drugset / Trial / NCT04283656
Evaluating Drug Interactions Between Doravirine With Estradiol and Spironolactone in Healthy Transgender Women
RandomizedCrossoverOpen-labelTreatment
Summary
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.
Timeline
- Start
- 2022-01-04
- Primary completion
- 2022-10-25
- Completion
- 2022-12-30
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Doravirine | Small molecule | 100 mg | Oral |
| Subject | Estradiol | Other / unclassified | 2 mg | Oral |
| Subject | Spironolactone | Small molecule | 100 mg | Oral |
| Subject | Tenofovir | Small molecule | 300 mg | Oral |
| Background | Lamivudine | Other / unclassified | 300 mg | Oral |