Trial Outcomes & Findings for Safety and Pharmacokinetic Study of Tenofovir Alafenamide (TAF)/Elvitegravir (EVG) Administered Rectally (NCT NCT04047420)

Last Updated: 2023-12-22

Results Overview

Graded per the Division of AIDS (DAIDS) Table for Grading Adult and Pediatric Adverse Events, Corrected Version 2.1, July 2017 and/or Addenda 1, 2 and 3 (Female Genital \[Dated November 2007\], Male Genital \[Dated November 2007\] and Rectal \[Clarification Dated May 2012\] Grading Tables for Use in Microbicide Studies).

Recruitment status

COMPLETED

Study phase

PHASE1

Target enrollment

23 participants

Primary outcome timeframe

Measured from Enrollment through Final Contact at Visit 11 with a median (IQR) of 76 (47, 292) days. COVID restrictions delayed first dosing 9-10 months in 5 participants. Follow-up time from first dosing was a median (IQR) of 34 (22, 39) days.

Results posted on

2023-12-22

Participant Flow

A total of 23 participants were eligible and enrolled. Two participants terminated early due to "Refused participation", so 21 participants received the one insert dose. After the one insert dose, two additional participants terminated early due to "Refused participation", so 19 participants received the two insert dose.

Participant milestones

Participant milestones
Measure	Tenofovir Alafenamide (TAF)/Elvitegravir (EVG) Insert On the first dosing visit (Visit 3), participants will receive a single TAF/EVG Insert for rectal administration. On the second dosing visit (Visit 7), after a washout period of at least 7 days, participants will receive two TAF/EVG Inserts for rectal administration. Each participant will be on study for approximately 6-13 weeks. TAF/EVG Insert: TAF/EVG Insert (20/16 mg) administered rectally by study staff
Enrollment (Pre-dose) Period STARTED	23
Enrollment (Pre-dose) Period COMPLETED	21
Enrollment (Pre-dose) Period NOT COMPLETED	2
One TAF/EVG Insert Dose STARTED	21
One TAF/EVG Insert Dose COMPLETED	21
One TAF/EVG Insert Dose NOT COMPLETED	0
Washout Period STARTED	21
Washout Period COMPLETED	19
Washout Period NOT COMPLETED	2
Two TAF/EVG Inserts Dose STARTED	19
Two TAF/EVG Inserts Dose COMPLETED	19
Two TAF/EVG Inserts Dose NOT COMPLETED	0

Reasons for withdrawal

Reasons for withdrawal
Measure	Tenofovir Alafenamide (TAF)/Elvitegravir (EVG) Insert On the first dosing visit (Visit 3), participants will receive a single TAF/EVG Insert for rectal administration. On the second dosing visit (Visit 7), after a washout period of at least 7 days, participants will receive two TAF/EVG Inserts for rectal administration. Each participant will be on study for approximately 6-13 weeks. TAF/EVG Insert: TAF/EVG Insert (20/16 mg) administered rectally by study staff
Enrollment (Pre-dose) Period Refused Participation	2
Washout Period Refused Participation	2

Baseline Characteristics

Safety and Pharmacokinetic Study of Tenofovir Alafenamide (TAF)/Elvitegravir (EVG) Administered Rectally

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Tenofovir Alafenamide (TAF)/Elvitegravir (EVG) Insert n=23 Participants On the first dosing visit (Visit 3), participants will receive a single TAF/EVG Insert for rectal administration. On the second dosing visit (Visit 7), after a washout period of at least 7 days, participants will receive two TAF/EVG Inserts for rectal administration. Each participant will be on study for approximately 6-13 weeks. TAF/EVG Insert: TAF/EVG Insert (20/16 mg) administered rectally by study staff
Age, Continuous	34.0 years n=5 Participants
Age, Customized 24 years or Under	6 Participants n=5 Participants
Age, Customized 25-29 years	2 Participants n=5 Participants
Age, Customized 30-34 years	4 Participants n=5 Participants
Age, Customized 35-39 years	3 Participants n=5 Participants
Age, Customized 40-44 years	4 Participants n=5 Participants
Age, Customized 45-49 years	1 Participants n=5 Participants
Age, Customized 50+ years	3 Participants n=5 Participants
Sex/Gender, Customized Gender · Male	15 Participants n=5 Participants
Sex/Gender, Customized Gender · Female	6 Participants n=5 Participants
Sex/Gender, Customized Gender · Transgender Male	0 Participants n=5 Participants
Sex/Gender, Customized Gender · Transgender Female	1 Participants n=5 Participants
Sex/Gender, Customized Gender · Gender Nonconforming/Gender Variant	0 Participants n=5 Participants
Sex/Gender, Customized Gender · Self-identify	0 Participants n=5 Participants
Sex/Gender, Customized Gender · Prefer Not to Answer	0 Participants n=5 Participants
Sex/Gender, Customized Gender · Multiple Genders	1 Participants n=5 Participants
Sex: Female, Male Female	17 Participants n=5 Participants
Sex: Female, Male Male	6 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	2 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	21 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Race/Ethnicity, Customized Race · American Indian or Alaska Native	0 Participants n=5 Participants
Race/Ethnicity, Customized Race · Asian	0 Participants n=5 Participants
Race/Ethnicity, Customized Race · Black or African American	8 Participants n=5 Participants
Race/Ethnicity, Customized Race · Native Hawaiian or other Pacific Islander	0 Participants n=5 Participants
Race/Ethnicity, Customized Race · White	13 Participants n=5 Participants
Race/Ethnicity, Customized Race · Other	1 Participants n=5 Participants
Race/Ethnicity, Customized Race · Mixed	1 Participants n=5 Participants
Region of Enrollment United States · Pittsburgh	11 Participants n=5 Participants
Region of Enrollment United States · Birmingham	12 Participants n=5 Participants
Sexual Orientation Gay/Lesbian/Homosexual	11 Participants n=5 Participants
Sexual Orientation Bisexual	6 Participants n=5 Participants
Sexual Orientation Queer	0 Participants n=5 Participants
Sexual Orientation Two Spirit	0 Participants n=5 Participants
Sexual Orientation Straight/Heterosexual	5 Participants n=5 Participants
Sexual Orientation Additional Category	1 Participants n=5 Participants
Sexual Orientation Not sure	0 Participants n=5 Participants
Sexual Orientation Prefer not to Answer	0 Participants n=5 Participants
Participant Height (cm)	175.0 cm n=5 Participants
Participant Weight (kg)	93.0 kg n=5 Participants
Participant BMI (kg/m^2)	30.8 kg/m^2 n=5 Participants

PRIMARY outcome

Timeframe: Measured from Enrollment through Final Contact at Visit 11 with a median (IQR) of 76 (47, 292) days. COVID restrictions delayed first dosing 9-10 months in 5 participants. Follow-up time from first dosing was a median (IQR) of 34 (22, 39) days.

Population: All participants with dosing of one insert or two inserts.

Outcome measures

Outcome measures
Measure	One Insert n=21 Participants All participants who received a single TAF/EVG rectal insert	Two Inserts n=19 Participants All participants who received two TAF/EVG rectal inserts
Number of Participants With Grade 2 and Higher Adverse Events (AEs) Participants experiencing grade 2+ AE · Yes	1 Participants	1 Participants
Number of Participants With Grade 2 and Higher Adverse Events (AEs) Participants experiencing grade 2+ AE · No	20 Participants	18 Participants
Number of Participants With Grade 2 and Higher Adverse Events (AEs) Gastritis · Yes	0 Participants	1 Participants
Number of Participants With Grade 2 and Higher Adverse Events (AEs) Gastritis · No	21 Participants	18 Participants
Number of Participants With Grade 2 and Higher Adverse Events (AEs) Reactogenicity event · Yes	1 Participants	0 Participants
Number of Participants With Grade 2 and Higher Adverse Events (AEs) Reactogenicity event · No	20 Participants	19 Participants

PRIMARY outcome

Timeframe: Samples collected at baseline (pre dose), 1, 2, 4, 6, 24, 48, and 72 hours after each dose (up to 9 weeks after first dose)

Population: Baseline data were collected once at the enrollment visit prior to receiving both one insert and two inserts. Participants had post dose blood samples collected at 1, 2, 4, 6, 24, 48, and 72 hours (One insert (n=21); Two inserts (n=19))). Missed sample collection (One insert (24-hour missed (n=1)); Two inserts (48-hour missed (n=1) and 72-hour missed (n=1))). Unable to draw sample (One insert (72-hours (n=1))).

Based on laboratory evaluations on samples collected at baseline (pre dose), 1, 2, 4, 6, 24, 48, and 72 hours post dose

Outcome measures

Outcome measures
Measure	One Insert n=21 Participants All participants who received a single TAF/EVG rectal insert	Two Inserts n=19 Participants All participants who received two TAF/EVG rectal inserts
Elvitegravir (EVG) Concentration in Blood Baseline (Enrollment Visit)	NA pg/mL Below the Limit of Quantification	—
Elvitegravir (EVG) Concentration in Blood 1 hour postdosing	1010.0 pg/mL Interval 564.0 to 2050.0	1510.0 pg/mL Interval 812.0 to 1890.0
Elvitegravir (EVG) Concentration in Blood 2 hours postdosing	1230 pg/mL Interval 605.0 to 3090.0	2140.0 pg/mL Interval 1240.0 to 3420.0
Elvitegravir (EVG) Concentration in Blood 4 hours postdosing	1080.0 pg/mL Interval 450.0 to 1960.0	1740.0 pg/mL Interval 933.0 to 3560.0
Elvitegravir (EVG) Concentration in Blood 6 hours postdosing	713.0 pg/mL Interval 441.0 to 1730.0	1290.0 pg/mL Interval 825.0 to 2230.0
Elvitegravir (EVG) Concentration in Blood 24 hours postdosing	39.0 pg/mL Interval to 201.5 Below the Limit of Quantification	76.0 pg/mL Interval 35.0 to 471.0
Elvitegravir (EVG) Concentration in Blood 48 hours postdosing	NA pg/mL Below the Limit of Quantification	NA pg/mL Below the Limit of Quantification
Elvitegravir (EVG) Concentration in Blood 72 hours postdosing	NA pg/mL Below the Limit of Quantification	NA pg/mL Below the Limit of Quantification

PRIMARY outcome

Timeframe: Samples collected at 2, 4, 6, 24, 48, and 72 hours after each dose (up to 9 weeks after first dose)

Population: Participants are randomly assigned 1:1 to post dose rectal fluid sampling at either 2, 6, and 48 hours (One insert (n=10); Two inserts (n=9)) or 4, 24, and 72 hours (One insert (n=11); Two inserts (n=10)). Missed sample collection (One insert (24-hour missed (n=1) but replaced by 48-hour sample); Two inserts (48-hour missed (n=1))).

Based on laboratory evaluations on samples collected at 2, 4, 6, 24, 48, and 72 hours post dose

Outcome measures

Outcome measures
Measure	One Insert n=21 Participants All participants who received a single TAF/EVG rectal insert	Two Inserts n=19 Participants All participants who received two TAF/EVG rectal inserts
Elvitegravir (EVG) Concentration in Rectal Fluid 48 hours postdosing	16.9 ng/mL Interval 2.1 to 278.0	36.4 ng/mL Interval 1.0 to 807.5
Elvitegravir (EVG) Concentration in Rectal Fluid 2 hours postdosing	67542.0 ng/mL Interval 31652.0 to 338721.0	176672.0 ng/mL Interval 50962.0 to 731606.0
Elvitegravir (EVG) Concentration in Rectal Fluid 4 hours postdosing	125676.0 ng/mL Interval 72779.0 to 319693.0	93888.5 ng/mL Interval 49922.0 to 236267.0
Elvitegravir (EVG) Concentration in Rectal Fluid 6 hours postdosing	4095.5 ng/mL Interval 338.0 to 8708.0	7791.0 ng/mL Interval 619.0 to 13131.0
Elvitegravir (EVG) Concentration in Rectal Fluid 24 hours postdosing	2233.5 ng/mL Interval 574.0 to 3517.0	2596.5 ng/mL Interval 89.1 to 18664.0
Elvitegravir (EVG) Concentration in Rectal Fluid 72 hours postdosing	5.9 ng/mL Interval to 16.5 Below the Limit of Quantification	29.1 ng/mL Interval 2.3 to 58.1

PRIMARY outcome

Timeframe: Samples collected at 2, 24, 48, and 72 hours after each dose (up to 9 weeks after first dose)

Population: Participants are randomly assigned 1:1 to post dose rectal tissue sampling at either 2 and 48 hours (One insert (n=10)); Two inserts (n=9)) or 24 and 72 hours (One insert (n=11); Two inserts (n=10)). Missed sample collection (One insert (24-hour missed (n=1)); Two inserts (48-hour missed (n=1) and 72-hour missed (n=1))).

Based on laboratory evaluations on samples collected at 2, 24, 48, and 72 hours post dose

Outcome measures

Outcome measures
Measure	One Insert n=21 Participants All participants who received a single TAF/EVG rectal insert	Two Inserts n=19 Participants All participants who received two TAF/EVG rectal inserts
Elvitegravir (EVG) Concentration in Rectal Mucosal Tissue Homogenates 24 hours postdosing	NA ng/mg Below the Limit of Quantification	0.1 ng/mg Interval to 0.7 Below the Limit of Quantification
Elvitegravir (EVG) Concentration in Rectal Mucosal Tissue Homogenates 48 hours postdosing	NA ng/mg Below the Limit of Quantification	NA ng/mg Below the Limit of Quantification
Elvitegravir (EVG) Concentration in Rectal Mucosal Tissue Homogenates 72 hours postdosing	NA ng/mg Below the Limit of Quantification	NA ng/mg Below the Limit of Quantification
Elvitegravir (EVG) Concentration in Rectal Mucosal Tissue Homogenates 2 hours postdosing	5.4 ng/mg Interval 0.6 to 10.2	9.0 ng/mg Interval 5.3 to 35.3

PRIMARY outcome

Timeframe: Samples collected at baseline (pre dose), 1, 2, 4, 6, 24, 48, and 72 hours after each dose (up to 9 weeks after first dose)

Based on laboratory evaluations on samples collected at baseline (pre dose), 1, 2, 4, 6, 24, 48, and 72 hours post dose

Outcome measures

Outcome measures
Measure	One Insert n=21 Participants All participants who received a single TAF/EVG rectal insert	Two Inserts n=19 Participants All participants who received two TAF/EVG rectal inserts
Tenofovir Alafenamide (TAF) Concentration in Blood Baseline (Enrollment visit)	NA pg/mL Below the Limit of Quantification	—
Tenofovir Alafenamide (TAF) Concentration in Blood 1 hour postdosing	29500.0 pg/mL Interval 16700.0 to 37900.0	40400.0 pg/mL Interval 22600.0 to 65900.0
Tenofovir Alafenamide (TAF) Concentration in Blood 2 hours postdosing	14000.0 pg/mL Interval 5850.0 to 32100.0	26200.0 pg/mL Interval 8970.0 to 54300.0
Tenofovir Alafenamide (TAF) Concentration in Blood 4 hours postdosing	747.0 pg/mL Interval 169.0 to 1660.0	1350.0 pg/mL Interval 525.0 to 6650.0
Tenofovir Alafenamide (TAF) Concentration in Blood 6 hours postdosing	56.0 pg/mL Interval to 222.0 Below the Limit of Quantification	95.0 pg/mL Interval 27.0 to 427.0
Tenofovir Alafenamide (TAF) Concentration in Blood 24 hours postdosing	NA pg/mL Below the Limit of Quantification	NA pg/mL Below the Limit of Quantification
Tenofovir Alafenamide (TAF) Concentration in Blood 48 hours postdosing	NA pg/mL Below the Limit of Quantification	NA pg/mL Below the Limit of Quantification
Tenofovir Alafenamide (TAF) Concentration in Blood 72 hours postdosing	NA pg/mL Below the Limit of Quantification	NA pg/mL Below the Limit of Quantification

PRIMARY outcome

Timeframe: Samples collected at 2, 4, 6, 24, 48, and 72 hours after each dose (up to 9 weeks after first dose)

Based on laboratory evaluations on samples collected at 2, 4, 6, 24, 48, and 72 hours post dose

Outcome measures

Outcome measures
Measure	One Insert n=21 Participants All participants who received a single TAF/EVG rectal insert	Two Inserts n=19 Participants All participants who received two TAF/EVG rectal inserts
Tenofovir Alafenamide (TAF) Concentration in Rectal Fluid 2 hours postdosing	1394.0 ng/mL Interval 358.0 to 6085.0	531.0 ng/mL Interval 196.0 to 16080.0
Tenofovir Alafenamide (TAF) Concentration in Rectal Fluid 4 hours postdosing	1279.0 ng/mL Interval 53.7 to 6056.0	954.0 ng/mL Interval 308.0 to 6008.0
Tenofovir Alafenamide (TAF) Concentration in Rectal Fluid 6 hours postdosing	10.8 ng/mL Interval 1.2 to 30.1	12.4 ng/mL Interval 1.3 to 58.4
Tenofovir Alafenamide (TAF) Concentration in Rectal Fluid 24 hours postdosing	NA ng/mL Below the Limit of Quantification	0.6 ng/mL Interval to 3.9 Below the Limit of Quantification
Tenofovir Alafenamide (TAF) Concentration in Rectal Fluid 48 hours postdosing	NA ng/mL Below the Limit of Quantification	NA ng/mL Below the Limit of Quantification
Tenofovir Alafenamide (TAF) Concentration in Rectal Fluid 72 hours postdosing	NA ng/mL Below the Limit of Quantification	NA ng/mL Below the Limit of Quantification

PRIMARY outcome

Timeframe: Samples collected at 2, 24, 48, and 72 hours after each dose (up to 9 weeks after first dose)

Based on laboratory evaluations on samples collected at 2, 24, 48, and 72 hours post dose

Outcome measures

Outcome measures
Measure	One Insert n=21 Participants All participants who received a single TAF/EVG rectal insert	Two Inserts n=19 Participants All participants who received two TAF/EVG rectal inserts
Tenofovir Alafenamide (TAF) Concentration in Rectal Mucosal Tissue Homogenates 2 hours postdosing	NA ng/mg Interval to 0.1 Below the Limit of Quantification	NA ng/mg Interval to 0.1 Below the Limit of Quantification
Tenofovir Alafenamide (TAF) Concentration in Rectal Mucosal Tissue Homogenates 24 hours postdosing	NA ng/mg Below the Limit of Quantification	NA ng/mg Below the Limit of Quantification
Tenofovir Alafenamide (TAF) Concentration in Rectal Mucosal Tissue Homogenates 48 hours postdosing	NA ng/mg Below the Limit of Quantification	NA ng/mg Below the Limit of Quantification
Tenofovir Alafenamide (TAF) Concentration in Rectal Mucosal Tissue Homogenates 72 hours postdosing	NA ng/mg Below the Limit of Quantification	NA ng/mg Below the Limit of Quantification

PRIMARY outcome

Timeframe: Samples collected at baseline (pre dose), 1, 2, 4, 6, 24, 48, and 72 hours after each dose (up to 9 weeks after first dose)

Based on laboratory evaluations on samples collected at baseline (pre dose), 1, 2, 4, 6, 24, 48, and 72 hours post dose

Outcome measures

Outcome measures
Measure	One Insert n=21 Participants All participants who received a single TAF/EVG rectal insert	Two Inserts n=19 Participants All participants who received two TAF/EVG rectal inserts
Tenofovir (TFV) Concentration in Blood Baseline (Enrollment visit)	NA pg/mL Below the Limit of Quantification	—
Tenofovir (TFV) Concentration in Blood 1 hour postdosing	1290.0 pg/mL Interval 796.0 to 1880.0	2140.0 pg/mL Interval 1520.0 to 3070.0
Tenofovir (TFV) Concentration in Blood 2 hours postdosing	2080.0 pg/mL Interval 1690.0 to 3430.0	3700.0 pg/mL Interval 2490.0 to 5170.0
Tenofovir (TFV) Concentration in Blood 4 hours postdosing	2380.0 pg/mL Interval 1510.0 to 3580.0	4080.0 pg/mL Interval 2360.0 to 5520.0
Tenofovir (TFV) Concentration in Blood 6 hours postdosing	1780.0 pg/mL Interval 1050.0 to 3010.0	3420.0 pg/mL Interval 1910.0 to 4640.0
Tenofovir (TFV) Concentration in Blood 24 hours postdosing	1105.0 pg/mL Interval 558.5 to 1995.0	1910.0 pg/mL Interval 1100.0 to 3210.0
Tenofovir (TFV) Concentration in Blood 48 hours postdosing	570.0 pg/mL Interval 311.0 to 1020.0	1085.0 pg/mL Interval 852.0 to 1480.0
Tenofovir (TFV) Concentration in Blood 72 hours postdosing	340.5 pg/mL Interval 133.0 to 696.0	687.0 pg/mL Interval 438.0 to 841.0

PRIMARY outcome

Timeframe: Samples collected at 2, 4, 6, 24, 48, and 72 hours after each dose (up to 9 weeks after first dose)

Based on laboratory evaluations on samples collected at 2, 4, 6, 24, 48, and 72 hours post dose

Outcome measures

Outcome measures
Measure	One Insert n=21 Participants All participants who received a single TAF/EVG rectal insert	Two Inserts n=19 Participants All participants who received two TAF/EVG rectal inserts
Tenofovir (TFV) Concentration in Rectal Fluid 2 hours postdosing	18086.0 ng/mL Interval 15509.0 to 34292.0	43188.0 ng/mL Interval 26667.0 to 78240.0
Tenofovir (TFV) Concentration in Rectal Fluid 4 hours post dosing	85434.0 ng/mL Interval 37836.0 to 126430.0	100834.5 ng/mL Interval 58003.0 to 141675.0
Tenofovir (TFV) Concentration in Rectal Fluid 6 hours postdosing	9794.0 ng/mL Interval 2076.5 to 18268.0	10214.5 ng/mL Interval 5255.0 to 26800.5
Tenofovir (TFV) Concentration in Rectal Fluid 24 hours postdosing	2909.0 ng/mL Interval 1744.0 to 8465.0	8276.5 ng/mL Interval 5261.0 to 23540.0
Tenofovir (TFV) Concentration in Rectal Fluid 48 hours postdosing	924.0 ng/mL Interval 337.0 to 2010.0	1057.0 ng/mL Interval 687.0 to 2289.0
Tenofovir (TFV) Concentration in Rectal Fluid 72 hours postdosing	380.0 ng/mL Interval 41.8 to 881.0	545.5 ng/mL Interval 78.2 to 1011.0

PRIMARY outcome

Timeframe: Samples collected at 2, 24, 48, and 72 hours after each dose (up to 9 weeks after first dose)

Based on laboratory evaluations on samples collected at 2, 24, 48, and 72 hours post dose

Outcome measures

Outcome measures
Measure	One Insert n=21 Participants All participants who received a single TAF/EVG rectal insert	Two Inserts n=19 Participants All participants who received two TAF/EVG rectal inserts
Tenofovir (TFV) Concentration in Rectal Mucosal Tissue Homogenates 2 hours postdosing	15.4 ng/mg Interval 3.2 to 35.6	28.4 ng/mg Interval 16.7 to 40.6
Tenofovir (TFV) Concentration in Rectal Mucosal Tissue Homogenates 24 hours postdosing	1.5 ng/mg Interval 0.2 to 9.8	10.2 ng/mg Interval 2.5 to 21.9
Tenofovir (TFV) Concentration in Rectal Mucosal Tissue Homogenates 48 hours postdosing	2.3 ng/mg Interval to 5.1 Below the Limit of Quantification	3.3 ng/mg Interval 2.3 to 5.5
Tenofovir (TFV) Concentration in Rectal Mucosal Tissue Homogenates 72 hours postdosing	NA ng/mg Interval to 2.1 Below the Limit of Quantification	1.0 ng/mg Interval 0.4 to 5.2

PRIMARY outcome

Timeframe: Samples collected at 2, 24, 48, and 72 hours after each dose (up to 9 weeks after first dose)

Based on laboratory evaluations on samples collected at 2, 24, 48, and 72 hours post dose

Outcome measures

Outcome measures
Measure	One Insert n=21 Participants All participants who received a single TAF/EVG rectal insert	Two Inserts n=19 Participants All participants who received two TAF/EVG rectal inserts
Tenofovir Diphosphate (TFV-DP) Concentration in Rectal Mucosal Tissue Cell Isolates 2 hours postdosing	8219.0 fmol/10^6 Cells Interval 3443.0 to 12723.0	6230.0 fmol/10^6 Cells Interval 5704.0 to 12783.0
Tenofovir Diphosphate (TFV-DP) Concentration in Rectal Mucosal Tissue Cell Isolates 24 hours postdosing	2315.5 fmol/10^6 Cells Interval 335.0 to 8055.0	6727.0 fmol/10^6 Cells Interval 2189.0 to 12295.0
Tenofovir Diphosphate (TFV-DP) Concentration in Rectal Mucosal Tissue Cell Isolates 48 hours postdosing	2459.0 fmol/10^6 Cells Interval 89.0 to 4559.0	2822.0 fmol/10^6 Cells Interval 815.0 to 3599.0
Tenofovir Diphosphate (TFV-DP) Concentration in Rectal Mucosal Tissue Cell Isolates 72 hours postdosing	149.0 fmol/10^6 Cells Interval 43.6 to 1075.0	2022.0 fmol/10^6 Cells Interval 347.0 to 3122.0

SECONDARY outcome

Timeframe: 24 hours after each dose (Visits 4 and 8) (up to 9 weeks after first dose)

Population: All participants who completed the follow-up computer-administered self-interview (CASI) questionnaire at 24 hours post-dosing.

Response for "Overall, how easy or difficult was it to use the study product when inserted by clinic staff?

Outcome measures

Outcome measures
Measure	One Insert n=21 Participants All participants who received a single TAF/EVG rectal insert	Two Inserts n=19 Participants All participants who received two TAF/EVG rectal inserts
Participant Self-report Rectal Insert Acceptability - Ease of Use Very difficult	0 Participants	0 Participants
Participant Self-report Rectal Insert Acceptability - Ease of Use Difficult	0 Participants	0 Participants
Participant Self-report Rectal Insert Acceptability - Ease of Use Easy	7 Participants	8 Participants
Participant Self-report Rectal Insert Acceptability - Ease of Use Very easy	14 Participants	11 Participants
Participant Self-report Rectal Insert Acceptability - Ease of Use Decline to answer	0 Participants	0 Participants

SECONDARY outcome

Timeframe: 24 hours after each dose (Visits 4 and 8) (up to 9 weeks after first dose)

Population: All participants who completed the follow-up computer-administered self-interview (CASI) questionnaire at 24 hours post-dosing.

Response for "How did it feel to have the insert inside you?"

Outcome measures

Outcome measures
Measure	One Insert n=21 Participants All participants who received a single TAF/EVG rectal insert	Two Inserts n=19 Participants All participants who received two TAF/EVG rectal inserts
Participant Self-report Rectal Insert Acceptability - Feeling When Inserted Very comfortable	8 Participants	8 Participants
Participant Self-report Rectal Insert Acceptability - Feeling When Inserted Comfortable	10 Participants	10 Participants
Participant Self-report Rectal Insert Acceptability - Feeling When Inserted Uncomfortable	2 Participants	1 Participants
Participant Self-report Rectal Insert Acceptability - Feeling When Inserted Very uncomfortable	0 Participants	0 Participants
Participant Self-report Rectal Insert Acceptability - Feeling When Inserted Decline to answer	1 Participants	0 Participants

SECONDARY outcome

Timeframe: 24 hours after each dose (Visits 4 and 8) (up to 9 weeks after first dose)

Population: All participants who completed the follow-up computer-administered self-interview (CASI) questionnaire at 24 hours post-dosing.

Responses for questions related to problems with Rectal Insert

Outcome measures

Outcome measures
Measure	One Insert n=21 Participants All participants who received a single TAF/EVG rectal insert	Two Inserts n=19 Participants All participants who received two TAF/EVG rectal inserts
Participant Self-report Rectal Insert Acceptability - Problems With Rectal Insert Did you have any problems using the study insert after it was inserted? · No	20 Participants	19 Participants
Participant Self-report Rectal Insert Acceptability - Problems With Rectal Insert Did you have any problems using the study insert after it was inserted? · Yes	1 Participants	0 Participants
Participant Self-report Rectal Insert Acceptability - Problems With Rectal Insert Did you have any problems using the study insert after it was inserted? · Decline to answer	0 Participants	0 Participants
Participant Self-report Rectal Insert Acceptability - Problems With Rectal Insert Did you experience any leakage after you used the insert? · No	20 Participants	18 Participants
Participant Self-report Rectal Insert Acceptability - Problems With Rectal Insert Did you experience any leakage after you used the insert? · Yes	1 Participants	1 Participants
Participant Self-report Rectal Insert Acceptability - Problems With Rectal Insert Did you experience any leakage after you used the insert? · Decline to answer	0 Participants	0 Participants
Participant Self-report Rectal Insert Acceptability - Problems With Rectal Insert Since your last study visit, have you experienced any soiling of your underwear or linens? · No	20 Participants	18 Participants
Participant Self-report Rectal Insert Acceptability - Problems With Rectal Insert Since your last study visit, have you experienced any soiling of your underwear or linens? · Yes	1 Participants	1 Participants
Participant Self-report Rectal Insert Acceptability - Problems With Rectal Insert Since your last study visit, have you experienced any soiling of your underwear or linens? · Decline to answer	0 Participants	0 Participants
Participant Self-report Rectal Insert Acceptability - Problems With Rectal Insert Since your last study visit, have you experienced any diarrhea? · No	20 Participants	18 Participants
Participant Self-report Rectal Insert Acceptability - Problems With Rectal Insert Since your last study visit, have you experienced any diarrhea? · Yes	1 Participants	1 Participants
Participant Self-report Rectal Insert Acceptability - Problems With Rectal Insert Since your last study visit, have you experienced any diarrhea? · Decline to answer	0 Participants	0 Participants
Participant Self-report Rectal Insert Acceptability - Problems With Rectal Insert Since your last visit, have you experienced any other stomach or abdominal problems? · No	12 Participants	9 Participants
Participant Self-report Rectal Insert Acceptability - Problems With Rectal Insert Since your last visit, have you experienced any other stomach or abdominal problems? · Yes	9 Participants	10 Participants
Participant Self-report Rectal Insert Acceptability - Problems With Rectal Insert Since your last visit, have you experienced any other stomach or abdominal problems? · Decline to answer	0 Participants	0 Participants

Adverse Events

Baseline (Pre-dosing)

Serious events: 0 serious events

Other events: 3 other events

Deaths: 0 deaths

One Insert

Serious events: 0 serious events

Other events: 4 other events

Deaths: 0 deaths

Two Inserts

Serious events: 0 serious events

Other events: 4 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Baseline (Pre-dosing) n=23 participants at risk All participants who were enrolled in the study, prior to any inserts.	One Insert n=21 participants at risk All participants who received a single TAF/EVG rectal insert	Two Inserts n=19 participants at risk All participants who received two TAF/EVG rectal inserts
Gastrointestinal disorders Gastritis	0.00% 0/23 • Measured from Enrollment through Final Contact at Visit 11 with a median (IQR) of 76 (47, 292) days. COVID restrictions delayed first dosing 9-10 months in 5 participants. Follow-up time from first dosing was a median (IQR) of 34 (22, 39) days. COVID-19 pandemic related scheduling delays occurred for seven participants resulting in collection of pre-dose adverse events over a 9-10 month period prior to first dosing. Of the 23 participants enrolled, two of these seven participants did not return for first dosing, thus 21 participants received the one insert dose.	0.00% 0/21 • Measured from Enrollment through Final Contact at Visit 11 with a median (IQR) of 76 (47, 292) days. COVID restrictions delayed first dosing 9-10 months in 5 participants. Follow-up time from first dosing was a median (IQR) of 34 (22, 39) days. COVID-19 pandemic related scheduling delays occurred for seven participants resulting in collection of pre-dose adverse events over a 9-10 month period prior to first dosing. Of the 23 participants enrolled, two of these seven participants did not return for first dosing, thus 21 participants received the one insert dose.	5.3% 1/19 • Number of events 1 • Measured from Enrollment through Final Contact at Visit 11 with a median (IQR) of 76 (47, 292) days. COVID restrictions delayed first dosing 9-10 months in 5 participants. Follow-up time from first dosing was a median (IQR) of 34 (22, 39) days. COVID-19 pandemic related scheduling delays occurred for seven participants resulting in collection of pre-dose adverse events over a 9-10 month period prior to first dosing. Of the 23 participants enrolled, two of these seven participants did not return for first dosing, thus 21 participants received the one insert dose.
General disorders Reactogenicity event	4.3% 1/23 • Number of events 1 • Measured from Enrollment through Final Contact at Visit 11 with a median (IQR) of 76 (47, 292) days. COVID restrictions delayed first dosing 9-10 months in 5 participants. Follow-up time from first dosing was a median (IQR) of 34 (22, 39) days. COVID-19 pandemic related scheduling delays occurred for seven participants resulting in collection of pre-dose adverse events over a 9-10 month period prior to first dosing. Of the 23 participants enrolled, two of these seven participants did not return for first dosing, thus 21 participants received the one insert dose.	9.5% 2/21 • Number of events 2 • Measured from Enrollment through Final Contact at Visit 11 with a median (IQR) of 76 (47, 292) days. COVID restrictions delayed first dosing 9-10 months in 5 participants. Follow-up time from first dosing was a median (IQR) of 34 (22, 39) days. COVID-19 pandemic related scheduling delays occurred for seven participants resulting in collection of pre-dose adverse events over a 9-10 month period prior to first dosing. Of the 23 participants enrolled, two of these seven participants did not return for first dosing, thus 21 participants received the one insert dose.	5.3% 1/19 • Number of events 1 • Measured from Enrollment through Final Contact at Visit 11 with a median (IQR) of 76 (47, 292) days. COVID restrictions delayed first dosing 9-10 months in 5 participants. Follow-up time from first dosing was a median (IQR) of 34 (22, 39) days. COVID-19 pandemic related scheduling delays occurred for seven participants resulting in collection of pre-dose adverse events over a 9-10 month period prior to first dosing. Of the 23 participants enrolled, two of these seven participants did not return for first dosing, thus 21 participants received the one insert dose.
Musculoskeletal and connective tissue disorders Arthralgia	4.3% 1/23 • Number of events 1 • Measured from Enrollment through Final Contact at Visit 11 with a median (IQR) of 76 (47, 292) days. COVID restrictions delayed first dosing 9-10 months in 5 participants. Follow-up time from first dosing was a median (IQR) of 34 (22, 39) days. COVID-19 pandemic related scheduling delays occurred for seven participants resulting in collection of pre-dose adverse events over a 9-10 month period prior to first dosing. Of the 23 participants enrolled, two of these seven participants did not return for first dosing, thus 21 participants received the one insert dose.	0.00% 0/21 • Measured from Enrollment through Final Contact at Visit 11 with a median (IQR) of 76 (47, 292) days. COVID restrictions delayed first dosing 9-10 months in 5 participants. Follow-up time from first dosing was a median (IQR) of 34 (22, 39) days. COVID-19 pandemic related scheduling delays occurred for seven participants resulting in collection of pre-dose adverse events over a 9-10 month period prior to first dosing. Of the 23 participants enrolled, two of these seven participants did not return for first dosing, thus 21 participants received the one insert dose.	0.00% 0/19 • Measured from Enrollment through Final Contact at Visit 11 with a median (IQR) of 76 (47, 292) days. COVID restrictions delayed first dosing 9-10 months in 5 participants. Follow-up time from first dosing was a median (IQR) of 34 (22, 39) days. COVID-19 pandemic related scheduling delays occurred for seven participants resulting in collection of pre-dose adverse events over a 9-10 month period prior to first dosing. Of the 23 participants enrolled, two of these seven participants did not return for first dosing, thus 21 participants received the one insert dose.
Infections and infestations Urinary tract infection	4.3% 1/23 • Number of events 3 • Measured from Enrollment through Final Contact at Visit 11 with a median (IQR) of 76 (47, 292) days. COVID restrictions delayed first dosing 9-10 months in 5 participants. Follow-up time from first dosing was a median (IQR) of 34 (22, 39) days. COVID-19 pandemic related scheduling delays occurred for seven participants resulting in collection of pre-dose adverse events over a 9-10 month period prior to first dosing. Of the 23 participants enrolled, two of these seven participants did not return for first dosing, thus 21 participants received the one insert dose.	0.00% 0/21 • Measured from Enrollment through Final Contact at Visit 11 with a median (IQR) of 76 (47, 292) days. COVID restrictions delayed first dosing 9-10 months in 5 participants. Follow-up time from first dosing was a median (IQR) of 34 (22, 39) days. COVID-19 pandemic related scheduling delays occurred for seven participants resulting in collection of pre-dose adverse events over a 9-10 month period prior to first dosing. Of the 23 participants enrolled, two of these seven participants did not return for first dosing, thus 21 participants received the one insert dose.	0.00% 0/19 • Measured from Enrollment through Final Contact at Visit 11 with a median (IQR) of 76 (47, 292) days. COVID restrictions delayed first dosing 9-10 months in 5 participants. Follow-up time from first dosing was a median (IQR) of 34 (22, 39) days. COVID-19 pandemic related scheduling delays occurred for seven participants resulting in collection of pre-dose adverse events over a 9-10 month period prior to first dosing. Of the 23 participants enrolled, two of these seven participants did not return for first dosing, thus 21 participants received the one insert dose.
Nervous system disorders Extrapyramidal disorder	4.3% 1/23 • Number of events 1 • Measured from Enrollment through Final Contact at Visit 11 with a median (IQR) of 76 (47, 292) days. COVID restrictions delayed first dosing 9-10 months in 5 participants. Follow-up time from first dosing was a median (IQR) of 34 (22, 39) days. COVID-19 pandemic related scheduling delays occurred for seven participants resulting in collection of pre-dose adverse events over a 9-10 month period prior to first dosing. Of the 23 participants enrolled, two of these seven participants did not return for first dosing, thus 21 participants received the one insert dose.	0.00% 0/21 • Measured from Enrollment through Final Contact at Visit 11 with a median (IQR) of 76 (47, 292) days. COVID restrictions delayed first dosing 9-10 months in 5 participants. Follow-up time from first dosing was a median (IQR) of 34 (22, 39) days. COVID-19 pandemic related scheduling delays occurred for seven participants resulting in collection of pre-dose adverse events over a 9-10 month period prior to first dosing. Of the 23 participants enrolled, two of these seven participants did not return for first dosing, thus 21 participants received the one insert dose.	0.00% 0/19 • Measured from Enrollment through Final Contact at Visit 11 with a median (IQR) of 76 (47, 292) days. COVID restrictions delayed first dosing 9-10 months in 5 participants. Follow-up time from first dosing was a median (IQR) of 34 (22, 39) days. COVID-19 pandemic related scheduling delays occurred for seven participants resulting in collection of pre-dose adverse events over a 9-10 month period prior to first dosing. Of the 23 participants enrolled, two of these seven participants did not return for first dosing, thus 21 participants received the one insert dose.
General disorders Fatigue	0.00% 0/23 • Measured from Enrollment through Final Contact at Visit 11 with a median (IQR) of 76 (47, 292) days. COVID restrictions delayed first dosing 9-10 months in 5 participants. Follow-up time from first dosing was a median (IQR) of 34 (22, 39) days. COVID-19 pandemic related scheduling delays occurred for seven participants resulting in collection of pre-dose adverse events over a 9-10 month period prior to first dosing. Of the 23 participants enrolled, two of these seven participants did not return for first dosing, thus 21 participants received the one insert dose.	4.8% 1/21 • Number of events 1 • Measured from Enrollment through Final Contact at Visit 11 with a median (IQR) of 76 (47, 292) days. COVID restrictions delayed first dosing 9-10 months in 5 participants. Follow-up time from first dosing was a median (IQR) of 34 (22, 39) days. COVID-19 pandemic related scheduling delays occurred for seven participants resulting in collection of pre-dose adverse events over a 9-10 month period prior to first dosing. Of the 23 participants enrolled, two of these seven participants did not return for first dosing, thus 21 participants received the one insert dose.	0.00% 0/19 • Measured from Enrollment through Final Contact at Visit 11 with a median (IQR) of 76 (47, 292) days. COVID restrictions delayed first dosing 9-10 months in 5 participants. Follow-up time from first dosing was a median (IQR) of 34 (22, 39) days. COVID-19 pandemic related scheduling delays occurred for seven participants resulting in collection of pre-dose adverse events over a 9-10 month period prior to first dosing. Of the 23 participants enrolled, two of these seven participants did not return for first dosing, thus 21 participants received the one insert dose.
Gastrointestinal disorders Anal erythema	0.00% 0/23 • Measured from Enrollment through Final Contact at Visit 11 with a median (IQR) of 76 (47, 292) days. COVID restrictions delayed first dosing 9-10 months in 5 participants. Follow-up time from first dosing was a median (IQR) of 34 (22, 39) days. COVID-19 pandemic related scheduling delays occurred for seven participants resulting in collection of pre-dose adverse events over a 9-10 month period prior to first dosing. Of the 23 participants enrolled, two of these seven participants did not return for first dosing, thus 21 participants received the one insert dose.	4.8% 1/21 • Number of events 1 • Measured from Enrollment through Final Contact at Visit 11 with a median (IQR) of 76 (47, 292) days. COVID restrictions delayed first dosing 9-10 months in 5 participants. Follow-up time from first dosing was a median (IQR) of 34 (22, 39) days. COVID-19 pandemic related scheduling delays occurred for seven participants resulting in collection of pre-dose adverse events over a 9-10 month period prior to first dosing. Of the 23 participants enrolled, two of these seven participants did not return for first dosing, thus 21 participants received the one insert dose.	0.00% 0/19 • Measured from Enrollment through Final Contact at Visit 11 with a median (IQR) of 76 (47, 292) days. COVID restrictions delayed first dosing 9-10 months in 5 participants. Follow-up time from first dosing was a median (IQR) of 34 (22, 39) days. COVID-19 pandemic related scheduling delays occurred for seven participants resulting in collection of pre-dose adverse events over a 9-10 month period prior to first dosing. Of the 23 participants enrolled, two of these seven participants did not return for first dosing, thus 21 participants received the one insert dose.
Gastrointestinal disorders Anal fissure	0.00% 0/23 • Measured from Enrollment through Final Contact at Visit 11 with a median (IQR) of 76 (47, 292) days. COVID restrictions delayed first dosing 9-10 months in 5 participants. Follow-up time from first dosing was a median (IQR) of 34 (22, 39) days. COVID-19 pandemic related scheduling delays occurred for seven participants resulting in collection of pre-dose adverse events over a 9-10 month period prior to first dosing. Of the 23 participants enrolled, two of these seven participants did not return for first dosing, thus 21 participants received the one insert dose.	0.00% 0/21 • Measured from Enrollment through Final Contact at Visit 11 with a median (IQR) of 76 (47, 292) days. COVID restrictions delayed first dosing 9-10 months in 5 participants. Follow-up time from first dosing was a median (IQR) of 34 (22, 39) days. COVID-19 pandemic related scheduling delays occurred for seven participants resulting in collection of pre-dose adverse events over a 9-10 month period prior to first dosing. Of the 23 participants enrolled, two of these seven participants did not return for first dosing, thus 21 participants received the one insert dose.	5.3% 1/19 • Number of events 1 • Measured from Enrollment through Final Contact at Visit 11 with a median (IQR) of 76 (47, 292) days. COVID restrictions delayed first dosing 9-10 months in 5 participants. Follow-up time from first dosing was a median (IQR) of 34 (22, 39) days. COVID-19 pandemic related scheduling delays occurred for seven participants resulting in collection of pre-dose adverse events over a 9-10 month period prior to first dosing. Of the 23 participants enrolled, two of these seven participants did not return for first dosing, thus 21 participants received the one insert dose.
Reproductive system and breast disorders Vulvovaginal discomfort	0.00% 0/23 • Measured from Enrollment through Final Contact at Visit 11 with a median (IQR) of 76 (47, 292) days. COVID restrictions delayed first dosing 9-10 months in 5 participants. Follow-up time from first dosing was a median (IQR) of 34 (22, 39) days. COVID-19 pandemic related scheduling delays occurred for seven participants resulting in collection of pre-dose adverse events over a 9-10 month period prior to first dosing. Of the 23 participants enrolled, two of these seven participants did not return for first dosing, thus 21 participants received the one insert dose.	0.00% 0/21 • Measured from Enrollment through Final Contact at Visit 11 with a median (IQR) of 76 (47, 292) days. COVID restrictions delayed first dosing 9-10 months in 5 participants. Follow-up time from first dosing was a median (IQR) of 34 (22, 39) days. COVID-19 pandemic related scheduling delays occurred for seven participants resulting in collection of pre-dose adverse events over a 9-10 month period prior to first dosing. Of the 23 participants enrolled, two of these seven participants did not return for first dosing, thus 21 participants received the one insert dose.	5.3% 1/19 • Number of events 1 • Measured from Enrollment through Final Contact at Visit 11 with a median (IQR) of 76 (47, 292) days. COVID restrictions delayed first dosing 9-10 months in 5 participants. Follow-up time from first dosing was a median (IQR) of 34 (22, 39) days. COVID-19 pandemic related scheduling delays occurred for seven participants resulting in collection of pre-dose adverse events over a 9-10 month period prior to first dosing. Of the 23 participants enrolled, two of these seven participants did not return for first dosing, thus 21 participants received the one insert dose.
Gastrointestinal disorders Diarrhoea	0.00% 0/23 • Measured from Enrollment through Final Contact at Visit 11 with a median (IQR) of 76 (47, 292) days. COVID restrictions delayed first dosing 9-10 months in 5 participants. Follow-up time from first dosing was a median (IQR) of 34 (22, 39) days. COVID-19 pandemic related scheduling delays occurred for seven participants resulting in collection of pre-dose adverse events over a 9-10 month period prior to first dosing. Of the 23 participants enrolled, two of these seven participants did not return for first dosing, thus 21 participants received the one insert dose.	4.8% 1/21 • Number of events 1 • Measured from Enrollment through Final Contact at Visit 11 with a median (IQR) of 76 (47, 292) days. COVID restrictions delayed first dosing 9-10 months in 5 participants. Follow-up time from first dosing was a median (IQR) of 34 (22, 39) days. COVID-19 pandemic related scheduling delays occurred for seven participants resulting in collection of pre-dose adverse events over a 9-10 month period prior to first dosing. Of the 23 participants enrolled, two of these seven participants did not return for first dosing, thus 21 participants received the one insert dose.	0.00% 0/19 • Measured from Enrollment through Final Contact at Visit 11 with a median (IQR) of 76 (47, 292) days. COVID restrictions delayed first dosing 9-10 months in 5 participants. Follow-up time from first dosing was a median (IQR) of 34 (22, 39) days. COVID-19 pandemic related scheduling delays occurred for seven participants resulting in collection of pre-dose adverse events over a 9-10 month period prior to first dosing. Of the 23 participants enrolled, two of these seven participants did not return for first dosing, thus 21 participants received the one insert dose.
Gastrointestinal disorders Abdominal discomfort	0.00% 0/23 • Measured from Enrollment through Final Contact at Visit 11 with a median (IQR) of 76 (47, 292) days. COVID restrictions delayed first dosing 9-10 months in 5 participants. Follow-up time from first dosing was a median (IQR) of 34 (22, 39) days. COVID-19 pandemic related scheduling delays occurred for seven participants resulting in collection of pre-dose adverse events over a 9-10 month period prior to first dosing. Of the 23 participants enrolled, two of these seven participants did not return for first dosing, thus 21 participants received the one insert dose.	4.8% 1/21 • Number of events 1 • Measured from Enrollment through Final Contact at Visit 11 with a median (IQR) of 76 (47, 292) days. COVID restrictions delayed first dosing 9-10 months in 5 participants. Follow-up time from first dosing was a median (IQR) of 34 (22, 39) days. COVID-19 pandemic related scheduling delays occurred for seven participants resulting in collection of pre-dose adverse events over a 9-10 month period prior to first dosing. Of the 23 participants enrolled, two of these seven participants did not return for first dosing, thus 21 participants received the one insert dose.	0.00% 0/19 • Measured from Enrollment through Final Contact at Visit 11 with a median (IQR) of 76 (47, 292) days. COVID restrictions delayed first dosing 9-10 months in 5 participants. Follow-up time from first dosing was a median (IQR) of 34 (22, 39) days. COVID-19 pandemic related scheduling delays occurred for seven participants resulting in collection of pre-dose adverse events over a 9-10 month period prior to first dosing. Of the 23 participants enrolled, two of these seven participants did not return for first dosing, thus 21 participants received the one insert dose.
Blood and lymphatic system disorders Thrombocytopenia	0.00% 0/23 • Measured from Enrollment through Final Contact at Visit 11 with a median (IQR) of 76 (47, 292) days. COVID restrictions delayed first dosing 9-10 months in 5 participants. Follow-up time from first dosing was a median (IQR) of 34 (22, 39) days. COVID-19 pandemic related scheduling delays occurred for seven participants resulting in collection of pre-dose adverse events over a 9-10 month period prior to first dosing. Of the 23 participants enrolled, two of these seven participants did not return for first dosing, thus 21 participants received the one insert dose.	0.00% 0/21 • Measured from Enrollment through Final Contact at Visit 11 with a median (IQR) of 76 (47, 292) days. COVID restrictions delayed first dosing 9-10 months in 5 participants. Follow-up time from first dosing was a median (IQR) of 34 (22, 39) days. COVID-19 pandemic related scheduling delays occurred for seven participants resulting in collection of pre-dose adverse events over a 9-10 month period prior to first dosing. Of the 23 participants enrolled, two of these seven participants did not return for first dosing, thus 21 participants received the one insert dose.	5.3% 1/19 • Number of events 1 • Measured from Enrollment through Final Contact at Visit 11 with a median (IQR) of 76 (47, 292) days. COVID restrictions delayed first dosing 9-10 months in 5 participants. Follow-up time from first dosing was a median (IQR) of 34 (22, 39) days. COVID-19 pandemic related scheduling delays occurred for seven participants resulting in collection of pre-dose adverse events over a 9-10 month period prior to first dosing. Of the 23 participants enrolled, two of these seven participants did not return for first dosing, thus 21 participants received the one insert dose.

Additional Information

Sharon Riddler, MD, MPH

University of Pittsburgh

Phone: 4123831741

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place