Clinical study
PD
STIS, SEXUALLY TRANSMITTED INFECTIONS
CONRAD 146 was a Phase I, open-label, randomized, parallel-group study conducted at the CONRAD Intramural Clinical Research Center at Eastern Virginia Medical School (EVMS) (Norfolk, VA). The study was approved by the Advarra (central, independent) Institutional Review Board (Pro00030334) under a waiver of oversight from EVMS and registered with ClinicalTrials.gov (#NCT03762772). All participants signed written informed consent prior to any study procedures. We screened healthy women, 18 – 50 years old, who were HIV-1 uninfected, at low risk of sexually transmitted infections (STIs) and were protected from pregnancy during the study (by abstinence from sexual activity or consistent use of hormonal contraception (except depot medroxyprogesterone acetate (DMPA), due to its potential impact on study PK and PD endpoints (The study visits are summarized in 