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

NCT04616963 | Active Not Recruiting Phase 4 DMC FDA Drug

• 1 other identifier: CCTG 605
• Study Type: interventional
• Target: 64
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Hiv; Hormone Therapy

Keywords

Pre-exposure Prophylaxis; PrEP; Hormone Therapy; HT

Outcome Measures

Primary Outcomes (1)

• Measuring tenofovir diphosphate (TFV-DP) concentrations

  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.

  Baseline-48 weeks

Secondary Outcomes (5)

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

  Baseline-48 weeks

• Evaluating tolerability of F/TAF in transgender individuals compared to F/TDF.

  Baseline-48 weeks

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

  Baseline-48 weeks

• Evaluating serum creatinine between F/TDF and F/TAF.

  Week 12

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

  Week 12

Study Arms (1)

FTC 200 mg / TDF 300 mg and FTC 200 mg / TAF 25 mg

OTHER

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.

Drug: Emtricitabine / Tenofovir Disoproxil Oral Tablet 200/300 mg; Drug: Emtricitabine Tenofovir Alafenamide 200/25 mg

Interventions

Emtricitabine / Tenofovir Disoproxil Oral Tablet 200/300 mg DRUG

Following Phase I lead-in, all participants will continue PrEP with fixed dose combination daily oral F/TAF substituting for F/TDF in Phase II. Participants will continue to receive PrEP in accordance with standardized comprehensive methods of prescribing, which includes risk reduction counseling, adherence counseling, and clinical assessments with safety monitoring, as well as HIV and STI screening. Participants will receive daily adherence-supporting text message reminders through 12 weeks after F/TAF initiation.

Also known as: Truvada 200Mg-300Mg Tablet

FTC 200 mg / TDF 300 mg and FTC 200 mg / TAF 25 mg

Emtricitabine Tenofovir Alafenamide 200/25 mg DRUG

Following Phase I lead-in, all participants will continue PrEP with fixed dose combination daily oral F/TAF substituting for F/TDF in Phase II. Participants will continue to receive PrEP in accordance with standardized comprehensive methods of prescribing, which includes risk reduction counseling, adherence counseling, and clinical assessments with safety monitoring, as well as HIV and STI screening. Participants will receive daily adherence-supporting text message reminders through 12 weeks after F/TAF initiation

Also known as: Descovy 200Mg-25Mg Tablet

FTC 200 mg / TDF 300 mg and FTC 200 mg / TAF 25 mg

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Transgender or non-binary, defined as identifying with a gender differently from sex assigned at birth
• Age 18 years or older
• Currently eligible to take F/TDF for PrEP and willing to switch to F/TAF
• Negative for HIV infection
• Acceptable renal function as measured by calculated creatinine clearance of at least 60 mL/min by the Cockcroft-Gault formula in the past 30 days

You may not qualify if:

• Unable to give informed consent
• Active hepatitis B defined by a positive hepatitis B surface antigen (HBsAg)
• Substantial medical condition that, in the opinion of the investigator, would preclude participation, as defined by
• gastrointestinal condition that would impair absorption of study drugs
• known condition of reduced bone density (e.g. osteoporosis or osteogenesis imperfect) that significantly elevate the risk of bone fracture
• neurological or severe psychiatric condition that would significantly impair the ability to adhere to PrEP
• tubular or glomerular kidney disease that could be exacerbated by tenofovir
• other medical condition that would unacceptably increase the risk of harm from study drug or significantly impair the ability to adhere to PrEP
• Suspected sensitivity or allergy to the study drug or any of its components
• Currently using an essential product or medication that interacts with the study drug such as the following:
• other antiretroviral agent other than F/TDF (including nucleoside analogs, non-nucleoside reverse transcriptase inhibitors, integrase inhibitors, protease inhibitors or investigational antiretroviral agents)
• agents with known nephrotoxic potential:
• aminoglycoside antibiotics (including gentamicin)
• IV amphotericin B
• cidofovir

Sponsors & Collaborators

• University of California, San Diego: lead

Study Sites (1)

UC San Diego AntiViral Research Center (AVRC)

San Diego, California, 92103, United States

Location

Related Publications (1)

• Patel N, Awdishu L, Burke LB, Vaingankar S, Chow K, Pacheco D, Silva J, Higgins N, Muttera L, Blumenthal J, Morris S. Comparison of Existing and New Race- and Sex-Free Kidney Function Equations in Transgender Adults without CKD. Clin J Am Soc Nephrol. 2025 Jul 22;20(9):1280-1282. doi: 10.2215/CJN.0000000688. No abstract available.

  PMID: 40694414 DERIVED

MeSH Terms

Conditions

Acquired Immunodeficiency Syndrome

Interventions

Emtricitabine; Tenofovir; Emtricitabine, Tenofovir Disoproxil Fumarate Drug Combination; emtricitabine tenofovir alafenamide

Condition Hierarchy (Ancestors)

HIV Infections; Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Slow Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases

Intervention Hierarchy (Ancestors)

Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Deoxyribonucleosides; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides; Organophosphonates; Organophosphorus Compounds; Organic Chemicals; Adenine; Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Drug Combinations; Pharmaceutical Preparations

Study Officials

• Sheldon Morris, MD

  UC San Diego AntiViral Research Center (AVRC)

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Professor

Model Details: Following Phase I lead-in, all participants will continue PrEP with fixed dose combination daily oral F/TAF substituting for F/TDF in Phase II. Participants will continue to receive PrEP in accordance with standardized comprehensive methods of prescribing, which includes risk reduction counseling, adherence counseling, and clinical assessments with safety monitoring, as well as HIV and STI screening. Participants will receive daily adherence-supporting text message reminders through 12 weeks after F/TAF initiation.

Study Record Dates

• First Submitted: July 13, 2020
• First Posted: November 5, 2020
• Study Start: October 24, 2019
• Primary Completion: January 31, 2024
• Study Completion: January 31, 2024
• Last Updated: May 6, 2023

Record last verified: 2023-05

Locations

US (1)