Trial Outcomes & Findings for Biomarkers for Event-driven PrEP Adherence (NCT NCT04298697)
NCT ID: NCT04298697
Last Updated: 2024-09-19
Results Overview
Concentration of TFV-DP was measured 24 hours after the last dose to compare accumulation of drug following weekly event-driven PrEP (ED-PrEP) dosing. Dried blood spot samples were collected from participants using a 6 millimeter (mm) dried blood spot card punch system.
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
43 participants
Primary outcome timeframe
24 Hours After Last Dose (Week 1 for Arm A, Week 13 for Arms B, C, and D)
Results posted on
2024-09-19
Participant Flow
Participants were recruited from the Hope Clinic in Atlanta, Georgia, USA. Participant enrollment began February 28, 2020 and all follow-up assessments were completed by August 9, 2022.
Participant milestones
| Measure |
Tenofovir Disoproxil Fumarate/Emtricitabine (TDF/FTC) for 1 Week
The first 10 participants (Arm A) were assigned to take TDF/FTC for three consecutive days of one week, taking 2 pills on the first day and one pill on the second and third day, for a total of 4 doses.
TDF/FTC is a combination anti-HIV medication that contains the drugs tenofovir disoproxil fumarate (300 mg) and emtricitabine (200 mg). Participants took 2 pills on the first day of the week and one pill per day on the second and third days of the week, according to the dosing schedule of the study arm they were in. Participants had biologic specimens collected at specific time points until 28 days after the last dose.
|
TDF/FTC for 13 Weeks
The second 10 participants (Arm B) were assigned to take TDF/FTC for three consecutive days for thirteen weeks, taking 2 pills on the first day and one pill on the second and third day of each week, for a total of 52 doses.
TDF/FTC is a combination anti-HIV medication that contains the drugs tenofovir disoproxil fumarate (300 mg) and emtricitabine (200 mg). Participants took 2 pills on the first day of the week and one pill per day on the second and third days of the week, according to the dosing schedule of the study arm they were in. Participants had biologic specimens collected at specific time points until 28 days after the last dose.
|
TDF/FTC for 13 Weeks With Weekly Alternating Schedule
The third 10 participants (Arm C) were assigned to take TDF/FTC for three consecutive days, alternating weeks over a 13-week period, taking 2 pills on the first day and one pill on the second and third day of each dosing week, for a total of 28 doses.
TDF/FTC is a combination anti-HIV medication that contains the drugs tenofovir disoproxil fumarate (300 mg) and emtricitabine (200 mg). Participants took 2 pills on the first day of the week and one pill per day on the second and third days of the week, according to the dosing schedule of the study arm they were in. Participants had biologic specimens collected at specific time points until 28 days after the last dose.
|
TDF/FTC for 13 Weeks With Weekly Alternating Schedule Every Two Weeks
The fourth 10 participants (Arm D) were assigned to take TDF/FTC for three consecutive days over a 13-week period, alternating two weeks of study medication followed by two weeks with no medication, taking 2 pills on the first day and one pill on the second and third day of dosing each week, for a total of 28 doses.
TDF/FTC is a combination anti-HIV medication that contains the drugs tenofovir disoproxil fumarate (300 mg) and emtricitabine (200 mg). Participants took 2 pills on the first day of the week and one pill per day on the second and third days of the week, according to the dosing schedule of the study arm they were in. Participants had biologic specimens collected at specific time points until 28 days after the last dose.
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
15
|
17
|
6
|
5
|
|
Overall Study
COMPLETED
|
10
|
9
|
3
|
2
|
|
Overall Study
NOT COMPLETED
|
5
|
8
|
3
|
3
|
Reasons for withdrawal
| Measure |
Tenofovir Disoproxil Fumarate/Emtricitabine (TDF/FTC) for 1 Week
The first 10 participants (Arm A) were assigned to take TDF/FTC for three consecutive days of one week, taking 2 pills on the first day and one pill on the second and third day, for a total of 4 doses.
TDF/FTC is a combination anti-HIV medication that contains the drugs tenofovir disoproxil fumarate (300 mg) and emtricitabine (200 mg). Participants took 2 pills on the first day of the week and one pill per day on the second and third days of the week, according to the dosing schedule of the study arm they were in. Participants had biologic specimens collected at specific time points until 28 days after the last dose.
|
TDF/FTC for 13 Weeks
The second 10 participants (Arm B) were assigned to take TDF/FTC for three consecutive days for thirteen weeks, taking 2 pills on the first day and one pill on the second and third day of each week, for a total of 52 doses.
TDF/FTC is a combination anti-HIV medication that contains the drugs tenofovir disoproxil fumarate (300 mg) and emtricitabine (200 mg). Participants took 2 pills on the first day of the week and one pill per day on the second and third days of the week, according to the dosing schedule of the study arm they were in. Participants had biologic specimens collected at specific time points until 28 days after the last dose.
|
TDF/FTC for 13 Weeks With Weekly Alternating Schedule
The third 10 participants (Arm C) were assigned to take TDF/FTC for three consecutive days, alternating weeks over a 13-week period, taking 2 pills on the first day and one pill on the second and third day of each dosing week, for a total of 28 doses.
TDF/FTC is a combination anti-HIV medication that contains the drugs tenofovir disoproxil fumarate (300 mg) and emtricitabine (200 mg). Participants took 2 pills on the first day of the week and one pill per day on the second and third days of the week, according to the dosing schedule of the study arm they were in. Participants had biologic specimens collected at specific time points until 28 days after the last dose.
|
TDF/FTC for 13 Weeks With Weekly Alternating Schedule Every Two Weeks
The fourth 10 participants (Arm D) were assigned to take TDF/FTC for three consecutive days over a 13-week period, alternating two weeks of study medication followed by two weeks with no medication, taking 2 pills on the first day and one pill on the second and third day of dosing each week, for a total of 28 doses.
TDF/FTC is a combination anti-HIV medication that contains the drugs tenofovir disoproxil fumarate (300 mg) and emtricitabine (200 mg). Participants took 2 pills on the first day of the week and one pill per day on the second and third days of the week, according to the dosing schedule of the study arm they were in. Participants had biologic specimens collected at specific time points until 28 days after the last dose.
|
|---|---|---|---|---|
|
Overall Study
Lost to Follow-up
|
5
|
5
|
1
|
0
|
|
Overall Study
Withdrawal by Subject
|
0
|
3
|
2
|
3
|
Baseline Characteristics
Biomarkers for Event-driven PrEP Adherence
Baseline characteristics by cohort
| Measure |
TDF/FTC for 1 Week
n=15 Participants
The first 10 participants (Arm A) were assigned to take TDF/FTC for three consecutive days of one week, taking 2 pills on the first day and one pill on the second and third day, for a total of 4 doses.
|
TDF/FTC for 13 Weeks
n=17 Participants
The second 10 participants (Arm B) were assigned to take TDF/FTC for three consecutive days for thirteen weeks, taking 2 pills on the first day and one pill on the second and third day of each week, for a total of 52 doses.
|
TDF/FTC for 13 Weeks With Weekly Alternating Schedule
n=6 Participants
The third 10 participants (Arm C) were assigned to take TDF/FTC for three consecutive days, alternating weeks over a 13-week period, taking 2 pills on the first day and one pill on the second and third day of each dosing week, for a total of 28 doses.
|
TDF/FTC for 13 Weeks With Weekly Alternating Schedule Every Two Weeks
n=5 Participants
The fourth 10 participants (Arm D) were assigned to take TDF/FTC for three consecutive days over a 13-week period, alternating two weeks of study medication followed by two weeks with no medication, taking 2 pills on the first day and one pill on the second and third day of dosing each week, for a total of 28 doses.
|
Total
n=43 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
|
0 Participants
n=21 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
15 Participants
n=5 Participants
|
17 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
5 Participants
n=4 Participants
|
43 Participants
n=21 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Age, Continuous
|
29.5 years
STANDARD_DEVIATION 7.3 • n=5 Participants
|
34.6 years
STANDARD_DEVIATION 9.3 • n=7 Participants
|
33.2 years
STANDARD_DEVIATION 11.8 • n=5 Participants
|
29.0 years
STANDARD_DEVIATION 14.2 • n=4 Participants
|
32.0 years
STANDARD_DEVIATION 9.6 • n=21 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
15 Participants
n=5 Participants
|
17 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
5 Participants
n=4 Participants
|
43 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
3 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
7 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
12 Participants
n=5 Participants
|
14 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
4 Participants
n=4 Participants
|
36 Participants
n=21 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
|
0 Participants
n=21 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
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=21 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
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Black or African American
|
7 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
17 Participants
n=21 Participants
|
|
Race (NIH/OMB)
White
|
7 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
22 Participants
n=21 Participants
|
|
Race (NIH/OMB)
More than one race
|
1 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
3 Participants
n=21 Participants
|
|
Race (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
|
0 Participants
n=21 Participants
|
|
Region of Enrollment
United States
|
15 Participants
n=5 Participants
|
17 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
5 Participants
n=4 Participants
|
43 Participants
n=21 Participants
|
PRIMARY outcome
Timeframe: 24 Hours After Last Dose (Week 1 for Arm A, Week 13 for Arms B, C, and D)Population: This analysis includes participants who attended the study visit that occurred 24 hours after the last dose of study medication and consistently took the study medication. Three participants in Arm B, assigned to take TDF/FTC for 13 weeks, stopped dosing early or had missed doses and were not included in this analysis since they may not have achieved steady-state drug levels as intended.
Concentration of TFV-DP was measured 24 hours after the last dose to compare accumulation of drug following weekly event-driven PrEP (ED-PrEP) dosing. Dried blood spot samples were collected from participants using a 6 millimeter (mm) dried blood spot card punch system.
Outcome measures
| Measure |
TDF/FTC for 1 Week
n=10 Participants
The first 10 participants (Arm A) were assigned to take TDF/FTC for three consecutive days of one week, taking 2 pills on the first day and one pill on the second and third day, for a total of 4 doses.
|
TDF/FTC for 13 Weeks
n=6 Participants
The second 10 participants (Arm B) were assigned to take TDF/FTC for three consecutive days for thirteen weeks, taking 2 pills on the first day and one pill on the second and third day of each week, for a total of 52 doses.
|
TDF/FTC for 13 Weeks With Weekly Alternating Schedule
n=3 Participants
The third 10 participants (Arm C) were assigned to take TDF/FTC for three consecutive days, alternating weeks over a 13-week period, taking 2 pills on the first day and one pill on the second and third day of each dosing week, for a total of 28 doses.
|
TDF/FTC for 13 Weeks With Weekly Alternating Schedule Every Two Weeks
n=2 Participants
The fourth 10 participants (Arm D) were assigned to take TDF/FTC for three consecutive days over a 13-week period, alternating two weeks of study medication followed by two weeks with no medication, taking 2 pills on the first day and one pill on the second and third day of dosing each week, for a total of 28 doses.
|
|---|---|---|---|---|
|
Tenofovir-diphosphate (TFV-DP) Concentration
|
217 femtomoles
Interval 154.0 to 267.0
|
1041 femtomoles
Interval 540.0 to 1241.0
|
578 femtomoles
Interval 450.0 to 1240.0
|
789 femtomoles
Interval 261.0 to 1317.0
|
Adverse Events
TDF/FTC for 1 Week
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
TDF/FTC for 13 Weeks
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
TDF/FTC for 13 Weeks With Weekly Alternating Schedule
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
TDF/FTC for 13 Weeks With Weekly Alternating Schedule Every Two Weeks
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