Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT04283656 · ClinicalTrials.gov registry record · Phase 1
Evaluating Drug Interactions Between Doravirine With Estradiol and Spironolactone in Healthy Transgender Women
A Phase 1 study of Human Immunodeficiency Virus and Gender Dysphoria, sponsored by Thomas Jefferson University.
- Completed
- Registry status
- Phase 1
- Development phase
- 8
- Enrollment target
- 1
- Study location
NCT04283656: Completed Phase 1 study of Human Immunodeficiency Virus and Gender Dysphoria, sponsored by Thomas Jefferson University.
NCT04283656 is a Phase 1 study of Human Immunodeficiency Virus and Gender Dysphoria that has completed, run by Thomas Jefferson University. The registered enrollment target is 8 participants, below the 184-participant average among 39 other Human Immunodeficiency Virus trials with a reported enrollment target (96% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04283656, a Phase 1 study of Human Immunodeficiency Virus and Gender Dysphoria, has completed, sponsored by Thomas Jefferson University.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 8 participants
- Enrollment target
- 1
- Study location
Study 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.
Primary Outcome
Doravirine AUC derived from plasma sampling with geometric mean ratio compared between treatment arms
Conditions Studied
Interventions
- OTHER Placebo
- DRUG Doravirine/Lamivudine/Tenofovir
- DRUG Spironolactone 100mg
- DRUG Estradiol 2mg
Study Locations (1)
Pennsylvania
- Clinical Research Unit at Thomas Jefferson University - Philadelphia
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 8 participants |
| Start Date | 2022-01-04 |
| Est. Completion | 2022-12-30 |
| Phase | Phase 1 |
What the finished NCT04283656 record still lists
NCT04283656 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 8 participants, a relatively small participant target, below the 184-participant average among 39 other Human Immunodeficiency Virus trials with a reported enrollment target (96% lower).
The record links to 4 conditions, with Human Immunodeficiency Virus appearing as the primary indexed condition, and to 4 interventions - of which Placebo is the first listed.
NCT04283656 reports a single indexed study location in Pennsylvania.
Frequently Asked Questions
What is clinical trial NCT04283656 about?
NCT04283656 is a clinical study titled "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 st...
What is the current status of trial NCT04283656?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 8 participants. The study started on 2022-01-04. Estimated completion is 2022-12-30.
What conditions does trial NCT04283656 study?
This clinical trial studies the following conditions: Human Immunodeficiency Virus, Gender Dysphoria, Transgender Women, Transgender Health.
What interventions are being tested in trial NCT04283656?
The interventions under investigation include: Placebo (OTHER), Doravirine/Lamivudine/Tenofovir (DRUG), Spironolactone 100mg (DRUG), Estradiol 2mg (DRUG).
Who is sponsoring clinical trial NCT04283656?
This trial is sponsored by Thomas Jefferson University, which has 292 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04283656 being conducted?
This trial has 1 study location across Pennsylvania. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Human Immunodeficiency Virus
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT04283656's enrollment target sits among peer trials
8 40th of 39 the lowest of 39 other Human Immunodeficiency Virus trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Human Immunodeficiency Virus trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
-
Lenacapavir Intensification to Disrupt HIV Reservoirs in Virologically Suppressed People With HIV Receiving Antiretroviral Therapy
RECRUITING · Phase 1
-
3BNC117-LS and 10-1074-LS Plus N-803 (bNAb+N-803)
ACTIVE NOT RECRUITING · Phase 1
-
First-in-human Study of 10-1074-LS Alone and in Combination With 3BNC117-LS
COMPLETED · Phase 1
-
Pharmacokinetic Interactions Between an Herbal Medicine (African Potato) and Antiretroviral Agents (Lopinavir/Ritonavir)
COMPLETED · Phase 1
-
Evaluation of the Safety of a Polyvalent Virus in Healthy Adults
COMPLETED · Phase 1
-
First in Human Study of TLC-ART 101 (ACTU 2001)
COMPLETED · Phase 1
Nationwide trials with similar profiles
Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.
Similar registry start date
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia
- NCT07125183 · started 2026-12 · Phase 2
Study on Efficacy and Tolerability of Weekly Doxorubicin in Elderly Patients With Advanced or Metastatic Leiomyosarcoma
- NCT07292298 · started 2026-11 · Phase 2
Phase 2 Single-Arm Rectal Cancer Brachytherapy for Patients With Low-Lying Residual Adenocarcinoma After Total Neoadjuvant Therapy to Improve Organ Preservation Rates
- NCT04263285 · started 2026-10 · NA
Treatment of Depression Post-SCI