Giving Standardized Estradiol Therapy In Transgender Women to Research Interactions with HIV Therapy: the GET IT RIgHT Study (A5403)

The study is a phase IIb, 48-week, open-label, non-randomized, three-group trial of adult transgender women (TW) and other individuals identifying as
female or transfeminine but with male sex assigned at birth (henceforth referred to in aggregate as TW) living with human immunodeficiency virus-1 (HIV-1).
The primary objectives of the study are to 1)
assess whether TW continue to achieve therapeutic concentrations of ART while receiving FHT for 48 weeks, and 2) assess whether serum estradiol concentrations on FHT (across a range of estradiol doses) vary between boosted and unboosted ART regimens.