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Antiretroviral
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
TAF4TRANS Trial 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.Check my eligibility
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.See study design
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.
TAF4TRANS Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ baseline-48 weeks
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline-48 weeks
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Measuring tenofovir diphosphate (TFV-DP) concentrations
Secondary outcome measures
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 moreTAF4TRANS 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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Logistics
Accomodation is reimbursed
Your expenses for accomodation during the trial will be reimbursed.
Who is running the clinical trial?
University of California, San DiegoLead Sponsor
1,120 Previous Clinical Trials
1,521,343 Total Patients Enrolled
1 Trials studying Hormone Replacement Therapy
42 Patients Enrolled for Hormone Replacement Therapy
Sheldon Morris, MDPrincipal Investigator - UC San Diego AntiViral Research Center (AVRC)
Regents of the University of California - UCSD Medical Group, UCSD Medical Center-Hillcrest
University Of British Columbia (Medical School)
University Ca Sf School Of Medicine (Residency)
4 Previous Clinical Trials
267 Total Patients Enrolled
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Eligibility Criteria:
This trial includes the following eligibility criteria:Research Study Groups:
This trial has the following groups:- Group 1: FTC 200 mg / TDF 300 mg and FTC 200 mg / TAF 25 mg
Awards:
This trial has 3 awards, including:- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- Drug Has Already Been Approved - The FDA has already approved this drug, and is just seeking more data.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
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