CI

At a glance

ClinicalIndex Comparison Record
Phase 1Completed· 8 enrolled
Drug / intervention
Doravirine/Lamivudine/Tenofovir +3 moredrug
Likely dose
Spironolactone 100mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT04283656
NCT04283656Phase 1Completed
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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

Thomas Jefferson University·interventional·Posted Feb 25, 2020·Updated Mar 26, 2025

In Brief

A Phase 1 clinical trial evaluating Doravirine/Lamivudine/Tenofovir, Spironolactone 100mg, and 2 other interventions for Transgender Health and 3 related conditions. Completed, enrolled 8 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsTransgender Health, Gender Dysphoria, Transgender Women, Human Immunodeficiency Virus
CountriesUnited States
Collaborators--

Timeline

Phase 1CompletedFinished
2020202120222023202420252026
First PostedFeb 25, 2020
Enrollment StartJan 4, 2022
Primary CompletionOct 25, 2022
Study CompletionDec 30, 2022
TodayJul 2, 2026
Enrollment to primary: 10 monthsPosted 6.4 years ago

Interventions

Doravirine/Lamivudine/Tenofovirdrug

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

Spironolactone 100mgdrug

200mg orally for two doses, twice-daily

Estradiol 2mgdrug

4mg orally for two doses, twice-daily

Placeboother

Placebo for one dose, daily