Trial Outcomes & Findings for Body Compartment PK for New HIV Pre-exposure Prophylaxis Modalities (NCT NCT02985996)
NCT ID: NCT02985996
Last Updated: 2019-09-17
Results Overview
Intracellular emtricitabine triphosphate (FTC-TP) is measured and compared from blood specimen in both arms from baseline to visit 4. For the pharmacokinetic analysis, values reported as "Below the Limit of Quantification" (BLOQ) are assigned a value of zero if it occurs in a profile after dosing at time zero and before the first measurable concentration.
COMPLETED
PHASE1
48 participants
Baseline, Visit 4 (Up to ten days post drug)
2019-09-17
Participant Flow
24 participants were recruited in Phase II, but only 18 were randomized to either Genvoya or Truvada due to lost to follow up. 19 participants were recruited in Phase III, but only 16 were randomized to either Genvoya or Truvada due to lost to follow up.
Participant milestones
| Measure |
Phase I/Pre-Drug
Participants will be asked to complete study phase 1. Participants will be asked to provide blood and urine samples and undergo penile, urethral, and rectal swabs. Up to 12 rectal biopsies will be taken.
|
Phase II/Genvoya
Participants will receive one dose Genvoya. Participants will be asked to provide blood and urine samples and undergo penile, urethral, and rectal swabs. Up to 12 rectal biopsies will be taken.
|
Phase II/Truvada
Participants will receive one dose of Truvada. Participants will be asked to provide blood and urine samples and undergo penile, urethral, and rectal swabs. Up to 12 rectal biopsies will be taken.
|
Phase III/Genvoya
Participants will receive Genvoya once daily for ten days. Participants will be asked to provide blood and urine samples and undergo penile, urethral, and rectal swabs. Up to 12 rectal biopsies will be taken.
|
Phase III/Truvada
Participants will receive Truvada once daily for ten days. Participants will be asked to provide blood and urine samples and undergo penile, urethral, and rectal swabs. Up to 12 rectal biopsies will be taken.
|
|---|---|---|---|---|---|
|
Overall Study
STARTED
|
5
|
8
|
10
|
7
|
9
|
|
Overall Study
COMPLETED
|
5
|
7
|
9
|
7
|
9
|
|
Overall Study
NOT COMPLETED
|
0
|
1
|
1
|
0
|
0
|
Reasons for withdrawal
| Measure |
Phase I/Pre-Drug
Participants will be asked to complete study phase 1. Participants will be asked to provide blood and urine samples and undergo penile, urethral, and rectal swabs. Up to 12 rectal biopsies will be taken.
|
Phase II/Genvoya
Participants will receive one dose Genvoya. Participants will be asked to provide blood and urine samples and undergo penile, urethral, and rectal swabs. Up to 12 rectal biopsies will be taken.
|
Phase II/Truvada
Participants will receive one dose of Truvada. Participants will be asked to provide blood and urine samples and undergo penile, urethral, and rectal swabs. Up to 12 rectal biopsies will be taken.
|
Phase III/Genvoya
Participants will receive Genvoya once daily for ten days. Participants will be asked to provide blood and urine samples and undergo penile, urethral, and rectal swabs. Up to 12 rectal biopsies will be taken.
|
Phase III/Truvada
Participants will receive Truvada once daily for ten days. Participants will be asked to provide blood and urine samples and undergo penile, urethral, and rectal swabs. Up to 12 rectal biopsies will be taken.
|
|---|---|---|---|---|---|
|
Overall Study
Withdrawal by Subject
|
0
|
0
|
1
|
0
|
0
|
|
Overall Study
Protocol Violation
|
0
|
1
|
0
|
0
|
0
|
Baseline Characteristics
Body Compartment PK for New HIV Pre-exposure Prophylaxis Modalities
Baseline characteristics by cohort
| Measure |
Phase I/Pre-Drug
n=5 Participants
Participants will be asked to provide blood and urine samples and undergo penile, urethral, and rectal swabs. Up to 12 rectal biopsies will be taken.
|
Phase II/Genvoya
n=8 Participants
Participants will receive one dose Genvoya. Participants will be asked to provide blood and urine samples and undergo penile, urethral, and rectal swabs. Up to 12 rectal biopsies will be taken.
|
Phase II/Truvada
n=10 Participants
Experimental: Phase II/Truvada Participants will receive one dose of Truvada. Participants will be asked to provide blood and urine samples and undergo penile, urethral, and rectal swabs. Up to 12 rectal biopsies will be taken.
|
Phase III/Genvoya
n=7 Participants
Participants will receive Genvoya once daily for ten days. Participants will be asked to provide blood and urine samples and undergo penile, urethral, and rectal swabs. Up to 12 rectal biopsies will be taken.
|
Phase III/Truvada
n=9 Participants
Participants will receive Truvada once daily for ten days. Participants will be asked to provide blood and urine samples and undergo penile, urethral, and rectal swabs. Up to 12 rectal biopsies will be taken.
|
Total
n=39 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
0 Participants
n=31 Participants
|
0 Participants
n=146 Participants
|
0 Participants
n=19 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
5 Participants
n=39 Participants
|
8 Participants
n=41 Participants
|
10 Participants
n=35 Participants
|
7 Participants
n=31 Participants
|
9 Participants
n=146 Participants
|
39 Participants
n=19 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
0 Participants
n=31 Participants
|
0 Participants
n=146 Participants
|
0 Participants
n=19 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
0 Participants
n=31 Participants
|
0 Participants
n=146 Participants
|
0 Participants
n=19 Participants
|
|
Sex: Female, Male
Male
|
5 Participants
n=39 Participants
|
8 Participants
n=41 Participants
|
10 Participants
n=35 Participants
|
7 Participants
n=31 Participants
|
9 Participants
n=146 Participants
|
39 Participants
n=19 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
0 Participants
n=31 Participants
|
0 Participants
n=146 Participants
|
0 Participants
n=19 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
0 Participants
n=31 Participants
|
0 Participants
n=146 Participants
|
0 Participants
n=19 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
0 Participants
n=31 Participants
|
0 Participants
n=146 Participants
|
0 Participants
n=19 Participants
|
|
Race (NIH/OMB)
Black or African American
|
2 Participants
n=39 Participants
|
3 Participants
n=41 Participants
|
7 Participants
n=35 Participants
|
6 Participants
n=31 Participants
|
4 Participants
n=146 Participants
|
22 Participants
n=19 Participants
|
|
Race (NIH/OMB)
White
|
3 Participants
n=39 Participants
|
5 Participants
n=41 Participants
|
2 Participants
n=35 Participants
|
1 Participants
n=31 Participants
|
4 Participants
n=146 Participants
|
15 Participants
n=19 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
1 Participants
n=35 Participants
|
0 Participants
n=31 Participants
|
0 Participants
n=146 Participants
|
1 Participants
n=19 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
0 Participants
n=31 Participants
|
1 Participants
n=146 Participants
|
1 Participants
n=19 Participants
|
|
Region of Enrollment
United States
|
5 participants
n=39 Participants
|
8 participants
n=41 Participants
|
10 participants
n=35 Participants
|
7 participants
n=31 Participants
|
9 participants
n=146 Participants
|
39 participants
n=19 Participants
|
PRIMARY outcome
Timeframe: Baseline, Visit 4 (Up to ten days post drug)Intracellular emtricitabine triphosphate (FTC-TP) is measured and compared from blood specimen in both arms from baseline to visit 4. For the pharmacokinetic analysis, values reported as "Below the Limit of Quantification" (BLOQ) are assigned a value of zero if it occurs in a profile after dosing at time zero and before the first measurable concentration.
Outcome measures
| Measure |
Phase I/Pre-Drug
n=5 Participants
Participants will be asked to provide blood and urine samples and undergo penile, urethral, and rectal swabs. Up to 12 rectal biopsies will be taken.
|
Phase II/Genvoya
n=7 Participants
Participants will receive one dose Genvoya. Participants will be asked to provide blood and urine samples and undergo penile, urethral, and rectal swabs. Up to 12 rectal biopsies will be taken.
|
Phase II/Truvada
n=9 Participants
Participants will receive one dose of Truvada. Participants will be asked to provide blood and urine samples and undergo penile, urethral, and rectal swabs. Up to 12 rectal biopsies will be taken.
|
Phase III/Genvoya
n=7 Participants
Participants will receive Genvoya once daily for ten days. Participants will be asked to provide blood and urine samples and undergo penile, urethral, and rectal swabs. Up to 12 rectal biopsies will be taken.
|
Phase III/Truvada
n=9 Participants
Participants will receive Truvada once daily for ten days. Participants will be asked to provide blood and urine samples and undergo penile, urethral, and rectal swabs. Up to 12 rectal biopsies will be taken.
|
|---|---|---|---|---|---|
|
Changes in Intracellular Emtricitabine Triphosphate (FTC-TP)
|
0 fmol/1000000 PBMC
Interval 0.0 to 0.0
|
3380 fmol/1000000 PBMC
Interval 2091.0 to 4320.0
|
2580 fmol/1000000 PBMC
Interval 1531.0 to 5340.0
|
6470 fmol/1000000 PBMC
Interval 3030.0 to
|
7660 fmol/1000000 PBMC
Interval 3170.0 to
|
PRIMARY outcome
Timeframe: Baseline, Visit 4 (Up to ten days post drug)Intracellular tenofovir diphosphate (TFV-DP) is measured and compared from blood specimen in both arms from baseline to visit 4. For the pharmacokinetic analysis, values reported as "Below the Limit of Quantification" (BLOQ) are assigned a value of zero if it occurs in a profile after dosing at time zero and before the first measurable concentration.
Outcome measures
| Measure |
Phase I/Pre-Drug
n=5 Participants
Participants will be asked to provide blood and urine samples and undergo penile, urethral, and rectal swabs. Up to 12 rectal biopsies will be taken.
|
Phase II/Genvoya
n=7 Participants
Participants will receive one dose Genvoya. Participants will be asked to provide blood and urine samples and undergo penile, urethral, and rectal swabs. Up to 12 rectal biopsies will be taken.
|
Phase II/Truvada
n=9 Participants
Participants will receive one dose of Truvada. Participants will be asked to provide blood and urine samples and undergo penile, urethral, and rectal swabs. Up to 12 rectal biopsies will be taken.
|
Phase III/Genvoya
n=7 Participants
Participants will receive Genvoya once daily for ten days. Participants will be asked to provide blood and urine samples and undergo penile, urethral, and rectal swabs. Up to 12 rectal biopsies will be taken.
|
Phase III/Truvada
n=9 Participants
Participants will receive Truvada once daily for ten days. Participants will be asked to provide blood and urine samples and undergo penile, urethral, and rectal swabs. Up to 12 rectal biopsies will be taken.
|
|---|---|---|---|---|---|
|
Changes in Intracellular Tenofovir Diphosphate (TFV-DP)
|
0 fmol/1000000 PBMC
Interval 0.0 to 0.0
|
213 fmol/1000000 PBMC
Interval 111.0 to 323.0
|
28 fmol/1000000 PBMC
Interval 0.0 to 32.0
|
453 fmol/1000000 PBMC
Interval 138.0 to 897.0
|
80 fmol/1000000 PBMC
Interval 0.0 to 156.0
|
SECONDARY outcome
Timeframe: Baseline, Visit 4 (Up to ten days post drug)Plasma emtricitabine (FTC) concentration is measured from blood specimen. For the pharmacokinetic analysis, values reported as "Below the Limit of Quantification" (BLOQ) are assigned a value of zero if it occurs in a profile after dosing at time zero and before the first measurable concentration.
Outcome measures
| Measure |
Phase I/Pre-Drug
n=5 Participants
Participants will be asked to provide blood and urine samples and undergo penile, urethral, and rectal swabs. Up to 12 rectal biopsies will be taken.
|
Phase II/Genvoya
n=7 Participants
Participants will receive one dose Genvoya. Participants will be asked to provide blood and urine samples and undergo penile, urethral, and rectal swabs. Up to 12 rectal biopsies will be taken.
|
Phase II/Truvada
n=9 Participants
Participants will receive one dose of Truvada. Participants will be asked to provide blood and urine samples and undergo penile, urethral, and rectal swabs. Up to 12 rectal biopsies will be taken.
|
Phase III/Genvoya
n=7 Participants
Participants will receive Genvoya once daily for ten days. Participants will be asked to provide blood and urine samples and undergo penile, urethral, and rectal swabs. Up to 12 rectal biopsies will be taken.
|
Phase III/Truvada
n=9 Participants
Participants will receive Truvada once daily for ten days. Participants will be asked to provide blood and urine samples and undergo penile, urethral, and rectal swabs. Up to 12 rectal biopsies will be taken.
|
|---|---|---|---|---|---|
|
Change in Plasma Emtricitabine (FTC) Concentration
|
0 ng/mL
Interval 0.0 to 0.0
|
30 ng/mL
Interval 12.0 to 46.0
|
34 ng/mL
Interval 20.0 to 206.0
|
152 ng/mL
Interval 31.0 to 613.0
|
280 ng/mL
Interval 66.0 to 518.0
|
SECONDARY outcome
Timeframe: Baseline, Visit 4 (Up to ten days post drug)Plasma tenofovir disoproxil fumarate (TDF) concentration is measured from blood specimen. For the pharmacokinetic analysis, values reported as "Below the Limit of Quantification" (BLOQ) are assigned a value of zero if it occurs in a profile after dosing at time zero and before the first measurable concentration.
Outcome measures
| Measure |
Phase I/Pre-Drug
n=5 Participants
Participants will be asked to provide blood and urine samples and undergo penile, urethral, and rectal swabs. Up to 12 rectal biopsies will be taken.
|
Phase II/Genvoya
n=7 Participants
Participants will receive one dose Genvoya. Participants will be asked to provide blood and urine samples and undergo penile, urethral, and rectal swabs. Up to 12 rectal biopsies will be taken.
|
Phase II/Truvada
n=9 Participants
Participants will receive one dose of Truvada. Participants will be asked to provide blood and urine samples and undergo penile, urethral, and rectal swabs. Up to 12 rectal biopsies will be taken.
|
Phase III/Genvoya
n=7 Participants
Participants will receive Genvoya once daily for ten days. Participants will be asked to provide blood and urine samples and undergo penile, urethral, and rectal swabs. Up to 12 rectal biopsies will be taken.
|
Phase III/Truvada
n=9 Participants
Participants will receive Truvada once daily for ten days. Participants will be asked to provide blood and urine samples and undergo penile, urethral, and rectal swabs. Up to 12 rectal biopsies will be taken.
|
|---|---|---|---|---|---|
|
Change in Plasma Tenofovir Disoproxil Fumarate (TDF) Concentration
|
0 ng/mL
Interval 0.0 to 0.0
|
0 ng/mL
Interval 0.0 to 0.0
|
28 ng/mL
Interval 20.0 to 59.0
|
0 ng/mL
Interval 0.0 to 0.0
|
59 ng/mL
Interval 38.0 to 89.0
|
SECONDARY outcome
Timeframe: Baseline, Visit 4 (Up to ten days post drug)Population: TAF was not measured, only the metabolite TFV was measured
Plasma tenofovir alafenamide (TAF) concentration is measured from blood specimen. For the pharmacokinetic analysis, values reported as "Below the Limit of Quantification" (BLOQ) are assigned a value of zero if it occurs in a profile after dosing at time zero and before the first measurable concentration.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline, Visit 4 (Up to ten days post drug)Plasma elvitegravir (EVG) concentration is measured from blood specimen. For the pharmacokinetic analysis, values reported as "Below the Limit of Quantification" (BLOQ) are assigned a value of zero if it occurs in a profile after dosing at time zero and before the first measurable concentration.
Outcome measures
| Measure |
Phase I/Pre-Drug
n=5 Participants
Participants will be asked to provide blood and urine samples and undergo penile, urethral, and rectal swabs. Up to 12 rectal biopsies will be taken.
|
Phase II/Genvoya
n=7 Participants
Participants will receive one dose Genvoya. Participants will be asked to provide blood and urine samples and undergo penile, urethral, and rectal swabs. Up to 12 rectal biopsies will be taken.
|
Phase II/Truvada
n=9 Participants
Participants will receive one dose of Truvada. Participants will be asked to provide blood and urine samples and undergo penile, urethral, and rectal swabs. Up to 12 rectal biopsies will be taken.
|
Phase III/Genvoya
n=7 Participants
Participants will receive Genvoya once daily for ten days. Participants will be asked to provide blood and urine samples and undergo penile, urethral, and rectal swabs. Up to 12 rectal biopsies will be taken.
|
Phase III/Truvada
n=9 Participants
Participants will receive Truvada once daily for ten days. Participants will be asked to provide blood and urine samples and undergo penile, urethral, and rectal swabs. Up to 12 rectal biopsies will be taken.
|
|---|---|---|---|---|---|
|
Change in Plasma Elvitegravir (EVG) Concentration
|
0 ng/mL
Interval 0.0 to 0.0
|
102 ng/mL
Interval 0.0 to 295.0
|
0 ng/mL
Interval 0.0 to 0.0
|
384 ng/mL
Interval 99.0 to 705.0
|
0 ng/mL
Interval 0.0 to 0.0
|
SECONDARY outcome
Timeframe: Baseline, Visit 4 (Up to ten days post drug)Emtricitabine (FTC) concentration is measured from rectal secretion specimen. For the pharmacokinetic analysis, values reported as "Below the Limit of Quantification" (BLOQ) are assigned a value of zero if it occurs in a profile after dosing at time zero and before the first measurable concentration.
Outcome measures
| Measure |
Phase I/Pre-Drug
n=5 Participants
Participants will be asked to provide blood and urine samples and undergo penile, urethral, and rectal swabs. Up to 12 rectal biopsies will be taken.
|
Phase II/Genvoya
n=7 Participants
Participants will receive one dose Genvoya. Participants will be asked to provide blood and urine samples and undergo penile, urethral, and rectal swabs. Up to 12 rectal biopsies will be taken.
|
Phase II/Truvada
n=9 Participants
Participants will receive one dose of Truvada. Participants will be asked to provide blood and urine samples and undergo penile, urethral, and rectal swabs. Up to 12 rectal biopsies will be taken.
|
Phase III/Genvoya
n=7 Participants
Participants will receive Genvoya once daily for ten days. Participants will be asked to provide blood and urine samples and undergo penile, urethral, and rectal swabs. Up to 12 rectal biopsies will be taken.
|
Phase III/Truvada
n=9 Participants
Participants will receive Truvada once daily for ten days. Participants will be asked to provide blood and urine samples and undergo penile, urethral, and rectal swabs. Up to 12 rectal biopsies will be taken.
|
|---|---|---|---|---|---|
|
Change in Rectal Emtricitabine (FTC) Concentration
|
0 ng/swab
Interval 0.0 to 0.0
|
288 ng/swab
Interval 0.0 to
|
419 ng/swab
Interval 64.0 to 6935.0
|
371 ng/swab
Interval 0.0 to 3830.0
|
109 ng/swab
Interval 0.0 to 3900.0
|
SECONDARY outcome
Timeframe: Baseline, Visit 4 (Up to ten days post drug)Tenofovir disoproxil fumarate (TDF), concentration is measured from rectal secretion specimen. For the pharmacokinetic analysis, values reported as "Below the Limit of Quantification" (BLOQ) are assigned a value of zero if it occurs in a profile after dosing at time zero and before the first measurable concentration.
Outcome measures
| Measure |
Phase I/Pre-Drug
n=5 Participants
Participants will be asked to provide blood and urine samples and undergo penile, urethral, and rectal swabs. Up to 12 rectal biopsies will be taken.
|
Phase II/Genvoya
n=7 Participants
Participants will receive one dose Genvoya. Participants will be asked to provide blood and urine samples and undergo penile, urethral, and rectal swabs. Up to 12 rectal biopsies will be taken.
|
Phase II/Truvada
n=9 Participants
Participants will receive one dose of Truvada. Participants will be asked to provide blood and urine samples and undergo penile, urethral, and rectal swabs. Up to 12 rectal biopsies will be taken.
|
Phase III/Genvoya
n=7 Participants
Participants will receive Genvoya once daily for ten days. Participants will be asked to provide blood and urine samples and undergo penile, urethral, and rectal swabs. Up to 12 rectal biopsies will be taken.
|
Phase III/Truvada
n=9 Participants
Participants will receive Truvada once daily for ten days. Participants will be asked to provide blood and urine samples and undergo penile, urethral, and rectal swabs. Up to 12 rectal biopsies will be taken.
|
|---|---|---|---|---|---|
|
Change in Rectal Tenofovir Disoproxil Fumarate (TDF) Concentration
|
0 ng/swab
Interval 0.0 to 0.0
|
58 ng/swab
Interval 0.0 to 1195.0
|
45 ng/swab
Interval 0.0 to 263.0
|
533 ng/swab
Interval 0.0 to
|
1325 ng/swab
Interval 0.0 to 6145.0
|
SECONDARY outcome
Timeframe: Baseline, Visit 4 (Up to ten days post drug)Population: The study didn't measure TAF, only the metabolite TFV
Tenofovir alafenamide (TAF) concentration is measured from rectal secretion specimen. For the pharmacokinetic analysis, values reported as "Below the Limit of Quantification" (BLOQ) are assigned a value of zero if it occurs in a profile after dosing at time zero and before the first measurable concentration.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline, Visit 4 (Up to ten days post drug)Elvitegravir (EVG) concentration is measured from rectal secretion specimen. For the pharmacokinetic analysis, values reported as "Below the Limit of Quantification" (BLOQ) are assigned a value of zero if it occurs in a profile after dosing at time zero and before the first measurable concentration.
Outcome measures
| Measure |
Phase I/Pre-Drug
n=5 Participants
Participants will be asked to provide blood and urine samples and undergo penile, urethral, and rectal swabs. Up to 12 rectal biopsies will be taken.
|
Phase II/Genvoya
n=7 Participants
Participants will receive one dose Genvoya. Participants will be asked to provide blood and urine samples and undergo penile, urethral, and rectal swabs. Up to 12 rectal biopsies will be taken.
|
Phase II/Truvada
n=9 Participants
Participants will receive one dose of Truvada. Participants will be asked to provide blood and urine samples and undergo penile, urethral, and rectal swabs. Up to 12 rectal biopsies will be taken.
|
Phase III/Genvoya
n=7 Participants
Participants will receive Genvoya once daily for ten days. Participants will be asked to provide blood and urine samples and undergo penile, urethral, and rectal swabs. Up to 12 rectal biopsies will be taken.
|
Phase III/Truvada
n=9 Participants
Participants will receive Truvada once daily for ten days. Participants will be asked to provide blood and urine samples and undergo penile, urethral, and rectal swabs. Up to 12 rectal biopsies will be taken.
|
|---|---|---|---|---|---|
|
Change in Rectal Elvitegravir (EVG) Concentration
|
0 ng/swab
Interval 0.0 to 0.0
|
405 ng/swab
Interval 55.0 to 7975.0
|
0 ng/swab
Interval 0.0 to 0.0
|
219 ng/swab
Interval 0.0 to
|
0 ng/swab
Interval 0.0 to 0.0
|
SECONDARY outcome
Timeframe: Baseline, Visit 4 (Up to ten days post drug)Population: The study didn't measure TAF, only the metabolite TFV
Intracellular tenofovir alafenamide (TAF) concentration is measured from isolated PBMCs collected via blood draw. For the pharmacokinetic analysis, values reported as "Below the Limit of Quantification" (BLOQ) are assigned a value of zero if it occurs in a profile after dosing at time zero and before the first measurable concentration.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline, Visit 4 (Up to ten days post drug)Population: EVG is very difficult to measure intracellularly, therefore the study only measured plasma or extracellular concentrations.
Intracellular elvitegravir (EVG) concentration is measured from isolated PBMCs collected via blood draw. For the pharmacokinetic analysis, values reported as "Below the Limit of Quantification" (BLOQ) are assigned a value of zero if it occurs in a profile after dosing at time zero and before the first measurable concentration.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline, Visit 4 (Up to ten days post drug)Tissue emtricitabine (FTC) concentration is measured from rectal biopsies and isolated cells. For the pharmacokinetic analysis, values reported as "Below the Limit of Quantification" (BLOQ) are assigned a value of zero if it occurs in a profile after dosing at time zero and before the first measurable concentration.
Outcome measures
| Measure |
Phase I/Pre-Drug
n=5 Participants
Participants will be asked to provide blood and urine samples and undergo penile, urethral, and rectal swabs. Up to 12 rectal biopsies will be taken.
|
Phase II/Genvoya
n=7 Participants
Participants will receive one dose Genvoya. Participants will be asked to provide blood and urine samples and undergo penile, urethral, and rectal swabs. Up to 12 rectal biopsies will be taken.
|
Phase II/Truvada
n=9 Participants
Participants will receive one dose of Truvada. Participants will be asked to provide blood and urine samples and undergo penile, urethral, and rectal swabs. Up to 12 rectal biopsies will be taken.
|
Phase III/Genvoya
n=7 Participants
Participants will receive Genvoya once daily for ten days. Participants will be asked to provide blood and urine samples and undergo penile, urethral, and rectal swabs. Up to 12 rectal biopsies will be taken.
|
Phase III/Truvada
n=9 Participants
Participants will receive Truvada once daily for ten days. Participants will be asked to provide blood and urine samples and undergo penile, urethral, and rectal swabs. Up to 12 rectal biopsies will be taken.
|
|---|---|---|---|---|---|
|
Change in Intracellular Emtricitabine (FTC) Concentration in Rectal Tissue
|
0 fmol/mg tissue
Interval 0.0 to 0.0
|
0 fmol/mg tissue
Interval 0.0 to 11.0
|
0 fmol/mg tissue
Interval 0.0 to 51.0
|
27 fmol/mg tissue
Interval 0.0 to 79.0
|
41 fmol/mg tissue
Interval 0.0 to 110.0
|
SECONDARY outcome
Timeframe: Baseline, Visit 4 (Up to ten days post drug)Intracellular tenofovir (TFV) Concentration in Rectal Tissue is measured from rectal biopsies and isolated cells. For the pharmacokinetic analysis, values reported as "Below the Limit of Quantification" (BLOQ) are assigned a value of zero if it occurs in a profile after dosing at time zero and before the first measurable concentration.
Outcome measures
| Measure |
Phase I/Pre-Drug
n=5 Participants
Participants will be asked to provide blood and urine samples and undergo penile, urethral, and rectal swabs. Up to 12 rectal biopsies will be taken.
|
Phase II/Genvoya
n=7 Participants
Participants will receive one dose Genvoya. Participants will be asked to provide blood and urine samples and undergo penile, urethral, and rectal swabs. Up to 12 rectal biopsies will be taken.
|
Phase II/Truvada
n=9 Participants
Participants will receive one dose of Truvada. Participants will be asked to provide blood and urine samples and undergo penile, urethral, and rectal swabs. Up to 12 rectal biopsies will be taken.
|
Phase III/Genvoya
n=7 Participants
Participants will receive Genvoya once daily for ten days. Participants will be asked to provide blood and urine samples and undergo penile, urethral, and rectal swabs. Up to 12 rectal biopsies will be taken.
|
Phase III/Truvada
n=9 Participants
Participants will receive Truvada once daily for ten days. Participants will be asked to provide blood and urine samples and undergo penile, urethral, and rectal swabs. Up to 12 rectal biopsies will be taken.
|
|---|---|---|---|---|---|
|
Change in Intracellular Tenofovir (TFV) Concentration in Rectal Tissue
|
0 fmol/mg tissue
Interval 0.0 to 0.0
|
17 fmol/mg tissue
Interval 0.0 to 65.0
|
11 fmol/mg tissue
Interval 0.0 to 74.0
|
0 fmol/mg tissue
Interval 0.0 to 102.0
|
0 fmol/mg tissue
Interval 0.0 to 17.0
|
SECONDARY outcome
Timeframe: Baseline, Visit 4 (Up to ten days post drug)Population: The study didn't measure TAF, only the metabolite TFV
Tissue tenofovir alafenamide (TAF) concentration is measured from rectal biopsies and isolated cells. For the pharmacokinetic analysis, values reported as "Below the Limit of Quantification" (BLOQ) are assigned a value of zero if it occurs in a profile after dosing at time zero and before the first measurable concentration.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline, Visit 4 (Up to ten days post drug)Tissue elvitegravir (EVG) concentration is measured from rectal biopsies and isolated cells. For the pharmacokinetic analysis, values reported as "Below the Limit of Quantification" (BLOQ) are assigned a value of zero if it occurs in a profile after dosing at time zero and before the first measurable concentration.
Outcome measures
| Measure |
Phase I/Pre-Drug
n=5 Participants
Participants will be asked to provide blood and urine samples and undergo penile, urethral, and rectal swabs. Up to 12 rectal biopsies will be taken.
|
Phase II/Genvoya
n=7 Participants
Participants will receive one dose Genvoya. Participants will be asked to provide blood and urine samples and undergo penile, urethral, and rectal swabs. Up to 12 rectal biopsies will be taken.
|
Phase II/Truvada
n=9 Participants
Participants will receive one dose of Truvada. Participants will be asked to provide blood and urine samples and undergo penile, urethral, and rectal swabs. Up to 12 rectal biopsies will be taken.
|
Phase III/Genvoya
n=7 Participants
Participants will receive Genvoya once daily for ten days. Participants will be asked to provide blood and urine samples and undergo penile, urethral, and rectal swabs. Up to 12 rectal biopsies will be taken.
|
Phase III/Truvada
n=9 Participants
Participants will receive Truvada once daily for ten days. Participants will be asked to provide blood and urine samples and undergo penile, urethral, and rectal swabs. Up to 12 rectal biopsies will be taken.
|
|---|---|---|---|---|---|
|
Change in Elvitegravir (EVG) Concentration in Rectal Tissue
|
0 ng/mg tissue
Interval 0.0 to 0.0
|
2.7 ng/mg tissue
Interval 1.2 to 9.8
|
0 ng/mg tissue
Interval 0.0 to 0.0
|
6.8 ng/mg tissue
Interval 4.5 to 11.1
|
0 ng/mg tissue
Interval 0.0 to 0.0
|
SECONDARY outcome
Timeframe: Baseline, Visit 4 (Up to ten days post drug)Emtricitabine (FTC) concentrations is measured from urethral and penile specimen. For the pharmacokinetic analysis, values reported as "Below the Limit of Quantification" (BLOQ) are assigned a value of zero if it occurs in a profile after dosing at time zero and before the first measurable concentration.
Outcome measures
| Measure |
Phase I/Pre-Drug
n=5 Participants
Participants will be asked to provide blood and urine samples and undergo penile, urethral, and rectal swabs. Up to 12 rectal biopsies will be taken.
|
Phase II/Genvoya
n=7 Participants
Participants will receive one dose Genvoya. Participants will be asked to provide blood and urine samples and undergo penile, urethral, and rectal swabs. Up to 12 rectal biopsies will be taken.
|
Phase II/Truvada
n=9 Participants
Participants will receive one dose of Truvada. Participants will be asked to provide blood and urine samples and undergo penile, urethral, and rectal swabs. Up to 12 rectal biopsies will be taken.
|
Phase III/Genvoya
n=7 Participants
Participants will receive Genvoya once daily for ten days. Participants will be asked to provide blood and urine samples and undergo penile, urethral, and rectal swabs. Up to 12 rectal biopsies will be taken.
|
Phase III/Truvada
n=9 Participants
Participants will receive Truvada once daily for ten days. Participants will be asked to provide blood and urine samples and undergo penile, urethral, and rectal swabs. Up to 12 rectal biopsies will be taken.
|
|---|---|---|---|---|---|
|
Change in Emtricitabine (FTC) Concentration in Penile Secretions
|
0 ng/swab
Interval 0.0 to 0.0
|
32 ng/swab
Interval 0.0 to 77.0
|
30 ng/swab
Interval 0.0 to 406.0
|
175 ng/swab
Interval 0.0 to 1775.0
|
54 ng/swab
Interval 0.0 to 9685.0
|
SECONDARY outcome
Timeframe: Baseline, Visit 4 (Up to ten days post drug)Tenofovir disoproxil fumarate (TDF) concentrations is measured from urethral and penile specimen. For the pharmacokinetic analysis, values reported as "Below the Limit of Quantification" (BLOQ) are assigned a value of zero if it occurs in a profile after dosing at time zero and before the first measurable concentration.
Outcome measures
| Measure |
Phase I/Pre-Drug
n=5 Participants
Participants will be asked to provide blood and urine samples and undergo penile, urethral, and rectal swabs. Up to 12 rectal biopsies will be taken.
|
Phase II/Genvoya
n=7 Participants
Participants will receive one dose Genvoya. Participants will be asked to provide blood and urine samples and undergo penile, urethral, and rectal swabs. Up to 12 rectal biopsies will be taken.
|
Phase II/Truvada
n=9 Participants
Participants will receive one dose of Truvada. Participants will be asked to provide blood and urine samples and undergo penile, urethral, and rectal swabs. Up to 12 rectal biopsies will be taken.
|
Phase III/Genvoya
n=7 Participants
Participants will receive Genvoya once daily for ten days. Participants will be asked to provide blood and urine samples and undergo penile, urethral, and rectal swabs. Up to 12 rectal biopsies will be taken.
|
Phase III/Truvada
n=9 Participants
Participants will receive Truvada once daily for ten days. Participants will be asked to provide blood and urine samples and undergo penile, urethral, and rectal swabs. Up to 12 rectal biopsies will be taken.
|
|---|---|---|---|---|---|
|
Change in Tenofovir Disoproxil Fumarate (TDF) Concentration in Penile Secretions
|
0 ng/swab
Interval 0.0 to 0.0
|
0 ng/swab
Interval 0.0 to 0.0
|
0 ng/swab
Interval 0.0 to 385.0
|
0 ng/swab
Interval 0.0 to 30.0
|
17 ng/swab
Interval 0.0 to 818.0
|
SECONDARY outcome
Timeframe: Baseline, Visit 4 (Up to ten days post drug)Population: The study did not measure TAF, only the metabolite TFV
Tenofovir alafenamide (TAF) concentrations is measured from urethral and penile specimen. For the pharmacokinetic analysis, values reported as "Below the Limit of Quantification" (BLOQ) are assigned a value of zero if it occurs in a profile after dosing at time zero and before the first measurable concentration.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline, Visit 4 (Up to ten days post drug)Elvitegravir (EVG) concentrations is measured from urethral and penile specimen. For the pharmacokinetic analysis, values reported as "Below the Limit of Quantification" (BLOQ) are assigned a value of zero if it occurs in a profile after dosing at time zero and before the first measurable concentration.
Outcome measures
| Measure |
Phase I/Pre-Drug
n=5 Participants
Participants will be asked to provide blood and urine samples and undergo penile, urethral, and rectal swabs. Up to 12 rectal biopsies will be taken.
|
Phase II/Genvoya
n=7 Participants
Participants will receive one dose Genvoya. Participants will be asked to provide blood and urine samples and undergo penile, urethral, and rectal swabs. Up to 12 rectal biopsies will be taken.
|
Phase II/Truvada
n=9 Participants
Participants will receive one dose of Truvada. Participants will be asked to provide blood and urine samples and undergo penile, urethral, and rectal swabs. Up to 12 rectal biopsies will be taken.
|
Phase III/Genvoya
n=7 Participants
Participants will receive Genvoya once daily for ten days. Participants will be asked to provide blood and urine samples and undergo penile, urethral, and rectal swabs. Up to 12 rectal biopsies will be taken.
|
Phase III/Truvada
n=9 Participants
Participants will receive Truvada once daily for ten days. Participants will be asked to provide blood and urine samples and undergo penile, urethral, and rectal swabs. Up to 12 rectal biopsies will be taken.
|
|---|---|---|---|---|---|
|
Change in Elvitegravir (EVG) Concentration in Penile Secretions
|
0 ng/swab
Interval 0.0 to 0.0
|
0 ng/swab
Interval 0.0 to 28.0
|
0 ng/swab
Interval 0.0 to 0.0
|
0 ng/swab
Interval 0.0 to 12.0
|
0 ng/swab
Interval 0.0 to 0.0
|
SECONDARY outcome
Timeframe: Up to 10 months post-baselineRectal biopsies will be subjected to in vitro infection with HIV to test for changes in susceptibility to virus infection. Concentrations of cumulative p24 production in supernatants following in vitro infection of rectal biopsies correlate with viral infection and replication in rectal biopsies. Therefore, lower concentrations of p24 production in biopsies collected from men receiving PrEP compared to controls indicates a potential greater protection from infection and potential increased PrEP efficacy. For the pharmacokinetic analysis, values reported as "Below the Limit of Quantification" (BLOQ) are assigned a value of zero if it occurs in a profile after dosing at time zero and before the first measurable concentration.
Outcome measures
| Measure |
Phase I/Pre-Drug
n=5 Participants
Participants will be asked to provide blood and urine samples and undergo penile, urethral, and rectal swabs. Up to 12 rectal biopsies will be taken.
|
Phase II/Genvoya
n=7 Participants
Participants will receive one dose Genvoya. Participants will be asked to provide blood and urine samples and undergo penile, urethral, and rectal swabs. Up to 12 rectal biopsies will be taken.
|
Phase II/Truvada
n=9 Participants
Participants will receive one dose of Truvada. Participants will be asked to provide blood and urine samples and undergo penile, urethral, and rectal swabs. Up to 12 rectal biopsies will be taken.
|
Phase III/Genvoya
n=7 Participants
Participants will receive Genvoya once daily for ten days. Participants will be asked to provide blood and urine samples and undergo penile, urethral, and rectal swabs. Up to 12 rectal biopsies will be taken.
|
Phase III/Truvada
n=9 Participants
Participants will receive Truvada once daily for ten days. Participants will be asked to provide blood and urine samples and undergo penile, urethral, and rectal swabs. Up to 12 rectal biopsies will be taken.
|
|---|---|---|---|---|---|
|
PrEP Efficacy as Measured by Inhibition of in Vitro Infection of Rectal Biopsies to HIV
|
740 ng p24
Interval 271.0 to 2319.0
|
225 ng p24
Interval 128.0 to 535.0
|
298 ng p24
Interval 224.0 to 381.0
|
348 ng p24
Interval 159.0 to 504.0
|
327 ng p24
Interval 94.0 to 465.0
|
Adverse Events
Phase I/Pre-Drug
Phase II/Genvoya
Phase II/Truvada
Phase III/Genvoya
Phase III/Truvada
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