Quantification of Estradiol's Impact on Nucleotides in Cellular Populations of the Lower GI Tract
Status:
Completed
Trial end date:
2019-09-04
Target enrollment:
Participant gender:
Summary
Purpose: To Assess the impact of high and low in vivo estradiol exposure on PrEP
(Pre-exposure prophylaxis) nucleotide concentrations in different cellular populations of the
lower GI (gastrointestinal) tract and to quantify the relationship between estradiol,
progesterone, and testosterone on PrEP nucleotide concentrations in rectal and peripheral
blood mononuclear cells. As well as the relationship between estradiol, progesterone, and
testosterone on PrEP concentrations in plasma.
Participants: Healthy, cisgender female, volunteers, aged 18-49 inclusive on the date of
screening with an intact gastrointestinal system and regular menstrual cycle.
Procedures (methods): Participants will take a single daily dose of study drug for five days
before each sampling visit. The visits will be scheduled during the early follicular phase of
the menstrual cycle (approximately days 2-5 after the first day of menses, Visit 1) when
estradiol is predicted to be the lowest and the late follicular phase (approximately days
12-15 after the first day of menses, Visit 2) when estradiol is predicted to be highest.
Samples of blood, rectal cells, and rectal tissue will be collected at both Visits 1 and 2.
All participants will complete a follow-up safety visit within 14 days of completing study
sampling.
Phase:
Phase 1
Details
Lead Sponsor:
University of North Carolina, Chapel Hill
Collaborator:
National Institute of Allergy and Infectious Diseases (NIAID)
Treatments:
Emtricitabine Emtricitabine, Tenofovir Disoproxil Fumarate Drug Combination Estradiol Tenofovir