Clinical Trial

Drug Interactions in Transgendered Women

Study Description

Evaluating Drug Interactions Between Doravirine With Estradiol and Spironolactone in Healthy Transgender Women

Transgender women living with Human Immunodeficiency Virus (HIV) may prioritize gender-affirming hormonal therapy over antiretroviral drug therapy. Hormonal therapy typically consists of oral estradiol and spironolactone, which induce drug-metabolizing enzymes after prolonged administration. This study evaluates the bi-directional potential drug interaction between the antiretroviral drug, doravirine, when co-administered with estradiol and spironolactone.

Location

Locations Selected Location

Methods

Pharmaceutical medication involved Pharmaceutical medication involved
Patients and healthy individuals accepted Patients and healthy individuals accepted

Drug - Doravirine/Lamivudine/Tenofovir

100mg/300mg/300mg orally for one dose, daily

Drug - Spironolactone 100mg

200mg orally for two doses, twice-daily

Drug - Estradiol 2mg

4mg orally for two doses, twice-daily

Placebo

Placebo for one dose, daily

Additional Information

Official Study Title

A Prospective, Randomized, Three-period Crossover, Interaction Study to Evaluate the Pharmacokinetics of Doravirine and Tenofovir Disoproxil Fumarate Co-administered With Cross-sex Hormonal Therapy in Adult HIV-negative Transgender Women

Clinical Trial ID

NCT04283656

ParticipAid ID

b4x5gb