Transgender HealthPhase 1IDENTIFYNCT04283656

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

A Phase 1 study testing Doravirine/Lamivudine/Tenofovir, Spironolactone 100mg and Estradiol 2mg in people with Transgender Health and Gender Dysphoria, run by Thomas Jefferson University at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 18 to 45 years, women onlyHealthy volunteers can take part
Conditions the study is for: Transgender Health, Gender Dysphoria, Transgender Women
What is being tested?: Doravirine/Lamivudine/Tenofovir, Spironolactone 100mg and Estradiol 2mg
Type of treatment: Pill or oral medicine
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 8 participants
Where: 1 siteUnited States
Study dates: 4 Jan 2022to 30 Dec 2022
Phase: Phase 1
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 45 years
Women only
Healthy volunteers accepted
Adult

Who may be able to join

Healthy self-identified transgender women (male-to-female) between 18-45 years old at the time of screening
Have not undergone an orchiectomy
Receiving oral estradiol and spironolactone for >/= 3 months prior to study entry with a self-reported adherence to prescribed doses of >/= 90%
Agree to abstain from alcohol consumption throughout the duration of the study
Be willing to briefly interrupt hormonal therapy prior to and during the study
If on pre-exposure prophylaxis (PrEP) therapy containing tenofovir alafenamide or tenofovir disoproxil fumarate, willing to discontinue PrEP at least 2 weeks before study start and for the duration of the study
Agree to use condoms for all sexual activity prior to the start and throughout the duration of the study
Evidence of a personal signed and dated informed consent document indicating that the participant has been informed of all pertinent aspects of the study

Who cannot join

Presence of clinically significant acute or chronic disease, that in the investigator's opinion, would compromise the participant's safety during the study
Use of injectable or transdermal estradiol
Use of any other hormonal replacement therapy, wit h the exception of oral estradiol and spironolactone
Current use of any antiretroviral drug. This will not be exclusionary if participants reported discontinuing within 30 days of screening
Creatinine clearance </= 60 mL/min, as estimated by the Cockcroft-Gault equation
Known anaphylactic or severe systemic reactions to any components of doravirine, lamivudine, or tenofovir disoproxil fumarate
Positive HIV, hepatitis B or Hepatitis C virus at screening. Evidence of prior hepatitis B infection and immunity is not exclusionary. Positive hepatitis C antibody with negative viral load or documented antiviral hepatitis C treatment with one post treatment non-detectable hepatitis C viral load is not exclusionary
Recent significant blood or plasma donation

Trial locations and contacts

1 site in 1 country.

United States1 site

Clinical Research Unit at Thomas Jefferson University
Philadelphia, Pennsylvania, 19107

Other trials in United States

About this study

Official 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

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.

Read the 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: Transgender Health, Gender Dysphoria, Transgender Women, Human Immunodeficiency Virus
Being tested: Doravirine/Lamivudine/Tenofovir, Spironolactone 100mg, Estradiol 2mg, Placebo
Medical subject headings: Gender Dysphoria, Acquired Immunodeficiency Syndrome

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Doravirine/Lamivudine/TenofovirDrug
Also called Delstrigo
100mg/300mg/300mg orally for one dose, daily
Spironolactone 100mgDrug
Also called Aldactone
200mg orally for two doses, twice-daily
Estradiol 2mgDrug
4mg orally for two doses, twice-daily
PlaceboOther
Placebo for one dose, daily

Study groups in NCT04283656
Study group	Role	What they receive
Treatment A	Experimental	Single-dose oral Doravirine/lamivudine/tenofovir disoproxil Receives: Drug: Doravirine/Lamivudine/Tenofovir
Treatment B	Experimental	Single-dose estradiol and spironolactone co-administered with placebo Receives: Drug: Spironolactone 100mg; Drug: Estradiol 2mg; Other: Placebo
Treatment C	Experimental	Single-dose oral Doravirine/lamivudine/tenofovir disoproxil fumarate co-administered with estradiol and spironolactone Receives: Drug: Doravirine/Lamivudine/Tenofovir; Drug: Spironolactone 100mg; Drug: Estradiol 2mg

What is being measured

The primary outcome is the main question the study is designed to answer.

Doravirine Area Under the Plasma Concentration Versus Time Curve From 0 Hours to Infinity (AUC0-∞)
Doravirine AUC derived from plasma sampling with geometric mean ratio compared between treatment arms
Measured: Pre-dose, 0.5, 1, 2, 6, 12, 24, 48, 72, 96 hours post-dose for all participants
Doravirine Maximum Concentration (Cmax)
Doravirine maximum observed concentration during the dosing interval with geometric mean ratio compared between treatment arms
Measured: Pre-dose, 0.5, 1, 2, 6, 12, 24, 48, 72, 96 hours post-dose for all participants
Doravirine Trough Concentration (C24)
Doravirine observed trough concentration during the dosing interval with geometric mean ratio compared between treatment arms
Measured: 24 hours post-dose for all participants
Tenofovir Disoproxil Fumarate Area Under the Plasma Concentration Versus Time Curve From 0 Hours to Infinity (AUC0-∞)
Tenofovir AUC derived from plasma sampling with geometric mean ratio compared between treatment arms
Measured: Pre-dose, 0.5, 1, 2, 6, 12, 24, 48, 72, 96 hours post-dose for all participants
Tenofovir Disoproxil Fumarate Maximum Concentration (Cmax)
Tenofovir maximum observed concentration during the dosing interval
Measured: Pre-dose, 0.5, 1, 2, 6, 12, 24, 48, 72, 96 hours post-dose for all participants
Tenofovir Disoproxil Fumarate Trough Concentration (C24)
Tenofovir observed trough concentration during the dosing interval with geometric mean ratio compared between treatment arms
Measured: 24 hours post-dose for all participants
Estradiol Area Under the Plasma Concentration Versus Time Curve From 0 Hours to Infinity (AUC0-∞)
Estradiol area under the plasma concentration versus time curve from 0 hours to infinity (AUC) derived from plasma sampling
Measured: Pre-dose, 0.5, 2, 6, 12, 24, 48, 72, 96 hours post-dose for all participants
Estradiol Maximum Concentration (Cmax)
Estradiol maximum observed concentration during the dosing interval with geometric mean ratio compared between treatment arms
Measured: Pre-dose, 0.5, 2, 6, 12, 24, 48, 72, 96 hours post-dose for all participants
Estradiol Trough Concentration (C12)
Estradiol observed trough concentration during the dosing interval with geometric mean ratio compared between treatment arms
Measured: 12 hours post-dose for all participants

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

4 Jan 202230 Dec 2022

First posted25 Feb 2020
Study start4 Jan 2022
Primary completion25 Oct 2022
Study completion30 Dec 2022

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Transgender HealthStudies of the same condition, open and under way.
More trials run by Thomas Jefferson UniversityThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 1
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Crossover
Model description: Three period crossover
Masking: None (open label)
Enrolment: 8 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04283656
Sponsor's protocol ID: 15431
Acronym: IDENTIFY
Status last verified: Mar 2025
First submitted: 22 Feb 2020
Last updated: 26 Mar 2025
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: No: Pharmacokinetic data will be updated in study outcome and results.

Publications

Lam K, Kraft WK, Zhan T, Lam E. Bidirectional pharmacokinetics of doravirine, tenofovir, and feminizing hormones in transgender women (IDentify): A randomized crossover trial. Clin Transl Sci. 2024 Mar;17(3):e13721. doi: 10.1111/cts.13721.
PubMed 38421210

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 26 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

Official 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
ClinicalTrials.gov ID: NCT04283656
Acronym / sponsor ID: IDENTIFY / 15431
Conditions: Transgender Health, Gender Dysphoria, Transgender Women, Human Immunodeficiency Virus
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 8 participants (actual)
Lead sponsor: Thomas Jefferson UniversityUniversity, hospital or other
Study start: 4 Jan 2022 (actual)
Primary completion: 25 Oct 2022 (actual)
Study completion: 30 Dec 2022 (actual)
First posted: 25 Feb 2020 (actual)
Results: Posted 26 Mar 2025

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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

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

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Crossover
Masking: None (open label)
Number of arms: 3
Model description: Three period crossover

Arm	Type	Receives
Treatment A	Experimental	Drug: Doravirine/Lamivudine/TenofovirSingle-dose oral Doravirine/lamivudine/tenofovir disoproxil
Treatment B	Experimental	Drug: Spironolactone 100mg, Drug: Estradiol 2mg, Other: PlaceboSingle-dose estradiol and spironolactone co-administered with placebo
Treatment C	Experimental	Drug: Doravirine/Lamivudine/Tenofovir, Drug: Spironolactone 100mg, Drug: Estradiol 2mgSingle-dose oral Doravirine/lamivudine/tenofovir disoproxil fumarate co-administered with estradiol and spironolactone

Who may qualify

Ages: 18 to 45 years
Sex: Female only
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (8 listed)

Healthy self-identified transgender women (male-to-female) between 18-45 years old at the time of screening
Have not undergone an orchiectomy
Receiving oral estradiol and spironolactone for >/= 3 months prior to study entry with a self-reported adherence to prescribed doses of >/= 90%
Agree to abstain from alcohol consumption throughout the duration of the study
Be willing to briefly interrupt hormonal therapy prior to and during the study

Key exclusion criteria (8 listed)

Presence of clinically significant acute or chronic disease, that in the investigator's opinion, would compromise the participant's safety during the study
Use of injectable or transdermal estradiol
Use of any other hormonal replacement therapy, wit h the exception of oral estradiol and spironolactone
Current use of any antiretroviral drug. This will not be exclusionary if participants reported discontinuing within 30 days of screening
Creatinine clearance </= 60 mL/min, as estimated by the Cockcroft-Gault equation

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Doravirine/Lamivudine/TenofovirAlso: Delstrigo100mg/300mg/300mg orally for one dose, daily	Drug	Treatment A, Treatment C
Spironolactone 100mgAlso: Aldactone200mg orally for two doses, twice-daily	Drug	Treatment B, Treatment C
Estradiol 2mg4mg orally for two doses, twice-daily	Drug	Treatment B, Treatment C
PlaceboPlacebo for one dose, daily	Other	Treatment B

Primary outcome

Doravirine Area Under the Plasma Concentration Versus Time Curve From 0 Hours to Infinity (AUC0-∞)
Time frame: Pre-dose, 0.5, 1, 2, 6, 12, 24, 48, 72, 96 hours post-dose for all participants
Doravirine AUC derived from plasma sampling with geometric mean ratio compared between treatment arms
Doravirine Maximum Concentration (Cmax)
Time frame: Pre-dose, 0.5, 1, 2, 6, 12, 24, 48, 72, 96 hours post-dose for all participants
Doravirine maximum observed concentration during the dosing interval with geometric mean ratio compared between treatment arms
Doravirine Trough Concentration (C24)
Time frame: 24 hours post-dose for all participants
Doravirine observed trough concentration during the dosing interval with geometric mean ratio compared between treatment arms
Tenofovir Disoproxil Fumarate Area Under the Plasma Concentration Versus Time Curve From 0 Hours to Infinity (AUC0-∞)
Time frame: Pre-dose, 0.5, 1, 2, 6, 12, 24, 48, 72, 96 hours post-dose for all participants
Tenofovir AUC derived from plasma sampling with geometric mean ratio compared between treatment arms
Tenofovir Disoproxil Fumarate Maximum Concentration (Cmax)
Time frame: Pre-dose, 0.5, 1, 2, 6, 12, 24, 48, 72, 96 hours post-dose for all participants
Tenofovir maximum observed concentration during the dosing interval
Tenofovir Disoproxil Fumarate Trough Concentration (C24)
Time frame: 24 hours post-dose for all participants
Tenofovir observed trough concentration during the dosing interval with geometric mean ratio compared between treatment arms
Estradiol Area Under the Plasma Concentration Versus Time Curve From 0 Hours to Infinity (AUC0-∞)
Time frame: Pre-dose, 0.5, 2, 6, 12, 24, 48, 72, 96 hours post-dose for all participants
Estradiol area under the plasma concentration versus time curve from 0 hours to infinity (AUC) derived from plasma sampling
Estradiol Maximum Concentration (Cmax)
Time frame: Pre-dose, 0.5, 2, 6, 12, 24, 48, 72, 96 hours post-dose for all participants
Estradiol maximum observed concentration during the dosing interval with geometric mean ratio compared between treatment arms
Estradiol Trough Concentration (C12)
Time frame: 12 hours post-dose for all participants
Estradiol observed trough concentration during the dosing interval with geometric mean ratio compared between treatment arms

Results and safety

Results posted to the registry on 26 Mar 2025, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Sequence E	4	3
Sequence F	4	3

Primary outcome: Doravirine Area Under the Plasma Concentration Versus Time Curve From 0 Hours to Infinity (AUC0-∞)

Time frame: Pre-dose, 0.5, 1, 2, 6, 12, 24, 48, 72, 96 hours post-dose for all participants. Geometric mean (Geometric Coefficient of Variation). Unit: hr*ng/mL

Measure	Treatment C n = 6	Treatment A n = 6
Value	17798.14 (21.7)	18413.21 (41.75)

Treatment C: Geometric mean ratio: 0.97 (90% CI 0.76 to 1.24)

Population analysed: 6 participants completed the study and were included in the pharmacokinetic analysis.

Primary outcome: Doravirine Maximum Concentration (Cmax)

Time frame: Pre-dose, 0.5, 1, 2, 6, 12, 24, 48, 72, 96 hours post-dose for all participants. Geometric mean (Geometric Coefficient of Variation). Unit: ng/mL

Measure	Treatment C n = 6	Treatment A n = 6
Value	745.46 (21.43)	799.67 (26.01)

Treatment C: Geometric mean ratio: 0.93 (90% CI 0.66 to 1.32)

Population analysed: 6 participants completed the study and were included in the pharmacokinetic analysis.

Primary outcome: Doravirine Trough Concentration (C24)

Time frame: 24 hours post-dose for all participants. Geometric mean (Geometric Coefficient of Variation). Unit: ng/mL

Measure	Treatment C n = 6	Treatment A n = 6
Value	283.74 (25.42)	292.89 (49.3)

Treatment C: Geometric mean ratio: 0.97 (90% CI 0.76 to 1.24)

Population analysed: 6 participants completed the study and were included in the pharmacokinetic analysis.

Primary outcome: Tenofovir Disoproxil Fumarate Area Under the Plasma Concentration Versus Time Curve From 0 Hours to Infinity (AUC0-∞)

Time frame: Pre-dose, 0.5, 1, 2, 6, 12, 24, 48, 72, 96 hours post-dose for all participants. Geometric mean (Geometric Coefficient of Variation). Unit: hr*ng/mL

Measure	Treatment C n = 6	Treatment A n = 6
Value	2370.6 (23.42)	2031.84 (35.25)

Treatment C: Geometric mean ratio: 1.17 (90% CI 0.91 to 1.50)

Population analysed: 6 participants completed the study and were included in the pharmacokinetic analysis.

Adverse events

Time frame: 9 weeks, up to 30 days after last dose of drug administered. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Sequence E	0 of 4 (0%)	4 of 4 (100%)	0 of 4
Sequence F	0 of 4 (0%)	4 of 4 (100%)	0 of 4

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 26 Mar 2025.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Results publication: PubMed 38421210Lam K, Kraft WK, Zhan T, Lam E. Bidirectional pharmacokinetics of doravirine, tenofovir, and feminizing hormones in transgender women (IDentify): A randomized crossover trial. Clin Transl Sci. 2024 Mar;17(3):e13721. doi: 10.1111/cts.13721.
Individual participant dataSharing planned: No. Pharmacokinetic data will be updated in study outcome and results.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Walter K Kraft, MD principal investigator

Thomas Jefferson University

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 26 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 26 Mar 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Doravirine Area Under the Plasma Concentration Versus Time Curve From 0 Hours to Infinity (AUC0-∞) (time frame: Pre-dose, 0.5, 1, 2, 6, 12, 24, 48, 72, 96 hours post-dose for all participants). The study lists 9 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04283656, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Mar 2025.