Trial Outcomes & Findings for Therapy to Elevate CD4 Counts in HIV-1 Disease (NCT NCT01370018)

Last Updated: 2021-09-28

Results Overview

Recruitment status

COMPLETED

Study phase

PHASE2/PHASE3

Target enrollment

4 participants

Primary outcome timeframe

9 weeks after initiation of treatment

Results posted on

2021-09-28

Participant milestones
Measure	Alpha-1-Proteinase Inhibitor/HIV This pilot study was performed to examine the efficacy of alpha-1 proteinase inhibitor augmentation in HIV-1 infected patients undergoing research treatment to elevate alpha-1-proteinase inhibitor and thereby, CD4 helper immune cells.
Overall Study STARTED	4
Overall Study COMPLETED	3
Overall Study NOT COMPLETED	1

Reasons for withdrawal
Measure	Alpha-1-Proteinase Inhibitor/HIV This pilot study was performed to examine the efficacy of alpha-1 proteinase inhibitor augmentation in HIV-1 infected patients undergoing research treatment to elevate alpha-1-proteinase inhibitor and thereby, CD4 helper immune cells.
Overall Study Did not meet criteria for analysis	1

Therapy to Elevate CD4 Counts in HIV-1 Disease

Baseline characteristics by cohort
Measure	Alpha-1-Proteinase Inhibitor in HIV n=4 Participants This pilot study was performed to examine the efficacy of alpha-1 proteinase inhibitor augmentation in 4 HIV-1 infected patients undergoing research treatment to elevate alpha-1-proteinase inhibitor and thereby, CD4 helper immune cells.Study subjects were evaluated at Baseline and weekly for at least 8 weeks.
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	3 Participants n=5 Participants
Age, Categorical >=65 years	1 Participants n=5 Participants
Sex/Gender, Customized Male	4 participants n=5 Participants
Sex/Gender, Customized Female	0 participants n=5 Participants
Region of Enrollment United States	4 participants n=5 Participants
CD4 counts	294 cells/uL STANDARD_DEVIATION 125 • n=5 Participants
CD8	829 cells/uL STANDARD_DEVIATION 281 • n=5 Participants
CD4/CD8 Ratio	0.40 Ratio STANDARD_DEVIATION 0.19 • n=5 Participants
active alpha-1 proteinase inhibitor	8 μM STANDARD_DEVIATION 3 • n=5 Participants

Timeframe: 9 weeks after initiation of treatment

Outcome measures
Measure	Alpha-1-Proteinase Inhibitor in HIV n=3 Participants This pilot study was performed to show that Zemaira® treatment can be used in HIV-1 patients to elevate alpha-1-Proteinase Inhibitor and has the added benefit of elevating CD4 cells.
CD4/CD8 Ratio	0.44 Ratio Standard Deviation 0.30

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Adverse event data not reported

Adverse event data not reported

Institute for Human Genetics and Biochemistry

Phone: 6314446238