A Pharmacokinetic Evaluation of Tenofovir/Emtricitabine as HIV Pre-Exposure Prophylaxis in Transgender Women

NCT03270969 | Completed Phase 1 FDA Drug

• 1 other identifier: 0491-17-FB
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

Brief Summary

Human immunodeficiency virus (HIV) persists worldwide as an immense health burden among vulnerable populations. HIV pre-exposure prophylaxis (PrEP) has offered the promise of limiting the global burden of HIV. The objective of this proposal is to conduct a pharmacokinetic (PK) study in transgender women to describe the pharmacokinetics of tenofovir disoproxil fumarate/emtricitabine (TDF/FTC) as PrEP within this population.

Conditions

HIV Prevention

Outcome Measures

Primary Outcomes (1)

• TFV plasma exposure

  Intensive PK sampling compared to historical controls

  14 days

Secondary Outcomes (7)

• FTC plasma exposure

  14 days

• Tenofovir-diphosphate (TFV-DP) intracellular concentrations

  14 days

• Emtricitabine-triphosphate (FTC-TP) intracellular concentrations

  14 days

• TFV maximum plasma concentration (Cmax)

  14 days

• FTC maximum plasma concentration (Cmax)

  14 days

Study Arms (1)

TDF/FTC

EXPERIMENTAL

Tenofovir Disoproxil Fumarate/Emtricitabine group HIV-uninfected transgender women receiving feminizing hormone therapy plus tenofovir disoproxil fumarate/emtricitabine

Drug: Tenofovir Disoproxil Fumarate/Emtricitabine

Interventions

Tenofovir Disoproxil Fumarate/Emtricitabine DRUG

Participants will receive daily TDF/FTC for 14 days

Also known as: Descovy and Truvada

TDF/FTC

Eligibility Criteria

• Age: 19 Years+
• Gender Eligibility Details: transgender women
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Evidence of a personally signed and dated informed consent document indicating that the participant has been informed of all pertinent aspects of the study.
• Participants who are willing and able to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures.
• Self identify as a transgender woman.
• Receiving estradiol (oral/sublingual tablets or transdermal patches) with oral spironolactone for at least 3 months prior to study entry.
• Serum estradiol level \>100 pg/mL.
• Non-reactive 4th or 5th generation screening test for HIV.
• Adults (19 years or older).
• Able to read and speak English to ensure appropriate ability to obtain informed consent.

You may not qualify if:

• Participants will not be included in the study if one, or more, of the following criteria are met:
• Use of drugs known to be contraindicated with TDF, FTC, estradiol, or spironolactone within 30 days of study entry. The study team will review all concomitant medications at screening based on the US Department of Health and Human Services drug interaction table and the drug product labeling.
• Use of injectable estradiol (valerate or cypionate).
• Presence of any active condition or clinically significant disease that, in the investigator's opinion, would compromise the subject's safety or outcome of the study, including qualifying for non-occupational post-HIV exposure prophylaxis.
• Signs or symptoms of acute HIV infection within the last 30 days.
• Laboratory values obtained within 30 days prior to study entry:
• Creatinine clearance (CrCl) less than 60 mL/min as estimated by the Cockcroft-Gault equation.
• Positive hepatitis B surface antigen and/or hepatitis C antibody.
• Alanine transaminase (ALT), Aspartate transaminase (AST) or alkaline phosphatase \> 5x the upper limit of normal (ULN).
• Hemoglobin \<10 g/dL.
• Platelets \<50,000/mm3.

Sponsors & Collaborators

• University of Nebraska: lead

Study Sites (1)

University of Nebraska Medical Center

Omaha, Nebraska, 68198, United States

Location

Related Publications (1)

• Cirrincione LR, Podany AT, Havens JP, Bares SH, Dyavar SR, Gwon Y, Johnson TM, Amoura NJ, Fletcher CV, Scarsi KK. Plasma and intracellular pharmacokinetics of tenofovir disoproxil fumarate and emtricitabine in transgender women receiving feminizing hormone therapy. J Antimicrob Chemother. 2020 May 1;75(5):1242-1249. doi: 10.1093/jac/dkaa016.

  PMID: 32065631 DERIVED

MeSH Terms

Interventions

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

Intervention Hierarchy (Ancestors)

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

Study Officials

• Kimberly Scarsi, PharmD, MS

  University of Nebraska

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 23, 2017
• First Posted: September 1, 2017
• Study Start: January 5, 2018
• Primary Completion: September 10, 2018
• Study Completion: September 10, 2018
• Last Updated: September 15, 2023

Record last verified: 2023-09

Locations

US (1)