.00%
0/4 • Up to 48 weeks per participant
|
0.00%
0/4 • Up to 48 weeks per participant
|
20.0%
1/5 • Number of events 1 • Up to 48 weeks per participant
|
|
Gastrointestinal disorders
Tongue discolouration
|
0.00%
0/4 • Up to 48 weeks per participant
|
25.0%
1/4 • Number of events 1 • Up to 48 weeks per participant
|
0.00%
0/5 • Up to 48 weeks per participant
|
|
General disorders
Catheter site pain
|
0.00%
0/4 • Up to 48 weeks per participant
|
0.00%
0/4 • Up to 48 weeks per participant
|
20.0%
1/5 • Number of events 1 • Up to 48 weeks per participant
|
|
General disorders
Influenza like illness
|
25.0%
1/4 • Number of events 1 • Up to 48 weeks per participant
|
0.00%
0/4 • Up to 48 weeks per participant
|
0.00%
0/5 • Up to 48 weeks per participant
|
|
Infections and infestations
Bronchitis
|
0.00%
0/4 • Up to 48 weeks per participant
|
0.00%
0/4 • Up to 48 weeks per participant
|
20.0%
1/5 • Number of events 1 • Up to 48 weeks per participant
|
|
Infections and infestations
Diverticulitis
|
0.00%
0/4 • Up to 48 weeks per participant
|
0.00%
0/4 • Up to 48 weeks per participant
|
20.0%
1/5 • Number of events 1 • Up to 48 weeks per participant
|
|
Gastrointestinal disorders
Gastroenteritis
|
0.00%
0/4 • Up to 48 weeks per participant
|
0.00%
0/4 • Up to 48 weeks per participant
|
20.0%
1/5 • Number of events 1 • Up to 48 weeks per participant
|
|
Infections and infestations
Gingivitis
|
0.00%
0/4 • Up to 48 weeks per participant
|
0.00%
0/4 • Up to 48 weeks per participant
|
20.0%
1/5 • Number of events 1 • Up to 48 weeks per participant
|
|
Infections and infestations
Secondary syphilis
|
0.00%
0/4 • Up to 48 weeks per participant
|
25.0%
1/4 • Number of events 1 • Up to 48 weeks per participant
|
0.00%
0/5 • Up to 48 weeks per participant
|
|
Infections and infestations
Staphylococcal infection
|
0.00%
0/4 • Up to 48 weeks per participant
|
0.00%
0/4 • Up to 48 weeks per participant
|
20.0%
1/5 • Number of events 1 • Up to 48 weeks per participant
|
|
Infections and infestations
Tinea pedis
|
0.00%
0/4 • Up to 48 weeks per participant
|
0.00%
0/4 • Up to 48 weeks per participant
|
20.0%
1/5 • Number of events 1 • Up to 48 weeks per participant
|
|
Injury, poisoning and procedural complications
Contusion
|
0.00%
0/4 • Up to 48 weeks per participant
|
0.00%
0/4 • Up to 48 weeks per participant
|
20.0%
1/5 • Number of events 1 • Up to 48 weeks per participant
|
|
Injury, poisoning and procedural complications
Head injury
|
0.00%
0/4 • Up to 48 weeks per participant
|
25.0%
1/4 • Number of events 1 • Up to 48 weeks per participant
|
0.00%
0/5 • Up to 48 weeks per participant
|
|
Injury, poisoning and procedural complications
Road traffic accident
|
25.0%
1/4 • Number of events 1 • Up to 48 weeks per participant
|
0.00%
0/4 • Up to 48 weeks per participant
|
0.00%
0/5 • Up to 48 weeks per participant
|
|
Investigations
Alanine aminotransferase increased
|
0.00%
0/4 • Up to 48 weeks per participant
|
0.00%
0/4 • Up to 48 weeks per participant
|
20.0%
1/5 • Number of events 1 • Up to 48 weeks per participant
|
|
Investigations
Aspartate aminotransferase increased
|
0.00%
0/4 • Up to 48 weeks per participant
|
0.00%
0/4 • Up to 48 weeks per participant
|
20.0%
1/5 • Number of events 1 • Up to 48 weeks per participant
|
|
Investigations
CD4 lymphocytes decreased
|
0.00%
0/4 • Up to 48 weeks per participant
|
0.00%
0/4 • Up to 48 weeks per participant
|
20.0%
1/5 • Number of events 1 • Up to 48 weeks per participant
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
25.0%
1/4 • Number of events 1 • Up to 48 weeks per participant
|
0.00%
0/4 • Up to 48 weeks per participant
|
0.00%
0/5 • Up to 48 weeks per participant
|
|
Nervous system disorders
Confusional state
|
25.0%
1/4 • Number of events 1 • Up to 48 weeks per participant
|
0.00%
0/4 • Up to 48 weeks per participant
|
0.00%
0/5 • Up to 48 weeks per participant
|
|
Nervous system disorders
Hypoaesthesia
|
0.00%
0/4 • Up to 48 weeks per participant
|
0.00%
0/4 • Up to 48 weeks per participant
|
20.0%
1/5 • Number of events 1 • Up to 48 weeks per participant
|
|
Nervous system disorders
Migraine
|
0.00%
0/4 • Up to 48 weeks per participant
|
0.00%
0/4 • Up to 48 weeks per participant
|
20.0%
1/5 • Number of events 1 • Up to 48 weeks per participant
|
|
Nervous system disorders
Paraesthesia
|
0.00%
0/4 • Up to 48 weeks per participant
|
0.00%
0/4 • Up to 48 weeks per participant
|
20.0%
1/5 • Number of events 1 • Up to 48 weeks per participant
|
|
Nervous system disorders
Somnolence
|
25.0%
1/4 • Number of events 1 • Up to 48 weeks per participant
|
0.00%
0/4 • Up to 48 weeks per participant
|
0.00%
0/5 • Up to 48 weeks per participant
|
|
Psychiatric disorders
Depression
|
0.00%
0/4 • Up to 48 weeks per participant
|
25.0%
1/4 • Number of events 1 • Up to 48 weeks per participant
|
0.00%
0/5 • Up to 48 weeks per participant
|
|
Psychiatric disorders
Irritability
|
0.00%
0/4 • Up to 48 weeks per participant
|
0.00%
0/4 • Up to 48 weeks per participant
|
20.0%
1/5 • Number of events 1 • Up to 48 weeks per participant
|
|
Psychiatric disorders
Somnambulism
|
25.0%
1/4 • Number of events 1 • Up to 48 weeks per participant
|
0.00%
0/4 • Up to 48 weeks per participant
|
0.00%
0/5 • Up to 48 weeks per participant
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.00%
0/4 • Up to 48 weeks per participant
|
0.00%
0/4 • Up to 48 weeks per participant
|
20.0%
1/5 • Number of events 1 • Up to 48 weeks per participant
|
|
Respiratory, thoracic and mediastinal disorders
Paranasal sinus hypersecretion
|
0.00%
0/4 • Up to 48 weeks per participant
|
0.00%
0/4 • Up to 48 weeks per participant
|
20.0%
1/5 • Number of events 1 • Up to 48 weeks per participant
|
|
Respiratory, thoracic and mediastinal disorders
Sinus congestion
|
0.00%
0/4 • Up to 48 weeks per participant
|
0.00%
0/4 • Up to 48 weeks per participant
|
20.0%
1/5 • Number of events 1 • Up to 48 weeks per participant
|
|
Respiratory, thoracic and mediastinal disorders
Sneezing
|
25.0%
1/4 • Number of events 1 • Up to 48 weeks per participant
|
0.00%
0/4 • Up to 48 weeks per participant
|
0.00%
0/5 • Up to 48 weeks per participant
|
|
Respiratory, thoracic and mediastinal disorders
Throat irritation
|
0.00%
0/4 • Up to 48 weeks per participant
|
0.00%
0/4 • Up to 48 weeks per participant
|
20.0%
1/5 • Number of events 1 • Up to 48 weeks per participant
|
|
Respiratory, thoracic and mediastinal disorders
Tonsillar disorder
|
0.00%
0/4 • Up to 48 weeks per participant
|
0.00%
0/4 • Up to 48 weeks per participant
|
20.0%
1/5 • Number of events 1 • Up to 48 weeks per participant
|
|
Respiratory, thoracic and mediastinal disorders
Upper-airway cough syndrome
|
0.00%
0/4 • Up to 48 weeks per participant
|
0.00%
0/4 • Up to 48 weeks per participant
|
20.0%
1/5 • Number of events 1 • Up to 48 weeks per participant
|
|
Skin and subcutaneous tissue disorders
Acne
|
0.00%
0/4 • Up to 48 weeks per participant
|
0.00%
0/4 • Up to 48 weeks per participant
|
20.0%
1/5 • Number of events 1 • Up to 48 weeks per participant
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
0.00%
0/4 • Up to 48 weeks per participant
|
0.00%
0/4 • Up to 48 weeks per participant
|
20.0%
1/5 • Number of events 1 • Up to 48 weeks per participant
|
|
Skin and subcutaneous tissue disorders
Eosinophilic pustular folliculitis
|
0.00%
0/4 • Up to 48 weeks per participant
|
0.00%
0/4 • Up to 48 weeks per participant
|
20.0%
1/5 • Number of events 1 • Up to 48 weeks per participant
|
|
Skin and subcutaneous tissue disorders
Excoriation
|
0.00%
0/4 • Up to 48 weeks per participant
|
0.00%
0/4 • Up to 48 weeks per participant
|
20.0%
1/5 • Number of events 1 • Up to 48 weeks per participant
|
|
Skin and subcutaneous tissue disorders
Photosensitivity reaction
|
0.00%
0/4 • Up to 48 weeks per participant
|
0.00%
0/4 • Up to 48 weeks per participant
|
20.0%
1/5 • Number of events 1 • Up to 48 weeks per participant
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
0.00%
0/4 • Up to 48 weeks per participant
|
0.00%
0/4 • Up to 48 weeks per participant
|
20.0%
1/5 • Number of events 1 • Up to 48 weeks per participant
|
|
Skin and subcutaneous tissue disorders
Rash pruritic
|
0.00%
0/4 • Up to 48 weeks per participant
|
0.00%
0/4 • Up to 48 weeks per participant
|
20.0%
1/5 • Number of events 1 • Up to 48 weeks per participant
|
|
Skin and subcutaneous tissue disorders
Seborrhoeic dermatitis
|
0.00%
0/4 • Up to 48 weeks per participant
|
0.00%
0/4 • Up to 48 weeks per participant
|
20.0%
1/5 • Number of events 1 • Up to 48 weeks per participant
|
|
Skin and subcutaneous tissue disorders
Skin erosion
|
0.00%
0/4 • Up to 48 weeks per participant
|
0.00%
0/4 • Up to 48 weeks per participant
|
20.0%
1/5 • Number of events 1 • Up to 48 weeks per participant
|
|
Skin and subcutaneous tissue disorders
Skin mass
|
0.00%
0/4 • Up to 48 weeks per participant
|
0.00%
0/4 • Up to 48 weeks per participant
|
20.0%
1/5 • Number of events 1 • Up to 48 weeks per participant
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
0.00%
0/4 • Up to 48 weeks per participant
|
0.00%
0/4 • Up to 48 weeks per participant
|
20.0%
1/5 • Number of events 1 • Up to 48 weeks per participant
|
|
Vascular disorders
Hot flush
|
25.0%
1/4 • Number of events 1 • Up to 48 weeks per participant
|
0.00%
0/4 • Up to 48 weeks per participant
|
0.00%
0/5 • Up to 48 weeks per participant
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place