Trial Outcomes & Findings for Assessment of a New "Boosting" Strategy for HIV Pre-exposure Prophylaxis in Healthy Volunteers (NCT NCT03202511)
NCT ID: NCT03202511
Last Updated: 2021-05-07
Results Overview
The geometric mean ratio (GMR) of the plasma TFV area under the curve (AUC) comparing the test phase (T) to control phase (C) was assessed. PK samples were collected from 0 to 72 hours post-dose.
Recruitment status
COMPLETED
Study phase
EARLY_PHASE1
Target enrollment
15 participants
Primary outcome timeframe
The first 72 hours of each phase.
Results posted on
2021-05-07
Participant Flow
Participant milestones
| Measure |
Treatment TDF/FTC+PRO Dose First, Then Control TDF/FTC
Participants received the treatment phase of 600/400 mg oral TDF/FTC along with a 2 gram oral PRO on day 1, 2-week washout, then the control phase of 600/400 mg oral TDF/FTC on day 1 followed by 300/200 mg oral TDF/FTC on days 2 and 3.
|
Control TDF/FTC First, Then Treatment TDF/FTC+PRO Dose
Participants received the control phase of 600/400 mg oral TDF/FTC on day 1 followed by 300/200 mg oral TDF/FTC on days 2 and 3, 2-week washout, then the treatment phase of 600/400 mg oral TDF/FTC along with a 2 gram oral PRO on day 1.
|
|---|---|---|
|
Overall Study
STARTED
|
8
|
7
|
|
Overall Study
COMPLETED
|
7
|
7
|
|
Overall Study
NOT COMPLETED
|
1
|
0
|
Reasons for withdrawal
| Measure |
Treatment TDF/FTC+PRO Dose First, Then Control TDF/FTC
Participants received the treatment phase of 600/400 mg oral TDF/FTC along with a 2 gram oral PRO on day 1, 2-week washout, then the control phase of 600/400 mg oral TDF/FTC on day 1 followed by 300/200 mg oral TDF/FTC on days 2 and 3.
|
Control TDF/FTC First, Then Treatment TDF/FTC+PRO Dose
Participants received the control phase of 600/400 mg oral TDF/FTC on day 1 followed by 300/200 mg oral TDF/FTC on days 2 and 3, 2-week washout, then the treatment phase of 600/400 mg oral TDF/FTC along with a 2 gram oral PRO on day 1.
|
|---|---|---|
|
Overall Study
Withdrawal by Subject
|
1
|
0
|
Baseline Characteristics
Assessment of a New "Boosting" Strategy for HIV Pre-exposure Prophylaxis in Healthy Volunteers
Baseline characteristics by cohort
| Measure |
All Study Participants
n=15 Participants
All participants received control and/or treatment phase
The control phase will consist of subjects taking 600/400 mg oral tenofovir disoproxil fumarate/emtricitabine (TDF/FTC) on day 1 (2 tablets) followed by 300/200 mg (1 tablet) doses on days 2 and 3.
The treatment phase will consist of subjects taking 600/400 mg oral tenofovir disoproxil fumarate/emtricitabine (TDF/FTC) (2 tablets) along with a 2 gram oral probenecid (PRO) dose (4 tablets, 500 mg each) on day 1.
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
15 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
|
Age, Continuous
|
26 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
15 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
10 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
15 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: The first 72 hours of each phase.Population: Primary result was performed for geometric mean ratio of treatment phase to control phase.
The geometric mean ratio (GMR) of the plasma TFV area under the curve (AUC) comparing the test phase (T) to control phase (C) was assessed. PK samples were collected from 0 to 72 hours post-dose.
Outcome measures
| Measure |
Treatment Phase
n=14 Participants
The treatment phase will consist of subjects taking 600/400 mg oral TDF/FTC along with a 2 gram oral PRO dose on day 1.
|
Control Phase
n=14 Participants
The control phase will consist of subjects taking 600/400 mg oral TDF/FTC on day 1 followed by 300/200 mg TDF/FTC on days 2 and 3.
|
|---|---|---|
|
Plasma TFV AUC0-INF GMR
|
8.75 ng*h/mL
Interval 8.66 to 8.84
|
8.27 ng*h/mL
Interval 8.18 to 8.36
|
PRIMARY outcome
Timeframe: The first 72 hours of each phase.The geometric mean ratio (GMR) of the PBMC TFV-DP area under the curve (AUC) comparing the test phase (T) to control phase (C) was assessed. PK samples were collected from 0 to 72 hours post-dose.
Outcome measures
| Measure |
Treatment Phase
n=14 Participants
The treatment phase will consist of subjects taking 600/400 mg oral TDF/FTC along with a 2 gram oral PRO dose on day 1.
|
Control Phase
n=14 Participants
The control phase will consist of subjects taking 600/400 mg oral TDF/FTC on day 1 followed by 300/200 mg TDF/FTC on days 2 and 3.
|
|---|---|---|
|
PBMC TFV-DP AUC GMR
|
7.12 fmol*h/10^6cells
Interval 6.96 to 7.29
|
7.38 fmol*h/10^6cells
Interval 7.22 to 7.54
|
Adverse Events
Control Phase
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Treatment Phase
Serious events: 0 serious events
Other events: 8 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Control Phase
n=14 participants at risk
The control phase consisted of subjects taking 600/400 mg oral TDF/FTC on day 1 followed by 300/200 mg TDF/FTC on days 2 and 3.
|
Treatment Phase
n=15 participants at risk
The treatment phase consisted of subjects taking 600/400 mg oral TDF/FTC followed by 2 gram oral PRO on day 1.
|
|---|---|---|
|
Gastrointestinal disorders
Nausea, vomiting, or GERD
|
14.3%
2/14 • Number of events 2 • Adverse events were collected over 1 year during study conduction.
All adverse events reported from participant were included and graded for severity by the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE). Adverse events were reviewed per patient by treatment and was not separated individually.
|
53.3%
8/15 • Number of events 8 • Adverse events were collected over 1 year during study conduction.
All adverse events reported from participant were included and graded for severity by the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE). Adverse events were reviewed per patient by treatment and was not separated individually.
|
|
Nervous system disorders
Headache or loss of appetite
|
14.3%
2/14 • Number of events 2 • Adverse events were collected over 1 year during study conduction.
All adverse events reported from participant were included and graded for severity by the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE). Adverse events were reviewed per patient by treatment and was not separated individually.
|
33.3%
5/15 • Number of events 5 • Adverse events were collected over 1 year during study conduction.
All adverse events reported from participant were included and graded for severity by the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE). Adverse events were reviewed per patient by treatment and was not separated individually.
|
|
Blood and lymphatic system disorders
Nose bleed
|
0.00%
0/14 • Adverse events were collected over 1 year during study conduction.
All adverse events reported from participant were included and graded for severity by the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE). Adverse events were reviewed per patient by treatment and was not separated individually.
|
6.7%
1/15 • Number of events 1 • Adverse events were collected over 1 year during study conduction.
All adverse events reported from participant were included and graded for severity by the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE). Adverse events were reviewed per patient by treatment and was not separated individually.
|
Additional Information
Dr. Zeruesenay Desta
Division of Clinical Pharmacology, School of Medicine, Indiana University
Phone: 317-274-2823
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place