Trial Outcomes & Findings for Project ADHERE: Clinical Proof-of-Concept of a Tenofovir (TFV) Aptamer-Based Biosensor (NCT NCT04870671)
NCT ID: NCT04870671
Last Updated: 2024-01-30
Results Overview
TFV levels will be measured by the TFV aptasensor and compared to Liquid Chromatography with Tandem Mass Spectrometry (LC-MS/MS) values
Recruitment status
COMPLETED
Study phase
EARLY_PHASE1
Target enrollment
14 participants
Primary outcome timeframe
Baseline (pre-dose)
Results posted on
2024-01-30
Participant Flow
Participant milestones
| Measure |
High Adherence
Tenofovir Disoproxil Fumarate/Emtricitabine (TDF/FTC) (300/200 mg), 7 pills/week. Total of 14 pills
TDF/FTC: Women will take 1 pill orally according the dosing regimen of the arm to which they are assigned
|
Low Adherence
Tenofovir Disoproxil Fumarate/Emtricitabine (TDF/FTC) (300/2200 mg), 3 pills/week. Total of 6 pills
TDF/FTC: Women will take 1 pill orally according the dosing regimen of the arm to which they are assigned
|
|---|---|---|
|
Overall Study
STARTED
|
7
|
7
|
|
Overall Study
COMPLETED
|
7
|
7
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Project ADHERE: Clinical Proof-of-Concept of a Tenofovir (TFV) Aptamer-Based Biosensor
Baseline characteristics by cohort
| Measure |
High Adherence
n=7 Participants
Tenofovir Disoproxil Fumarate/Emtricitabine (TDF/FTC) (300/200 mg), 7 pills/week. Total of 14 pills
TDF/FTC: Women will take 1 pill orally according the dosing regimen of the arm to which they are assigned
|
Low Adherence
n=7 Participants
Tenofovir Disoproxil Fumarate/Emtricitabine (TDF/FTC) (300/2200 mg), 3 pills/week. Total of 6 pills
TDF/FTC: Women will take 1 pill orally according the dosing regimen of the arm to which they are assigned
|
Total
n=14 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
7 Participants
n=93 Participants
|
7 Participants
n=4 Participants
|
14 Participants
n=27 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Age, Continuous
|
40.1 years
STANDARD_DEVIATION 10.6 • n=93 Participants
|
37.7 years
STANDARD_DEVIATION 7.8 • n=4 Participants
|
38.9 years
STANDARD_DEVIATION 9.1 • n=27 Participants
|
|
Sex: Female, Male
Female
|
7 Participants
n=93 Participants
|
7 Participants
n=4 Participants
|
14 Participants
n=27 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=27 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
6 Participants
n=93 Participants
|
7 Participants
n=4 Participants
|
13 Participants
n=27 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Black or African American
|
2 Participants
n=93 Participants
|
2 Participants
n=4 Participants
|
4 Participants
n=27 Participants
|
|
Race (NIH/OMB)
White
|
5 Participants
n=93 Participants
|
5 Participants
n=4 Participants
|
10 Participants
n=27 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Region of Enrollment
United States
|
7 participants
n=93 Participants
|
7 participants
n=4 Participants
|
14 participants
n=27 Participants
|
|
Body Mass Index
|
31.3 kg/m^2
STANDARD_DEVIATION 7 • n=93 Participants
|
32.4 kg/m^2
STANDARD_DEVIATION 11.8 • n=4 Participants
|
31.8 kg/m^2
STANDARD_DEVIATION 9.3 • n=27 Participants
|
|
Creatinine Clearance
|
157.2 mL/min
STANDARD_DEVIATION 48.3 • n=93 Participants
|
169 mL/min
STANDARD_DEVIATION 77.9 • n=4 Participants
|
163.1 mL/min
STANDARD_DEVIATION 62.6 • n=27 Participants
|
PRIMARY outcome
Timeframe: Baseline (pre-dose)Population: The development of the aptasensor did not reach the target endpoint of detecting TFV in human plasma samples
TFV levels will be measured by the TFV aptasensor and compared to Liquid Chromatography with Tandem Mass Spectrometry (LC-MS/MS) values
Outcome measures
Outcome data not reported
PRIMARY outcome
Timeframe: 1 dayPopulation: The development of the aptasensor did not reach the target of detecting TFV in human plasma samples
TFV levels will be measured by the TFV aptasensor and compared to LC-MS/MS values
Outcome measures
Outcome data not reported
PRIMARY outcome
Timeframe: 7 daysPopulation: The development of the aptasensor did not reach the target of detecting TFV in human plasma samples
TFV levels will be measured by the TFV aptasensor and compared to LC-MS/MS values
Outcome measures
Outcome data not reported
PRIMARY outcome
Timeframe: 14 daysPopulation: The development of the aptasensor did not reach the target of detecting TFV in human plasma samples.
TFV levels will be measured by the TFV aptasensor and compared to LC-MS/MS values
Outcome measures
Outcome data not reported
Adverse Events
High Adherence
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Low Adherence
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
High Adherence
n=7 participants at risk
TDF/FTC (300/200 mg), 7 pills/week. Total of 14 pills
Tenofovir Disoproxil Fumarate: Women will take 1 pill orally according the dosing regimen of the arm to which they are assigned
|
Low Adherence
n=7 participants at risk
TDF/FTC (300/2200 mg), 3 pills/week. Total of 6 pills
Tenofovir Disoproxil Fumarate: Women will take 1 pill orally according the dosing regimen of the arm to which they are assigned
|
|---|---|---|
|
Gastrointestinal disorders
Diarrhea
|
14.3%
1/7 • Number of events 1 • 4 months
|
0.00%
0/7 • 4 months
|
|
General disorders
Nausea
|
14.3%
1/7 • Number of events 1 • 4 months
|
14.3%
1/7 • Number of events 1 • 4 months
|
|
Respiratory, thoracic and mediastinal disorders
upper respiratory infection
|
0.00%
0/7 • 4 months
|
14.3%
1/7 • Number of events 1 • 4 months
|
|
General disorders
increased appetite
|
14.3%
1/7 • Number of events 1 • 4 months
|
0.00%
0/7 • 4 months
|
|
General disorders
headache
|
14.3%
1/7 • Number of events 1 • 4 months
|
0.00%
0/7 • 4 months
|
|
Respiratory, thoracic and mediastinal disorders
Allergies
|
0.00%
0/7 • 4 months
|
14.3%
1/7 • Number of events 1 • 4 months
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place