Trial Outcomes & Findings for Body Compartment Pharmacokinetics of Anti-retroviral Agents That May be Considered for Future On-demand Peri-exposure HIV Prophylaxis Regimens (NCT NCT03976752)
NCT ID: NCT03976752
Last Updated: 2021-08-13
Results Overview
Median drug concentrations of the TFV component of Genvoya were determined at baseline and at each of the protocol specified follow-up time points. Concentrations below the limit of quantification (LOQ) are assigned a value of zero.
COMPLETED
PHASE1
41 participants
Baseline, and 2, 4, 8, 24, 48, 72, 96 hours after taking the second dose of medication
2021-08-13
Participant Flow
Participants were recruited from the Hope Clinic in Atlanta, Georgia, USA. Participant enrollment began on March 13, 2019 and all follow up was completed September 20, 2019.
After the completion of enrollment in the Pre-drug arm, enrollment began sequentially in Arm A, followed by Arm B and Arm C. Arms A, B, and C were further broken down into two different sub-groups, determining the timing of the rectal swab and biopsy procedure. Arm D was enrolled last and included a single time point specimen collection. Participants were able to take part in more than one study arm, with at least a 6 week period after completion of one study arm before beginning another one.
Participant milestones
| Measure |
Pre-drug
Participants enrolled in the pre-drug arm will not receive any drug. At visit 2, they will undergo blood, urine, penile swab, cheek swab, rectal swab and rectal biopsy collection.
|
Genvoya
Genvoya is a fixed-dose combination anti-retroviral drug containing tenofovir alafenamide (TAF), emtricitabine (FTC), elvitegravir (EVG), and cobicistat. At the second study visit, participants will be provided with a single dose of Genvoya, and instructed to take the dose at home with documentation by digital, time-stamped photo or video. At the third study visit, which will occur 24 hours after home dosing, participants will be given another single dose of Genvoya at the clinic.
Participants took Genvoya and had specimens collected at different time points.
* Arm A: specimen collection occurred 2 hours and after taking the medication in the clinic (visit 4), and 48 hours after taking the medication in the clinic (visit 5)
* Arm B: specimen collection occurred 4 hours and after taking the medication in the clinic (visit 4), and 72 hours after taking the medication in the clinic (visit 5)
* Arm C: specimen collection occurred 24 hours and after taking the medication in the clinic (visit 4), and 96 hours after taking the medication in the clinic (visit 5)
* Arm D: specimen collection occurred 8 hours after taking the medication in the clinic (visit 4), for a single time point of specimen collection
|
|---|---|---|
|
Overall Study
STARTED
|
4
|
37
|
|
Overall Study
Started Study Arm A
|
0
|
14
|
|
Overall Study
Completed Study Arm A
|
0
|
8
|
|
Overall Study
Started Study Arm B
|
0
|
8
|
|
Overall Study
Completed Study Arm B
|
0
|
8
|
|
Overall Study
Started Study Arm C
|
0
|
11
|
|
Overall Study
Completed Study Arm C
|
0
|
8
|
|
Overall Study
Started Study Arm D
|
0
|
6
|
|
Overall Study
Completed Study Arm D
|
0
|
4
|
|
Overall Study
COMPLETED
|
3
|
28
|
|
Overall Study
NOT COMPLETED
|
1
|
9
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Body Compartment Pharmacokinetics of Anti-retroviral Agents That May be Considered for Future On-demand Peri-exposure HIV Prophylaxis Regimens
Baseline characteristics by cohort
| Measure |
Pre-drug
n=4 Participants
Participants enrolled in the pre-drug arm did not receive any drug. At visit 2, they underwent blood, urine, penile swab, cheek swab, rectal swab and rectal biopsy collection.
|
Genvoya
n=37 Participants
Genvoya is a fixed-dose combination anti-retroviral drug containing tenofovir alafenamide (TAF), emtricitabine (FTC), elvitegravir (EVG), and cobicistat. At the second study visit, participants will be provided with a single dose of Genvoya, and instructed to take the dose at home with documentation by digital, time-stamped photo or video. At the third study visit, which will occur 24 hours after home dosing, participants will be given another single dose of Genvoya at the clinic.
Participants took Genvoya and had specimens collected at different time points. Arm A: specimen collection occurred 2 hours and after taking the medication in the clinic (visit 4), and 48 hours after taking the medication in the clinic (visit 5) Arm B: specimen collection occurred 4 hours and after taking the medication in the clinic (visit 4), and 72 hours after taking the medication in the clinic (visit 5) Arm C: specimen collection occurred 24 hours and after taking the medication in the clinic (visit 4), and 96 hours after taking the medication in the clinic (visit 5) Arm D: specimen collection occurred 8 hours after taking the medication in the clinic (visit 4), for a single time point of specimen collection
|
Total
n=41 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
4 Participants
n=5 Participants
|
36 Participants
n=7 Participants
|
40 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
4 Participants
n=5 Participants
|
37 Participants
n=7 Participants
|
41 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 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
|
|
Race (NIH/OMB)
Black or African American
|
4 Participants
n=5 Participants
|
26 Participants
n=7 Participants
|
30 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
0 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
4 Participants
n=5 Participants
|
37 Participants
n=7 Participants
|
41 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline, and 2, 4, 8, 24, 48, 72, 96 hours after taking the second dose of medicationPopulation: Data are reported per intervention, based on the time points of sample collection for each study arm (two participants were in multiple study arms). Analysis of drug concentrations in participants in the Pre-drug arm was not performed as no drugs were administered to this study arm.
Median drug concentrations of the TFV component of Genvoya were determined at baseline and at each of the protocol specified follow-up time points. Concentrations below the limit of quantification (LOQ) are assigned a value of zero.
Outcome measures
| Measure |
Genvoya - 2 and 48 Hours Specimen Collection
n=8 Participants
Specimen collection 2 hours after taking the medication in the clinic (visit 4), and 48 hours after taking the medication in the clinic (visit 5).
|
Genvoya - 4 and 72 Hours Specimen Collection
n=8 Participants
Specimen collection 4 hours after taking the medication in the clinic (visit 4), and 72 hours after taking the medication in the clinic (visit 5).
|
Genvoya - 24 and 96 Hours Specimen Collection
n=8 Participants
Specimen collection 24 hours after taking the medication in the clinic (visit 4), and 96 hours after taking the medication in the clinic (visit 5).
|
Genvoya - Single Time Point Specimen Collection
n=4 Participants
Specimen collection 8 hours after taking the medication in the clinic (visit 4).
|
|---|---|---|---|---|
|
Plasma Concentration of Tenofovir (TFV)
24 hours
|
—
|
—
|
0 ng/mL
Interval 0.0 to 13.0
|
—
|
|
Plasma Concentration of Tenofovir (TFV)
48 hours
|
0 ng/mL
Interval 0.0 to 0.0
|
—
|
—
|
—
|
|
Plasma Concentration of Tenofovir (TFV)
Baseline
|
0 ng/mL
Interval 0.0 to 0.0
|
0 ng/mL
Interval 0.0 to 0.0
|
0 ng/mL
Interval 0.0 to 0.0
|
0 ng/mL
Interval 0.0 to 0.0
|
|
Plasma Concentration of Tenofovir (TFV)
2 hours
|
0 ng/mL
Interval 0.0 to 0.0
|
—
|
—
|
—
|
|
Plasma Concentration of Tenofovir (TFV)
4 hours
|
—
|
0 ng/mL
Interval 0.0 to 0.0
|
—
|
—
|
|
Plasma Concentration of Tenofovir (TFV)
8 hours
|
—
|
—
|
—
|
0 ng/mL
Interval 0.0 to 0.0
|
|
Plasma Concentration of Tenofovir (TFV)
72 hours
|
—
|
0 ng/mL
Interval 0.0 to 0.0
|
—
|
—
|
|
Plasma Concentration of Tenofovir (TFV)
96 hours
|
—
|
—
|
0 ng/mL
Interval 0.0 to 60.0
|
—
|
PRIMARY outcome
Timeframe: Baseline, and 2, 4, 8, 24, 48, 72, 96 hours after taking the second dose of medicationPopulation: Data are reported per intervention, based on the time points of sample collection for each study arm (two participants were in multiple study arms). Analysis of drug concentrations in participants in the Pre-drug arm was not performed as no drugs were administered to this study arm.
Median drug concentrations of the FTC component of Genvoya were determined at baseline and at each of the protocol specified follow-up time points. Concentrations below the limit of quantification (LOQ) are assigned a value of zero.
Outcome measures
| Measure |
Genvoya - 2 and 48 Hours Specimen Collection
n=8 Participants
Specimen collection 2 hours after taking the medication in the clinic (visit 4), and 48 hours after taking the medication in the clinic (visit 5).
|
Genvoya - 4 and 72 Hours Specimen Collection
n=8 Participants
Specimen collection 4 hours after taking the medication in the clinic (visit 4), and 72 hours after taking the medication in the clinic (visit 5).
|
Genvoya - 24 and 96 Hours Specimen Collection
n=8 Participants
Specimen collection 24 hours after taking the medication in the clinic (visit 4), and 96 hours after taking the medication in the clinic (visit 5).
|
Genvoya - Single Time Point Specimen Collection
n=4 Participants
Specimen collection 8 hours after taking the medication in the clinic (visit 4).
|
|---|---|---|---|---|
|
Plasma Concentration of Emtricitabine (FTC)
Baseline
|
0 ng/mL
Interval 0.0 to 0.0
|
0 ng/mL
Interval 0.0 to 0.0
|
0 ng/mL
Interval 0.0 to 0.0
|
0 ng/mL
Interval 0.0 to 0.0
|
|
Plasma Concentration of Emtricitabine (FTC)
2 hours
|
2710 ng/mL
Interval 1765.0 to 3345.0
|
—
|
—
|
—
|
|
Plasma Concentration of Emtricitabine (FTC)
4 hours
|
—
|
1725 ng/mL
Interval 747.0 to 2565.0
|
—
|
—
|
|
Plasma Concentration of Emtricitabine (FTC)
8 hours
|
—
|
—
|
—
|
300 ng/mL
Interval 225.0 to 351.0
|
|
Plasma Concentration of Emtricitabine (FTC)
24 hours
|
—
|
—
|
113 ng/mL
Interval 37.0 to 258.0
|
—
|
|
Plasma Concentration of Emtricitabine (FTC)
48 hours
|
0 ng/mL
Interval 0.0 to 768.0
|
—
|
—
|
—
|
|
Plasma Concentration of Emtricitabine (FTC)
72 hours
|
—
|
0 ng/mL
Interval 0.0 to 0.0
|
—
|
—
|
|
Plasma Concentration of Emtricitabine (FTC)
96 hours
|
—
|
—
|
0 ng/mL
Interval 0.0 to 107.0
|
—
|
PRIMARY outcome
Timeframe: Baseline, and 2, 4, 8, 24, 48, 72, 96 hours after taking the second dose of medicationPopulation: Data are reported per intervention, based on the time points of sample collection for each study arm (two participants were in multiple study arms). Analysis of drug concentrations in participants in the Pre-drug arm was not performed as no drugs were administered to this study arm.
Median drug concentrations of the EVG component of Genvoya were determined at baseline and at each of the protocol specified follow-up time points. Concentrations below the limit of quantification (LOQ) are assigned a value of zero.
Outcome measures
| Measure |
Genvoya - 2 and 48 Hours Specimen Collection
n=8 Participants
Specimen collection 2 hours after taking the medication in the clinic (visit 4), and 48 hours after taking the medication in the clinic (visit 5).
|
Genvoya - 4 and 72 Hours Specimen Collection
n=8 Participants
Specimen collection 4 hours after taking the medication in the clinic (visit 4), and 72 hours after taking the medication in the clinic (visit 5).
|
Genvoya - 24 and 96 Hours Specimen Collection
n=8 Participants
Specimen collection 24 hours after taking the medication in the clinic (visit 4), and 96 hours after taking the medication in the clinic (visit 5).
|
Genvoya - Single Time Point Specimen Collection
n=4 Participants
Specimen collection 8 hours after taking the medication in the clinic (visit 4).
|
|---|---|---|---|---|
|
Plasma Concentration of Elvitegravir (EVG)
96 hours
|
—
|
—
|
0 ng/mL
Interval 0.0 to 18.0
|
—
|
|
Plasma Concentration of Elvitegravir (EVG)
Baseline
|
0 ng/mL
Interval 0.0 to 0.0
|
0 ng/mL
Interval 0.0 to 0.0
|
0 ng/mL
Interval 0.0 to 0.0
|
0 ng/mL
Interval 0.0 to 0.0
|
|
Plasma Concentration of Elvitegravir (EVG)
2 hours
|
2243 ng/mL
Interval 916.0 to 3455.0
|
—
|
—
|
—
|
|
Plasma Concentration of Elvitegravir (EVG)
4 hours
|
—
|
1818 ng/mL
Interval 1230.0 to 4095.0
|
—
|
—
|
|
Plasma Concentration of Elvitegravir (EVG)
8 hours
|
—
|
—
|
—
|
283 ng/mL
Interval 105.0 to 421.0
|
|
Plasma Concentration of Elvitegravir (EVG)
24 hours
|
—
|
—
|
232 ng/mL
Interval 22.0 to 527.0
|
—
|
|
Plasma Concentration of Elvitegravir (EVG)
48 hours
|
0 ng/mL
Interval 0.0 to 69.0
|
—
|
—
|
—
|
|
Plasma Concentration of Elvitegravir (EVG)
72 hours
|
—
|
0 ng/mL
Interval 0.0 to 0.0
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline, and 2, 4, 8, 24, 48, 72, 96 hours after taking the second dose of medicationPopulation: Data are reported per intervention, based on the time points of sample collection for each study arm (two participants were in multiple study arms). Analysis of drug concentrations in participants in the Pre-drug arm was not performed as no drugs were administered to this study arm.
A peripheral blood mononuclear cell (PBMC) is any peripheral blood cell having a round nucleus: lymphocytes (T cells, B cells, natural killer (NK) cells) and monocytes. Median drug concentrations were determined at baseline and at each of the protocol specified follow-up time points. Concentrations below the limit of quantification (LOQ) are assigned a value of zero.
Outcome measures
| Measure |
Genvoya - 2 and 48 Hours Specimen Collection
n=8 Participants
Specimen collection 2 hours after taking the medication in the clinic (visit 4), and 48 hours after taking the medication in the clinic (visit 5).
|
Genvoya - 4 and 72 Hours Specimen Collection
n=8 Participants
Specimen collection 4 hours after taking the medication in the clinic (visit 4), and 72 hours after taking the medication in the clinic (visit 5).
|
Genvoya - 24 and 96 Hours Specimen Collection
n=8 Participants
Specimen collection 24 hours after taking the medication in the clinic (visit 4), and 96 hours after taking the medication in the clinic (visit 5).
|
Genvoya - Single Time Point Specimen Collection
n=4 Participants
Specimen collection 8 hours after taking the medication in the clinic (visit 4).
|
|---|---|---|---|---|
|
Peripheral Blood Mononuclear Cell (PBMC) Concentration of Tenofovir-diphosphate (TFV-DP)
Baseline
|
0 fmol/10^6 cells
Interval 0.0 to 0.0
|
0 fmol/10^6 cells
Interval 0.0 to 0.0
|
0 fmol/10^6 cells
Interval 0.0 to 0.0
|
0 fmol/10^6 cells
Interval 0.0 to 0.0
|
|
Peripheral Blood Mononuclear Cell (PBMC) Concentration of Tenofovir-diphosphate (TFV-DP)
2 hours
|
569 fmol/10^6 cells
Interval 262.0 to 1287.0
|
—
|
—
|
—
|
|
Peripheral Blood Mononuclear Cell (PBMC) Concentration of Tenofovir-diphosphate (TFV-DP)
4 hours
|
—
|
621 fmol/10^6 cells
Interval 156.0 to 1375.0
|
—
|
—
|
|
Peripheral Blood Mononuclear Cell (PBMC) Concentration of Tenofovir-diphosphate (TFV-DP)
8 hours
|
—
|
—
|
—
|
375 fmol/10^6 cells
Interval 270.0 to 1294.0
|
|
Peripheral Blood Mononuclear Cell (PBMC) Concentration of Tenofovir-diphosphate (TFV-DP)
48 hours
|
291 fmol/10^6 cells
Interval 202.0 to 421.0
|
—
|
—
|
—
|
|
Peripheral Blood Mononuclear Cell (PBMC) Concentration of Tenofovir-diphosphate (TFV-DP)
24 hours
|
—
|
—
|
429 fmol/10^6 cells
Interval 276.0 to 659.0
|
—
|
|
Peripheral Blood Mononuclear Cell (PBMC) Concentration of Tenofovir-diphosphate (TFV-DP)
72 hours
|
—
|
158 fmol/10^6 cells
Interval 81.0 to 436.0
|
—
|
—
|
|
Peripheral Blood Mononuclear Cell (PBMC) Concentration of Tenofovir-diphosphate (TFV-DP)
96 hours
|
—
|
—
|
117 fmol/10^6 cells
Interval 92.0 to 227.0
|
—
|
SECONDARY outcome
Timeframe: Baseline, and 2, 4, 8, 24, 48, 72, 96 hours after taking the second dose of medicationPopulation: Data are reported per intervention, based on the time points of sample collection for each study arm (two participants were in multiple study arms). Analysis of drug concentrations in participants in the Pre-drug arm was not performed as no drugs were administered to this study arm.
A peripheral blood mononuclear cell (PBMC) is any peripheral blood cell having a round nucleus: lymphocytes (T cells, B cells, NK cells) and monocytes. Median drug levels were determined at baseline and at each of the protocol specified follow-up time points. Concentrations below the limit of quantification (LOQ) are assigned a value of zero.
Outcome measures
| Measure |
Genvoya - 2 and 48 Hours Specimen Collection
n=8 Participants
Specimen collection 2 hours after taking the medication in the clinic (visit 4), and 48 hours after taking the medication in the clinic (visit 5).
|
Genvoya - 4 and 72 Hours Specimen Collection
n=8 Participants
Specimen collection 4 hours after taking the medication in the clinic (visit 4), and 72 hours after taking the medication in the clinic (visit 5).
|
Genvoya - 24 and 96 Hours Specimen Collection
n=8 Participants
Specimen collection 24 hours after taking the medication in the clinic (visit 4), and 96 hours after taking the medication in the clinic (visit 5).
|
Genvoya - Single Time Point Specimen Collection
n=4 Participants
Specimen collection 8 hours after taking the medication in the clinic (visit 4).
|
|---|---|---|---|---|
|
Peripheral Blood Mononuclear Cell (PBMC) Concentration of Emtricitabine-triphosphate (FTC-TP)
Baseline
|
0 fmol/10^6 cells
Interval 0.0 to 0.0
|
0 fmol/10^6 cells
Interval 0.0 to 0.0
|
0 fmol/10^6 cells
Interval 0.0 to 0.0
|
0 fmol/10^6 cells
Interval 0.0 to 0.0
|
|
Peripheral Blood Mononuclear Cell (PBMC) Concentration of Emtricitabine-triphosphate (FTC-TP)
2 hours
|
7705 fmol/10^6 cells
Interval 5230.0 to 8750.0
|
—
|
—
|
—
|
|
Peripheral Blood Mononuclear Cell (PBMC) Concentration of Emtricitabine-triphosphate (FTC-TP)
4 hour
|
—
|
7800 fmol/10^6 cells
Interval 3200.0 to 11650.0
|
—
|
—
|
|
Peripheral Blood Mononuclear Cell (PBMC) Concentration of Emtricitabine-triphosphate (FTC-TP)
96 hours
|
—
|
—
|
714 fmol/10^6 cells
Interval 333.0 to 6000.0
|
—
|
|
Peripheral Blood Mononuclear Cell (PBMC) Concentration of Emtricitabine-triphosphate (FTC-TP)
8 hours
|
—
|
—
|
—
|
6855 fmol/10^6 cells
Interval 5380.0 to 7710.0
|
|
Peripheral Blood Mononuclear Cell (PBMC) Concentration of Emtricitabine-triphosphate (FTC-TP)
24 hours
|
—
|
—
|
5140 fmol/10^6 cells
Interval 3110.0 to 7740.0
|
—
|
|
Peripheral Blood Mononuclear Cell (PBMC) Concentration of Emtricitabine-triphosphate (FTC-TP)
48 hours
|
2120 fmol/10^6 cells
Interval 1517.0 to 3390.0
|
—
|
—
|
—
|
|
Peripheral Blood Mononuclear Cell (PBMC) Concentration of Emtricitabine-triphosphate (FTC-TP)
72 hours
|
—
|
955 fmol/10^6 cells
Interval 648.0 to 2210.0
|
—
|
—
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline, and 2, 4, 8, 24, 48, 72, 96 hours after taking the second dose of medicationPopulation: Data are reported per intervention, based on the time points of sample collection for each study arm (two participants were in multiple study arms). Analysis of drug concentrations in participants in the Pre-drug arm was not performed as no drugs were administered to this study arm.
Median drug concentrations in rectal tissue of the TFN component of Genvoya were determined at baseline and at each of the protocol specified time points. Concentrations below the limit of quantification (LOQ) are assigned a value of zero.
Outcome measures
| Measure |
Genvoya - 2 and 48 Hours Specimen Collection
n=8 Participants
Specimen collection 2 hours after taking the medication in the clinic (visit 4), and 48 hours after taking the medication in the clinic (visit 5).
|
Genvoya - 4 and 72 Hours Specimen Collection
n=8 Participants
Specimen collection 4 hours after taking the medication in the clinic (visit 4), and 72 hours after taking the medication in the clinic (visit 5).
|
Genvoya - 24 and 96 Hours Specimen Collection
n=8 Participants
Specimen collection 24 hours after taking the medication in the clinic (visit 4), and 96 hours after taking the medication in the clinic (visit 5).
|
Genvoya - Single Time Point Specimen Collection
n=4 Participants
Specimen collection 8 hours after taking the medication in the clinic (visit 4).
|
|---|---|---|---|---|
|
Rectal Tissue Concentration of Tenofovir (TFN)
Baseline
|
0 ng/mg
Interval 0.0 to 0.0
|
0 ng/mg
Interval 0.0 to 0.0
|
0 ng/mg
Interval 0.0 to 0.0
|
0 ng/mg
Interval 0.0 to 0.0
|
|
Rectal Tissue Concentration of Tenofovir (TFN)
96 hours
|
—
|
—
|
0 ng/mg
Interval 0.0 to 0.0
|
—
|
|
Rectal Tissue Concentration of Tenofovir (TFN)
2 hours
|
0 ng/mg
Interval 0.0 to 0.48
|
—
|
—
|
—
|
|
Rectal Tissue Concentration of Tenofovir (TFN)
4 hours
|
—
|
0.30 ng/mg
Interval 0.0 to 1.23
|
—
|
—
|
|
Rectal Tissue Concentration of Tenofovir (TFN)
8 hours
|
—
|
—
|
—
|
0.01 ng/mg
Interval 0.0 to 0.01
|
|
Rectal Tissue Concentration of Tenofovir (TFN)
24 hours
|
—
|
—
|
0.03 ng/mg
Interval 0.0 to 1.2
|
—
|
|
Rectal Tissue Concentration of Tenofovir (TFN)
48 hours
|
0 ng/mg
Interval 0.0 to 0.0
|
—
|
—
|
—
|
|
Rectal Tissue Concentration of Tenofovir (TFN)
72 hours
|
—
|
0 ng/mg
Interval 0.0 to 0.0
|
—
|
—
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline, and 2, 4, 8, 24, 48, 72, 96 hours after taking the second dose of medicationPopulation: Data are reported per intervention, based on the time points of sample collection for each study arm (two participants were in multiple study arms). Analysis of drug concentrations in participants in the Pre-drug arm was not performed as no drugs were administered to this study arm.
Median drug concentrations in rectal tissue of the FTC component of Genvoya were determined at baseline and at each of the protocol specified time points. Concentrations below the limit of quantification (LOQ) are assigned a value of zero.
Outcome measures
| Measure |
Genvoya - 2 and 48 Hours Specimen Collection
n=8 Participants
Specimen collection 2 hours after taking the medication in the clinic (visit 4), and 48 hours after taking the medication in the clinic (visit 5).
|
Genvoya - 4 and 72 Hours Specimen Collection
n=8 Participants
Specimen collection 4 hours after taking the medication in the clinic (visit 4), and 72 hours after taking the medication in the clinic (visit 5).
|
Genvoya - 24 and 96 Hours Specimen Collection
n=8 Participants
Specimen collection 24 hours after taking the medication in the clinic (visit 4), and 96 hours after taking the medication in the clinic (visit 5).
|
Genvoya - Single Time Point Specimen Collection
n=4 Participants
Specimen collection 8 hours after taking the medication in the clinic (visit 4).
|
|---|---|---|---|---|
|
Rectal Tissue Concentration of Emtricitabine (FTC)
Baseline
|
0 ng/mg
Interval 0.0 to 0.0
|
0 ng/mg
Interval 0.0 to 0.0
|
0 ng/mg
Interval 0.0 to 0.0
|
0 ng/mg
Interval 0.0 to 0.0
|
|
Rectal Tissue Concentration of Emtricitabine (FTC)
2 hours
|
9.54 ng/mg
Interval 6.23 to 10.43
|
—
|
—
|
—
|
|
Rectal Tissue Concentration of Emtricitabine (FTC)
4 hours
|
—
|
9.25 ng/mg
Interval 0.0 to 12.11
|
—
|
—
|
|
Rectal Tissue Concentration of Emtricitabine (FTC)
8 hours
|
—
|
—
|
—
|
0.17 ng/mg
Interval 0.11 to 0.19
|
|
Rectal Tissue Concentration of Emtricitabine (FTC)
24 hours
|
—
|
—
|
1.23 ng/mg
Interval 0.29 to 12.86
|
—
|
|
Rectal Tissue Concentration of Emtricitabine (FTC)
48 hours
|
0.02 ng/mg
Interval 0.0 to 4.93
|
—
|
—
|
—
|
|
Rectal Tissue Concentration of Emtricitabine (FTC)
72 hours
|
—
|
0 ng/mg
Interval 0.0 to 0.0
|
—
|
—
|
|
Rectal Tissue Concentration of Emtricitabine (FTC)
96 hours
|
—
|
—
|
0.02 ng/mg
Interval 0.02 to 0.03
|
—
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline, and 2, 4, 8, 24, 72, 96 hours after taking the second dose of medicationPopulation: Data are reported per intervention, based on the time points of sample collection for each study arm (two participants were in multiple study arms). Analysis of drug concentrations in participants in the Pre-drug arm was not performed as no drugs were administered to this study arm.
Median drug concentrations in rectal tissue of the EVG component of Genvoya were determined at baseline and at each of the protocol specified time points. Concentrations below the limit of quantification (LOQ) are assigned a value of zero.
Outcome measures
| Measure |
Genvoya - 2 and 48 Hours Specimen Collection
n=8 Participants
Specimen collection 2 hours after taking the medication in the clinic (visit 4), and 48 hours after taking the medication in the clinic (visit 5).
|
Genvoya - 4 and 72 Hours Specimen Collection
n=8 Participants
Specimen collection 4 hours after taking the medication in the clinic (visit 4), and 72 hours after taking the medication in the clinic (visit 5).
|
Genvoya - 24 and 96 Hours Specimen Collection
n=8 Participants
Specimen collection 24 hours after taking the medication in the clinic (visit 4), and 96 hours after taking the medication in the clinic (visit 5).
|
Genvoya - Single Time Point Specimen Collection
n=4 Participants
Specimen collection 8 hours after taking the medication in the clinic (visit 4).
|
|---|---|---|---|---|
|
Rectal Tissue Concentration of Elvitegravir (EVG)
Baseline
|
0 ng/mg
Interval 0.0 to 0.0
|
0 ng/mg
Interval 0.0 to 0.0
|
0 ng/mg
Interval 0.0 to 0.0
|
0 ng/mg
Interval 0.0 to 0.0
|
|
Rectal Tissue Concentration of Elvitegravir (EVG)
2 hours
|
51.23 ng/mg
Interval 28.19 to 69.04
|
—
|
—
|
—
|
|
Rectal Tissue Concentration of Elvitegravir (EVG)
4 hours
|
—
|
41.47 ng/mg
Interval 8.95 to 66.17
|
—
|
—
|
|
Rectal Tissue Concentration of Elvitegravir (EVG)
8 hours
|
—
|
—
|
—
|
0.31 ng/mg
Interval 0.05 to 0.51
|
|
Rectal Tissue Concentration of Elvitegravir (EVG)
24 hours
|
—
|
—
|
0.60 ng/mg
Interval 0.29 to 40.02
|
—
|
|
Rectal Tissue Concentration of Elvitegravir (EVG)
48 hours
|
1.03 ng/mg
Interval 0.0 to 2.46
|
—
|
—
|
—
|
|
Rectal Tissue Concentration of Elvitegravir (EVG)
72 hours
|
—
|
0 ng/mg
Interval 0.0 to 0.0
|
—
|
—
|
|
Rectal Tissue Concentration of Elvitegravir (EVG)
96 hours
|
—
|
—
|
0.02 ng/mg
Interval 0.02 to 0.03
|
—
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline, and 2, 4, 8, 24, 48, 72, 96 hours after taking the second dose of medicationPopulation: Data are reported per intervention, based on the time points of sample collection for each study arm (two participants were in multiple study arms). Analysis of drug concentrations in participants in the Pre-drug arm was not performed as no drugs were administered to this study arm.
Median drug concentrations of TFV-DP in rectal tissue were determined at baseline and at each of the protocol specified follow-up time points. Concentrations below the limit of quantification (LOQ) are assigned a value of zero.
Outcome measures
| Measure |
Genvoya - 2 and 48 Hours Specimen Collection
n=8 Participants
Specimen collection 2 hours after taking the medication in the clinic (visit 4), and 48 hours after taking the medication in the clinic (visit 5).
|
Genvoya - 4 and 72 Hours Specimen Collection
n=8 Participants
Specimen collection 4 hours after taking the medication in the clinic (visit 4), and 72 hours after taking the medication in the clinic (visit 5).
|
Genvoya - 24 and 96 Hours Specimen Collection
n=8 Participants
Specimen collection 24 hours after taking the medication in the clinic (visit 4), and 96 hours after taking the medication in the clinic (visit 5).
|
Genvoya - Single Time Point Specimen Collection
n=4 Participants
Specimen collection 8 hours after taking the medication in the clinic (visit 4).
|
|---|---|---|---|---|
|
Rectal Tissue Concentration of Tenofovir-diphosphate (TFV-DP)
Baseline
|
0 fmol/mg
Interval 0.0 to 0.0
|
0 fmol/mg
Interval 0.0 to 0.0
|
0 fmol/mg
Interval 0.0 to 0.0
|
0 fmol/mg
Interval 0.0 to 0.0
|
|
Rectal Tissue Concentration of Tenofovir-diphosphate (TFV-DP)
2 hours
|
39.1 fmol/mg
Interval 34.2 to 74.6
|
—
|
—
|
—
|
|
Rectal Tissue Concentration of Tenofovir-diphosphate (TFV-DP)
4 hours
|
—
|
45.9 fmol/mg
Interval 15.7 to 135.4
|
—
|
—
|
|
Rectal Tissue Concentration of Tenofovir-diphosphate (TFV-DP)
8 hours
|
—
|
—
|
—
|
23.7 fmol/mg
Interval 14.7 to 27.4
|
|
Rectal Tissue Concentration of Tenofovir-diphosphate (TFV-DP)
24 hours
|
—
|
—
|
20.2 fmol/mg
Interval 5.0 to 35.7
|
—
|
|
Rectal Tissue Concentration of Tenofovir-diphosphate (TFV-DP)
48 hours
|
18.2 fmol/mg
Interval 15.9 to 22.1
|
—
|
—
|
—
|
|
Rectal Tissue Concentration of Tenofovir-diphosphate (TFV-DP)
72 hours
|
—
|
11.9 fmol/mg
Interval 6.7 to 22.2
|
—
|
—
|
|
Rectal Tissue Concentration of Tenofovir-diphosphate (TFV-DP)
96 hours
|
—
|
—
|
14.7 fmol/mg
Interval 4.6 to 1926.0
|
—
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline, and 2, 4, 8, 24, 48, 72, 96 hours after taking the second dose of medicationPopulation: Data are reported per intervention, based on the time points of sample collection for each study arm (two participants were in multiple study arms). Analysis of drug concentrations in participants in the Pre-drug arm was not performed as no drugs were administered to this study arm.
Median drug concentrations of FTC-TP in rectal tissue were determined at baseline and at each of the protocol specified follow-up time points. Concentrations below the limit of quantification (LOQ) are assigned a value of zero.
Outcome measures
| Measure |
Genvoya - 2 and 48 Hours Specimen Collection
n=8 Participants
Specimen collection 2 hours after taking the medication in the clinic (visit 4), and 48 hours after taking the medication in the clinic (visit 5).
|
Genvoya - 4 and 72 Hours Specimen Collection
n=8 Participants
Specimen collection 4 hours after taking the medication in the clinic (visit 4), and 72 hours after taking the medication in the clinic (visit 5).
|
Genvoya - 24 and 96 Hours Specimen Collection
n=8 Participants
Specimen collection 24 hours after taking the medication in the clinic (visit 4), and 96 hours after taking the medication in the clinic (visit 5).
|
Genvoya - Single Time Point Specimen Collection
n=4 Participants
Specimen collection 8 hours after taking the medication in the clinic (visit 4).
|
|---|---|---|---|---|
|
Rectal Tissue Concentration of Emtricitabine-triphosphate (FTC-TP)
Baseline
|
0 fmol/mg
Interval 0.0 to 0.0
|
0 fmol/mg
Interval 0.0 to 0.0
|
0 fmol/mg
Interval 0.0 to 0.0
|
0 fmol/mg
Interval 0.0 to 0.0
|
|
Rectal Tissue Concentration of Emtricitabine-triphosphate (FTC-TP)
2 hours
|
187.5 fmol/mg
Interval 146.6 to 255.9
|
—
|
—
|
—
|
|
Rectal Tissue Concentration of Emtricitabine-triphosphate (FTC-TP)
4 hours
|
—
|
198.2 fmol/mg
Interval 68.9 to 365.8
|
—
|
—
|
|
Rectal Tissue Concentration of Emtricitabine-triphosphate (FTC-TP)
8 hours
|
—
|
—
|
—
|
116.5 fmol/mg
Interval 62.3 to 176.6
|
|
Rectal Tissue Concentration of Emtricitabine-triphosphate (FTC-TP)
24 hours
|
—
|
—
|
104.3 fmol/mg
Interval 19.5 to 184.5
|
—
|
|
Rectal Tissue Concentration of Emtricitabine-triphosphate (FTC-TP)
48 hours
|
56.3 fmol/mg
Interval 18.1 to 91.7
|
—
|
—
|
—
|
|
Rectal Tissue Concentration of Emtricitabine-triphosphate (FTC-TP)
72 hours
|
—
|
15.1 fmol/mg
Interval 7.3 to 52.3
|
—
|
—
|
|
Rectal Tissue Concentration of Emtricitabine-triphosphate (FTC-TP)
96 hours
|
—
|
—
|
12.5 fmol/mg
Interval 6.3 to 141.3
|
—
|
Adverse Events
Pre-drug
Genvoya - 2 and 48 Hours Specimen Collection
Genvoya - 4 and 72 Hours Specimen Collection
Genvoya - 24 and 96 Hours Specimen Collection
Genvoya - Single Time Point Specimen Collection
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