Trials / Completed
CompletedNCT04283656
Evaluating Drug Interactions Between Doravirine With Estradiol and Spironolactone in Healthy Transgender Women
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
- Status
- Completed
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 8 (actual)
- Sponsor
- Thomas Jefferson University · Academic / Other
- Sex
- Female
- Age
- 18 Years – 45 Years
- Healthy volunteers
- Accepted
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.
Detailed description
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
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| 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 |
| OTHER | Placebo | Placebo for one dose, daily |
Timeline
- Start date
- 2022-01-04
- Primary completion
- 2022-10-25
- Completion
- 2022-12-30
- First posted
- 2020-02-25
- Last updated
- 2025-03-26
- Results posted
- 2025-03-26
Locations
1 site across 1 country: United States
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT04283656. Inclusion in this directory is not an endorsement.