Trial Outcomes & Findings for Safety and Efficacy of (α1Proteinase Inhibitor, α1PI) in HIV Disease (NCT NCT01731691)
NCT ID: NCT01731691
Last Updated: 2020-08-31
Results Overview
It has been observed that CD4 counts and cholesterol levels are correlated and that there is cyclic variation in individuals with and without HIV.
Recruitment status
TERMINATED
Study phase
PHASE2/PHASE3
Target enrollment
12 participants
Primary outcome timeframe
9 weeks after initiation of treatment
Results posted on
2020-08-31
Participant Flow
Volunteers were recruited by ACRIA by placing advertisements in neighborhood publications. A total of 227 patients were interviewed as potential candidates. The first study candidate was screened on January 14, 2013 and the first HIV+ subject was randomized (treatment/placebo) on April 25, 2013.
Of the 21 potential subjects screened, 12 (57%) reached the baseline visit. All 12 were enrolled and all completed the study.
Participant milestones
| Measure |
α1 Proteinase Inhibitor in HIV Disease
α1Proteinase Inhibitor (120mg/kg Prolastin-C) weekly for 8 weeks
α1 Proteinase Inhibitor: Prolastin-C treatment in HIV disease will be compared with placebo treatment in HIV disease and no treatment in uninfected volunteers.
|
Placebo in HIV Disease
Placebos weekly for 8 weeks
Placebos: Placebo treatment in HIV disease will be compared with Prolastin-C treatment in HIV disease and no treatment in uninfected volunteers.
|
Uninfected Controls
Blood collection only for 8 weeks
|
|---|---|---|---|
|
Overall Study
STARTED
|
3
|
5
|
4
|
|
Overall Study
COMPLETED
|
3
|
5
|
4
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Safety and Efficacy of (α1Proteinase Inhibitor, α1PI) in HIV Disease
Baseline characteristics by cohort
| Measure |
α1 Proteinase Inhibitor in HIV Disease
n=3 Participants
α1Proteinase Inhibitor (120mg/kg Prolastin-C) weekly for 8 weeks
α1 Proteinase Inhibitor: Prolastin-C treatment in HIV disease will be compared with placebo treatment in HIV disease and no treatment in uninfected volunteers.
The subjects in the HIV+ groups (Prolastin-C and Placebo) were not comparable to those in the HIV- group.
|
Placebo in HIV Disease
n=5 Participants
Placebos weekly for 8 weeks
Placebos: Placebo treatment in HIV disease will be compared with Prolastin-C treatment in HIV disease and no treatment in uninfected volunteers.
The subjects in the HIV+ groups (Prolastin-C and Placebo) were not comparable to those in the HIV- group.
|
Uninfected Controls
n=4 Participants
Blood collection only for 8 weeks
The subjects in the HIV+ groups (Prolastin-C and Placebo) were not comparable to those in the HIV- group.
|
Total
n=12 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
3 Participants
n=99 Participants
|
5 Participants
n=107 Participants
|
4 Participants
n=206 Participants
|
12 Participants
n=7 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
|
Age, Continuous
|
54 years
STANDARD_DEVIATION 5 • n=99 Participants
|
52 years
STANDARD_DEVIATION 7 • n=107 Participants
|
32 years
STANDARD_DEVIATION 10 • n=206 Participants
|
46 years
STANDARD_DEVIATION 13 • n=7 Participants
|
|
Sex: Female, Male
Female
|
1 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
3 Participants
n=7 Participants
|
|
Sex: Female, Male
Male
|
2 Participants
n=99 Participants
|
4 Participants
n=107 Participants
|
3 Participants
n=206 Participants
|
9 Participants
n=7 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
4 Participants
n=7 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
3 Participants
n=99 Participants
|
3 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
8 Participants
n=7 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
|
Region of Enrollment
United States
|
3 participants
n=99 Participants
|
5 participants
n=107 Participants
|
4 participants
n=206 Participants
|
12 participants
n=7 Participants
|
|
CD4
|
365 cells/uL
STANDARD_DEVIATION 116 • n=99 Participants
|
438 cells/uL
STANDARD_DEVIATION 108 • n=107 Participants
|
651 cells/uL
STANDARD_DEVIATION 239 • n=206 Participants
|
491 cells/uL
STANDARD_DEVIATION 193 • n=7 Participants
|
|
CD8
|
958 cells/uL
STANDARD_DEVIATION 340 • n=99 Participants
|
872 cells/uL
STANDARD_DEVIATION 271 • n=107 Participants
|
324 cells/uL
STANDARD_DEVIATION 53 • n=206 Participants
|
711 cells/uL
STANDARD_DEVIATION 363 • n=7 Participants
|
|
CD4/CD8 Ratio
|
0.42 Ratio
STANDARD_DEVIATION 0.17 • n=99 Participants
|
0.53 Ratio
STANDARD_DEVIATION 0.18 • n=107 Participants
|
2.00 Ratio
STANDARD_DEVIATION 0.58 • n=206 Participants
|
0.99 Ratio
STANDARD_DEVIATION 0.82 • n=7 Participants
|
|
α1 Proteinase Inhibitor
|
14 uM
STANDARD_DEVIATION 4 • n=99 Participants
|
12 uM
STANDARD_DEVIATION 6 • n=107 Participants
|
21 uM
STANDARD_DEVIATION 10 • n=206 Participants
|
15 uM
STANDARD_DEVIATION 8 • n=7 Participants
|
|
HDL
|
55 mg/dL
STANDARD_DEVIATION 14 • n=99 Participants
|
65 mg/dL
STANDARD_DEVIATION 14 • n=107 Participants
|
58 mg/dL
STANDARD_DEVIATION 10 • n=206 Participants
|
60 mg/dL
STANDARD_DEVIATION 12 • n=7 Participants
|
|
LDL
|
89 mg/dL
STANDARD_DEVIATION 1.5 • n=99 Participants
|
83 mg/dL
STANDARD_DEVIATION 16 • n=107 Participants
|
83 mg/dL
STANDARD_DEVIATION 20 • n=206 Participants
|
85 mg/dL
STANDARD_DEVIATION 14 • n=7 Participants
|
PRIMARY outcome
Timeframe: 9 weeks after initiation of treatmentIt has been observed that CD4 counts and cholesterol levels are correlated and that there is cyclic variation in individuals with and without HIV.
Outcome measures
| Measure |
α1 Proteinase Inhibitor in HIV Disease
n=3 Participants
α1Proteinase Inhibitor (120mg/kg Prolastin-C) weekly for 8 weeks
α1 Proteinase Inhibitor: Prolastin-C treatment in HIV disease will be compared with placebo treatment in HIV disease and no treatment in uninfected volunteers.
The subjects in the HIV+ groups (Prolastin-C and Placebo) were not comparable to those in the HIV- group.
|
Placebo in HIV Disease
n=5 Participants
Placebos weekly for 8 weeks
Placebos: Placebo treatment in HIV disease will be compared with Prolastin-C treatment in HIV disease and no treatment in uninfected volunteers.
The subjects in the HIV+ groups (Prolastin-C and Placebo) were not comparable to those in the HIV- group.
|
Uninfected Controls
n=4 Participants
Blood collection only for 8 weeks
The subjects in the HIV+ groups (Prolastin-C and Placebo) were not comparable to those in the HIV- group.
|
|---|---|---|---|
|
CD4 Counts
|
326 cells/uL
Standard Deviation 103
|
437 cells/uL
Standard Deviation 180
|
649 cells/uL
Standard Deviation 141
|
PRIMARY outcome
Timeframe: 9 weeks after initiation of treatmentIt has been observed that CD4 counts and cholesterol levels are correlated and that there is cyclic variation in individuals with and without HIV.
Outcome measures
| Measure |
α1 Proteinase Inhibitor in HIV Disease
n=3 Participants
α1Proteinase Inhibitor (120mg/kg Prolastin-C) weekly for 8 weeks
α1 Proteinase Inhibitor: Prolastin-C treatment in HIV disease will be compared with placebo treatment in HIV disease and no treatment in uninfected volunteers.
The subjects in the HIV+ groups (Prolastin-C and Placebo) were not comparable to those in the HIV- group.
|
Placebo in HIV Disease
n=5 Participants
Placebos weekly for 8 weeks
Placebos: Placebo treatment in HIV disease will be compared with Prolastin-C treatment in HIV disease and no treatment in uninfected volunteers.
The subjects in the HIV+ groups (Prolastin-C and Placebo) were not comparable to those in the HIV- group.
|
Uninfected Controls
n=4 Participants
Blood collection only for 8 weeks
The subjects in the HIV+ groups (Prolastin-C and Placebo) were not comparable to those in the HIV- group.
|
|---|---|---|---|
|
CD8
|
848 cells/uL
Standard Deviation 202
|
946 cells/uL
Standard Deviation 365
|
302 cells/uL
Standard Deviation 61
|
PRIMARY outcome
Timeframe: 9 weeks after initiation of treatmentIt has been observed that CD4 counts and cholesterol levels are correlated and that there is cyclic variation in individuals with and without HIV.
Outcome measures
| Measure |
α1 Proteinase Inhibitor in HIV Disease
n=3 Participants
α1Proteinase Inhibitor (120mg/kg Prolastin-C) weekly for 8 weeks
α1 Proteinase Inhibitor: Prolastin-C treatment in HIV disease will be compared with placebo treatment in HIV disease and no treatment in uninfected volunteers.
The subjects in the HIV+ groups (Prolastin-C and Placebo) were not comparable to those in the HIV- group.
|
Placebo in HIV Disease
n=5 Participants
Placebos weekly for 8 weeks
Placebos: Placebo treatment in HIV disease will be compared with Prolastin-C treatment in HIV disease and no treatment in uninfected volunteers.
The subjects in the HIV+ groups (Prolastin-C and Placebo) were not comparable to those in the HIV- group.
|
Uninfected Controls
n=4 Participants
Blood collection only for 8 weeks
The subjects in the HIV+ groups (Prolastin-C and Placebo) were not comparable to those in the HIV- group.
|
|---|---|---|---|
|
CD4/CD8 Ratio
|
0.41 Ratio
Standard Deviation 0.18
|
0.48 Ratio
Standard Deviation 0.14
|
2.20 Ratio
Standard Deviation 0.55
|
PRIMARY outcome
Timeframe: weekly for 8 weeksOutcome measures
| Measure |
α1 Proteinase Inhibitor in HIV Disease
n=3 Participants
α1Proteinase Inhibitor (120mg/kg Prolastin-C) weekly for 8 weeks
α1 Proteinase Inhibitor: Prolastin-C treatment in HIV disease will be compared with placebo treatment in HIV disease and no treatment in uninfected volunteers.
The subjects in the HIV+ groups (Prolastin-C and Placebo) were not comparable to those in the HIV- group.
|
Placebo in HIV Disease
n=5 Participants
Placebos weekly for 8 weeks
Placebos: Placebo treatment in HIV disease will be compared with Prolastin-C treatment in HIV disease and no treatment in uninfected volunteers.
The subjects in the HIV+ groups (Prolastin-C and Placebo) were not comparable to those in the HIV- group.
|
Uninfected Controls
n=4 Participants
Blood collection only for 8 weeks
The subjects in the HIV+ groups (Prolastin-C and Placebo) were not comparable to those in the HIV- group.
|
|---|---|---|---|
|
Alpha-1 Proteinase Inhibitor
|
13.7 micromol
Standard Deviation 3.4
|
13.6 micromol
Standard Deviation 4.1
|
19 micromol
Standard Deviation 9.5
|
PRIMARY outcome
Timeframe: weekly for 8 weeksOutcome measures
| Measure |
α1 Proteinase Inhibitor in HIV Disease
n=3 Participants
α1Proteinase Inhibitor (120mg/kg Prolastin-C) weekly for 8 weeks
α1 Proteinase Inhibitor: Prolastin-C treatment in HIV disease will be compared with placebo treatment in HIV disease and no treatment in uninfected volunteers.
The subjects in the HIV+ groups (Prolastin-C and Placebo) were not comparable to those in the HIV- group.
|
Placebo in HIV Disease
n=5 Participants
Placebos weekly for 8 weeks
Placebos: Placebo treatment in HIV disease will be compared with Prolastin-C treatment in HIV disease and no treatment in uninfected volunteers.
The subjects in the HIV+ groups (Prolastin-C and Placebo) were not comparable to those in the HIV- group.
|
Uninfected Controls
n=4 Participants
Blood collection only for 8 weeks
The subjects in the HIV+ groups (Prolastin-C and Placebo) were not comparable to those in the HIV- group.
|
|---|---|---|---|
|
sj/betaTrec Ratio
|
353.52 sj/beta ratio
Standard Deviation 353.54
|
271.19 sj/beta ratio
Standard Deviation 414.34
|
375.96 sj/beta ratio
Standard Deviation 357.81
|
PRIMARY outcome
Timeframe: weekly for 8 weeksOutcome measures
| Measure |
α1 Proteinase Inhibitor in HIV Disease
n=3 Participants
α1Proteinase Inhibitor (120mg/kg Prolastin-C) weekly for 8 weeks
α1 Proteinase Inhibitor: Prolastin-C treatment in HIV disease will be compared with placebo treatment in HIV disease and no treatment in uninfected volunteers.
The subjects in the HIV+ groups (Prolastin-C and Placebo) were not comparable to those in the HIV- group.
|
Placebo in HIV Disease
n=5 Participants
Placebos weekly for 8 weeks
Placebos: Placebo treatment in HIV disease will be compared with Prolastin-C treatment in HIV disease and no treatment in uninfected volunteers.
The subjects in the HIV+ groups (Prolastin-C and Placebo) were not comparable to those in the HIV- group.
|
Uninfected Controls
n=4 Participants
Blood collection only for 8 weeks
The subjects in the HIV+ groups (Prolastin-C and Placebo) were not comparable to those in the HIV- group.
|
|---|---|---|---|
|
High Density Lipoprotein (HDL)
|
49.29 mg/dL
Standard Deviation 6.21
|
63.14 mg/dL
Standard Deviation 14.51
|
61.13 mg/dL
Standard Deviation 10.40
|
PRIMARY outcome
Timeframe: weekly for 8 weeksOutcome measures
| Measure |
α1 Proteinase Inhibitor in HIV Disease
n=3 Participants
α1Proteinase Inhibitor (120mg/kg Prolastin-C) weekly for 8 weeks
α1 Proteinase Inhibitor: Prolastin-C treatment in HIV disease will be compared with placebo treatment in HIV disease and no treatment in uninfected volunteers.
The subjects in the HIV+ groups (Prolastin-C and Placebo) were not comparable to those in the HIV- group.
|
Placebo in HIV Disease
n=5 Participants
Placebos weekly for 8 weeks
Placebos: Placebo treatment in HIV disease will be compared with Prolastin-C treatment in HIV disease and no treatment in uninfected volunteers.
The subjects in the HIV+ groups (Prolastin-C and Placebo) were not comparable to those in the HIV- group.
|
Uninfected Controls
n=4 Participants
Blood collection only for 8 weeks
The subjects in the HIV+ groups (Prolastin-C and Placebo) were not comparable to those in the HIV- group.
|
|---|---|---|---|
|
Low Density Lipoprotein (LDL)
|
90.67 mg/dL
Standard Deviation 9.21
|
77.23 mg/dL
Standard Deviation 25.19
|
75.19 mg/dL
Standard Deviation 15.32
|
Adverse Events
α1 Proteinase Inhibitor in HIV Disease
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Placebo in HIV Disease
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Uninfected Controls
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Dr. Cynthia L. Bristow
Institute for Human Genetics and Biochemistry
Phone: 631-444-6238
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place