PrEP for HIV Prevention in Transgender Individuals (TAF4TRANS Trial)

Phase 4

Waitlist Available

Led By Sheldon Morris, MD

Research Sponsored by University of California, San Diego

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline-48 weeks

Awards & highlights

No Placebo-Only Group

Pivotal Trial

Drug Has Already Been Approved

Summary

This trial will study PrEP levels in trans/non-binary folks taking gender-affirming hormones. They'll get personalized text reminders and take F/TAF for 48 weeks. 60 people will be enrolled.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

Potential side effects may include digestive issues like nausea or diarrhea; headaches; fatigue; and changes in liver enzymes which could affect organ function. There might also be rare risks related to bone health or kidney function.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline-48 weeks

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline-48 weeks

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline-48 weeks for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Measuring tenofovir diphosphate (TFV-DP) concentrations

Secondary study objectives

Adherence to F/TAF in transgender individuals compared to F/TDF

Evaluating calculated creatinine clearance between F/TDF and F/TAF.

Evaluating safety of F/TAF in transgender individuals compared to F/TDF: adverse events

+2 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Drug Has Already Been Approved

The FDA has already approved this drug, and is just seeking more data.

Trial Design

1Treatment groups

Experimental Treatment

Group I: FTC 200 mg / TDF 300 mg and FTC 200 mg / TAF 25 mgExperimental Treatment2 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.

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