PrEP for HIV Prevention in Transgender Individuals

(TAF4TRANS Trial)

Recruiting in Palo Alto (17 mi)

Overseen by Sheldon Morris, MD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 4

Waitlist Available

Sponsor: University of California, San Diego

No Placebo Group

Prior Safety Data

Trial Summary

What is the purpose of this trial?

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.

Eligibility Criteria

This trial is for transgender or non-binary adults over 18 who are HIV-negative, currently taking F/TDF for PrEP, and have good kidney function. They must be willing to switch to F/TAF for PrEP. People with active hepatitis B, gastrointestinal issues affecting drug absorption, severe bone density conditions, major psychiatric disorders, certain kidney diseases, suspected drug allergies or those on conflicting medications cannot participate.

Inclusion Criteria

Age 18 years or older

Transgender or non-binary, defined as identifying with a gender differently from sex assigned at birth

Currently eligible to take F/TDF for PrEP and willing to switch to F/TAF

Exclusion Criteria

Unable to give informed consent

Active hepatitis B defined by a positive hepatitis B surface antigen (HBsAg)

Gastrointestinal condition that would impair absorption of study drugs

Treatment Details

Interventions

• Emtricitabine (Antiretroviral)
• Tenofovir Alafenamide (Antiretroviral)

Trial Overview The study tests the effectiveness of a daily oral dose of Emtricitabine Tenofovir Alafenamide (F/TAF) as an alternative to Emtricitabine / Tenofovir Disoproxil (F/TDF) in preventing HIV. It also examines how gender-affirming hormone therapy affects PrEP levels. Participants will receive adherence support via personalized text messages for 48 weeks.

Participant Groups

Group I: FTC 200 mg / TDF 300 mg and FTC 200 mg / TAF 25 mg Experimental Treatment 2 Interventions

Phase I: Participants will continue or initiate F/TDF for PrEP for a minimum 12-week lead-in period prior to switching to F/TAF. Phase II: Participants will be switched to study-provided F/TAF for PrEP until 48 weeks after initiation. Participants will receive study treatment for the duration of the study unless they meet criteria for discontinuation.

Emtricitabine is already approved in European Union, United States, Canada, Japan for the following indications:

🇪🇺 Approved in European Union as Emtriva for:

• HIV-1 infections

🇺🇸 Approved in United States as Emtriva for:

• HIV-1 infections
• Pre-exposure prophylaxis of HIV-1

🇨🇦 Approved in Canada as Emtriva for:

• HIV-1 infections

🇯🇵 Approved in Japan as Emtriva for:

• HIV-1 infections

Find a Clinic Near You

Research Locations Nearby Select from list below to view details:

UC San Diego AntiViral Research Center (AVRC) San Diego, CA

Who Is Running the Clinical Trial?

University of California, San Diego Lead Sponsor

References