Who is sponsoring NCT04616963?

NCT04616963 is sponsored by University of California, San Diego.

What drugs are being tested in NCT04616963?

Interventions in NCT04616963: Emtricitabine / Tenofovir Disoproxil Oral Tablet 200/300 mg, Emtricitabine Tenofovir Alafenamide 200/25 mg.

What condition does NCT04616963 study?

NCT04616963 studies Hiv, Hormone Therapy.

Is NCT04616963 still recruiting?

NCT04616963 is currently active, enrolled. Last updated 6 May 2023.

Last reviewed 2023-05-06 · How we verify

NCT04616963: TAF4TRANS

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

Emtricitabine/Tenofovir Alafenamide Switch Study for Transgender Individuals for HIV Pre-exposure Prophylaxis

Active, enrolled Phase 4 Last updated 6 May 2023

What this trial tests

Phase 4 trial testing Emtricitabine / Tenofovir Disoproxil Oral Tablet 200/300 mg in Hiv in 64 participants. Participants enrolled and being followed up; not accepting new ones.

Timeline

24 October 2019

Primary endpoint
31 January 2024

31 January 2024

Quick facts

Lead sponsor	University of California, San Diego
Phase	Phase 4
Status	Active, enrolled
Study type	INTERVENTIONAL
Allocation	na
Design	sequential
Masking	none
Primary purpose	prevention
Enrollment	64
Start date	24 October 2019
Primary completion	31 January 2024
Estimated completion	31 January 2024
Sites	1 location across United States

Drugs / interventions tested

Emtricitabine / Tenofovir Disoproxil Oral Tablet 200/300 mg — full drug profile →
Emtricitabine Tenofovir Alafenamide 200/25 mg — full drug profile →

Conditions studied

Hiv — all drugs for Hiv →
Hormone Therapy — all drugs for Hormone Therapy →

Sponsor

University of California, San Diego

Who can join

18 and older, any sex, with Hiv or Hormone Therapy. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

Approved HIV reverse transcriptase inhibitors in the past decade.
Li G, Wang Y, De Clercq E. · · 2022 · cited 71× · PMID 35847492 · DOI 10.1016/j.apsb.2021.11.009

Verify or expand the search:

Other recruiting trials for Hiv

Currently open trials in the same condition.

NCT06001814 — Mindfulness and Behavior Change to Improve Cardiovascular Health of Older People With HIV · NA · recruiting
NCT06999928 — Enhanced Mentor Mother Strategy for Pregnant and Postpartum Women Living With HIV · NA · recruiting
NCT06006143 — Off-Label Medications for Alcohol Use Disorder Among Patients With HIV: Pilot Study 2 · Phase 2 · active not recruiting
NCT07076043 — Multi-product PrEP Delivery to Young Women Seeking Reproductive Health Services and Coverage of HIV Prevention · Phase 4 · recruiting
NCT06389565 — Change My Story Task Shifted Mental Health Intervention · NA · recruiting

Other University of California, San Diego trials

Trials by the same sponsor.

NCT07342543 — Guided Physical Activity Counseling for Hypertension in Primary Care · NA · not yet recruiting
NCT06505317 — Artificial Intelligence for Early Detection of Peripheral Artery Disease · NA · not yet recruiting
NCT07211802 — CKM For Safe Use of SGLT2i in Type 1 Diabetes · Phase 3 · not yet recruiting
NCT07524751 — Culturally Adapted Pain Management for Indigenous Peoples · NA · not yet recruiting
NCT07518784 — Accurate Point of Care Liver Disease Diagnostics (Phase 2) · recruiting

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT04616963 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by University of California, San Diego
Last refreshed: 6 May 2023

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04616963.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing