Trial Outcomes & Findings for Quantification of Estradiol's Impact on Nucleotides in Cellular Populations of the Lower GI Tract (NCT NCT03917420)

NCT ID: NCT03917420

Last Updated: 2023-04-12

Results Overview

Average tenofovir diphosphate concentrations measured in mixed rectal cells collected via cytobrush during the early (low estradiol) follicular phases of the menstrual cycle reported in Fmol/million cells.

• Recruitment status: COMPLETED
• Study phase: PHASE1
• Target enrollment: 10 participants
• Primary outcome timeframe: Days 2-5
• Results posted on: 2023-04-12

Participant Flow

Participant milestones

Measure	Tenofovir/Emtricitabine Participants will take 5 once daily doses above noted combination tab at 200mg/300mg before each sampling visit Tenofovir 300Mg Oral Tablet: Once daily dose of the combo tab x 5 days pre-sampling Emtricitabine 200 MG: Once daily dose of the combo tab x 5 days pre-sampling
Overall Study STARTED	10
Overall Study COMPLETED	10
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Quantification of Estradiol's Impact on Nucleotides in Cellular Populations of the Lower GI Tract

Baseline characteristics by cohort

Measure	Tenofovir/Emtricitabine n=10 Participants Participants will take 5 once daily doses above noted combination tab at 200mg/300mg before each sampling visit Tenofovir 300Mg Oral Tablet: Once daily dose of the combo tab x 5 days pre-sampling Emtricitabine 200 MG: Once daily dose of the combo tab x 5 days pre-sampling
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	10 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants
Age, Continuous	24 years n=5 Participants
Sex: Female, Male Female	10 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	1 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	9 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	4 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	1 Participants n=5 Participants
Race (NIH/OMB) White	5 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Region of Enrollment United States	10 Participants n=5 Participants

PRIMARY outcome

Timeframe: Days 2-5

Average tenofovir diphosphate concentrations measured in mixed rectal cells collected via cytobrush during the early (low estradiol) follicular phases of the menstrual cycle reported in Fmol/million cells.

Outcome measures

Measure	Tenofovir/Emtricitabine n=10 Participants Participants will take 5 once daily doses above noted combination tab at 200mg/300mg before each sampling visit Tenofovir 300Mg Oral Tablet: Once daily dose of the combo tab x 5 days pre-sampling Emtricitabine 200 MG: Once daily dose of the combo tab x 5 days pre-sampling
Average Tenofovir Diphosphate Concentrations in Mixed Rectal Cells During the Early (Low Estradiol) Follicular Phases of the Menstrual Cycle.	406.14 fmol/million cells Standard Deviation 819.0428

PRIMARY outcome

Timeframe: Days 12-15

Average tenofovir diphosphate concentrations measured in mixed rectal cells collected via cytobrush during the late (high estradiol) follicular phases of the menstrual cycle reported in Fmol/million cells

Outcome measures

Measure	Tenofovir/Emtricitabine n=10 Participants Participants will take 5 once daily doses above noted combination tab at 200mg/300mg before each sampling visit Tenofovir 300Mg Oral Tablet: Once daily dose of the combo tab x 5 days pre-sampling Emtricitabine 200 MG: Once daily dose of the combo tab x 5 days pre-sampling
Average Tenofovir Diphosphate Concentrations Measured in Mixed Rectal Cells During the Late (High Estradiol) Follicular Phases of the Menstrual Cycle.	480.4 fmol/million cells Standard Deviation 577.9748

PRIMARY outcome

Timeframe: Days 2-5

Average emtricitabine triphosphate concentrations measured in mixed rectal cells collected via cytobrush during the early (low estradiol) follicular phases of the menstrual cycle reported in Fmol/million cells.

Outcome measures

Measure	Tenofovir/Emtricitabine n=10 Participants Participants will take 5 once daily doses above noted combination tab at 200mg/300mg before each sampling visit Tenofovir 300Mg Oral Tablet: Once daily dose of the combo tab x 5 days pre-sampling Emtricitabine 200 MG: Once daily dose of the combo tab x 5 days pre-sampling
Average Emtricitabine Triphosphate Concentrations Measured in Mixed Rectal Cells During the Early (Low Estradiol) Follicular Phases of the Menstrual Cycle.	13.005 fmol/million cells Standard Deviation 7.715

PRIMARY outcome

Timeframe: Days 12-15

Average emtricitabine triphosphate concentrations measured in mixed rectal cells collected via cytobrush during the late (high estradiol) follicular phases of the menstrual cycle reported in Fmol/million cells.

Outcome measures

Measure	Tenofovir/Emtricitabine n=10 Participants Participants will take 5 once daily doses above noted combination tab at 200mg/300mg before each sampling visit Tenofovir 300Mg Oral Tablet: Once daily dose of the combo tab x 5 days pre-sampling Emtricitabine 200 MG: Once daily dose of the combo tab x 5 days pre-sampling
Average Emtricitabine Triphosphate Concentrations Measured in Mixed Rectal Cells During the Late (High Estradiol) Follicular Phases of the Menstrual Cycle.	74.822 fmol/million cells Standard Deviation 97.280

SECONDARY outcome

Timeframe: Day 5

Average estradiol concentrations in serum reported in pg/mL

Outcome measures

Measure	Tenofovir/Emtricitabine n=10 Participants Participants will take 5 once daily doses above noted combination tab at 200mg/300mg before each sampling visit Tenofovir 300Mg Oral Tablet: Once daily dose of the combo tab x 5 days pre-sampling Emtricitabine 200 MG: Once daily dose of the combo tab x 5 days pre-sampling
Average Estradiol Concentrations in Serum.	101.06 pg/ml Standard Deviation 74.52

SECONDARY outcome

Timeframe: Day 5

Average progesterone concentrations in serum measured in ng/mL.

Outcome measures

Measure	Tenofovir/Emtricitabine n=10 Participants Participants will take 5 once daily doses above noted combination tab at 200mg/300mg before each sampling visit Tenofovir 300Mg Oral Tablet: Once daily dose of the combo tab x 5 days pre-sampling Emtricitabine 200 MG: Once daily dose of the combo tab x 5 days pre-sampling
Average Progesterone Concentrations in Serum.	2.46 ng/ml Standard Deviation 4.54

SECONDARY outcome

Timeframe: Day 5

Average testosterone concentrations in serum measured in ng/mL

Outcome measures

Measure	Tenofovir/Emtricitabine n=10 Participants Participants will take 5 once daily doses above noted combination tab at 200mg/300mg before each sampling visit Tenofovir 300Mg Oral Tablet: Once daily dose of the combo tab x 5 days pre-sampling Emtricitabine 200 MG: Once daily dose of the combo tab x 5 days pre-sampling
Average Testosterone Concentrations in Serum.	55.45 ng/ml Standard Deviation 21.58

SECONDARY outcome

Timeframe: Day 5

Average tenofovir diphosphate concentrations in peripheral blood mononuclear cells reported in Fmol/million cells.

Outcome measures

Measure	Tenofovir/Emtricitabine n=10 Participants Participants will take 5 once daily doses above noted combination tab at 200mg/300mg before each sampling visit Tenofovir 300Mg Oral Tablet: Once daily dose of the combo tab x 5 days pre-sampling Emtricitabine 200 MG: Once daily dose of the combo tab x 5 days pre-sampling
Average Tenofovir Diphosphate Concentrations in Peripheral Blood Mononuclear Cells.	96.40 Fmol/million cells Standard Deviation 45.01

SECONDARY outcome

Timeframe: Day 5

Average emtricitabine concentrations in peripheral blood mononuclear cells reported in Fmol/million cells.

Outcome measures

Measure	Tenofovir/Emtricitabine n=10 Participants Participants will take 5 once daily doses above noted combination tab at 200mg/300mg before each sampling visit Tenofovir 300Mg Oral Tablet: Once daily dose of the combo tab x 5 days pre-sampling Emtricitabine 200 MG: Once daily dose of the combo tab x 5 days pre-sampling
Average Emtricitabine Concentrations in Peripheral Blood Mononuclear Cells.	5601.95 Fmol/million cells Standard Deviation 2235.02

SECONDARY outcome

Timeframe: Day 5

Average tenofovir concentrations in plasma reported in ng/mL.

Outcome measures

Measure	Tenofovir/Emtricitabine n=10 Participants Participants will take 5 once daily doses above noted combination tab at 200mg/300mg before each sampling visit Tenofovir 300Mg Oral Tablet: Once daily dose of the combo tab x 5 days pre-sampling Emtricitabine 200 MG: Once daily dose of the combo tab x 5 days pre-sampling
Average Tenofovir Concentrations in Plasma.	61.02 ng/ml Standard Deviation 10.90

SECONDARY outcome

Timeframe: Day 5

Average emtricitabine concentrations in plasma reported in ng/mL.

Outcome measures

Measure	Tenofovir/Emtricitabine n=10 Participants Participants will take 5 once daily doses above noted combination tab at 200mg/300mg before each sampling visit Tenofovir 300Mg Oral Tablet: Once daily dose of the combo tab x 5 days pre-sampling Emtricitabine 200 MG: Once daily dose of the combo tab x 5 days pre-sampling
Average Emtricitabine Concentrations in Plasma.	78.07 ng/ml Standard Deviation 27.72

Adverse Events

Tenofovir/Emtricitabine

Serious events: 0 serious events

Other events: 4 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	Tenofovir/Emtricitabine n=10 participants at risk Participants will take 5 once daily doses above noted combination tab at 200mg/300mg before each sampling visit Tenofovir 300Mg Oral Tablet: Once daily dose of the combo tab x 5 days pre-sampling Emtricitabine 200 MG: Once daily dose of the combo tab x 5 days pre-sampling
Gastrointestinal disorders Constipation	10.0% 1/10 • Number of events 1 • Adverse events were assessed during the interval from study enrollment to follow-up visit, up to a total of 28 days.
Gastrointestinal disorders Diarrhea	20.0% 2/10 • Number of events 2 • Adverse events were assessed during the interval from study enrollment to follow-up visit, up to a total of 28 days.
Infections and infestations Viral Pharyngitis	10.0% 1/10 • Number of events 1 • Adverse events were assessed during the interval from study enrollment to follow-up visit, up to a total of 28 days.

Additional Information

Amanda Poliseno

UNC Chapel Hill

Phone: 919-962-5344

Email: amanda_poliseno@unc.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place