Trial Outcomes & Findings for Analysis of Cellular Kinases and Aging in PBMCs and Colorectal Tissue (NCT NCT06132386)
NCT ID: NCT06132386
Last Updated: 2025-12-24
Results Overview
Concentration in nanometers (nm) of CKM in colorectal tissue
Recruitment status
COMPLETED
Target enrollment
21 participants
Primary outcome timeframe
Once within one month
Results posted on
2025-12-24
Participant Flow
Three cohorts of participants will be recruited, with younger adults (18-50 years old) and older adults (65-80 years old) in each cohort.
Participant milestones
| Measure |
HIV Negative, Not Taking Tenofovir (TFV) Based PrEP (18-50 Years)
biopsy: colorectal biopsy for tissue acquisition
|
HIV Positive Taking Tenofovir (TFV) and Emtricitabine (FTC) Based HIV Treatment (18-50 Yrs)
biopsy: colorectal biopsy for tissue acquisition
|
HIV Negative, Steady State Tenofovir (TFV) Based Regimen (18-50 Years)
biopsy: colorectal biopsy for tissue acquisition
|
HIV Negative, Not Taking Tenofovir (TFV) Based PrEP (65-80 Years)
biopsy: colorectal biopsy for tissue acquisition
|
HIV Positive Taking Tenofovir (TFV) and Emtricitabine (FTC) Based HIV Treatment (65-80 Yrs)
biopsy: colorectal biopsy for tissue acquisition
|
HIV Negative, Steady State Tenofovir (TFV) Based Regimen (65-80 Years)
biopsy: colorectal biopsy for tissue acquisition
|
|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
11
|
1
|
0
|
3
|
6
|
0
|
|
Overall Study
COMPLETED
|
10
|
0
|
0
|
3
|
5
|
0
|
|
Overall Study
NOT COMPLETED
|
1
|
1
|
0
|
0
|
1
|
0
|
Reasons for withdrawal
| Measure |
HIV Negative, Not Taking Tenofovir (TFV) Based PrEP (18-50 Years)
biopsy: colorectal biopsy for tissue acquisition
|
HIV Positive Taking Tenofovir (TFV) and Emtricitabine (FTC) Based HIV Treatment (18-50 Yrs)
biopsy: colorectal biopsy for tissue acquisition
|
HIV Negative, Steady State Tenofovir (TFV) Based Regimen (18-50 Years)
biopsy: colorectal biopsy for tissue acquisition
|
HIV Negative, Not Taking Tenofovir (TFV) Based PrEP (65-80 Years)
biopsy: colorectal biopsy for tissue acquisition
|
HIV Positive Taking Tenofovir (TFV) and Emtricitabine (FTC) Based HIV Treatment (65-80 Yrs)
biopsy: colorectal biopsy for tissue acquisition
|
HIV Negative, Steady State Tenofovir (TFV) Based Regimen (65-80 Years)
biopsy: colorectal biopsy for tissue acquisition
|
|---|---|---|---|---|---|---|
|
Overall Study
ineligble laboratory
|
1
|
0
|
0
|
0
|
1
|
0
|
|
Overall Study
ineligible vital signs
|
0
|
1
|
0
|
0
|
0
|
0
|
Baseline Characteristics
Analysis of Cellular Kinases and Aging in PBMCs and Colorectal Tissue
Baseline characteristics by cohort
| Measure |
HIV Negative, Not Taking Tenofovir (TFV) Based PrEP (18 - 50 Years)
n=11 Participants
biopsy: colorectal biopsy for tissue acquisition
|
HIV Positive Taking Tenofovir (TFV) and Emtricitabine (FTC) Based HIV Treatment (18 - 50 Yrs)
n=1 Participants
biopsy: colorectal biopsy for tissue acquisition
|
HIV Negative, Steady State Tenofovir (TFV) Based Regimen (18 - 50 Years)
biopsy: colorectal biopsy for tissue acquisition
|
HIV Negative, Not Taking Tenofovir (TFV) Based PrEP (65 - 80 Years)
n=3 Participants
biopsy: colorectal biopsy for tissue acquisition
|
HIV Positive Taking Tenofovir (TFV) and Emtricitabine (FTC) Based HIV Treatment (65 - 80 Yrs)
n=6 Participants
biopsy: colorectal biopsy for tissue acquisition
|
HIV Negative, Steady State Tenofovir (TFV) Based Regimen (65 - 80 Years)
biopsy: colorectal biopsy for tissue acquisition
|
Total
n=21 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=30 Participants
|
0 Participants
n=30 Participants
|
0 Participants
n=60 Participants
|
0 Participants
n=219 Participants
|
0 Participants
n=880 Participants
|
0 Participants
n=5449 Participants
|
0 Participants
n=391 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
11 Participants
n=30 Participants
|
1 Participants
n=30 Participants
|
0 Participants
n=60 Participants
|
0 Participants
n=219 Participants
|
0 Participants
n=880 Participants
|
0 Participants
n=5449 Participants
|
12 Participants
n=391 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=30 Participants
|
0 Participants
n=30 Participants
|
0 Participants
n=60 Participants
|
3 Participants
n=219 Participants
|
6 Participants
n=880 Participants
|
0 Participants
n=5449 Participants
|
9 Participants
n=391 Participants
|
|
Sex: Female, Male
Female
|
4 Participants
n=30 Participants
|
1 Participants
n=30 Participants
|
0 Participants
n=60 Participants
|
2 Participants
n=219 Participants
|
0 Participants
n=880 Participants
|
0 Participants
n=5449 Participants
|
7 Participants
n=391 Participants
|
|
Sex: Female, Male
Male
|
7 Participants
n=30 Participants
|
0 Participants
n=30 Participants
|
0 Participants
n=60 Participants
|
1 Participants
n=219 Participants
|
6 Participants
n=880 Participants
|
0 Participants
n=5449 Participants
|
14 Participants
n=391 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=30 Participants
|
0 Participants
n=30 Participants
|
—
|
0 Participants
n=219 Participants
|
0 Participants
n=880 Participants
|
—
|
0 Participants
n=391 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=30 Participants
|
0 Participants
n=30 Participants
|
—
|
0 Participants
n=219 Participants
|
0 Participants
n=880 Participants
|
—
|
1 Participants
n=391 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=30 Participants
|
0 Participants
n=30 Participants
|
—
|
0 Participants
n=219 Participants
|
0 Participants
n=880 Participants
|
—
|
0 Participants
n=391 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=30 Participants
|
1 Participants
n=30 Participants
|
—
|
1 Participants
n=219 Participants
|
2 Participants
n=880 Participants
|
—
|
5 Participants
n=391 Participants
|
|
Race (NIH/OMB)
White
|
9 Participants
n=30 Participants
|
0 Participants
n=30 Participants
|
—
|
2 Participants
n=219 Participants
|
4 Participants
n=880 Participants
|
—
|
15 Participants
n=391 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=30 Participants
|
0 Participants
n=30 Participants
|
—
|
0 Participants
n=219 Participants
|
0 Participants
n=880 Participants
|
—
|
0 Participants
n=391 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=30 Participants
|
0 Participants
n=30 Participants
|
—
|
0 Participants
n=219 Participants
|
0 Participants
n=880 Participants
|
—
|
0 Participants
n=391 Participants
|
|
Region of Enrollment
United States
|
11 Participants
n=30 Participants
|
1 Participants
n=30 Participants
|
—
|
3 Participants
n=219 Participants
|
6 Participants
n=880 Participants
|
—
|
21 Participants
n=391 Participants
|
PRIMARY outcome
Timeframe: Once within one monthPopulation: Only participants who completed the rectal tissue biopsy are included in the analysis population.
Concentration in nanometers (nm) of AK2 in colorectal tissue.
Outcome measures
| Measure |
HIV Negative, Not Taking Tenofovir (TFV) Based PrEP (18-50 Years)
n=10 Participants
biopsy: colorectal biopsy for tissue acquisition
|
HIV Positive Taking Tenofovir (TFV) and Emtricitabine (FC) Based HIV Treatment (18-50 Years)
biopsy: colorectal biopsy for tissue acquisition
|
HIV Negative, Steady State Tenofovir (TFV) Based Regimen (18-50 Years)
biopsy: colorectal biopsy for tissue acquisition
|
HIV Negative, Not Taking Tenofovir (TFV) Based PrEP (65-80 Years)
n=3 Participants
biopsy: colorectal biopsy for tissue acquisition
|
HIV Positive Taking Tenofovir (TFV) and Emtricitabine (FTC) Based HIV Treatment (65-80 Yrs)
n=5 Participants
biopsy: colorectal biopsy for tissue acquisition
|
HIV Negative, Steady State Tenofovir (TFV) Based Regimen (65-80 Years)
biopsy: colorectal biopsy for tissue acquisition
|
|---|---|---|---|---|---|---|
|
Concentration of AK2 in Colorectal Tissue
|
12232 nm
Interval 11658.0 to 12951.0
|
—
|
—
|
12975 nm
Interval 11874.0 to 13731.0
|
13173 nm
Interval 11767.0 to 13521.0
|
—
|
PRIMARY outcome
Timeframe: Once within one monthPopulation: Only participants who completed the rectal tissue biopsy are included in the analysis population.
Concentration in nanometers (nm) of CKM in colorectal tissue
Outcome measures
| Measure |
HIV Negative, Not Taking Tenofovir (TFV) Based PrEP (18-50 Years)
n=10 Participants
biopsy: colorectal biopsy for tissue acquisition
|
HIV Positive Taking Tenofovir (TFV) and Emtricitabine (FC) Based HIV Treatment (18-50 Years)
biopsy: colorectal biopsy for tissue acquisition
|
HIV Negative, Steady State Tenofovir (TFV) Based Regimen (18-50 Years)
biopsy: colorectal biopsy for tissue acquisition
|
HIV Negative, Not Taking Tenofovir (TFV) Based PrEP (65-80 Years)
n=3 Participants
biopsy: colorectal biopsy for tissue acquisition
|
HIV Positive Taking Tenofovir (TFV) and Emtricitabine (FTC) Based HIV Treatment (65-80 Yrs)
n=5 Participants
biopsy: colorectal biopsy for tissue acquisition
|
HIV Negative, Steady State Tenofovir (TFV) Based Regimen (65-80 Years)
biopsy: colorectal biopsy for tissue acquisition
|
|---|---|---|---|---|---|---|
|
Concentration of CKM in Colorectal Tissue
|
4143 nm
Interval 3873.0 to 4554.0
|
—
|
—
|
3236 nm
Interval 3157.0 to 3920.0
|
4176 nm
Interval 3750.0 to 4587.0
|
—
|
PRIMARY outcome
Timeframe: Once within one monthPopulation: Only participants who completed the rectal tissue biopsy are included in the analysis population.
Concentration in nanometers (nm) of AK2 in peripheral blood mononuclear cells
Outcome measures
| Measure |
HIV Negative, Not Taking Tenofovir (TFV) Based PrEP (18-50 Years)
n=10 Participants
biopsy: colorectal biopsy for tissue acquisition
|
HIV Positive Taking Tenofovir (TFV) and Emtricitabine (FC) Based HIV Treatment (18-50 Years)
biopsy: colorectal biopsy for tissue acquisition
|
HIV Negative, Steady State Tenofovir (TFV) Based Regimen (18-50 Years)
biopsy: colorectal biopsy for tissue acquisition
|
HIV Negative, Not Taking Tenofovir (TFV) Based PrEP (65-80 Years)
n=3 Participants
biopsy: colorectal biopsy for tissue acquisition
|
HIV Positive Taking Tenofovir (TFV) and Emtricitabine (FTC) Based HIV Treatment (65-80 Yrs)
n=5 Participants
biopsy: colorectal biopsy for tissue acquisition
|
HIV Negative, Steady State Tenofovir (TFV) Based Regimen (65-80 Years)
biopsy: colorectal biopsy for tissue acquisition
|
|---|---|---|---|---|---|---|
|
Concentration of AK2 in Peripheral Blood Mononuclear Cells
|
2035 nm
Interval 1561.0 to 2458.0
|
—
|
—
|
1175 nm
Interval 558.0 to 1799.0
|
1740 nm
Interval 1180.0 to 2253.0
|
—
|
Adverse Events
HIV Negative, Not Taking Tenofovir (TFV) Based PrEP (18-50 Years)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
HIV Positive Taking Tenofovir (TFV) and Emtricitabine (FTC) Based HIV Treatment (18-50 Yrs)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
HIV Negative, Not Taking Tenofovir (TFV) Based PrEP (65-80 Years
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
HIV Positive Taking Tenofovir (TFV) and Emtricitabine (FTC) Based HIV Treatment (65-80 Yrs)
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
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place