Trial Outcomes & Findings for Immunologic Response to Kansui in Treated HIV+ Individuals: a Dose Escalation Study (NCT NCT02531295)

Last Updated: 2024-04-19

Results Overview

The number of grade 2 or higher severity adverse events (AEs) or drug-related laboratory abnormalities that exceed a frequency of 5% over a 31 day study period.

Recruitment status

TERMINATED

Study phase

PHASE1

Target enrollment

5 participants

Primary outcome timeframe

31 days

Results posted on

2024-04-19

Participant Flow

Participant milestones

Participant milestones
Measure	Kansui 1g Per Day x 1 Day Study participants will be given 1 g of Euphorbia kansui extract powder prepared as tea for a total of 1 daily dose. Euphorbia kansui extract powder prepared as tea: 1 g of Euphorbia kansui extract powder, measured and reconstituted in 4 fluid ounces of boiled water allowed to cool and administered as tea, taken by mouth daily	Kansui 1g Per Day x 3 Days Study participants will be given 1 g of Euphorbia kansui extract powder prepared as tea for a total of 3 consecutive daily doses. Euphorbia kansui extract powder prepared as tea: 1 g of Euphorbia kansui extract powder, measured and reconstituted in 4 fluid ounces of boiled water allowed to cool and administered as tea, taken by mouth daily	Placebo 1g Per Day x 3 Days Study participants will be given 1 g of placebo prepared as tea for a total of 3 consecutive daily doses.
Overall Study STARTED	2	1	2
Overall Study COMPLETED	2	1	1
Overall Study NOT COMPLETED	0	0	1

Reasons for withdrawal

Reasons for withdrawal
Measure	Kansui 1g Per Day x 1 Day Study participants will be given 1 g of Euphorbia kansui extract powder prepared as tea for a total of 1 daily dose. Euphorbia kansui extract powder prepared as tea: 1 g of Euphorbia kansui extract powder, measured and reconstituted in 4 fluid ounces of boiled water allowed to cool and administered as tea, taken by mouth daily	Kansui 1g Per Day x 2 Days Study participants will be given 1 g of Euphorbia kansui extract powder prepared as tea for a total of 2 consecutive daily doses. Euphorbia kansui extract powder prepared as tea: 1 g of Euphorbia kansui extract powder, measured and reconstituted in 4 fluid ounces of boiled water allowed to cool and administered as tea, taken by mouth daily	Kansui 1g Per Day x 3 Days Study participants will be given 1 g of Euphorbia kansui extract powder prepared as tea for a total of 3 consecutive daily doses. Euphorbia kansui extract powder prepared as tea: 1 g of Euphorbia kansui extract powder, measured and reconstituted in 4 fluid ounces of boiled water allowed to cool and administered as tea, taken by mouth daily	Placebo 1g Per Day x 1 Day Study participants will be given 1 g of placebo prepared as tea for a total of 1 daily dose.	Placebo 1g Per Day x 2 Days Study participants will be given 1 g placebo prepared as tea for a total of 2 consecutive daily doses.	Placebo 1g Per Day x 3 Days Study participants will be given 1 g of placebo prepared as tea for a total of 3 consecutive daily doses.
Overall Study The study was terminated (Halted Prematurely).	0	0	0	0	0	1

Baseline Characteristics

Immunologic Response to Kansui in Treated HIV+ Individuals: a Dose Escalation Study

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Kansui 1g Per Day x 1 Day n=2 Participants Study participants will be given 1 g of Euphorbia kansui extract powder prepared as tea for a total of 1 daily dose. Euphorbia kansui extract powder prepared as tea: 1 g of Euphorbia kansui extract powder, measured and reconstituted in 4 fluid ounces of boiled water allowed to cool and administered as tea, taken by mouth daily	Kansui 1g Per Day x 2 Days Study participants will be given 1 g of Euphorbia kansui extract powder prepared as tea for a total of 2 consecutive daily doses. Euphorbia kansui extract powder prepared as tea: 1 g of Euphorbia kansui extract powder, measured and reconstituted in 4 fluid ounces of boiled water allowed to cool and administered as tea, taken by mouth daily	Kansui 1g Per Day x 3 Days n=1 Participants Study participants will be given 1 g of Euphorbia kansui extract powder prepared as tea for a total of 3 consecutive daily doses. Euphorbia kansui extract powder prepared as tea: 1 g of Euphorbia kansui extract powder, measured and reconstituted in 4 fluid ounces of boiled water allowed to cool and administered as tea, taken by mouth daily	Placebo 1g Per Day x 1 Day Study participants will be given 1 g of placebo prepared as tea for a total of 1 daily dose.	Placebo 1g Per Day x 2 Days Study participants will be given 1 g placebo prepared as tea for a total of 2 consecutive daily doses.	Placebo 1g Per Day x 3 Days n=2 Participants Study participants will be given 1 g of placebo prepared as tea for a total of 3 consecutive daily doses.	Total n=5 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	—	0 Participants n=5 Participants	—	—	0 Participants n=8 Participants	0 Participants n=8 Participants
Age, Categorical Between 18 and 65 years	2 Participants n=5 Participants	—	1 Participants n=5 Participants	—	—	2 Participants n=8 Participants	5 Participants n=8 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	—	0 Participants n=5 Participants	—	—	0 Participants n=8 Participants	0 Participants n=8 Participants
Age, Continuous	43.7 years STANDARD_DEVIATION 6.4 • n=5 Participants	—	56 years STANDARD_DEVIATION 0 • n=5 Participants	—	—	55.1 years STANDARD_DEVIATION 4.4 • n=8 Participants	49 years STANDARD_DEVIATION 9.1 • n=8 Participants
Sex: Female, Male Female	1 Participants n=5 Participants	—	0 Participants n=5 Participants	—	—	1 Participants n=8 Participants	2 Participants n=8 Participants
Sex: Female, Male Male	1 Participants n=5 Participants	—	1 Participants n=5 Participants	—	—	1 Participants n=8 Participants	3 Participants n=8 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	—	0 Participants n=5 Participants	—	—	0 Participants n=8 Participants	0 Participants n=8 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	—	0 Participants n=5 Participants	—	—	0 Participants n=8 Participants	0 Participants n=8 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	—	0 Participants n=5 Participants	—	—	0 Participants n=8 Participants	0 Participants n=8 Participants
Race (NIH/OMB) Black or African American	1 Participants n=5 Participants	—	0 Participants n=5 Participants	—	—	0 Participants n=8 Participants	1 Participants n=8 Participants
Race (NIH/OMB) White	1 Participants n=5 Participants	—	1 Participants n=5 Participants	—	—	2 Participants n=8 Participants	4 Participants n=8 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	—	0 Participants n=5 Participants	—	—	0 Participants n=8 Participants	0 Participants n=8 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	—	0 Participants n=5 Participants	—	—	0 Participants n=8 Participants	0 Participants n=8 Participants
Region of Enrollment United States	2 participants n=5 Participants	—	1 participants n=5 Participants	—	—	2 participants n=8 Participants	5 participants n=8 Participants
HIV VL<40	2 Participants n=5 Participants	—	1 Participants n=5 Participants	—	—	2 Participants n=8 Participants	5 Participants n=8 Participants
CD4 T Cell Count	914 cells/uL STANDARD_DEVIATION 359.7 • n=5 Participants	—	428 cells/uL STANDARD_DEVIATION 0 • n=5 Participants	—	—	745.5 cells/uL STANDARD_DEVIATION 225.6 • n=8 Participants	732.1 cells/uL STANDARD_DEVIATION 333.1 • n=8 Participants

PRIMARY outcome

Timeframe: 31 days

Population: The study was terminated (Halted Prematurely).

The number of grade 2 or higher severity adverse events (AEs) or drug-related laboratory abnormalities that exceed a frequency of 5% over a 31 day study period.

Outcome measures

Outcome measures
Measure	Kansui 1g Per Day x 1 Day n=2 Participants Study participants will be given 1 g of Euphorbia kansui extract powder prepared as tea for a total of 1 daily dose. Euphorbia kansui extract powder prepared as tea: 1 g of Euphorbia kansui extract powder, measured and reconstituted in 4 fluid ounces of boiled water allowed to cool and administered as tea, taken by mouth daily	Kansui 1g Per Day x 2 Days Study participants will be given 1 g of Euphorbia kansui extract powder prepared as tea for a total of 2 consecutive daily doses. Euphorbia kansui extract powder prepared as tea: 1 g of Euphorbia kansui extract powder, measured and reconstituted in 4 fluid ounces of boiled water allowed to cool and administered as tea, taken by mouth daily	Kansui 1g Per Day x 3 Days n=1 Participants Study participants will be given 1 g of Euphorbia kansui extract powder prepared as tea for a total of 3 consecutive daily doses. Euphorbia kansui extract powder prepared as tea: 1 g of Euphorbia kansui extract powder, measured and reconstituted in 4 fluid ounces of boiled water allowed to cool and administered as tea, taken by mouth daily	Placebo 1g Per Day x 1 Day Study participants will be given 1 g of placebo prepared as tea for a total of 1 daily dose.	Placebo 1g Per Day x 2 Days Study participants will be given 1 g placebo prepared as tea for a total of 2 consecutive daily doses.	Placebo 1g Per Day x 3 Days n=2 Participants Study participants will be given 1 g of placebo prepared as tea for a total of 3 consecutive daily doses.
Safety of Euphorbia Kansui Extract Powder Prepared as Tea Assessed by the Number of Grade 2 or Higher Severity Adverse Events or Drug-related Laboratory Abnormalities That Exceed a Frequency of 5%	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants

SECONDARY outcome

Timeframe: Baseline and 9 days

Population: The study was terminated (Halted Prematurely). We do not have data for the last participant in placebo 1g per day x 3 days group.

The change in early immune activation levels (as measured by the Change in Percent CD69+ CD4+ and CD8+ T cells) over a 9 day study period.

Outcome measures

Outcome measures
Measure	Kansui 1g Per Day x 1 Day n=2 Participants Study participants will be given 1 g of Euphorbia kansui extract powder prepared as tea for a total of 1 daily dose. Euphorbia kansui extract powder prepared as tea: 1 g of Euphorbia kansui extract powder, measured and reconstituted in 4 fluid ounces of boiled water allowed to cool and administered as tea, taken by mouth daily	Kansui 1g Per Day x 2 Days Study participants will be given 1 g of Euphorbia kansui extract powder prepared as tea for a total of 2 consecutive daily doses. Euphorbia kansui extract powder prepared as tea: 1 g of Euphorbia kansui extract powder, measured and reconstituted in 4 fluid ounces of boiled water allowed to cool and administered as tea, taken by mouth daily	Kansui 1g Per Day x 3 Days n=1 Participants Study participants will be given 1 g of Euphorbia kansui extract powder prepared as tea for a total of 3 consecutive daily doses. Euphorbia kansui extract powder prepared as tea: 1 g of Euphorbia kansui extract powder, measured and reconstituted in 4 fluid ounces of boiled water allowed to cool and administered as tea, taken by mouth daily	Placebo 1g Per Day x 1 Day Study participants will be given 1 g of placebo prepared as tea for a total of 1 daily dose.	Placebo 1g Per Day x 2 Days Study participants will be given 1 g placebo prepared as tea for a total of 2 consecutive daily doses.	Placebo 1g Per Day x 3 Days n=1 Participants Study participants will be given 1 g of placebo prepared as tea for a total of 3 consecutive daily doses.
Early T Cell Immune Activation (Change in Percent CD69+ CD4+ and CD8+ T Cells From Baseline to 9 Days) Change in Percent CD69+ CD4+ T Cells	-0.175 percentage of T cells Standard Deviation 0.445	—	0.5 percentage of T cells Standard Deviation 0	—	—	7.49 percentage of T cells Standard Deviation 0
Early T Cell Immune Activation (Change in Percent CD69+ CD4+ and CD8+ T Cells From Baseline to 9 Days) Change in Percent CD69+ CD8+ T Cells	0 percentage of T cells Standard Deviation 0.608	—	-2.1 percentage of T cells Standard Deviation 0	—	—	5.7 percentage of T cells Standard Deviation 0

SECONDARY outcome

Timeframe: Baseline and 9 days

Population: The study was terminated (Halted Prematurely). We do not have data for the last participant in placebo 1g per day x 3 days group.

The change in immune activation levels (as measured by the percent change in CD38+HLADR+ CD4+ and CD8+ T cells) over a 9 day study period.

Outcome measures

Outcome measures
Measure	Kansui 1g Per Day x 1 Day n=2 Participants Study participants will be given 1 g of Euphorbia kansui extract powder prepared as tea for a total of 1 daily dose. Euphorbia kansui extract powder prepared as tea: 1 g of Euphorbia kansui extract powder, measured and reconstituted in 4 fluid ounces of boiled water allowed to cool and administered as tea, taken by mouth daily	Kansui 1g Per Day x 2 Days Study participants will be given 1 g of Euphorbia kansui extract powder prepared as tea for a total of 2 consecutive daily doses. Euphorbia kansui extract powder prepared as tea: 1 g of Euphorbia kansui extract powder, measured and reconstituted in 4 fluid ounces of boiled water allowed to cool and administered as tea, taken by mouth daily	Kansui 1g Per Day x 3 Days n=1 Participants Study participants will be given 1 g of Euphorbia kansui extract powder prepared as tea for a total of 3 consecutive daily doses. Euphorbia kansui extract powder prepared as tea: 1 g of Euphorbia kansui extract powder, measured and reconstituted in 4 fluid ounces of boiled water allowed to cool and administered as tea, taken by mouth daily	Placebo 1g Per Day x 1 Day Study participants will be given 1 g of placebo prepared as tea for a total of 1 daily dose.	Placebo 1g Per Day x 2 Days Study participants will be given 1 g placebo prepared as tea for a total of 2 consecutive daily doses.	Placebo 1g Per Day x 3 Days n=2 Participants Study participants will be given 1 g of placebo prepared as tea for a total of 3 consecutive daily doses.
T Cell Immune Activation (Change in Percent CD38+HLA-DR+ CD4+ and CD8+ T Cells From Baseline to 9 Days) Change in Percent CD38+HLA-DR+ CD4+ T Cells	0.05 percentage of T cells Standard Deviation 0.03	—	-0.11 percentage of T cells Standard Deviation 0	—	—	0.03 percentage of T cells Standard Deviation 0
T Cell Immune Activation (Change in Percent CD38+HLA-DR+ CD4+ and CD8+ T Cells From Baseline to 9 Days) Change in Percent CD38+HLA-DR+ CD8+ T Cells	0.5 percentage of T cells Standard Deviation 0.72	—	-0.3 percentage of T cells Standard Deviation 0	—	—	0.2 percentage of T cells Standard Deviation 0

SECONDARY outcome

Timeframe: Baseline and 9 days

Population: The study was terminated (Halted Prematurely). We do not have data for the last participant in placebo 1g per day x 3 days group.

The change in HIV reservoir size (as measured by cell-associated unspliced ddPCR HIV RNA Pol levels in copies/ug) over a 9 day study period.

Outcome measures

Outcome measures
Measure	Kansui 1g Per Day x 1 Day n=2 Participants Study participants will be given 1 g of Euphorbia kansui extract powder prepared as tea for a total of 1 daily dose. Euphorbia kansui extract powder prepared as tea: 1 g of Euphorbia kansui extract powder, measured and reconstituted in 4 fluid ounces of boiled water allowed to cool and administered as tea, taken by mouth daily	Kansui 1g Per Day x 2 Days Study participants will be given 1 g of Euphorbia kansui extract powder prepared as tea for a total of 2 consecutive daily doses. Euphorbia kansui extract powder prepared as tea: 1 g of Euphorbia kansui extract powder, measured and reconstituted in 4 fluid ounces of boiled water allowed to cool and administered as tea, taken by mouth daily	Kansui 1g Per Day x 3 Days n=1 Participants Study participants will be given 1 g of Euphorbia kansui extract powder prepared as tea for a total of 3 consecutive daily doses. Euphorbia kansui extract powder prepared as tea: 1 g of Euphorbia kansui extract powder, measured and reconstituted in 4 fluid ounces of boiled water allowed to cool and administered as tea, taken by mouth daily	Placebo 1g Per Day x 1 Day Study participants will be given 1 g of placebo prepared as tea for a total of 1 daily dose.	Placebo 1g Per Day x 2 Days Study participants will be given 1 g placebo prepared as tea for a total of 2 consecutive daily doses.	Placebo 1g Per Day x 3 Days n=1 Participants Study participants will be given 1 g of placebo prepared as tea for a total of 3 consecutive daily doses.
HIV Reservoir Size (Change in HIV RNA Pol Levels in Copies/ug From Baseline to 9 Days)	-0.17 copies/ug Standard Deviation 0.24	—	-59.9 copies/ug Standard Deviation 0	—	—	-10.9 copies/ug Standard Deviation 0

SECONDARY outcome

Timeframe: Baseline and 9 days

Population: The study was terminated (Halted Prematurely). We do not have data for the last participant in placebo 1g per day x 3 days group.

The change in HIV reservoir size (as measured by ultra-sensitive plasma HIV RNA levels) over a 9 day study period.