Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT04616963 · ClinicalTrials.gov registry record · Phase 4
Emtricitabine/Tenofovir Alafenamide Switch Study for Transgender Individuals for HIV Pre-exposure Prophylaxis
A Phase 4 study of HIV and Hormone Therapy, sponsored by University of California, San Diego.
- Active
- Registry status
- Phase 4
- Development phase
- 64
- Enrollment target
- 1
- Study location
NCT04616963: Active Phase 4 study of HIV and Hormone Therapy, sponsored by University of California, San Diego.
NCT04616963 is a Phase 4 study of HIV and Hormone Therapy that is active but no longer recruiting, run by University of California, San Diego. The registered enrollment target is 64 participants, below the 440-participant average among 303 other HIV trials with a reported enrollment target (85% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04616963, a Phase 4 study of HIV and Hormone Therapy, is active but no longer recruiting, sponsored by University of California, San Diego.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 4
- Development phase
- 64 participants
- Enrollment target
- 1
- Study location
Study Summary
The purpose of this study is to evaluate Pre-Exposure Prophylaxis (PrEP) levels in transgender-identifying or gender non-binary individuals taking versus not taking gender affirming hormone therapy. Subjects who have previously taken F/TDF as PrEP will continue with a fixed dose combination of daily oral F/TAF substituting for F/TDF. Subjects will receive the iTAB text messaging adherence reminders to provide personalized, automated text messages to support and monitor adherence that will vary by participant choice until 12 weeks after switching medication. This study will enroll 60 individuals to take F/TAF as PrEP for 48 weeks.
Primary Outcome
Analysis will be performed on the primary outcome of TFV-DP levels by HT status. Comparison of those on and off HT will be done be t-test. Additional sub-analysis of the primary will stratify by HT type and using both concentrations of TFV-DP and estradiol levels test for correlation. Also cut offs for adherence consistent with 4 doses a week and 7 doses a week will be compared between strata.
Conditions Studied
Interventions
- DRUG Emtricitabine / Tenofovir Disoproxil Oral Tablet 200/300 mg
- DRUG Emtricitabine Tenofovir Alafenamide 200/25 mg
Study Locations (1)
California
- UC San Diego AntiViral Research Center (AVRC) - San Diego
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 64 participants |
| Start Date | 2019-10-24 |
| Est. Completion | 2024-01-31 |
| Phase | Phase 4 |
What the registry record for NCT04616963 still lists
NCT04616963 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 64 participants, a relatively small participant target, below the 440-participant average among 303 other HIV trials with a reported enrollment target (85% lower).
The record links to 2 conditions, with HIV appearing as the primary indexed condition, and to 2 interventions - of which Emtricitabine / Tenofovir Disoproxil Oral Tablet 200/300 mg is the first listed.
NCT04616963 reports a single indexed study location in California.
Frequently Asked Questions
What is clinical trial NCT04616963 about?
NCT04616963 is a clinical study titled "Emtricitabine/Tenofovir Alafenamide Switch Study for Transgender Individuals for HIV Pre-exposure Prophylaxis". The purpose of this study is to evaluate Pre-Exposure Prophylaxis (PrEP) levels in transgender-identifying or gender non-binary individuals taking versus not taking gender affirming hormone therapy. Subjects who have previously taken F/TDF as PrEP will continue with a fixed dose combination of daily...
What is the current status of trial NCT04616963?
This trial is currently active not recruiting. It is a Phase 4 study. The enrollment target is 64 participants. The study started on 2019-10-24. Estimated completion is 2024-01-31.
What conditions does trial NCT04616963 study?
This clinical trial studies the following conditions: HIV, Hormone Therapy.
What interventions are being tested in trial NCT04616963?
The interventions under investigation include: Emtricitabine / Tenofovir Disoproxil Oral Tablet 200/300 mg (DRUG), Emtricitabine Tenofovir Alafenamide 200/25 mg (DRUG).
Who is sponsoring clinical trial NCT04616963?
This trial is sponsored by University of California, San Diego, which has 775 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04616963 being conducted?
This trial has 1 study location across California. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for HIV
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 NCT04616963's enrollment target sits among peer trials
64 196th of 303 higher than 108 of 303 other HIV trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other HIV 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
-
Assessment of Metformin for Restoration of Immune Homeostasis in HIV+ and HIV- Individuals With a History of Injection Drug Use
RECRUITING · Phase 4
-
Integrated e-Health (Electronic Health) for HIV and Substance Use Disorders in Justice Involved Women
RECRUITING · Phase 4
-
Long-acting Cabotegravir Injectable Pre-exposure Prophylaxis for People Who Inject Drugs
RECRUITING · Phase 4
-
Implementation and Deliver of Lenacapavir for PrEP in a Community Pharmacy Setting
RECRUITING · Phase 4
-
Optimizing Evidence-based HIV Prevention Targeting People Who Inject Drugs on PrEP
RECRUITING · Phase 4
-
Immediate Initiation of Antiretroviral Therapy During "Hyperacute" HIV Infection
ACTIVE NOT RECRUITING · Phase 4
Nationwide trials with similar profiles
Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.
Similar enrollment target
- NCT01853631 · 64 participants · Phase 1
Activated T-Cells Expressing 2nd or 3rd Generation CD19-Specific CAR, Advanced B-Cell NHL, ALL, and CLL (SAGAN)
- NCT03739502 · 64 participants · Phase 2
A Randomized Phase II Study of Hyperbaric Oxygen in Improving Engraftment in Umbilical Cord Blood Stem Cell Transplant
- NCT03739814 · 64 participants · Phase 2
Inotuzumab Ozogamicin and Blinatumomab With or Without Ponatinib in Treating Patients With Newly Diagnosed, Recurrent, or Refractory CD22-Positive B-Lineage Acute Lymphoblastic Leukemia
- NCT03866408 · 64 participants · Early Phase 1
Insulin Regulation of Lipolysis and Lipolysis Proteins
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