Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Thomas Jefferson University
This study will consist of healthy transgender women volunteers randomized to a 1:1 sequence ("E" or "F") There are three periods and in each period there are one of three treatments
Treatment A: Single-dose oral Doravirine/lamivudine/tenofovir disoproxil fumarate alone Treatment B: Single-dose estradiol and spironolactone co-administered with placebo Treatment C: Single-dose oral Doravirine/lamivudine/tenofovir disoproxil fumarate co-administered with estradiol and spironolactone
The primary outcome measures are the drug concentrations
The primary comparisons are geometric mean ratios of drugs with potential perpetrators of drug interactions using a crossover method
Age
18–45
Sex
FEMALE
Healthy volunteers
Accepted
You may be eligible if
Healthy self-identified transgender women (male-to-female) between 18-45 years old at the time of screening
Have not undergone an orchiectomy
Receiving oral estradiol and spironolactone for \>/= 3 months prior to study entry with a self-reported adherence to prescribed doses of \>/= 90%
Agree to abstain from alcohol consumption throughout the duration of the study
Be willing to briefly interrupt hormonal therapy prior to and during the study
If on pre-exposure prophylaxis (PrEP) therapy containing tenofovir alafenamide or tenofovir disoproxil fumarate, willing to discontinue PrEP at least 2 weeks before study start and for the duration of the study
Agree to use condoms for all sexual activity prior to the start and throughout the duration of the study
Evidence of a personal signed and dated informed consent document indicating that the participant has been informed of all pertinent aspects of the study
You may not be if
Presence of clinically significant acute or chronic disease, that in the investigator's opinion, would compromise the participant's safety during the study
Use of injectable or transdermal estradiol
Use of any other hormonal replacement therapy, wit h the exception of oral estradiol and spironolactone
Current use of any antiretroviral drug. This will not be exclusionary if participants reported discontinuing within 30 days of screening
Creatinine clearance \</= 60 mL/min, as estimated by the Cockcroft-Gault equation
Known anaphylactic or severe systemic reactions to any components of doravirine, lamivudine, or tenofovir disoproxil fumarate
Positive HIV, hepatitis B or Hepatitis C virus at screening. Evidence of prior hepatitis B infection and immunity is not exclusionary. Positive hepatitis C antibody with negative viral load or documented antiviral hepatitis C treatment with one post treatment non-detectable hepatitis C viral load is not exclusionary
