Trial Outcomes & Findings for The Cellular Pharmacology of F-TAF in Dried Blood Spots (NCT NCT02962739)
NCT ID: NCT02962739
Last Updated: 2021-01-25
Results Overview
Tenofovir diphosphate (TFV-DP) concentrations in dried blood spots (DBS) respective to dosing regimens of 33%, 67%, 100% of daily dosing.
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
38 participants
Primary outcome timeframe
Assessed weekly for 9 months
Results posted on
2021-01-25
Participant Flow
Participant milestones
| Measure |
33%/67% Dosing
The 33% and 67% dosing regimens will use skipped doses spaced by days (i.e. 67% is two daily doses followed by skipping a day, repeated for 12 weeks; 33% dosing is a daily dose followed by two skipped days, repeated for 12 weeks).
emtricitabine 200 mg/tenofovir alafenamide 25mg: 1 tablet of Descovy contains emtricitabine 200 mg/tenofovir alafenamide 25mg
|
33%/100% Dosing
The 33% dosing regimens will use skipped doses spaced by days (i.e. 33% dosing is a daily dose followed by two skipped days, repeated for 12 weeks). 100% will dose daily for 12 weeks, no skipped doses.
emtricitabine 200 mg/tenofovir alafenamide 25mg: 1 tablet of Descovy contains emtricitabine 200 mg/tenofovir alafenamide 25mg
|
67%/33% Dosing
The 33% and 67% dosing regimens will use skipped doses spaced by days (i.e. 67% is two daily doses followed by skipping a day, repeated for 12 weeks; 33% dosing is a daily dose followed by two skipped days, repeated for 12 weeks).
emtricitabine 200 mg/tenofovir alafenamide 25mg: 1 tablet of Descovy contains emtricitabine 200 mg/tenofovir alafenamide 25mg
|
67%/100% Dosing
67% dosing regimens will use skipped doses spaced by days (i.e. 67% is two daily doses followed by skipping a day, repeated for 12 weeks. 100% will dose daily for 12 weeks, no skipped doses.
emtricitabine 200 mg/tenofovir alafenamide 25mg: 1 tablet of Descovy contains emtricitabine 200 mg/tenofovir alafenamide 25mg
|
100%/33% Dosing
The 33% dosing regimens will use skipped doses spaced by days (i.e. 33% dosing is a daily dose followed by two skipped days, repeated for 12 weeks). 100% will dose daily for 12 weeks, no skipped doses.
emtricitabine 200 mg/tenofovir alafenamide 25mg: 1 tablet of Descovy contains emtricitabine 200 mg/tenofovir alafenamide 25mg
|
100%/67% Dosing
67% dosing regimens will use skipped doses spaced by days (i.e. 67% is two daily doses followed by skipping a day, repeated for 12 weeks. 100% will dose daily for 12 weeks, no skipped doses.
emtricitabine 200 mg/tenofovir alafenamide 25mg: 1 tablet of Descovy contains emtricitabine 200 mg/tenofovir alafenamide 25mg
|
|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
6
|
7
|
7
|
6
|
6
|
6
|
|
Overall Study
COMPLETED
|
6
|
6
|
6
|
6
|
5
|
6
|
|
Overall Study
NOT COMPLETED
|
0
|
1
|
1
|
0
|
1
|
0
|
Reasons for withdrawal
| Measure |
33%/67% Dosing
The 33% and 67% dosing regimens will use skipped doses spaced by days (i.e. 67% is two daily doses followed by skipping a day, repeated for 12 weeks; 33% dosing is a daily dose followed by two skipped days, repeated for 12 weeks).
emtricitabine 200 mg/tenofovir alafenamide 25mg: 1 tablet of Descovy contains emtricitabine 200 mg/tenofovir alafenamide 25mg
|
33%/100% Dosing
The 33% dosing regimens will use skipped doses spaced by days (i.e. 33% dosing is a daily dose followed by two skipped days, repeated for 12 weeks). 100% will dose daily for 12 weeks, no skipped doses.
emtricitabine 200 mg/tenofovir alafenamide 25mg: 1 tablet of Descovy contains emtricitabine 200 mg/tenofovir alafenamide 25mg
|
67%/33% Dosing
The 33% and 67% dosing regimens will use skipped doses spaced by days (i.e. 67% is two daily doses followed by skipping a day, repeated for 12 weeks; 33% dosing is a daily dose followed by two skipped days, repeated for 12 weeks).
emtricitabine 200 mg/tenofovir alafenamide 25mg: 1 tablet of Descovy contains emtricitabine 200 mg/tenofovir alafenamide 25mg
|
67%/100% Dosing
67% dosing regimens will use skipped doses spaced by days (i.e. 67% is two daily doses followed by skipping a day, repeated for 12 weeks. 100% will dose daily for 12 weeks, no skipped doses.
emtricitabine 200 mg/tenofovir alafenamide 25mg: 1 tablet of Descovy contains emtricitabine 200 mg/tenofovir alafenamide 25mg
|
100%/33% Dosing
The 33% dosing regimens will use skipped doses spaced by days (i.e. 33% dosing is a daily dose followed by two skipped days, repeated for 12 weeks). 100% will dose daily for 12 weeks, no skipped doses.
emtricitabine 200 mg/tenofovir alafenamide 25mg: 1 tablet of Descovy contains emtricitabine 200 mg/tenofovir alafenamide 25mg
|
100%/67% Dosing
67% dosing regimens will use skipped doses spaced by days (i.e. 67% is two daily doses followed by skipping a day, repeated for 12 weeks. 100% will dose daily for 12 weeks, no skipped doses.
emtricitabine 200 mg/tenofovir alafenamide 25mg: 1 tablet of Descovy contains emtricitabine 200 mg/tenofovir alafenamide 25mg
|
|---|---|---|---|---|---|---|
|
Overall Study
Withdrawal by Subject
|
0
|
1
|
0
|
0
|
0
|
0
|
|
Overall Study
Protocol Violation
|
0
|
0
|
1
|
0
|
1
|
0
|
Baseline Characteristics
3 subjects withdrew- only 35 of 38 enrolled were analyzed
Baseline characteristics by cohort
| Measure |
All Dosing Regimens
n=35 Participants
Baseline characteristics for all 35 subjects analyzed. Baseline characteristics not stratified based on dosing regimen. Arms were combined to be consistent with protocol subject randomization. Subjects were randomized to one of six arms. Combined arms best categorize the study, population, and data.
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants • 3 subjects withdrew- only 35 of 38 enrolled were analyzed
|
|
Age, Categorical
Between 18 and 65 years
|
35 Participants
n=5 Participants • 3 subjects withdrew- only 35 of 38 enrolled were analyzed
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants • 3 subjects withdrew- only 35 of 38 enrolled were analyzed
|
|
Sex: Female, Male
Female
|
17 Participants
n=5 Participants • 3 subjects withdrew- only 35 of 38 enrolled were analyzed.
|
|
Sex: Female, Male
Male
|
18 Participants
n=5 Participants • 3 subjects withdrew- only 35 of 38 enrolled were analyzed.
|
|
Race/Ethnicity, Customized
African American
|
5 Participants
n=5 Participants • 38 subjects started study procedures. Of 38, 3 withdrew thus only 35 were analyzed.
|
|
Race/Ethnicity, Customized
Caucasian
|
24 Participants
n=5 Participants • 38 subjects started study procedures. Of 38, 3 withdrew thus only 35 were analyzed.
|
|
Race/Ethnicity, Customized
Hispanic
|
6 Participants
n=5 Participants • 38 subjects started study procedures. Of 38, 3 withdrew thus only 35 were analyzed.
|
PRIMARY outcome
Timeframe: Assessed weekly for 9 monthsPopulation: 34 participants received 2 of 3 dosing regimens and 1 participant only completed through week 8 of the second regimen, resulting in a total of 69 observations.
Tenofovir diphosphate (TFV-DP) concentrations in dried blood spots (DBS) respective to dosing regimens of 33%, 67%, 100% of daily dosing.
Outcome measures
| Measure |
DOT 33%
n=23 Participants
33% of daily dosing; dosing on day one followed by skipped doses on days two and three, repeated for 12 weeks
|
DOT 67%
n=23 Participants
67% of daily dosing; dosing on days one and two, skipped dose on day three, repeated for 12 weeks
|
DOT 100%
n=23 Participants
100% of daily dosing:dosing every day for 12 weeks
|
|---|---|---|---|
|
Steady State Concentrations of TFV-DP for Different Dosing Patterns of Descovy
|
657 fmol/punch
Standard Deviation 186
|
1451 fmol/punch
Standard Deviation 501
|
2381 fmol/punch
Standard Deviation 601
|
Adverse Events
All Subjects
Serious events: 2 serious events
Other events: 38 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
All Subjects
n=38 participants at risk
At study initiation Descovy was FDA approved for daily dosing (100% daily dosing). Thus, the AE profile was already established for 100% dosing and AE rates in the lower doses (33% and 67%) would not exceed the established rate for daily dosing (100%). This study was not designed to collect new safety data or to update the established AE/Safety profiles for Descovy. Therefore AE data was combined for all dosing regimens.
|
|---|---|
|
Injury, poisoning and procedural complications
traumatic leg fracture
|
2.6%
1/38 • Number of events 1 • Time of consenting to study exit (Week 36 or earlier), Max 10 months.
AEs were graded per the DAIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, Version 2.0, November, 2014. Available: http://rsc.tech-res.com/safetyandpharmacovigilance/. Arms were combined as Descovy was FDA approved for daily use (100% dosing) at the time of study initiation- no arm was considered to be more at risk for AEs than another.
|
|
Musculoskeletal and connective tissue disorders
Pleurisy VS costochondritis
|
2.6%
1/38 • Number of events 1 • Time of consenting to study exit (Week 36 or earlier), Max 10 months.
AEs were graded per the DAIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, Version 2.0, November, 2014. Available: http://rsc.tech-res.com/safetyandpharmacovigilance/. Arms were combined as Descovy was FDA approved for daily use (100% dosing) at the time of study initiation- no arm was considered to be more at risk for AEs than another.
|
Other adverse events
| Measure |
All Subjects
n=38 participants at risk
At study initiation Descovy was FDA approved for daily dosing (100% daily dosing). Thus, the AE profile was already established for 100% dosing and AE rates in the lower doses (33% and 67%) would not exceed the established rate for daily dosing (100%). This study was not designed to collect new safety data or to update the established AE/Safety profiles for Descovy. Therefore AE data was combined for all dosing regimens.
|
|---|---|
|
General disorders
Headache
|
21.1%
8/38 • Number of events 14 • Time of consenting to study exit (Week 36 or earlier), Max 10 months.
AEs were graded per the DAIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, Version 2.0, November, 2014. Available: http://rsc.tech-res.com/safetyandpharmacovigilance/. Arms were combined as Descovy was FDA approved for daily use (100% dosing) at the time of study initiation- no arm was considered to be more at risk for AEs than another.
|
|
General disorders
Abnormal Labs
|
39.5%
15/38 • Number of events 29 • Time of consenting to study exit (Week 36 or earlier), Max 10 months.
AEs were graded per the DAIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, Version 2.0, November, 2014. Available: http://rsc.tech-res.com/safetyandpharmacovigilance/. Arms were combined as Descovy was FDA approved for daily use (100% dosing) at the time of study initiation- no arm was considered to be more at risk for AEs than another.
|
|
General disorders
Cold Symptoms
|
81.6%
31/38 • Number of events 62 • Time of consenting to study exit (Week 36 or earlier), Max 10 months.
AEs were graded per the DAIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, Version 2.0, November, 2014. Available: http://rsc.tech-res.com/safetyandpharmacovigilance/. Arms were combined as Descovy was FDA approved for daily use (100% dosing) at the time of study initiation- no arm was considered to be more at risk for AEs than another.
|
|
Gastrointestinal disorders
Diarrhea
|
26.3%
10/38 • Number of events 14 • Time of consenting to study exit (Week 36 or earlier), Max 10 months.
AEs were graded per the DAIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, Version 2.0, November, 2014. Available: http://rsc.tech-res.com/safetyandpharmacovigilance/. Arms were combined as Descovy was FDA approved for daily use (100% dosing) at the time of study initiation- no arm was considered to be more at risk for AEs than another.
|
|
Gastrointestinal disorders
Abdominal Pain
|
10.5%
4/38 • Number of events 5 • Time of consenting to study exit (Week 36 or earlier), Max 10 months.
AEs were graded per the DAIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, Version 2.0, November, 2014. Available: http://rsc.tech-res.com/safetyandpharmacovigilance/. Arms were combined as Descovy was FDA approved for daily use (100% dosing) at the time of study initiation- no arm was considered to be more at risk for AEs than another.
|
|
Gastrointestinal disorders
Nausea
|
47.4%
18/38 • Number of events 22 • Time of consenting to study exit (Week 36 or earlier), Max 10 months.
AEs were graded per the DAIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, Version 2.0, November, 2014. Available: http://rsc.tech-res.com/safetyandpharmacovigilance/. Arms were combined as Descovy was FDA approved for daily use (100% dosing) at the time of study initiation- no arm was considered to be more at risk for AEs than another.
|
|
Gastrointestinal disorders
Vomiting
|
26.3%
10/38 • Number of events 14 • Time of consenting to study exit (Week 36 or earlier), Max 10 months.
AEs were graded per the DAIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, Version 2.0, November, 2014. Available: http://rsc.tech-res.com/safetyandpharmacovigilance/. Arms were combined as Descovy was FDA approved for daily use (100% dosing) at the time of study initiation- no arm was considered to be more at risk for AEs than another.
|
Additional Information
Dr. Peter Anderson
University of Colorado | Skaggs School of Pharmacy and Pharmaceutical Sciences
Phone: 3037246128
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place