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NCT04050371 · ClinicalTrials.gov registry record · Phase 4
Study of Truvada for HIV Pre Exposure Prophylaxis Using Daily Directly Observed Therapy to Look at Potential Interactions Between Truvada and Hormone Therapy
A Phase 4 study, sponsored by University of California, San Francisco.
- Completed
- Registry status
- Phase 4
- Development phase
- 48
- Enrollment target
NCT04050371: Completed Phase 4 study, sponsored by University of California, San Francisco.
NCT04050371 is a Phase 4 study that has completed, run by University of California, San Francisco. The registered enrollment target is 48 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (91% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04050371, a Phase 4 study, has completed, sponsored by University of California, San Francisco.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 48 participants
- Enrollment target
Study Summary
Truvada (Emtricitabine or FTC and tenofovir disoproxil fumarate or TDF) has been approved for HIV prevention since 2012. Drug concentrations after receipt of oral Truvada for HIV Pre Exposure Prophylaxis (or PrEP) appeared to be lower in transgender women compared to Men who Have Sex with Men (MSM) in the iPrEx study, the landmark study of PrEP for HIV prevention. Concentrations were especially low among transgender women (TGW) reporting use of feminizing hormones. Reasons for the lower drug concentrations may be behavioral or biomedical, or a combination of both. While there are no systemic drug-drug interactions between TDF and oral contraception, there are known interactions involving these classes of medications with drug transporters that could affect drug concentrations in target tissues. Drug-drug interactions with natural estrogens and anti-androgenic agents used for gender affirming hormone therapy among transgender women have not been studied, neither have interactions between emtricitabine and female hormones. Concerns about the impact of PrEP on gender affirming hormone therapy is the main barrier for uptake of PrEP among transgender women. In addition, very little is known about TDF/FTC pharmacokinetics in transgender men using testosterone hormonal therapy. Drug-drug interactions with masculinizing hormones have never been properly investigated as trans gender men have not been formally involved in PrEP clinical trials or demonstrations projects.This small study will assess pharmacokinetic drug-drug interactions between tenofovir disoproxil fumarate/emtricitabine and cross-sex hormone therapy. The I-BrEATHe study is a substudy of the Triumph study, a culturally-relevant community-led PrEP demonstration project in transgender communities. The I- BrEATHe pharmacokinetic substudy will provide Truvada daily using directly observed therapy in 24 transgender women and 24 transgender men over a one month period, and will measure drug and hormone therapy level
Primary Outcome
Tenofovir diphosphate concentration in dried blood spots at week 4
Interventions
- DRUG 200 mg emtricitabine and 300 mg tenofovir disoproxil fumarate
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 48 participants |
| Start Date | 2017-08-03 |
| Est. Completion | 2018-05-23 |
| Phase | Phase 4 |
What the finished NCT04050371 record still lists
NCT04050371 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 48 participants, a relatively small participant target, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (91% lower).
The record links to 0 conditions, and to 1 intervention - of which 200 mg emtricitabine and 300 mg tenofovir disoproxil fumarate is the first listed.
NCT04050371 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04050371 about?
NCT04050371 is a clinical study titled "Study of Truvada for HIV Pre Exposure Prophylaxis Using Daily Directly Observed Therapy to Look at Potential Interactions Between Truvada and Hormone Therapy". Truvada (Emtricitabine or FTC and tenofovir disoproxil fumarate or TDF) has been approved for HIV prevention since 2012. Drug concentrations after receipt of oral Truvada for HIV Pre Exposure Prophylaxis (or PrEP) appeared to be lower in transgender women compared to Men who Have Sex with Men (MSM) ...
What is the current status of trial NCT04050371?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 48 participants. The study started on 2017-08-03. Estimated completion is 2018-05-23.
What interventions are being tested in trial NCT04050371?
The interventions under investigation include: 200 mg emtricitabine and 300 mg tenofovir disoproxil fumarate (DRUG).
Who is sponsoring clinical trial NCT04050371?
This trial is sponsored by University of California, San Francisco, which has 1,713 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04050371's enrollment target sits among peer trials
48 1331st of 2000 higher than 653 of 2,000 other Phase 4 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 4 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
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