IRB 16-2122: Does Sex Hormone Therapy decrease Nucleos(t)ide Reverse Transcriptase Inhibitors (NRTI) Active Metabolite Formation in Mucosal Tissues?
|Q:||To determine whether sex hormone therapy alters TDF/FTC intracellular pharmacology in the genital and lower gastrointestinal tracts by decreasing concentrations of active metabolites|
|POP:||There will be 20 HIV-infected participants receiving TDF/FTC divided evenly over 5 cohorts including: Post-menopausal women both on and off of hormonal therapy for menopause, Males both and off hormonal therapy for hypoganadism, and transgendered females taking cross-sex hormone therapy|
|MED:||On a background regimen containing TDF/FTC (All Cohorts)|
|DUR:||Between 1-2 months (Screening visit, Sampling visit, and Follow-up)|
|CALL:||Heather Prince, PA-C 919-962-5344|