Trial Outcomes & Findings for Validation of a Urine Assay to Measure Tenofovir Levels in Patients Taking Tenofovir Alafenamide (NCT NCT03350672)

Last Updated: 2021-09-30

Results Overview

Cohort 1b: To determine how long TFV is excreted in the urine in patients at steady state of TAF/FTC. Ten healthy subjects will be given seven daily doses of TAF/FTC under direct observation to ensure adherence. Morning urine samples will be collected starting the day the last is given (1 hour later) and every day thereafter for 9 days (total of 10 days). Urine samples collected from all participants were analyzed via LC-MS/MS for tenofovir concentrations.

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

37 participants

Primary outcome timeframe

Daily for a maximum of 10 days

Results posted on

2021-09-30

Participant Flow

Participant milestones

Participant milestones
Measure	Cohort 2 Person living with HIV, currently prescribed an FTC/TAF based regimen, who reports recent adherence	Cohort 1a HIV negative adults, who are not taking FTC/TDF for PrEP; given 7 consecutive, daily doses of FTC/TAF	Cohort 1b HIV negative adults, who are not currently taking FTC/TDF for PrEP; administered single dose of FTC/TAF
Overall Study STARTED	17	10	10
Overall Study COMPLETED	10	10	10
Overall Study NOT COMPLETED	7	0	0

Reasons for withdrawal

Reasons for withdrawal
Measure	Cohort 2 Person living with HIV, currently prescribed an FTC/TAF based regimen, who reports recent adherence	Cohort 1a HIV negative adults, who are not taking FTC/TDF for PrEP; given 7 consecutive, daily doses of FTC/TAF	Cohort 1b HIV negative adults, who are not currently taking FTC/TDF for PrEP; administered single dose of FTC/TAF
Overall Study Withdrawal by Subject	7	0	0

Baseline Characteristics

Validation of a Urine Assay to Measure Tenofovir Levels in Patients Taking Tenofovir Alafenamide

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Cohort 2 n=10 Participants Person living with HIV, currently prescribed an FTC/TAF based regimen, who reports recent adherence	Cohort 1b n=10 Participants HIV negative adults, who are not currently taking FTC/TDF for PrEP; administered single dose of FTC/TAF	Cohort 1a n=10 Participants HIV negative adults, who are not taking FTC/TDF for PrEP; given 7 consecutive, daily doses of FTC/TAF	Total n=30 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Age, Categorical Between 18 and 65 years	8 Participants n=5 Participants	10 Participants n=7 Participants	10 Participants n=5 Participants	28 Participants n=4 Participants
Age, Categorical >=65 years	2 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	2 Participants n=4 Participants
Age, Continuous	57.00 years STANDARD_DEVIATION 8.88 • n=5 Participants	30.10 years STANDARD_DEVIATION 6.12 • n=7 Participants	33.00 years STANDARD_DEVIATION 9.12 • n=5 Participants	40.03 years STANDARD_DEVIATION 14.32 • n=4 Participants
Sex: Female, Male Female	1 Participants n=5 Participants	4 Participants n=7 Participants	3 Participants n=5 Participants	8 Participants n=4 Participants
Sex: Female, Male Male	9 Participants n=5 Participants	6 Participants n=7 Participants	7 Participants n=5 Participants	22 Participants n=4 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	1 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	1 Participants n=4 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	9 Participants n=5 Participants	10 Participants n=7 Participants	10 Participants n=5 Participants	29 Participants n=4 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants	2 Participants n=4 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Race (NIH/OMB) Black or African American	4 Participants n=5 Participants	2 Participants n=7 Participants	1 Participants n=5 Participants	7 Participants n=4 Participants
Race (NIH/OMB) White	6 Participants n=5 Participants	6 Participants n=7 Participants	8 Participants n=5 Participants	20 Participants n=4 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	1 Participants n=7 Participants	0 Participants n=5 Participants	1 Participants n=4 Participants
Region of Enrollment United States	10 participants n=5 Participants	10 participants n=7 Participants	10 participants n=5 Participants	30 participants n=4 Participants

PRIMARY outcome

Timeframe: Daily for a maximum of 10 days

Population: 10 samples were collected each day during the sampling period (1 per participant).

Outcome measures

Outcome measures
Measure	Cohort 1b n=100 urine samples HIV negative adults, who are not taking FTC/TDF for PrEP; given 7 consecutive, daily doses of FTC/TAF
Percentage of Urine Samples Containing TFV in Concentrations Greater Than or Equal to 1000ng/mL From the 7-dose Cohort (1b). Day 0 post dosing	100 percentage of urine samples
Percentage of Urine Samples Containing TFV in Concentrations Greater Than or Equal to 1000ng/mL From the 7-dose Cohort (1b). Day 1 post dosing	80 percentage of urine samples
Percentage of Urine Samples Containing TFV in Concentrations Greater Than or Equal to 1000ng/mL From the 7-dose Cohort (1b). Day 2 post dosing	80 percentage of urine samples
Percentage of Urine Samples Containing TFV in Concentrations Greater Than or Equal to 1000ng/mL From the 7-dose Cohort (1b). Day 3 post dosing	80 percentage of urine samples
Percentage of Urine Samples Containing TFV in Concentrations Greater Than or Equal to 1000ng/mL From the 7-dose Cohort (1b). Day 4 post dosing	30 percentage of urine samples
Percentage of Urine Samples Containing TFV in Concentrations Greater Than or Equal to 1000ng/mL From the 7-dose Cohort (1b). Day 5 post dosing	30 percentage of urine samples
Percentage of Urine Samples Containing TFV in Concentrations Greater Than or Equal to 1000ng/mL From the 7-dose Cohort (1b). Day 6 post dosing	20 percentage of urine samples
Percentage of Urine Samples Containing TFV in Concentrations Greater Than or Equal to 1000ng/mL From the 7-dose Cohort (1b). Day 7 post dosing	20 percentage of urine samples
Percentage of Urine Samples Containing TFV in Concentrations Greater Than or Equal to 1000ng/mL From the 7-dose Cohort (1b). Day 8 post dosing	0 percentage of urine samples
Percentage of Urine Samples Containing TFV in Concentrations Greater Than or Equal to 1000ng/mL From the 7-dose Cohort (1b). Day 9 post Dosing	0 percentage of urine samples

PRIMARY outcome

Timeframe: 7 days

Population: 10 urine samples collected on each of 7 collection days (1 per participant).

To determine how long TFV is excreted in the urine in patients who have taken one dose of TAF/FTC. Ten healthy subjects will be given one dose of TAF/FTC under direct observation to ensure adherence. Morning urine samples will be collected starting the day the dose is given (1 hour later) and every day thereafter for 6 days (total of 7 days of sample collection). This will allow for the assessment of the length of time TFV can be measured in the urine after last dose is taken (the "lookback" period) in the context of inconsistent or intermittent (1 day only) adherence, as well as to determine how many days a patient has been off drug if a urine specimen has no detectable TFV.

Outcome measures

Outcome measures
Measure	Cohort 1b n=70 urine samples HIV negative adults, who are not taking FTC/TDF for PrEP; given 7 consecutive, daily doses of FTC/TAF
Percent of Urine Samples Containing TFV Levels Greater Than or Equal to 1000ng/mL in the Single Dose Cohort (1a). Day 0 post dosng	60 percentage of urine samples
Percent of Urine Samples Containing TFV Levels Greater Than or Equal to 1000ng/mL in the Single Dose Cohort (1a). Day 1 post dosing	60 percentage of urine samples
Percent of Urine Samples Containing TFV Levels Greater Than or Equal to 1000ng/mL in the Single Dose Cohort (1a). Day 2 post dosing	30 percentage of urine samples
Percent of Urine Samples Containing TFV Levels Greater Than or Equal to 1000ng/mL in the Single Dose Cohort (1a). Day 3 post dosing	20 percentage of urine samples
Percent of Urine Samples Containing TFV Levels Greater Than or Equal to 1000ng/mL in the Single Dose Cohort (1a). Day 4 post dosing	0 percentage of urine samples
Percent of Urine Samples Containing TFV Levels Greater Than or Equal to 1000ng/mL in the Single Dose Cohort (1a). Day 5 post dosing	0 percentage of urine samples
Percent of Urine Samples Containing TFV Levels Greater Than or Equal to 1000ng/mL in the Single Dose Cohort (1a). Day 6 post dosing	10 percentage of urine samples

PRIMARY outcome

Timeframe: 1 day

To determine the expected urine tenofovir levels in a population of patients living with HIV on TAF-based regimens. A cross-sectional analysis of ten patients living with HIV with undetectable viral loads on a TAF-based single tablet HIV regimen will be conducted. Morning urine samples will be collected at one time point to determine urine TFV concentration in the setting of steady state dosing in HIV patients with presumably very good adherence to medication.

Outcome measures

Outcome measures
Measure	Cohort 1b n=10 urine samples HIV negative adults, who are not taking FTC/TDF for PrEP; given 7 consecutive, daily doses of FTC/TAF
Percentage of Urine Samples Containing Tenofovir at Concentrations Greater Than or Equal to 1000ng/mL (Cohort 2).	100 percentage of urine samples

Adverse Events

Cohort 2

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Cohort 1b

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Cohort 1a

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Cohort 2 n=10 participants at risk Person living with HIV, currently prescribed an FTC/TAF based regimen, who reports recent adherence	Cohort 1b n=10 participants at risk HIV negative adults, who are not currently taking FTC/TDF for PrEP; administered single dose of FTC/TAF	Cohort 1a n=10 participants at risk HIV negative adults, who are not taking FTC/TDF for PrEP; given 7 consecutive, daily doses of FTC/TAF
Gastrointestinal disorders Viral gastroenteritis	0.00% 0/10 • Beginning after first dose and extending through completion of the study (Cohort 1a = 7 days; Cohort 1b = 10 days; Cohort 2 = only AEs related to blood draw collected).	10.0% 1/10 • Number of events 1 • Beginning after first dose and extending through completion of the study (Cohort 1a = 7 days; Cohort 1b = 10 days; Cohort 2 = only AEs related to blood draw collected).	0.00% 0/10 • Beginning after first dose and extending through completion of the study (Cohort 1a = 7 days; Cohort 1b = 10 days; Cohort 2 = only AEs related to blood draw collected).

Additional Information

Linden Lalley-Chareczko

Philadelphia FIGHT Community Health Centers

Phone: 2155258695

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place